450 FR Journal officiel de l'Union européenne 23.9.2003

Appendice A

visé au Chapitre 1, point 2, de l'annexe XI (*)

Liste, fournie en une seule langue par Malte, des médicaments pour lesquels l'autorisation de mise sur le marché délivrée en vertu du droit maltais avant la date d'adhésion demeurera valable jusqu'à ce qu'elle soit renouvelée conformément à l'acquis ou jusqu'au 31 décembre 2006, si cette dernière date est plus proche.

L'inscription d'un médicament sur cette liste ne signifie pas forcément que l'autorisation de mise sur le marché obtenue est conforme à l'acquis.

LISTE DES MÉDICAMENTS À INCLURE DANS L'ARRANGEMENT NÉGOCIÉ DANS LE CADRE DU CHAPITRE I

Trade Name Dosage Form Dose MA Holder Country

0.45% SODIUM CHLORIDE IN 5% INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY GLUCOSE AG

0.45% SODIUM CHLORIDE SOLUTION FOR 0.45% ABBOTT LABORATORIES UNITED STATES OF INJECTION USP INJECTION AMERICA

0.45% SODIUM CHLORIDE SOLUTION FOR IV 4.5MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION, USP INJECTION AMERICA

0.9% SOD. CHLORIDE AND 5% SOLUTION FOR N/A BAXTER HEALTHCARE UNITED KINGDOM GLUCOSE INJECTION LIMITED

0.9% SODIUM CHLORIDE AND 5% INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY GLUCOSE IV INF AG

0.9% SODIUM CHLORIDE SOLUTION FOR INJ 9MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

0.9% SODIUM CHLORIDE SOLUTION FOR 0.9% ABBOTT LABORATORIES UNITED STATES OF INJECTION USP INJECTION AMERICA

0.9% SODIUM CHLORIDE SOLUTION FOR 0.9% ABBOTT LABORATORIES UNITED STATES OF INJECTION USP INJECTION AMERICA

0.9% SODIUM CHLORIDE SOLUTION FOR 9MG/ML ABBOTT LABORATORIES UNITED STATES OF IRRIGATION IRRIGATION AMERICA

0.9% SODIUM CHLORIDE SOLUTION FOR 0.9% ABBOTT LABORATORIES UNITED STATES OF IRRIGATION USP IRRIGATION AMERICA

0.9% W/V SODIUM CHLORIDE SOLUTION FOR 0.9% W/V B.BRAUN MELSUNGEN GERMANY INJECTION BP INJECTION AG

0.9% W/V SODIUM CHLORIDE IRRIGATION SOLUTION 0.9% W/V B.BRAUN MELSUNGEN GERMANY IRRIGATION SOL. AG

0.9% W/V SODIUM CHLORIDE IV INFUSION SOLUTION 0.9% W/V B.BRAUN MELSUNGEN GERMANY INFUSION BP AG

1% W/V LIDOCAINE INJECTION INJECTION SOLUTION 1% W/V B.BRAUN MELSUNGEN GERMANY AG

1.5% GLYCINE IRRIGATION IRRIGATION SOLUTION 15MG/ML ABBOTT LABORATORIES UNITED STATES OF SOLUTION USP AMERICA

1.5% GLYCINE IRRIGATION USP SOLUTION FOR 15MG/ML ABBOTT LABORATORIES UNITED STATES OF IRRIGATION AMERICA

1.5% W/V GLYCINE IRRIGATION IRRIGATION SOLUTION 1.5% W/V B.BRAUN MELSUNGEN GERMANY SOL. BP AG

1/2 STRENGTH CMPD. SODIUM SOLUTION FOR N/A BAXTER HEALTHCARE UNITED KINGDOM LACTATE + GLUC INJECTION LIMITED

(*) Pour le texte de l'annexe XI, voir JO L 236 du 23.9.2003, p. 859. 23.9.2003 FR Journal officiel de l'Union européenne 451

Trade Name Dosage Form Dose MA Holder Country

10% CALCIUM CHLORIDE SOLUTION FOR 100MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

10% CALCIUM CHLORIDE SOLUTION FOR 100MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION USP (ABBOJECT INJECTION AMERICA INJECTION)

10% DEXTROSE AND 0.225% SOLUTION FOR N/A ABBOTT LABORATORIES UNITED STATES OF SODIUM CHLORIDE US INJECTION AMERICA

10% DEXTROSE AND 0.225% SOLUTION FOR NA ABBOTT LABORATORIES UNITED STATES OF SODIUM CHLORIDE INJECTION INJECTION AMERICA USP

10% DEXTROSE INJECTION USP SOLUTION FOR 100MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

10% DEXTROSE INJECTION USP SOLUTION FOR 10% ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

10% MANNITOL I.V. INJECTION SOLUTION FOR 100MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION LTD. AMERICA

10% MANNITOL IV INJECTION SOLUTION FOR 10% ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

10% MANNITOL IV INJECTION USP SOLUTION FOR 10% ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

10% W/V CALCIUM GLUCONATE INJECTION SOLUTION 10% W/V B.BRAUN MELSUNGEN GERMANY INJECTION BP AG

10% W/V GLUCOSE INTRAVENOUS INFUSION SOLUTION 10% W/V B.BRAUN MELSUNGEN GERMANY INFUSION BP AG

10%DEXTROSE AND 0.225% SOLUTION FOR IV N/A ABBOTT LABORATORIES UNITED STATES OF SODIUM CHLORIDE INJ INJECTION AMERICA

1G VENA N I.V. 2.5G/50ML SOL FOR I.V INF 2.5G/50ML KEDRION S.P.A. ITALY

1G VENA N I.V SOL FOR IV INF 10G/200ML KEDRION S.P.A. ITALY

1G VENA N I.V. 1G/20ML SOL FOR IV INF 1G/20ML KEDRION S.P.A. ITALY

1G VENA N I.V. 5G/100ML SOL FOR IV INF 5G/100ML KEDRION S.P.A. ITALY

2% LIDOCAINE HCL INJECTION SOLUTION FOR 20MG/ML ABBOTT LABORATORIES UNITED STATES OF USP INJECTION AMERICA

2% W/V LIDOCAINE INJECTION INJECTION SOLUTION 2% W/V B.BRAUN MELSUNGEN GERMANY AG

20% DEXTROSE INJECTION USP SOLUTION FOR 20% ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

20% DEXTROSE INJECTION, USP SOLUTION FOR IV 200MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

20% MANNITOL IV INJECTION SOLUTION FOR 200MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

20% MANNITOL IV INJECTION USP SOLUTION FOR 20% ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

20% W/V CALCIUM GLUCONATE SOLUTION FOR 20% W/V B.BRAUN MELSUNGEN GERMANY INJECTION BP INJECTION AG

20% W/V GLUCOSE INTRAVENOUS INFUSION SOLUTION 20% W/V B.BRAUN MELSUNGEN GERMANY SOLUTION BP AG

30% W/V GLUCOSE INJECTION BP INFUSION SOLUTION 30% W/V B.BRAUN MELSUNGEN GERMANY AG 452 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

37.5%W/V GLUCOSE WITH INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY ELECTROLYTES IVI AG

3-CIF POWDER FOR INJECTION 1000MG ELSAAD PHARMA SYRIA

4.2% W/V SODIUM BICARBONATE INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY IVI BP AG

40% W/V GLUCOSE INJECTION BP INFUSION SOLUTION 40% W/V B.BRAUN MELSUNGEN GERMANY CONCENT AG

40% W/V GLUCOSE INTRAVENOUS INFUSION SOLUTION 40% W/V B.BRAUN MELSUNGEN GERMANY INFUSION BP AG

5% DEXTROSE AND 0.225% NACL SOLUTION FOR NA ABBOTT LABORATORIES UNITED STATES OF INJECTION INJECTION AMERICA

5% DEXTROSE AND 0.225% SOLUTION FOR N/A ABBOTT LABORATORIES UNITED STATES OF SODIUM CHLORIDE INJ INJECTION AMERICA

5% DEXTROSE AND 0.45% NACL SOLUTION FOR NA ABBOTT LABORATORIES UNITED STATES OF INJ. INJECTION AMERICA

5% DEXTROSE AND 0.45% SODIUM SOLUTION FOR IV INJ N/A ABBOTT LABORATORIES UNITED STATES OF CHLORIDE INJ AMERICA

5% DEXTROSE AND 0.9% NACL SOLUTION FOR NA ABBOTT LABORATORIES UNITED STATES OF INJ. INJECTION AMERICA

5% DEXTROSE AND 0.9% SODIUM SOLUTION FOR IV INJ N/A ABBOTT LABORATORIES UNITED STATES OF CHLORIDE INJ AMERICA

5% DEXTROSE AND LACTATED SOLUTION FOR IV N/A ABBOTT LABORATORIES UNITED STATES OF RINGER'S INJ USP INFUSION AMERICA

5% DEXTROSE INJECTION USP SOLUTION FOR 5% ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

5% DEXTROSE INJECTION, USP SOLUTION FOR 50MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

5% W/V GLUCOSE INJECTION BP SOLUTION FOR 5% W/V B.BRAUN MELSUNGEN GERMANY INJECTION AG

5% W/V GLUCOSE INTRAVENOUS INFUSION SOLUTION 5% W/V B.BRAUN MELSUNGEN GERMANY INFUSION BP AG

5.85% W/V SODIUM CHLORIDE SOLUTION FOR 5.85% W/V B.BRAUN MELSUNGEN GERMANY INJECTION BP INJECTION AG

50% DEXTROSE INJECTION USP SOLUTION FOR 50% W/V ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

50% DEXTROSE INJECTION USP SOLUTION FOR 50% ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

50% DEXTROSE INJECTION, USP SOLUTION FOR 500MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

50% MAGNESIUM SULFATE SOLUTION FOR IV/IM INJ 500MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

50% MAGNESIUM SULFATE SOLUTION FOR 4 MEQ MG++/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION, USP INJECTION AMERICA

50% MAGNESIUM SULPHATE INJ SOLUTION FOR 50% ABBOTT LABORATORIES UNITED STATES OF USP INJECTION AMERICA

50% W/V GLUCOSE INJECTION BP INFUSION SOLUTION 50% W/V B.BRAUN MELSUNGEN AG GERMANY

50% W/V GLUCOSE INJECTION BP INFUSION SOLUTION 50% W/V B.BRAUN MELSUNGEN AG GERMANY CONCENT 23.9.2003 FR Journal officiel de l'Union européenne 453

Trade Name Dosage Form Dose MA Holder Country

7.45% W/V POTASSIUM CHLORIDE SOLUTION FOR 7.45% W/V B.BRAUN MELSUNGEN GERMANY INJECTION INJECTION AG

70% W/V GLUCOSE INJECTION BP INFUSION SOLUTION 70% W/V B.BRAUN MELSUNGEN GERMANY AG

8.4% SODIUM BICARBONATE INJ SOLUTION F/INJECTION 84MG/ML ABBOTT LABORATORIES UNITED STATES OF USP AMERICA

8.4% SODIUM BICARBONATE INJ SOLUTION FOR 8.4% ABBOTT LABORATORIES UNITED STATES OF USP INJECTION AMERICA

8.4% SODIUM BICARBONATE SOLUTION FOR IV 84MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION,USP INJECTION AMERICA

8.4% W/V SODIUM BICARBONATE INFUSION SOL. CONCEN- 8.4% W/V B.BRAUN MELSUNGEN GERMANY INJECTION BP TRATE AG

8.4%W/V SODIUM BICARBONATE INFUSION SOLUTION 8.4% W/V B.BRAUN MELSUNGEN GERMANY IV INFUSION AG

AAA MOUTH AND THROAT SPRAY OROMUCOSAL SPRAY 1.5MG/SP MANX PHARMA LIMITED UNITED KINGDOM

AB-ACICLOVIR 250 POWDER FOR INJECTION 250MG/VIAL ASTRAPIN PHARMA GERMANY GMBH & CO. KG

AB-DICLOFENAC 75 SOLUTION FOR 75MG/3ML ASTRAPIN PHARMA GERMANY INJECTION GMBH & CO.KG

ABDINE COLD RELIEF POWDER POWDER FOR ORAL 650MG BELL SONS & CO UNITED KINGDOM SOLUTION (DRUGGISTS) LIMITED

AB-ERYTHROMYCIN 1000 POWDER FOR INJECTION 1000MG ASTRAPIN PHARMA GERMANY GMBH & CO.KG

AB-HYDROCORTISONE 100 POWDER FOR INJECTION 100MG ASTRAPIN PHARMA GERMANY GMBH & CO. KG

ABIDEC DROPS ORAL SOLUTION N/A WARNER-LAMBERT UNITED KINGDOM CONSUMER HEALTHCARE

ABIDEC DROPS ORAL SOLUTION N/A PFIZER CONSUMER UNITED KINGDOM HEALTHCARE

AB-METHYLPREDNISOLONE SUSPENSION FOR 40MG/ML ASTRAPIN PHARMA GERMANY ACETATE 40 INJECTION GMBH & CO. KG

AB-METOCLOPRAMIDE HCL 10 SOLUTION FOR 10MG/2ML ASTRAPIN PHARMA GERMANY INJECTION GMBH & CO. KG

ABSINT 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS

ABSINT 2MG CAPSULE 2MG MEDOCHEMIE LTD CYPRUS

ACCOLATE FILM COATED TABLETS 20MG ZENECA LIMITED UNITED KINGDOM

ACCOLATE FILM COATED TABLETS 40MG ZENECA LIMITED UNITED KINGDOM

ACCOLATE COATED TABLETS 20MG ZENECA LIMITED UNITED KINGDOM

ACESAL TABLETS 300MG GEYMONAT SPA ITALY

ACETAZOLAMIDE 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

ACETAZOLAMIDE BP 250MG TABLETS 250MG REMEDICA LTD CYPRUS TABLETS

ACETAZONE FORTE TAB TABLET N/A TECHNILAB INC. CANADA 454 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ACETOAMINOPHEN (ACAMOL) TABLET 500MG TEVA PHARMACEUTICAL ISRAEL TABLETS INDUSTRIES LTD

ACETYSALICYLIC ACID (ASPIRIN) TABLETS 300MG PHARMAMED LTD. MALTA 300MG

ACIC CREME FUR LIPPENHERPES CREAM 50MG/G HEXAL AG GERMANY

ACICLOSTAD CREAM 50MG/1G STADAPHARM GMBH GERMANY

ACICLOSTAD 200 TABLET 200MG STADAPHARM GMBH GERMANY

ACICLOSTAD 800 TABLET 800MG STADAPHARM GERMANY

ACICLOVIR 800MG DISPERSIBLE TABLET 800MG SANOFI WINTHROP UNITED KINGDOM TABLETS BP LIMITED

ACICLOVIR TABLETS BP 200MG TABLET 200MG SANOFI WINTHROP LTD UNITED KINGDOM

ACICLOVIR TABLETS BP 200MG TABLET 200MG SANOFI WINTHROP UNITED KINGDOM LIMITED

ACICLOVIR TABLETS BP 400MG TABLET 400MG SANOFI WINTHROP UNITED KINGDOM LIMITED

ACICLOVIR TABLETS BP 800MG TABLET 800MG CP PHARMACEUTICALS UNITED KINGDOM LTD

ACIVIR EYE OINTMENT NA CIPLA LIMITED INDIA

ACNE AID SOAP SOAP 6.38% W/W UNITED KINGDOM (UK) LIMITED

ACQUA PER PREPARAZIONI INIET- SOLUTION FOR NA INDUSTRIA ITALY TABILI INJECTION FARMACEUTICA GALENICA SENESE S.R.L.

ACRICEPT 5MG COATED TABLET 5MG EISAI LIMITED UNITED KINGDOM

ACTAL TABLETS 360MG SEVEN SEAS LIMITED T/A UNITED KINGDOM MERCK CONSUMER HEALTH

ACT-HIB, VACCIN HAEMOPHILUS SOLUTION FOR I.M. & S.C. N/A PASTEUR MERIEUX FRANCE TYPE B CONJU SERUMS ET VACCINS

ACTIFED DM LINCTUS ORAL SOLUTION N/A GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ACTIFED EXPECTORANT ORAL SOLUTION N/A GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ACTIFED SYRUP SYRUP N/A GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ACTIFED TABLETS TABLETS N/A GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ACTIFED TABLETS TABLETS N/A GLAXOSMITHKLINE SA BELGIUM

ACTIFED TABLETS TABLETS NA GLAXO WELLCOME BELGIUM BELGIUM S.A.

ACTILYSE VIALS 50MG BOEHRINGER INGELHEIM GERMANY PHARMA KG

ACTIVELLE -28 TABLETS TABLET NA NOVO NORDISK A/S DENMARK

ACTONEL FILM-COATED TABLETS 5MG GRUPPO LEPETIT SPA ITALY

ACTONEL FILM-COATED TABLETS 30MG GRUPPO LEPETIT SPA ITALY 23.9.2003 FR Journal officiel de l'Union européenne 455

Trade Name Dosage Form Dose MA Holder Country

ACTONORM GEL ORAL SUSPENSION N/A WALLACE UNITED KINGDOM MANUFACTURING CHEMISTS LIMITED

ACTOS TABLETS 15MG TAKEDA EUROPE R&D UNITED KINGDOM CENTRE LIMITED

ACTOS TABLETS 30MG TAKEDA EUROPE R&D UNITED KINGDOM CENTRE LIMITED

ACTRAPID HM 1001U/ML1OML SOLUTION FOR 1001UML10MLVIAL NOVO NORDISK DENMARK VIAL INJECTION

ACTRAPID HM PENFILL SOLUTION FOR 100IU/ML NOVO NORDISK A/S DENMARK INJECTION

ACULAR (KETOROLAC EYE DROPS, SOLUTION 0.5% W/V ALLERGAN IRELAND TROMETHAMINE) 0.5% PHARMACEUTICALS (IRE- LAND) LTD., INC.

ACUPAN TABLETS COATED TABLET 30MG 3M HEALTH CARE UNITED KINGDOM LIMITED

ACYCLOVIR DENK 200 TABLETS 200MG E.DENK OHG GERMANY

ACYCLOVIR DENK 400 TABLETS 400MG E.DENK OHG GERMANY

ACYCLOVIR DENK 5% CREAM CREAM 5% E.DENK OHG GERMANY

ACYPRONT EFFERVESCENT TABLETS 200MG HEINRICH MACK NACHF. GERMANY GMBH & CO. KG

ADALAT CAPSULE 10MG BAYER PAKISTAN

ADALAT CAPSULE 10MG BAYER PAKISTAN

ADALAT 10 CAPSULE 10MG BAYER VITAL GMBH & GERMANY CO. KG

ADALAT LA 30MG RETARD TABLET 33MG BAYER AG GERMANY

ADALAT LA 30MG TABLETS MODIFIED RELEASE 30MG BAYER PLC UNITED KINGDOM TABLET

ADALAT LA 60MG RETARD TABLET 66MG BAYER AG GERMANY

ADALAT LA 60MG TABLET MODIFIED RELEASE 60MG BAYER PLC UNITED KINGDOM TABLET

ADALAT RETARD RETARD TABLET 20MG BAYER VITAL GMBH & GERMANY CO. KG

ADALAT RETARD TABLET 20MG BAYER PAKISTAN

ADALAT RETARD LACQUER COATED 20MG BAYER PAKISTAN TABLET

ADALAT RETARD 10MG COATED TABLET 10MG BAYER PLC UNITED KINGDOM

ADCO-AMOXYCILLIN 250MG/5ML SUSPENSION 250MG/5ML ADCOCK INGRAM LTD SOUTH AFRICA

ADCO-AMOXYCILLIN 500MG CAPSULES 500MG ADCOCK INGRAM LTD SOUTH AFRICA

ADCO-LOPERAMIDE TABLET 2MG ADCOCK INGRAM LTD SOUTH AFRICA

ADD-ACTEN TABLET N/A MEDOCHEMIE LTD CYPRUS

ADDITIVA VITAMIN C PINK EFFERVESCENT TABLET 1000MG KRUGER GMBH & CO. KG GERMANY GRAPEFRUIT 456 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ADDITRACE CONCENTRATE FOR INFU- N/A FRESENIUS KABI LIMITED UNITED KINGDOM SION

ADDITRACE, CONCENTRATE FOR CONCENTRATE FOR INFU- N/A FRESENIUS KABI LIMITED UNITED KINGDOM INFUSION SION -UK

ADENOCOR INJECTION 3MG/ML SOLUTION FOR 3MG/ML SANOFI WINTHROP UNITED KINGDOM INJECTION LIMITED

ADIOS COATED TABLETS NA BROME AND SCHIMMER UNITED KINGDOM LIMITED T/A DIOMED HERBALS

ADIZEM-XL CAPSULES 120MG MODIFIED RELEASE CAP- 120MG NAPP LABORATORIES UNITED KINGDOM SULE LIMITED

ADIZEM-XL CAPSULES 180MG MODIFIED RELEASE CAP- 180MG NAPP LABORATORIES UNITED KINGDOM SULE LIMITED

ADIZEM-XL CAPSULES 240MG MODIFIED RELEASE CAP- 240MG NAPP LABORATORIES UNITED KINGDOM SULE LIMITED

ADIZEM-XL CAPSULES 300MG MODIFIED RELEASE CAP- 300MG NAPP LABORATORIES UNITED KINGDOM SULE LIMITED

AD-MUC OINTMENT N/A MERZ+CO. GMBH & CO. GERMANY

ADRENALINE AGUETTANT INJECTABLE SOLUTION 1MG/1ML LABORATOIRE FRANCE AGUETTANT

ADRENALINE INJECTION BP 1/1000 SOLUTION FOR 1MG/1ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

ADRENALINE INJECTION BP 1/1000 SOLUTION FOR 1.0MG/ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS

ADRENALINE INJECTION/DEMO SOLUTION FOR 1MG/1ML DEMO ABEE GREECE INJECTION

ADRENALINE TARTRATE SOLUTION FOR 1 IN 1000 EVANS MEDICAL LIMITED UNITED KINGDOM INJECTION BP INJECTION

ADRIBLASTINA POWDER FOR INJECTION 10MG/VIAL PHARMACIA & UPJOHN ITALY S.P.A.

ADRIBLASTINA POWDER FOR SOLN FOR 50MG PHARMACIA ITALIA S.P.A ITALY INJECTION

ADRIBLASTINA SOLUTION FOR 10MG/5ML PHARMACIA ITALIA S.P.A ITALY INJECTION

ADRIBLASTINA SOLUTION FOR 50MG/25ML PHARMACIA ITALIA S.P.A ITALY INJECTION

ADRIBLASTINA POWDER AND SOLVENT 10MG/5ML PHARMACIA ITALIA S.P.A ITALY FOR IV INJ.

ADRIBLASTINA RTU SOLUTION FOR 10MG/5ML PHARMACIA & UPJOHN ITALY INJECTION S.P.A.

ADRIBLASTINA RD SOLUTION FOR 50MG/25ML PHARMACIA & UPJOHN ITALY INJECTION S.P.A.

ADRIBLASTINA RTU POWDER FOR INJECTION 50MG/VIAL PHARMACIA & UPJOHN ITALY S.P.A.

ADULT DIFTAVAX INJECTABLE SUSPENSION N/A PASTEUR MERIEUX FRANCE

ADULT MELTUS DRY TICKLY ORAL SOLUTION N/A CUPAL LTD UNITED KINGDOM COUGHS/CATARRH 23.9.2003 FR Journal officiel de l'Union européenne 457

Trade Name Dosage Form Dose MA Holder Country

ADULT MELTUS CHESTY COUGH ORAL SOLUTION N/A CUPAL LTD UNITED KINGDOM W/DECONGESTANT

ADULT MELTUS CHESTY COUGH ORAL SOLUTION N/A CUPAL LIMITED UNITED KINGDOM WITH DECONGEST

ADULT MELTUS FOR CHESTY ORAL SOLUTION N/A CUPAL LIMITED UNITED KINGDOM COUGHS AND CATARRH

ADULT MELTUS FOR DRY TICKLY ORAL LIQUID N/A CUPAL LIMITED UNITED KINGDOM COUGHS AND CAT

ADULT MELTUS NIGHT TIME SYRUP N/A CUPAL LIMITED UNITED KINGDOM

ADVANTAN FATTY OINTMENT 1MG/G SCHERING AG ITALY

ADVANTAN CREAM 1MG/G SCHERING AG ITALY

ADVANTAN OINTMENT 1MG/G SCHERING AG ITALY

ADVANTAN OINTMENT 0.1% W/W SCHERING SPA ITALY

ADVANTAN FATTY OINTMENT 0.1% W/W SCHERING SPA ITALY

ADVANTAN CREAM 0.1% W/W SCHERING SPA ITALY

ADVIL TABLETS 200MG WHITEHALL CANADA INTERNATIONAL INC.

ADVIL COLD AND SINUS CAPLETS TABLET N/A WHITEHALL-ROBINS INC. CANADA

ADVIL IBUPROFEN TAB 200MG TABLETS 200MG WHITEHALL-ROBINS INC. CANADA

A-E-MULSIN FORTE EMULSION N/A MUCOS PHARMA GMBH GERMANY & CO.

AERANNE LIQUID FOR 100% V/V PHARMACIA UNITED KINGDOM INHALATION LABORATORIES LIMITED

AERIUS FILM-COATED TABLETS 5MG SCHERING-PLOUGH S.P.A. UNITED KINGDOM

AERIUS FILM-COATED TABLETS 5MG SCHERING-PLOUGH S.P.A. ITALY

AEROCROM INHALER MET. DOSE PRESS. N/A FISONS LIMITED T/A UNITED KINGDOM AEROSOL RHONE-POULENC RORER

AEROCROM INHALER AEROSOL N/A FISONS LTD T/A RHONE- UNITED KINGDOM POULENC RORER

AERODIOL NASAL SPRAY 150MCG/DOSE LES LABORATOIRES FRANCE SOLUTION SERVIER

AEROLID NEBULIZER SOLUTION 0.1% W/V VECCHI & C. PIAM ITALY S.A.P.A.

AERO-OM TABLET 40MG OM PORTUGUESA PORTUGAL

AERO-OM ORAL SOLUTION 100MG/ML OM PORTOGUESA PORTUGAL

AERO-OM TABLET 40MG OM PORTUGUESA PORTUGAL

AERO-OM ORAL SOLUTION 100MG/ML OM PORTUGUESA PORTUGAL

AETHOXYSKLEROL 0.5% SOLUTION FOR 0.5% W/V CHEMISCHE FABRIK GERMANY INJECTION KREUSSLER & CO GMBH

AETHOXYSKLEROL 1% SOLUTION FOR 1% W/V CHEMISCHE FABRIK GERMANY INJECTION KREUSSIER & CO GMBH 458 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

AETHOXYSKLEROL 2% SOLUTION FOR 2% W/V CHEMISCHE FABRIK GERMANY INJECTION KREUSSIER & CO GMBH

AETHOXYSKLEROL 3% SOLUTION FOR 3% W/V CHEMISCHE FABRIK GERMANY INJECTION KREUSSIER & CO GMBH

AETHOXYSKLEROL 4% SOLUTION FOR 4% W/V CHEMISCHE FABRIK GERMANY INJECTION KREUSSIER & CO GMBH

AETHROMA-30 TIME RELEASE TABLETS 30MG MEPHA PHARMA AG SWITZERLAND

AFLOXAN CAPSULE 150MG ROTTA RESEARCH ITALY LABORATORIUM SPA

AFLOXAN CREAM 5% W/W ROTTAPHARM S.R.L ITALY

AFRAZINE NASAL SPRAY 0.05% NASAL SPRAY 0.05% W/V SCHERING-PLOUGH UNITED KINGDOM LIMITED

AGELMIN TABLETS 10MG KLEVA LTD. GREECE

AGGRASTAT 0.25MG/ML CONC. FOR SOLN. FOR 0.25MG/ML MERCK SHARP & DOHME NETHERLANDS INFUS B.V.

AGIOLAX POWDER FOR ORAL SUSP. NA MADAUS AG GERMANY

AGRIMONY (BACH) ORAL LIQUID N/A NELSON A. & CO LTD UNITED KINGDOM

AILAX ORAL SUSPENSION N/A GALEN LIMITED UNITED KINGDOM

AIMAFIX D.I. SOLUTION FOR IV N/A ISTITUTO ITALY SIEROVACCINOGENO ITALIANO I.S.I. S.P.A.

AIMKIN (BB-K8) INJECTABLE SOLUTION 500MG/2ML BRISTOL MYERS SQUIBB ITALY S.P.A

AIRCORT NASAL SPRAY 100MCG ITALCHIMICI SPA ITALY

AIRCORT SUSPENSION FOR 40MG ITALCHIMICI SPA ITALY INHALATION

AKAMIN TABLET 50MG ALPHAPHARM PTY AUSTRALIA LIMITED

AKAMIN CAPSULE 100MG ALPHAPHARM PTY AUSTRALIA LIMITED

AKAMON 1.5MG TABLET 1.5MG MEDOCHEMIE LTD CYPRUS

AKAMON 3MG TABLET 3MG MEDOCHEMIE LTD CYPRUS

AKAMON 6MG TABLET 6MG MEDOCHEMIE LTD CYPRUS

AKATINOL MEMANTINE TABLETS 10 MG MERZ + CO. GMBH & CO. GERMANY

AKILEN 40MG TABLET 40MG MEDOCHEMIE LTD CYPRUS

AKLONIL 0.5MG TABLET 0.5MG MEDOCHEMIE LTD CYPRUS

AKLONIL 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS

AKTIFERRIN-F SUSCAPS N/A MEPHA PHARMA AG SWITZERLAND

ALBUMIN 20% — GCPD 50ML SOLUTION FOR 20% GREENCROSS PLASMA KOREA REPUBLIC INJECTION DERIVATIVES CORP.

ALBUMIN PHARMACIA SOLUTION FOR N/A PHARMACIA & UPJOHN SWEDEN INFUSION AB 23.9.2003 FR Journal officiel de l'Union européenne 459

Trade Name Dosage Form Dose MA Holder Country

ALBUMIN PHARMACIA SOLUTION FOR 200MG/ML BIOVITRUM AB SWEDEN INFUSION

ALCITON METER DOSE NASAL 100IU/DOSE KLEVA LIMITED GREECE SPRAY

ALDACTIDE COATED TABLET N/A MONSANTO PLC UNITED KINGDOM

ALDACTIDE 25 TABLETS N/A MONSANTO PLC T/A UNITED KINGDOM SEARLE

ALDACTONE TABLETS 100MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

ALDACTONE COATED TABLET 25MG MONSANTO PLC UNITED KINGDOM

ALDACTONE COATED TABLETS 100MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

ALDACTONE TABLETS 25MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

ALDACTONE TABLETS 100MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

ALDACTONE TABLETS 100MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

ALDACTONE TABLET 25MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

ALDACTONE 100 MG TABLETS COATED TABLET 100 MG PHARMACIA LIMITED UNITED KINGDOM

ALDACTONE 100MG TABLET 100MG SEARLE PAKISTAN

ALDACTONE 25 MG TABLETS COATED TABLET 25 MG PHARMACIA LIMITED UNITED KINGDOM

ALDACTONE A TABLET 25MG SEARLE PAKISTAN

ALDARA CREAM NA 3M HEALTHCARE EUROPEAN COMMUNITY LIMITED

ALDIX 40MG TABLET 40MG MEDOCHEMIE LTD CYPRUS

ALDOMET TABLET 250MG M.S.D. PAKISTAN

ALDOMET 250MG TABLET 250MG MERCK SHARP & DOHME NETHERLANDS B.V.

ALDOMET TABLETS TABLETS 250MG MSD PAKISTAN

ALENOST TABLET 10MG MACLEODS INDIA PHARMACEUTICALS LTD

ALEXAN SOLUTION FOR NA HEINRICH MACK NACHF GERMANY INJECTION

ALFACALCIDOL (ALPHA D3) CAPSULE 1MCG TEVA PHARMACEUTICAL ISRAEL INDUSTRIES LTD

ALFACIP-0.25MCG CAPSULES CAPSULES 0.25MCG CIPLA LTD. INDIA

ALFINOR 8MG TABLET 8MG MEDOCHEMIE LTD CYPRUS

ALFOXAN CAPSULES 250MG REMEDICA LTD CYPRUS

ALFOXAN SYRUP 50MG/5ML REMEDICA LTD CYPRUS

ALFOXAN 500 F.C. TABLETS 500MG REMEDICA LTD CYPRUS 460 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ALGESAL SURACTIVE CREAM N/A LABORATOIRES SOLVAY FRANCE PHARMA

ALGICON TABLET N/A RORER UNITED KINGDOM PHARMACEUTICALS LTD.

ALGIPAN CREAM N/A -LEDERLE PAKISTAN

A-LICES SHAMPOO NA HOE PHARMACEUTICALS MALAYSIA SDN BHD

A-LICES SCALP AND BODY SHAMPOO 1% W/V HOE PHARMACEUTICALS MALAYSIA HYGIENE SHAMPOO SDN. BHD

ALKA-SELTZER EFFERVESCENT TABLET 324MG BAYER VITAL GMBH & UNITED KINGDOM CO. KG

ALKA-SELTZER EFFERVESCENT EFFERVESCENT TABLET N/A BAYER DIAGNOSTICS UNITED KINGDOM TABLETS MANUFACTURING LIMITED

ALKA-SELTZER ORIGINAL EFFERVESCENT TABLET N/A BAYER DIAGNOSTICS UNITED KINGDOM MANUFACTURING LIMITED

ALKERAN COMPRESSION-COATED 2MG WELLCOME UNITED KINGDOM TABLET FOUNDATION LTD.

ALKERAN COMPRESSION-COATED 5MG WELLCOME UNITED KINGDOM TABLET FOUNDATION LTD.

ALKERAN POWDER FOR INJECTION 50MG WELLCOME UNITED KINGDOM FOUNDATION LTD.

ALKERAN COATED TABLET 2MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD. T/A GLAXO WELLCOME

ALKERAN COATED TABLETS 2MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

ALKERAN POWDER AND SOLVENT NA GLAXOSMITHKLINE SPA ITALY F/SOLUTION F/INJECTION

ALLERGAN CREAM 2G/100G SPA ITALIANA ITALY LABORATORI BOUTY

ALLERGO-COMOD EYE DROPS 20MG/ML URSAPHARM GERMANY ARZNEIMITTEL GMBH

ALLERGOCROM SOLUTION, EYE DROPS 20MG/ML URSAPHARM GERMANY ARZNEIMITTEL GMBH

ALLERGOPOS N EYE DROPS N/A URSAPHARM GERMANY ARZNEIMITTEL GMBH

ALLO-100 TABLET TABLET 100MG CAMDEN INDUSTRIES (M) MALAYSIA SDN BHD

ALLOPURINOL TABLETS 300MG DANBURY PHARMACAL PUERTO RICO INC.

ALLOPURINOL TABLETS 100MG TABLETS 100MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

ALLOPURINOL TABLETS 300MG TABLETS 300MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

ALLOPURINOL TABLETS BP TABLETS 100MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

ALLOPURINOL TABLETS BP TABLETS 300MG CP PHARMACEUTICALS UNITED KINGDOM 23.9.2003 FR Journal officiel de l'Union européenne 461

Trade Name Dosage Form Dose MA Holder Country

ALLOPURINOL TABLETS BP 100MG TABLETS 100MG CP PHARMACEUTICALS UNITED KINGDOM LTD

ALLOPURINOL TABLETS BP 300MG TABLET 300MG CP PHARMACEUTICALS UNITED KINGDOM LTD

ALLUMAG MPS SUSPENSION SUSPENSION N/A CAMDEN INDUSTRIES (M) MALAYSIA SDN BHD

ALLUPOL TABLET 100MG GRODZISK POLAND PHARMACEUTICAL WORKS POLFA

ALMIRAL 100MG SUPPOSITORY 100MG MEDOCHEMIE LTD CYPRUS

ALMIRAL 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

ALMIRAL 50MG TABLET 50MG MEDOCHEMIE LTD CYPRUS

ALMIRAL 50MG SUPPOSITORY 50MG MEDOCHEMIE LTD CYPRUS

ALMIRAL 75MG/3ML LIQUID FOR INJECTION 75MG/3ML MEDOCHEMIE LTD CYPRUS

ALMIRAL SR 100MG TABLET 100MG MEDOCHEMIE LTD CYPRUS

ALMORA POWD. FOR ORAL SD. 5.9G/SACHET ELPEN S.A. GREECE

ALOMIDE OPHTHALMIC SOLUTION 1MG/ML S.A. ALCON-COUVREUR BELGIUM N.V.

ALOPEXY 2% SOLUTN. FOR 2% W/V LABORATOIRES PIERRE FRANCE CUTANEOUS USE FABRE DERMATOLOGIE

ALOPRON 100 TABLETS 100MG REMEDICA LTD CYPRUS

ALOPRON 300 TABLETS 300MG REMEDICA LTD CYPRUS

ALPHA D3 (ALFACALCIDOL) CAPSULE 0.25MCG TEVA PHARMACEUTICAL ISRAEL INDUSTRIES LTD

ALPHADINE FILM-COATED TABLETS 150MG MINERVA PHARMACEUTI- GREECE CAL S.A.

ALPHAGAN (BRIMONIDINE OPHTHALMIC SOLUTION 0.2% W/V ALLERGAN PHARMACEU- IRELAND TARTRATE) 0.2% TICALS (IRELAND) LTD., INC.

ALPHAMOX POWDER FOR ORAL 125MG/ML ALPHAPHARM PTY AUSTRALIA LIQUID LIMITED

ALPHAMOX POWDER FOR ORAL 250MG/ML ALPHAPHARM PTY AUSTRALIA LIQUID LIMITED

ALPHAMOX 250 CAPSULE 250MG ALPHAPHARM PTY AUSTRALIA LIMITED

ALPHAMOX 500 CAPSULE 500MG ALPHAPHARM PTY AUSTRALIA LIMITED

ALPHOSYL CREAM N/A STAFFORD-MILLER UNITED KINGDOM LIMITED

ALPHOSYL 2 IN 1 SHAMPOO 5% W/W STAFFORD-MILLER UNITED KINGDOM LIMITED

ALPHOSYL 2 IN 1 SHAMPOO SHAMPOO 5%W/W STAFFORD MILLER UNITED KINGDOM LIMITED

ALPHOSYL CREAM CREAM NA STAFFORD MILLER UNITED KINGDOM LIMITED 462 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ALPHOSYL HC CREAM N/A STAFFORD-MILLER UNITED KINGDOM LIMITED

ALPHOSYL HC CREAM CREAM NA STAFFORD-MILLER UNITED KINGDOM LIMITED

ALPHOSYL LOTION TOPICAL EMULSION N/A STAFFORD-MILLER UNITED KINGDOM LIMITED

ALPHOSYL LOTION TOPICAL EMULSION NA STAFFORD MILLER UNITED KINGDOM LIMITED

ALPRENOLOL HCL BP 50MG TABLETS 50MG REMEDICA LTD CYPRUS

ALUDROX LIQUID ORAL GEL 4.16% W/W UNICLIFFE LIMITED T/A UNITED KINGDOM PFIZER CONSUMER HEALTHCARE

ALUMINIUM HYDROXIDE SOLVENT SOLVENT F/PARENTERAL 1MG/0.5ML CHIRON S.P.A ITALY USE

ALUTRIL CHEWABLE TABLETS N/A REMEDICA LTD CYPRUS

ALVEOFACT SUSPENSION 54MG/1.2ML BOEHRINGER INGELHEIM GERMANY PHARMA KG

ALVERCOL GRANULES GRANULES N/A NORGINE LIMITED UNITED KINGDOM

ALVERIX 5 TABLETS 5MG REMEDICA LTD CYPRUS

ALVITYL COATED TABLET N/A LABORATOIRES SOLVAY FRANCE PHARMA

ALVITYL SYRUP N/A LABORATOIRES SOLVAY FRANCE PHARMA

ALYRANE INHALATION LIQUID 99.9% W/V PHARMACIA UNITED KINGDOM LABORATORIES LIMITED

AMAREL 1MG TABLET 1MG LABORATOIRES FRANCE HOECHST

AMAREL 2MG TABLET 2MG LABORATOIRES FRANCE HOECHST

AMAREL 3MG TABLET 3MG LABORATOIRES FRANCE HOECHST

AMAREL 4MG TABLET 4MG LABORATOIRES FRANCE HOECHST

AMBISONE POWDER FOR INJECTION 50MG NEXSTAR IRELAND PHARMACEUTICALS LTD.

AMBISONE LYOPH. PWDR. FOR IV INF 50MG GILEAD SCIENCES IRELAND INTERNATIONAL LTD

AMBROHEXAL RETARD SLOW RELEASE CAPSULE 75MG HEXAL AG GERMANY

AMBROHEXAL SAFT SOLUTION 3MG/ML HEXAL AG GERMANY

AMBROLITIC SYRUP 300MG/100ML CHIESI WASSERMANN SPAIN S.A.

AMBROLITIC 20 CAPSULE 30MG CHIESI WASSERMANN SPAIN S.A.

AMBROLITIC 20 CAPSULES 30MG CHIESI ESPANA S.A. SPAIN

AMBROLITIC SYRUP SYRUP 328.9MG/100ML CHIESI ESPANA S.A. SPAIN 23.9.2003 FR Journal officiel de l'Union européenne 463

Trade Name Dosage Form Dose MA Holder Country

AMEN 100MG TABLETS TABLETS 100MG MEDOCHEMIE LTD. — CYPRUS CYPRUS

AMERSCAN (DMSA) AGENT POWDER FOR INJECTION 1MG/VIAL NYCOMED AMERSHAM UNITED KINGDOM PLC

AMERSCAN MEDRONATE II AGENT POWDER FOR INJECTION 6.25MG/VIAL NYCOMED AMERSHAM UNITED KINGDOM PLC

AMERSCAN PENTETATE II POWDER FOR INJECTION 20.6MG/10ML NYCOMED AMERSHAM UNITED KINGDOM PLC

AMERSCAN STANNOUS AGENT POWDER FOR INJECTION 4MG/VIAL NYCOMED AMERSHAM UNITED KINGDOM PLC

A-METHAPRED POWDER FOR INJ. WITH 40MG/VIAL ABBOTT LABORATORIES UNITED STATES OF SOLV AMERICA

AMICLAV TABLETS 250/125 MG FILM COATED TAB GENERICS (UK) LIMITED UNITED KINGDOM

AMIDATE (SINGLE DOSE AMPUL) SOLUTION FOR 20MG (2MG/ML) ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

AMIDATE (SINGLE DOSE FLIPTOP SOLUTION FOR 20MG (2MG/ML) ABBOTT LABORATORIES UNITED STATES OF VIAL) INJECTION AMERICA

AMIDATE INJECTION SOLUTION FOR 2MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

AMIKACINE MERCK 500MG POWDER FOR INJECTION 500MG/VIAL MERCK GENERIQUES FRANCE

AMIKALEM SOLUTION FOR 100MG/250MG/500 LEMERY S.A. DE C.V MEXICO INJECTION

AMIKIN INJECTABLE SOLUTION 500MG/2ML BRISTOL-MYERS SQUIBB ESTONIA EESTI AS

AMIL-CO TABLETS TABLETS N/A NORTON HEALTHCARE UNITED KINGDOM LIMITED

AMILORETIC TABLET N/A PHARMACARE LIMITED SOUTH AFRICA

AMILORIDE HCL TABLETS 5MG TABLETS 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

AMILORIDE TABLETS BP TABLETS 5MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

AMILORIDE TABLETS BP 5MG TABLET 5MG CP PHARMACEUTICALS UNITED KINGDOM LTD

AMINOPHYLLIN IV-FRESENIUS SOLUTION FOR 250MG/10ML BODENE (PROPIETARY) SOUTH AFRICA INJECTION LIMITED T/A INTRAMED- SOUTH AFRICA

AMINOPHYLLINE SOLUTION FOR 250MG/10ML DEMO ABEE GREECE INJECTION

AMINOPHYLLINE TABLETS 225MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

AMINOPHYLLINE SOLUTION FOR 250MG PHARMAMED PARENTE- MALTA INJECTION RALS LTD.

AMINOPHYLLINE BP 250MG TABLETS 250MG REMEDICA LTD CYPRUS

AMINOPHYLLINE BP 360MG SUPPOSITORIES 360MG REMEDICA LTD CYPRUS

AMINOPHYLLINE INJECTION INJECTION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY 240MG BP AG 464 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

AMINOPHYLLINE INJECTION BP SOLUTION FOR 250MG/10ML EVANS MEDICAL UNITED KINGDOM INJECTION LIMITED

AMINOPHYLLINE INJECTION BP SOLUTION FOR 250MG/10ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

AMINOPHYLLINE INJECTION BP SOLUTION FOR N/A INTERNATIONAL UNITED KINGDOM MINIJET INJECTION SYSTEMS LTD

AMINOPHYLLINE INJECTION SOLUTION FOR N/A INTERNATIONAL UNITED KINGDOM MINIJET INJECTION MEDICATION SYSTEMS (UK) LIMITED

AMINOPHYLLINE MINJET SOLUTION FOR N/A INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS (UK) LIMITED

AMINOPHYLLINE TABLETS 100MG TABLET 100MG NORTON UNITED KINGDOM PHARMACEUTICALS LIMITED

AMINOPLASMAL 10% INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY AG

AMINOPLASMAL 10% E INFUSION SOLTION N/A B.BRAUN MELSUNGEN GERMANY AG

AMINOPLASMAL 12.5% E INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY AG

AMINOPLASMAL 15% INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY AG

AMINOPLASMAL 15% E INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY AG

AMINOPLASMAL 5% E INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY AG

AMINOPLASMAL HEPA 10% INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY AG

AMINOSYN 10% SOLUTION SOL. FOR I.V. INFUSION N/A ABBOTT LABORATORIES UNITED STATES OF AMERICA

AMINOSYN 8.5% WITH SOLUTION FOR N/A ABBOTT LABORATORIES UNITED STATES OF ELECTROLYTES INJECTION AMERICA

AMINOSYN II 10% INJECTION SOL. FOR I.V. INJECTION N/A ABBOTT LABORATORIES UNITED STATES OF AMERICA

AMINOSYN II 4.25% M IN 10% SOLUTION FOR N/A ABBOTT LABORATORIES UNITED STATES OF DEXTROSE INJ. INJECTION AMERICA

AMIODARONE 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

AMIROL 10 TABLETS 10MG REMEDICA LTD CYPRUS

AMIROL 25 TABLETS 25MG REMEDICA LTD CYPRUS

AMITRIPTYLIN SLOVAKOFARMA TABLETS 0.028300G SLOVAKOFARMA SLOVAK REPUBLIC

AMITRIPTYLINE SUGAR COATED TABLETS 25MG EXTRACTUM-PHARMA HUNGARY CO. LTD

AMITRIPTYLINE TABLET 25MG TABLET 25MG CAMDEN INDUSTRIES (M) MALAYSIA SDN BHD 23.9.2003 FR Journal officiel de l'Union européenne 465

Trade Name Dosage Form Dose MA Holder Country

AMITRYPTYLLIN COATED TABLET 25MG ICN POLFA RZESZOW POLAND S.A. PHARMACEUTICAL WORKS

AMLO 10 MG, TABLETS TABLETS 10 MG OMEGA FARMA EHF ICELAND

AMLO 2.5 MG, TABLETS TABLETS 2.5 MG OMEGA FARMA EHF. ICELAND

AMLO 5 MG, TABLETS TABLETS 5 MG OMEGA FARMA EHF. ICELAND

AMOCLAN TABLETS 375MG HIKMA PHARMACEUTI- JORDAN CALS

AMOCLAN POWDER FOR INJECTION NA HIKMA PHARMACEUTI- JORDAN CALS

AMOX CAPSULE 250MG CAPSULE 250MG CAMDEN INDUSTRIES (M) MALAYSIA SDN BHD

AMOXAPEN 125 ORAL SUSPENSION 125MG/5ML REMEDICA LTD CYPRUS

AMOXAPEN 250 CAPSULES 250MG REMEDICA LTD CYPRUS

AMOXAPEN 250 ORAL SUSPENSION 250MG/5ML REMEDICA LTD CYPRUS

AMOXAPEN 250 F.C. TABLETS 250MG REMEDICA LTD CYPRUS

AMOXAPEN 500 CAPSULES 500MG REMEDICA LTD CYPRUS

AMOXAPEN 500 F.C. TABLETS 500MG REMEDICA LTD CYPRUS

AMOXICILLIN CAPSULES 250MG CAPSULE 250MG GENERICS (UK) LIMITED UNITED KINGDOM

AMOXICILLINE CAPSULE 250MG PHARMACEUTICAL POLAND WORKS POLFA-KRAKOW S.A.

AMOXICILLIN-RATIOPHARM GRANULES FOR ORAL 250MG/5ML RATIOPHARM GMBH GERMANY 250 TS SUSPN.

AMOXICILLIN-RATIOPHARM 500 FILM COATED TABLETS 500MG RATIOPHARM GMBH GERMANY

AMOXICOMP,,GENERICON FILM COATED TABLET 625 MG GENERICON PHARMA GERMANY GES.M.B.H.

AMOXIHEXAL 500 FILM-COATED TABLET 500MG HEXAL AG GERMANY

AMOXIHEXAL SAFT DRY SUBSTANCE FOR 200MG/5ML HEXAL AG GERMANY SUSP

AMOXIL CAPSULE 250MG SMITH KLINE BEECHAM PAKISTAN

AMOXIL CAPSULE 500MG SMITH KLINE BEECHAM PAKISTAN

AMOXIL SYRUP IN POWDER FORM 125MG/5ML SMITH KLINE & BEE- PAKISTAN CHAM

AMOXIL CAPSULE 250MG SMITH KLINE & BEE- PAKISTAN CHAM

AMOXIL CAPSULE 500MG SMITH KLINE & BEE- PAKISTAN CHAM

AMOXIL CAPSULES 250MG CAPSULE 250MG PLC UNITED KINGDOM

AMOXIL CAPSULES 500MG CAPSULE 500MG BEECHAM GROUP PLC UNITED KINGDOM

AMOXIL FORTE SYRUP IN POWDER FORM 250MG/5ML SMITH KLINE & PAKISTAN BEECHAM 466 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

AMOXIL PAEDIATRIC SUSPENSION POWDER FOR ORAL 125MG/1.25ML BEECHAM GROUP PLC UNITED KINGDOM SOLUTION

AMOXIL SACHET 3G GRANULES FOR ORAL 3G BEECHAM GROUP PLC UNITED KINGDOM SUCROSE-FREE SOLN.

AMOXIL SYRUP SUCROSE-FREE POWDER FOR ORAL 125MG/5ML BEECHAM GROUP PLC UNITED KINGDOM SUSPENSION SUSPEN.

AMOXIL SYRUP SUCROSE-FREE POWDER FOR ORAL 250MG/5ML BEECHAM GROUP PLC UNITED KINGDOM SUSPENSION SUSPEN.

AMOXIL VIALS FOR INJECTION POWDER FOR INJECTION 250MG BEECHAM GROUP PLC UNITED KINGDOM 250MG

AMOXIL VIALS FOR INJECTION POWDER FOR INJECTION 500MG BEECHAM GROUP PLC UNITED KINGDOM 500MG

AMOXYCILLIN CAPSULES 250MG NORTON UNITED KINGDOM PHARMACEUTICALS LIMITED

AMOXYCILLIN CAPSULES 500MG NORTON IRELAND PHARMACEUTICALS LIMITED

AMOXYCILLIN CAPSULE 250MG PLIVA PAKISTAN

AMOXYCILLIN 3GM SACHETS S.F. POWDER FOR ORAL 3GM NORTON HEALTHCARE UNITED KINGDOM SOLUTION LIMITED

AMOXYCILLIN CAPSULES CAPSULES 500MG ATHLONE IRELAND B.P.500MG LABORATORIES LIMITED

AMOXYCILLIN MIXTURE ORAL SOLUTION 125MG/5ML NORTON HEALTHCARE UNITED KINGDOM LIMITED

AMOXYCILLIN MIXTURE 250MG/ ORAL SOLUTION 250MG/5ML NORTON HEALTHCARE UNITED KINGDOM 5ML LIMITED

AMOXYCILLIN S/F MIXTURE ORAL SOLUTION 125MG/5ML NORTON HEALTHCARE UNITED KINGDOM 125MG/5ML LIMITED

AMOXYCILLIN S/F MIXTURE ORAL SOLUTION 250MG/5ML NORTON HEALTHCARE UNITED KINGDOM 250MG/5ML LIMITED

AMOXYCILLIN S/F SACHETS POWDER FOR 3MG/5ML NORTON HEALTHCARE UNITED KINGDOM RECONSTITUTION LIMITED

AMOXYCILLIN SUGAR FREE SUGAR FREE 125MG/5ML ATHLONE IRELAND SUSPENSION B.P. SUSPENSION LABORATORIES LIMITED

AMOXYDAR CAPSULES 250MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

AMOXYDAR 125 GRANULES FOR ORAL 125MG/5ML DAR AL DAWA JORDAN SUSPEN. DEVELOPMENT AND INVESTMENT CO. LTD

AMPHOCIL POWDER FOR SOLUTION 50MG INTERMUNE EUROPE UNITED KINGDOM FOR INFUSION LIMITED

AMPICILLIN CAPSULES 250MG CAPSULES 250MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

AMPICILLIN CAPSULES 500MG CAPSULES 500MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

AMPICLLIN CAPSULES B.P. CAPSULES 500MG ATHLONE LABORATO- IRELAND RIES LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 467

Trade Name Dosage Form Dose MA Holder Country

AMPICLOX CAPSULE N/A SMITH KLINE & PAKISTAN BEECHAM

AMPICLOX CAPSULES 500MG CAPSULE N/A BEECHAM GROUP PLC UNITED KINGDOM

AMPICLOX INJECTION 500MG POWDER FOR INJECTION N/A BEECHAM GROUP PLC UNITED KINGDOM

AMPICLOX NEONATAL INJECTION POWDER FOR INJECTION N/A BEECHAM GROUP PLC UNITED KINGDOM

AMPICLOX NEONATAL POWDER FOR ORAL N/A BEECHAM GROUP PLC UNITED KINGDOM SUSPENSION SUSPEN.

AMPICLOX SYRUP POWDER FOR SYRUP N/A BEECHAM GROUP PLC UNITED KINGDOM

AMPISUL 250 CAPSULES 250MG AEGIS LTD. CYPRUS

AMPISUL 500 CAPSULES 500MG AEGIS LTD. CYPRUS

AMSIDINE 50 MG/ML SOLUTION FOR 50 MG/ML GOLDSHIELD GROUP PLC UNITED KINGDOM INJECTION T/A GOLDSHIELD PHARMACEUTICALS

AMSIDINE INJECTION SOLUTION FOR 50MG/ML GOLDSHIELD UNITED KINGDOM INJECTION PHARMACEUTICALS LTD

AMURETIC TABLETS NA DAR ALA DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

ANABACT METRONIDAZOLE GEL 0.75% W / W BIOGLAN UNITED KINGDOM TOPICAL GEL 0.75% PHARMACEUTICALS LTD

ANACAINE INJECTION 1% SOLUTION FOR 10MG/ML SM PHARMACEUTICALS MALAYSIA INJECTION SDN. BHD.

ANACAL RECTAL OINTMENT RECTAL OINTMENT N/A SANKYO PHARMA UK UNITED KINGDOM LIMITED

ANACAL SUPPOSITORIES SUPPOSITORY N/A SANKYO PHARMA UK UNITED KINGDOM LIMITED

ANADIN TABLETS N/A WHITEHALL UNITED KINGDOM LABORATORIES LTD

ANADIN EXTRA / POWERIN TABLETS N/A WHITEHALL UNITED KINGDOM LABORATORIES LTD

ANADIN PARACETAMOL TABLETS 500MG WHITEHALL UNITED KINGDOM LABORATORIES LTD

ANAFRANIL SUGAR COATED TABLETS 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

ANAFRANIL SUGAR COATED TABLETS 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

ANAFRANIL TABLET 10MG NOVARTIS PAKISTAN

ANAFRANIL TABLET 25MG GEIGY PAKISTAN

ANAFRANIL TABLET 25MG NOVARTIS PAKISTAN

ANAFRANIL S/C TABLETS 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

ANAFRANIL FIM-COATED TABLET 75MG NOVARTIS SPAIN FARMACEUTICA S.A. — SPAIN

ANAFRANIL SUGAR-COATED TABLETS 10MG NOVARTIS SPAIN FARMACEUTICA S.A 468 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ANAFRANIL SUGAR-COATED TABLETS 25MG NOVARTIS SPAIN FARMACEUTICA S.A

ANAFRANIL SUGAR (FILM)-COATED 10MG NOVARTIS FARMA SPA ITALY TABLETS

ANAFRANIL SUGAR (FILM)-COATED 25MG NOVARTIS FARMA SPA ITALY TABLETS

ANAFRANIL SR 75 DIVITABS 75MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

ANAPRIN TABLETS TABLETS 75MG OPAL PAKISTAN

ANARGIL 100MG CAPSULE 100MG MEDOCHEMIE LTD CYPRUS

ANARGIL 200MG CAPSULE 200MG MEDOCHEMIE LTD CYPRUS

ANATOXAL DI TE BERNA SOUTION FOR INJECTION N/A ISTITUTO ITALY SIEROTERAPICO BERNA S.R.L.

ANCID CHEWING TABLET 500MG HEXAL AG GERMANY

ANCOPIR TABLET N/A DR.GROSSMANN AG SWITZERLAND PHARMACA

ANCOTIL SOLUTION FOR 2.5G/250ML ICN PHARMACEUTICALS UNITED KINGDOM INJECTION LIMITED

ANCOTIL SOLUTION FOR 2.5G/250ML ICN PHARMACEUTICALS UNITED KINGDOM INJECTION LIMITED

ANCOTIL 2.5G/250ML SOLUTION FOR N/A ICN PHARMACEUTICALS UNITED KINGDOM INJECTION LIMITED

ANDRACTIM GEL N/A BESINS INTERNATIONAL FRANCE

ANDREWS ANTACID TABLETS TABLET N/A SMITHKLINE BEECHAM UNITED KINGDOM (SWG) LTD T/A STERLING HEALTH

ANDRIOL CAPSULES 40MG N.V. ORGANON NETHERLANDS

ANDROCUR TABLET 50MG SCHERING AG GERMANY

ANDROCUR TABLET 50MG SCHERING S.A. FRANCE

ANDROCUR-10 TABLET 10MG SCHERING AG GERMANY

ANDROCUR-DEPOT OILY SOLN FOR IM 100MG/ML SCHERING AG GERMANY INJECT.

ANECTINE SOLUTION FOR 5%W/V THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION LIMITED

ANECTINE SOLUTION FOR 5%W/W THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION LIMITED

ANECTINE (MIDARINE) SOLUTION FOR 5% W/V WELLCOME UNITED KINGDOM INJECTION FOUNDATION LTD.

ANEXATE AQUEOSUS SOLUTION 0.5MG/5ML ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

ANGINESIN LIQUID N/A DR. GROSSMAN AG SWITZERLAND PHARMACA

ANGINOVAG AEROSOL N/A LABORATORIOS NOVAG, SPAIN S.A. 23.9.2003 FR Journal officiel de l'Union européenne 469

Trade Name Dosage Form Dose MA Holder Country

ANGIOCIS POWDER FOR INJECTION N/A CIS BIO INTERNATIONAL FRANCE

ANGISED TABLETS TABLETS 0.5MG GLAXOWELLCOME PAKISTAN

ANGISED TABLETS TABLETS 0.5MG GLAXOSMITHKLINE SOUTH AFRICA SOUTH AFRICA (PTY) LTD

ANGISPRAY SPRAY SOLN F/ORAL N/A LABORATOIRES MONOT FRANCE CAVITY

ANTACID PLUS ANTIFLATULENT SUSPENSION N/A STANLEY CANADA PHARMACEUTICALS LTD

ANTHISAN CREAM 2% W/W CREAM 2% W/W MAY & BAKER LIMITED UNITED KINGDOM (T/A RHONE-POULENC RORER)

ANTIBIOPTAL EYE DROPS N/A FARMILA FARMACEUTICI ITALY MILANO S.P.A.

ANTIBIOTIC OINTMENT OINTMENT N/A STANLEY CANADA PHARMACEUTICALS LTD

ANTIBLUT S.R.F.C. TABLET 20MG GENEPHARM S.A. GREECE

ANTIDOL COATED TABLETS 500MG LABORATORIOS CINFA SPAIN S.A

ANTIGREG TABLET 250MG VECCHI & C PIAM S.A.P.A. ITALY

ANTIGREG TABLET 250MG VECCHI & C PIAM ITALY

ANTILIPID FILM COATED TABLETS 600MG KLEVA LIMITED GREECE

ANTIPEOL OINTMENT OINTMENT N/A MEDICO-BIOLOGICAL UNITED KINGDOM LABS LTD

ANTIPHLOGISTINE PASTE FOR TOPICAL N/A LABORATOIRES FRANCE APPLIC. FUMOUZE

ANTIPREX TABLETS 5MG ELPEN PHARM. CO. INC. GREECE

ANTIRRINUM NASAL SPRAY SOLUTION NA LABORATORIO REIG SPAIN JOFRE S.A

ANTISPASMINA COLICA GASTRORESISTANT N/A RECORDATI INDUSTRIA ITALY TABLET CHIMICA FARMACEUTICA S.P.A.

ANTISPASMINA COLICA (FORTE) GASTRORESISTANT N/A RECORDATI INDUSTRIA ITALY TABLET CHIMICA FARMACEUTICA S.P.A.

ANTITHROMBIN III HUMAN SOLUTION FOR N/A BAXTER AG AUSTRIA THROMBHIBIN INJECTION

ANTI-THYROX TABLETS 5MG MACLEODS INDIA PHARMACEUTICALS LTD

ANTORAL SOLUTION FOR BUCCAL 0.05G/100ML RECORDATI INDUSTRIA ITALY USE CHIMICA FARMACEUTICA S.P.A.

ANTORAL LOZENGE (THROAT) 5MG RECORDATI INDUSTRIA ITALY CHIMICA FARMACEUTICA S.P.A.

ANUSOL SUPPOSITORY N/A PARKE DAVIS FRANCE

ANUSOL RECTAL OINTMENT N/A PARKE DAVIS FRANCE 470 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ANUSOL SUPPOSITORIES SUPPOSITORY N/A WARNER-LAMBERT UNITED KINGDOM CONSUMER HEALTHCARE

ANXETIN CAPSULES 20MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

ANXIOLAN 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

ANZEMET 100MG/5ML SOLUTION FOR IV 100MG/5ML LABORATOIRES AVENTIS FRANCE INJECTION

ANZEMET 12.5MG/0.625ML SOLUTION FOR IV 12.5MG/0.625ML LABORATOIRES AVENTIS FRANCE INJECTION

ANZEMET 200MG COATED TABLET 200MG LABORATOIRES FRANCE ROUSSEL DIAMANT

APIOCOLINA CREAM 106MG/100G BRUSCHETTINI SRL ITALY

APIOCOLINA SUPPOSITORY 4MG BRUSCHETTINI SRL ITALY

APO ACETAZOLAMIDE TABLET 250MG APOTEX INC CANADA TAB 250MG

APO ALLOPURINOL 100MG TABLET 100MG APOTEX INC CANADA

APO AMPI CAPSULES 500MG CAPSULE 500MG APOTEX INC CANADA

APO TAB 200MG TABLET 200MG APOTEX INC CANADA

APO FOLIC ACID TAB 5MG TABLET 5MG APOTEX INC CANADA

APO GLYBURIDE TAB 2.5MG TABLET 2.5MG APOTEX INC CANADA

APO IMIPRAMINE TAB 10MG TABLET 10MG APOTEX INC CANADA

APO IMIPRAMINE TAB 25MG TABLET 25MG APOTEX INC CANADA

APO ISDN TABLET 10MG APOTEX INC CANADA

APO PRIMIDONE TABLET 250MG APOTEX INC CANADA

APO SULFATRIM TAB TABLET N/A APOTEX INC CANADA

APO TETRA CAP 250MG CAPSULE 250MG APOTEX INC CANADA

APO THIORIDAZINE TABLET 10MG APOTEX INC CANADA

APO TRIHEX TAB 2MG TABLET 2MG APOTEX INC CANADA

APO ZIDOVUDINE CAP 100MG CAPSULE 100MG APOTEX INC CANADA

APO-ALPRAZ TAB 0.5MG TABLET 0.5MG APOTEX INC CANADA

APO-AMITRIPTYLINE HCL TABLET 25MG APOTEX INC CANADA TAB 25MG

APO-AMOXI CAP 500MG CAPSULE 500MG APOTEX INC CANADA

APO-ATENOLOL TABLET 100MG APOTEX INC CANADA

APO-CEPHALEX TAB 500MG TABLET 500MG APOTEX INC CANADA

APO-CLOMIPRAMINE TABLETS TABLET 10MG APOTEX INC CANADA 10MG

APO-CLOMIPRAMINE TABLETS TABLET 25MG APOTEX INC CANADA 25MG 23.9.2003 FR Journal officiel de l'Union européenne 471

Trade Name Dosage Form Dose MA Holder Country

APO-DICLO SR 100MG MODIFIED RELEASE 100MG APOTEX INC CANADA TABLET

APO-DOXY CAP 100MG CAPSULE 100MG APOTEX INC CANADA

APO-FLUOXETINE — CAP 20MG CAPSULE 20MG APOTEX INC CANADA

APO-GLYBURIDE TAB 5MG TABLET 5MG APOTEX INC CANADA

APO-PREDNISONE 5MG TABLETS TABLET 5MG APOTEX INC CANADA

APO- 300MG TABLETS 300MG APOTEX INC CANADA

APO-RANITIDINE TAB 150MG TABLET 150MG APOTEX INC CANADA

APRAZOL CAPSULES 30MG HUSNU ARSAN ILACLARI TURKEY A.S.

APRAZOL ENTERIC COATED 30MG HUSNU ARSAN ILACLARI TURKEY CAPSULE30M A.S.- TURKEY

APRESOLINE SUGAR COATED TABLETS 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

APRESOLINE SUGAR COATED TABLETS 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

APROTININ INJECTION SOLUTION FOR 10 KIU/ML FERRING UNITED KINGDOM INJECTION PHARMACEUTICALS LTD

APROVEL 150MG TABETS TABLET 150MG SANOFI PHARMA FRANCE BRISTOL-MYERS SQUIBB SNC

APROVEL 300MG TABLETS TABLET 300MG SANOFI PHARMA FRANCE BRISTOL-MYERS SQUIBB SNC

APROVEL75MG TABLET TABLET 75MG SANOFI PHARMA FRANCE BRISTOL-MYERS SQUIBB SNC

AQUEOUS CREAM BP CREAM 9% W/W ADAMS HEALTHCARE UNITED KINGDOM LIMITED

AQUEOUS CREAM BP CREAM NO ACTIVE ING. THORNTON & ROSS LTD UNITED KINGDOM

AQUEOUS CREAM BP CREAM N/A RUSCO LIMITED T/A UNITED KINGDOM RUSCO PHARMACEUTICALS

ARAVA FILM-COATED TABLET 10MG HOECHST MARION GERMANY ROUSSEL DEUTSCHLAND GMBH

ARAVA FILM-COATED TABLET 20MG HOECHST MARION GERMANY ROUSSEL DEUTSCHLAND GMBH

ARAVA FILM-COATED TABLET 100MG HOECHST MARION GERMANY ROUSSEL DEUTSCHLAND GMBH

ARCALION TABLETS 200MG SERVIER PAKISTAN

ARCALION 200MG COATED TABLETS SERVIER EGYPT EGYPT INDUSTRIES LTD

ARCALION 200MG COATED TABLET 200MG LABORATOIRES SERVIER FRANCE

ARCALION TABLETS TABLETS 200MG SERVIER PAKISTAN 472 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ARCOXIA FILM-COATED TABLETS 120MG MERCK SHARP AND UNITED KINGDOM DOHME LIMITED

ARCOXIA FILM COATED TABLETS 90MG MERCK SHARP & DOHME UNITED KINGDOM LIMITED

ARCOXIA FILM COATED TABLETS 60MG MERCK SHARP & DOHME UNITED KINGDOM LIMITED

AREDIA DRY SUBSTANCE FOR INJ. 15MG/VIAL NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

AREDIA POWDER FOR INJECTION 30MG/VIAL NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

AREDIA POWDER FOR INJECTION 60MG/VIAL NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

AREDIA POWDER FOR INJECTION 90MG/VIAL NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

AREDIA POWDER FOR INFUSION 15MG NOVARTIS SPAIN FARMACEUTICA S.A. — SPAIN

AREDIA POWDER FOR INFUSION 30MG NOVARTIS SPAIN FARMACEUTICA S.A. — SPAIN

AREDIA POWDER FOR INFUSION 60 MG NOVARTIS SPAIN FARMACEUTICA S.A. — SPAIN

AREDIA POWDER FOR INFUSION 90MG NOVARTIS SPAIN FARMACEUTICA S.A. — SPAIN

ARESTON TABLETS 50MG MEDOCHEMIE LTD. CYPRUS

ARFEN SUSPENSION 120MG/5ML MEDOCHEMIE LTD CYPRUS

ARFEN 125MG SUPPOSITORY 125MG MEDOCHEMIE LTD CYPRUS

ARFEN 250MG SUPPOSITORY 250MG MEDOCHEMIE LTD CYPRUS

ARFEN 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS

ARFEN 500MG SUPPOSITORY 500MG MEDOCHEMIE LTD CYPRUS

ARICEPT 10MG COATED TABLET 10MG EISAI LIMITED UNITED KINGDOM

ARIDIL TABLETS N/A CP PHARMACEUTICALS UNITED KINGDOM LTD.

ARIDIL TABLETS N/A CP PHARMACEUTICALS UNITED KINGDOM LTD.

ARIDIL TABLETS N/A CP PHARMACEUTICALS UNITED KINGDOM LTD.

ARIDIL TABLET N/A CP PHARMACEUTICALS UNITED KINGDOM LTD

ARIDIL TABLET N/A CP PHARMACEUTICALS UNITED KINGDOM LTD

ARIDIL TABLET N/A CP PHARMACEUTICALS UNITED KINGDOM LTD

ARILVAX — YELOW FEVER FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL LIMITED UNITED KINGDOM VACCINE 23.9.2003 FR Journal officiel de l'Union européenne 473

Trade Name Dosage Form Dose MA Holder Country

ARIMIDEX COATED TABLET 1MG ZENECA LIMITED UNITED KINGDOM

ARISTIN-C INJ.SOLUTION OF 200MG/100ML ANFARM HELLAS S.A. GREECE INFUSION

ARISTIN-C FILM COATED TABLETS 500MG ANFARM HELLAS S.A. GREECE

ARISTIN-C FILM-COATED TABLET 250MG ANFARM HELLAS S.A GREECE

ARNETIN 150MG TABLET 150MG MEDOCHEMIE LTD CYPRUS

ARNETIN 50MG/2ML LIQUID FOR INJECTION 50MG/2ML MEDOCHEMIE LTD CYPRUS

ARNICA CREAM 9% A NELSON AND UNITED KINGDOM COMPANY LTD

AROMASIN COATED TABLETS 25MG PHARMACIA & UPJOHN ITALY LIMITED

AROMASIN FILM-COATED TABLETS 25MG PHARMACIA ITALIA SPA ITALY

ARPHOS ORAL SOLUTION N/A LABORATORIES FRANCE FOURNIER S.A.

ART CAPSULE 50MG LABORATOIRES NEGMA FRANCE

ART 50 CAPSULES 50MG NEGMA-LERADS FRANCE

ARTANE TABLETS 2MG CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD.

ARTEX 5MG SCORED COATED TABLET 5MG LES LABORATOIRES FRANCE SERVIER

ARTHRINAL F.C. TABLETS 20MG REMEDICA LTD CYPRUS

ARTHROTEC 50 TABLETS N/A MONSANTO PLC UNITED KINGDOM

ARTHROTEC 50 TABLETS GASTRO-RESISTANT N/A MONSANTO PLC T/A UNITED KINGDOM TABLETS SEARLE

ARTHROTEC 50 TABLETS GASTRO-RESISTANT N/A PHARMACIA LIMITED UNITED KINGDOM TABLET

ARTHROTEC 75 TABLETS N/A MONSANTO PLC T/A UNITED KINGDOM SEARLE

ARTHROTEC 75 GASTRO RESISTANT NA MONSANTO PLC T/A UNITED KINGDOM TABLET SEARLE

ARTHROTEC TABLETS TABLETS NA SEARLE PAKISTAN

ARTHROXEN TABLET 250MG CP PHARMACEUTICALS UNITED KINGDOM LTD

ARTHROXEN TABLET 500MG CP PHARMACEUTICALS UNITED KINGDOM LIMITED

ARTROSILENE FOAM N/A DOMPE FARMACEUTICI ITALY SPA

ARTROSILENE GEL N/A DOMPE FARMACEUTICI ITALY SPA

ARTROSILENE «RETARD» CAPSULES 320MG DOMPE FARMACEUTICI ITALY SPA

ARTROXICAM CAPSULE 20MG FONTEN FARMACEUTICI ITALY S.R.L. 474 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ASCARD TABLETS 75MG ATCO LABORATORIES PAKISTAN (PVT) LTD

ASCARD TABLETS 300MG ATCO LABORATORIES PAKISTAN (PVT) LTD

ASCARD TABLETS 150MG ATCO LABORATORIES PAKISTAN (PVT) LTD

ASCORBIC ACID 100MG TABLETS 100MG PHARMAMED LTD. MALTA

ASCORBIC ACID 250MG TABLETS 250MG PHARMAMED LTD. MALTA

ASCORBIC ACID 500MG CHEWABLE TABLETS 500MG PHARMAMED LTD. MALTA

ASCORBIC ACID BP 100MG TABLET 100MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

ASCORBIC ACID BP 200MG TABLET 200MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

ASCORBIC ACID BP 500MG TABLET 500MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

ASCORBIC ACID BP 50MG TABLET 50MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

ASCORBIC ACID INJECTION SOLUTION FOR 500MG/5ML F.H. FAULDING & CO LTD AUSTRALIA AMPOULE INJECTION (T/A DAVID BULL LABS)

ASCORBIC ACID INJECTION BPC SOLUTION FOR 500MG/5ML EVANS MEDICAL UNITED KINGDOM INJECTION LIMITED

ASCOSAL EFFERVESCENT TABLETS N/A DR. GROSSMAN AG SWITZERLAND PHARMACA

ASCRIPTIN TABLET N/A RORER UNITED KINGDOM PHARMACEUTICALS LTD. (T/A RHONE POULENC RORER)

ASERBINE TOPICAL SOLUTION NA FORLEY LIMITED T/A UNITED KINGDOM FORLEY PHARMACEUTICALS

ASERBINE CREAM NA FORLEY LIMITED T/A UNITED KINGDOM FORLEY PHARMACEUTICALS

ASILONE ANTACID LIQUID ORAL SUSPENSION N/A SETON PRODUCTS UNITED KINGDOM LIMITED

ASILONE ANTACID TABLETS TABLETS N/A SETON PRODUCTS UNITED KINGDOM LIMITED

ASILONE HEARTBURN LIQUID ORAL SUSPENSION N/A SETON PRODUCTS UNITED KINGDOM LIMITED

ASILONE HEARTBURN TABLETS TABLETS N/A SETON PRODUCTS UNITED KINGDOM LIMITED

ASMABEC INHALATION POWDER 50MCG/AC MEDEVA PHARMA UNITED KINGDOM LIMITED

ASMABEC CLICKHALER INHALATION POWDER 250MCG/AC MEDEVA PHARMA UNITED KINGDOM LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 475

Trade Name Dosage Form Dose MA Holder Country

ASMABEC CLICKHALER 100 INHALATION POWDER 100MCG/AC MEDEVA PHARMA UNITED KINGDOM LIMITED

ASMASAL CLICKHALER INHALATION POWDER 95MCG/AC MEDEVA PHARMA UNITED KINGDOM LIMITED

ASMOVAL TABLETS 10MG REMEDICA LTD CYPRUS

ASPARAGINASE 10000 MEDAC POWDER FOR INJECTION 10000IU MEDAC GMBH GERMANY

ASPEGIC 500MG POWDER FOR ORAL SOL. 500MG/SACHET LABORATOIRES FRANCE SYNTHELABO

ASPEGIC FOR INJECTION POWDER FOR INJECTABLE 500MG/5ML LABORATOIRES FRANCE 500MG/5ML SOL SYNTHELABO

ASPIREM 125 SUPPOSITORIES 125MG REMEDICA LTD CYPRUS

ASPIREM 150 E.C. TABLETS 150MG REMEDICA LTD CYPRUS

ASPIREM 300 E.C. TABLETS 300MG REMEDICA LTD CYPRUS

ASPIREM 75 E.C. TABLETS 75MG REMEDICA LTD CYPRUS

ASPIRIN ENTERIC COATED TABLET 75MG THE WALLIS UNITED KINGDOM LABORATORY LIMITED

ASPIRIN TABLETS 75MG PHARMAMED LTD. MALTA

ASPIRIN TABLETS 75MG PHARMAMED LTD. MALTA

ASPIRIN TABLETS 300MG M & A PHARMACHEM UNITED KINGDOM LIMITED

ASPIRIN BP 300MG TABLET 300MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

ASPIRIN BP 75MG TABLET 75MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

ASPIRIN PLUS C EFFERVESCENT TABLET N/A BAYER VITAL GMBH & GERMANY CO. KG

ASPIRIN PROTECT 100 ENTERIC COATED TABLET 100MG BAYER VITAL GMBH & GERMANY CO. KG

ASPIRIN PROTECT 300 ENTERIC COATED TABLET 300MG BAYER VITAL GMBH & GERMANY CO. KG

ASPIRIN TABLETS 75MG EC GASTRO-RESISTANT 75MG THE WALLIS LABORA- UNITED KINGDOM TABS TORY LIMITED

ASPIRIN TABLETS DISPERSIBLE BP DISPERSIBLE TABLETS 75MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

ASPRO 320MG TABLET 320MG LABORATOIRES ROCHE FRANCE NICHOLAS S.A.

ASPRO 500MG EFFERVESCENT TABLET 500MG LABORATOIRES ROCHE FRANCE NICHOLAS S.A.

ASTHALIN 4 TABLET TABLET 4MG CIPLA LTD. INDIA

ASTHALIN INHALER INHALATION AEROSOL 100MCG/DOSE CIPLA LIMITED INDIA

ASTHALIN RESPIRATOR SOLUTION RESPIRATOR SOLUTION 5MG/1ML CIPLA LIMITED INDIA

ASTHALIN SYRUP SYRUP N/A CIPLA LTD INDIA 476 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ASTIZOL TABLETS 10MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LIMITED

ASTRIX 100 CAPSULE 100MG FAULDING AUSTRALIA PHARMACEUTICALS

ASYRAN TABLETS 150MG DELTA HF ICELAND

ASYRAN TABLETS 300MG DELTA HF ICELAND

ATACAND TABLET 16MG ASTRA SWEDEN PHARMACEUTICALS LIMITED

ATACAND 8MG TABLET 8MG ASTRA SWEDEN PHARMACEUTICALS LTD

ATALINE 2.5MG TABLET 2.5MG MEDOCHEMIE LTD CYPRUS

ATARAX FILM-COATED TABLET 25MG U.C.B. S.A. BELGIUM

ATARAX SYRUP 2MG/ML U.C.B. S.A. BELGIUM

ATARAX TABLET 25MG UNITED CHEMICALS OF PAKISTAN BELGIUM

ATENOLOL TABLETS 50MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

ATENOLOL TABLETS 100MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

ATENOLOL TABLETS 100MG PHARMAMED LTD. MALTA

ATENOLOL TABLETS 50MG PHARMAMED LTD. MALTA

ATENOLOL COATED TABLETS 100MG GENERICS (UK) LIMITED UNITED KINGDOM

ATENOLOL DELTA TABLETS 25MG DELTA HF ICELAND

ATENOLOL DELTA TABLETS 50MG DELTA HF ICELAND

ATENOLOL DELTA TABLETS 100MG DELTA HF ICELAND

ATENOLOL DENK 50 FILM-COATED TABLETS 50MG E.DENK OHG GERMANY

ATENSIN 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

ATENSIN 40MG TABLET 40MG MEDOCHEMIE LTD CYPRUS

ATIVAN TABLETS 2.5MG JOHN WYETH & IRELAND BROTHER LIMITED T/A WYETH LABORATORIES

ATIVAN 1MG TABLETS 1MG WYETH-PHARMA GMBH GERMANY

ATIVAN 1MG TABLETS 1MG JOHN WYETH AND UNITED KINGDOM BROTHER LTD T/A WYETH LABORATORIES

ATIVAN 2MG TABLET 2MG WYETH-PHARMA GMBH GERMANY

ATIVAN 2MG TABLETS 2MG JOHN WYETH AND IRELAND BROTHER LIMITED T/A WYETH LABORATORIES

ATODEL TABLETS 1MG REMEDICA LTD. CYPRUS

ATODEL TABLETS 2MG REMEDICA LTD. CYPRUS 23.9.2003 FR Journal officiel de l'Union européenne 477

Trade Name Dosage Form Dose MA Holder Country

ATODEL 1 TABLETS 1MG REMEDICA LTD CYPRUS

ATODEL 2 TABLETS 2MG REMEDICA LTD CYPRUS

ATODEL 5 TABLETS 5MG REMEDICA LTD CYPRUS

ATOMASE AQUEOUS NASAL NASAL SPRAY 50MCG/DOSE DOUGLAS NEW ZEALAND SPRAY PHARMACEUTICALS LTD.

ATROMID-S CAPSULES 500MG ZENECA LIMITED UNITED KINGDOM

ATROPINA 1% FARMIGEA OPHTHALMIC DROPS 5MG FARMIGEA SPA ITALY

ATROPINE SOLUTION FOR 0.5MG/ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

ATROPINE DISPERSA 1% EYE DROPS 1% W/V CIBA VISION AG SWITZERLAND

ATROPINE DISPERSA 1.0% EYE DROPS 10.0MG/ML NOVARTIS SWITZERLAND OPHTHALMICS AG

ATROPINE INJECTION BP MINIJECT SOLUTION FOR N/A INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS (UK) LIMITED

ATROPINE INJECTION BP MINIJET SOLUTION FOR 0.1MG/ML INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS LTD

ATROPINE MINIJET SOLUTION FOR 0.1MG/ML INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS (UK) LIMITED

ATROPINE SULFATE INJECTION USP SOLUTION FOR 0.1MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

ATROPINE SULPHATE TABLETS 600 MCG CP PHARMACEUTICALS UNITED KINGDOM LIMITED

ATROPINE SULPHATE TABLETS 600MCG CP PHARMACEUTICALS UNITED KINGDOM LTD.

ATROPINE SULPHATE SOLUTION FOR 600MCG/ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS

ATROPINE SULPHATE INJECTION INJECTION SOLUTION 0.05% W/V B.BRAUN MELSUNGEN GERMANY 0.5MG AG

ATROPINE SULPHATE INJECTION INJECTION SOLUTION 0.1% W/V B.BRAUN MELSUNGEN GERMANY 1MG AG

ATROPINE SULPHATE INJECTION SOLUTION FOR 600MCG/1ML ANTIGEN IRELAND BP INJECTIONS PHARMACEUTICALS LIMITED

ATROPINE SULPHATE INJECTION SOLUTION FOR 600MCG/ML MACARTHYS UNITED KINGDOM BP 600MCG/ML INJECTION LABORATORIES LIMITED T/A MARTINDALE LIMITED

ATROVENT NEBULISER SOLUTION 500MCG/2ML BOEHRINGER INGELHEIM UNITED KINGDOM LTD

ATROVENT N METERED AEROSOL PUFF SOLUTION 20MCG BOEHRINGER INGELHEIM GERMANY PHARMA KG — GERMANY

ATROVENT NASAL PUMP SPRAY NASAL PUMP SPRAY 0.314MG/ML BOEHRINGER INGELHEIM GERMANY 0.03% PHARMA KG

AUDAX EAR DROPS DROPS N/A MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD. 478 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

AUGMENTIN TABLET 375MG SMITH KLINE & PAKISTAN BEECHAM

AUGMENTIN TABLET N/A SMITH KLINE & PAKISTAN BEECHAM

AUGMENTIN 1.2G IV POWDER FOR INJECTION N/A BEECHAM GROUP PLC UNITED KINGDOM

AUGMENTIN 156MG SUSPENSION POWDER FOR ORAL N/A BEECHAM GROUP PLC UNITED KINGDOM SOLUTION

AUGMENTIN 1G COATED TABLET N/A BEECHAM GROUP PLC UNITED KINGDOM

AUGMENTIN 228MG SUSPENSION POWDER FOR ORAL N/A SMITHKLINE BEECHAM UNITED KINGDOM SUSPEN. PLC

AUGMENTIN 312MG SUSPENSION POWDER FOR ORAL N/A BEECHAM PLC UNITED KINGDOM SOLUTION

AUGMENTIN 457MG SUSPENSION POWDER FOR ORAL N/A SMITHKLINE BEECHAM UNITED KINGDOM SUSPEN. PLC

AUGMENTIN 600MG IV POWDER FOR INJECTION N/A BEECHAM GROUP PLC UNITED KINGDOM

AUGMENTIN 625MG TABLETS COATED TABLET N/A BEECHAM GROUP PLC UNITED KINGDOM

AUGMENTIN 625MG TABS. TWICE COATED TABLET N/A BEECHAM GROUP PLC UNITED KINGDOM DAILY DOSING

AUGMENTIN DISPERSIBLE TABLETS TABLET FOR ORAL N/A BEECHAM GROUP PLC UNITED KINGDOM 375MG SOLUTION

AUGMENTIN INFANT DROPS POWDER FOR ORAL N/A BEECHAM GROUP PLC UNITED KINGDOM SOLUTION

AUGMENTIN TABLETS 375MG COATED TABLET N/A BEECHAM GROUP PLC UNITED KINGDOM

AULIN TABLETS 100MG HELSINN BIREX IRELAND PHARMACEUTICALS LTD.

AULIN ORAL POWDER FOR 100MG/SACHET HELSINN BIREX IRELAND RECON. PHARMACEUTICALS LTD.

AUNATIV SOLUTION FOR 250IU/ML PHARMACIA & UPJOHN SWEDEN INJECTION AB

AUNATIV SOLUTION FOR SOLUTION FOR 200IU/ML BIOVITRUM SWEDEN INJECTION INJECTION

AUREOMYCIN OINTMENT OINTMENT 3% W/W CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD.

AUREOMYCIN SALBE OINTMENT 3G/100G LEDERLE ARZNEIMITTEL GERMANY GMBH & CO

AUREOMYCINE MONOT 3% OINTMENT 3% LABORATOIRES MONOT FRANCE

AURIGOUTTE EAR DROPS N/A LABORAOIRES MONOT FRANCE

AVALOX 400MG FILM-COATED TABLET 400MG BAYER VITAL GMBH & GERMANY CO. KG

AVANDIA TABLET 2MG SMITHKLINE BEECHAM UNITED STATES OF CORPORATION AMERICA

AVANDIA TABLET 4MG SMITHKLINE BEECHAM UNITED STATES OF CORPORATION AMERICA

AVANDIA TABLET 8MG SMITHKLINE BEECHAM UNITED STATES OF CORPORATION AMERICA 23.9.2003 FR Journal officiel de l'Union européenne 479

Trade Name Dosage Form Dose MA Holder Country

AVANDIA FILM-COATED TABLETS 1MG SMITHKLINE BEECHAM EUROPEAN COMMUNITY PLC

AVANDIA FILM-COATED TABLETS 2MG SMITHKLINE BEECHAM EUROPEAN COMMUNITY PLC

AVANDIA FILM COATED TABLETS 4MG SMITHKLINE BEECHAM EUROPEAN COMMUNITY PLC

AVANDIA FILM COATED TABLETS 8MG SMITHKLINE BEECHAM EUROPEAN COMMUNITY PLC

AVANT 1.5MG TABLET 1.5MG MEDOCHEMIE LTD CYPRUS

AVANT 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

AVANT 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

AVAXIM SUSPENSION FOR 160 AU/0.5ML PASTEUR MERIEUX FRANCE INJECTION

AVELOX FILM-COATED TABLET 400MG BAYER VITAL GMBH & GERMANY CO. KG

AVERNOL TABLETS 25MG MEDOCHEMIE LTD. CYPRUS

AVIPUR TABLETS 50,000IU TARO ISRAEL PHARMACEUTICAL INDUSTRIES LTD.

AVIPUR TABLETS TABLET 50,000 IU TARO ISRAEL PHARMACEUTICAL INDUSTRIES LTD

AVIRAL-200 TABLETS 200MG MEPHA PHARMA AG SWITZERLAND

AVIRAL-400 TABLETS 400MG MEPHA PAHRMA AG SWITZERLAND

AVIRAL-800 TABLETS 800MG MEPHA PHARMA AG SWITZERLAND

AVOCLOR TABLET 250MG ZENECA LIMITED UNITED KINGDOM

AVOMINE TABLETS 25MG MANX PHARMA LIMITED UNITED KINGDOM

AVOMINE TABLET 25MG RHONE-POULENC RORER PAKISTAN PAKISTAN (PVT) LIMITED

AVONEX POWDER + SOLVENT FOR 30UG/ML BIOGEN FRANCE S.A. FRANCE INJ.

AVONEX POWDER AND SOLVENT 30MCG BIOGEN FRANCE S.A. EUROPEAN COMMUNITY FOR INJ

AXETINE 250MG POWDER FOR INJECTION 250MG MEDOCHEMIE LTD CYPRUS

AXETINE 750MG POWDER FOR INJECTION 750MG MEDOCHEMIE LTD CYPRUS

AXSAIN CREAM 0.075% W / W BIOGLAN UNITED KINGDOM LABORATORIES LTD

AXURA FILM-COATED TABLETS 10MG MERZ EUROPEAN COMMUNITY PHARMACEUTICALS GMBH

AXURA ORAL DROPS SOLUTION 10MG/G MERZ EUROPEAN COMMUNITY HARMACEUTICALS GMBH

AZACTAM POWDER FOR INJECTION 500MG BRISTOL-MYERS SQUIBB ITALY S.P.A 480 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

AZACTAM POWDER FOR INJECTION 1G BRISTOL-MYERS SQUIBB ITALY S.P.A

AZACTAM POWDER FOR INJECTION 1G E R SQUIBB & SONS UNITED KINGDOM LIMITED

AZACTAM POWDER FOR INJECTION 2GM ER SQUIBB & SONS UNITED KINGDOM LIMITED

AZAMUN FILM COATED TABLET 50MG DOUGLAS NEW ZEALAND PHARMACEUTICALS LTD

AZANTAC 150MG EFFERVESCENT TABLET 150MG GLAXO WELLCOME FRANCE

AZANTAC 300MG EFFEVESCENT TABLET 300MG GLAXO WELLCOME FRANCE

AZATHIOPRINE BP FILM COATED TABLETS 50MG GENERICS (UK) LIMITED UNITED KINGDOM

AZATHIOPRINE PCH TABLET 50MG PHARMACHEMIE BV NETHERLANDS

AZATHIOPRINE TABLETS 50MG TABLETS 50MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

AZATHIOPRINE TABLETS BP 50MG FILM COATED TABLETS 50MG GENERICS (UK) LIMITED UNITED KINGDOM

AZATRILEM TABLETS 50MG LEMERY S.A. MEXICO

AZEE, AZITHROMYCIN CAPSULES CAPSULES 250 MG CIPLA LTD. INDIA USP

AZELDERM CREAM 20%W/W KLEVA LIMITED GREECE

AZEPTIL 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

AZEPTIL 500MG CAPSULE 500MG MEDOCHEMIE LTD CYPRUS

AZEPTIL 500MG/5ML LIQUID FOR INJECTION 500MG/5ML MEDOCHEMIE LTD CYPRUS

AZITHROMYCIN CAPSULE 250MG PFIZER LIMITED UNITED KINGDOM

AZOPT OPHTHALMIC 10MG/ML ALCON LABORATORIES UNITED STATES OF SUSPENSION INC. AMERICA

AZOPT EYE DROPS SOLUTION 10MG/ML ALCON LABORATORIES EUROPEAN COMMUNITY UK LIMITED

BABY MELTUS FOR BABIES ORAL SOLUTION 0.42 ML CUPAL LIMITED UNITED KINGDOM COUGHS

BACLOFEN TABLETS 10MG TABLET 10MG GENERICS (UK) LIMITED UNITED KINGDOM

BACLOFEN TABLETS 10MG TABLET 10MG GENERICS (UK) LIMITED UNITED KINGDOM

BACLOFEN TABLETS 10MG TABLETS 10MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

BACLON 10MG TABLET 10MG LEIRAS OY FINLAND

BACTROBAN OINTMENT 2% W/W BEECHAM GROUP PLC UNITED KINGDOM

BACTROBAN CREAM 2% W/W SMITHKLINE BEECHAM UNITED STATES OF PHARMACEUTICALS AMERICA

BACTROBAN CREAM CREAM 2% W/W BEECHAM GROUP PLC UNITED KINGDOM

BACTROBAN NASAL OINTMENT NASAL OINTMENT 2% W/W BEECHAM GROUP PLC UNITED KINGDOM 2% W/W

BALANCED SALT SOLUTION IRRIGATING SOLUTION N/A TAYLOR UNITED STATES OF (AKORN) PHARMACEUTICALS AMERICA 23.9.2003 FR Journal officiel de l'Union européenne 481

Trade Name Dosage Form Dose MA Holder Country

BALKIS 0.05% NASAL DROPS SOLUTION 0.05% W/V DOLORGIET GMBH & CO. GERMANY KG

BALKIS 0.1% NASAL DROPS SOLUTION 0.1% W/V DOLORGIET GMBH & CO. GERMANY KG

BALKIS NASAL SPRAY SOLUTION 1MG/ML DOLORGIET GMBH & CO. GERMANY KG

BALKIS NASAL SPRAY SOLUTION NASAL SPRAY 1MG/ML DOLORGIET GMBH & CO GERMANY KG

BALMOSA CREAM N/A PHARMAX LIMITED UNITED KINGDOM

BALTO FOOT BALM OINTMENT N/A G R LANE HEALTH UNITED KINGDOM PRODUCTS LTD

BARILUX HD POWDER 96.805% W/W GOLDHAM PHARMA GERMANY GMBH

BAYCUTEN N CREAM N/A BAYER VITAL GMBH & GERMANY CO. AG

BAYCUTEN N CREAM N/A BAYER PAKISTAN

BAYCUTEN-N CREAM N/A BAYER PAKISTAN

BAYRO GEL GEL NA TROPON GMBH GERMANY

BAYROGEL GEL 50MG/G BAYER VITAL GMBH & GERMANY CO. KG

BAZUKA EXTRA STRENGTH GEL GEL 26% W/W DIOMED DEVELOPMENTS UNITED KINGDOM LIMITED T/A DERMAL LABORATORIES

BAZUKA GEL GEL N/A DIOMED DEVELOPMENTS UNITED KINGDOM LIMITED T/A DERMAL LABORATORIES

BCG VACCINE INTRADERMAL BP FREEZE DIRED PREP. F/INJ. N/A EVANS MEDICAL LIMITED UNITED KINGDOM

BCG VACCINE INTRADERMAL BP FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL LIMITED UNITED KINGDOM ISONIAZID RES

BCG VACCINE PERCUTANEOUS BP FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL LIMITED UNITED KINGDOM

BCG VACCINE SSI POWDER FOR INJECTION 0.75MG/ML STATENS SERUM INSTI- DENMARK TUT

BEBEGEL RECTAL GEL N/A ASTA MEDICA FRANCE

BECADRIL 500 CASULES 500MG REMEDICA LTD CYPRUS

BECEDRIL 1G TABLETS 1G REMEDICA LTD CYPRUS

BECEVIT S.C. TABLETS N/A REMEDICA LTD CYPRUS

BECEVIT TABLETS NA REMEDICA LTD. CYPRUS

BECLATE 250 INHALER INHALER 250MCG/ACTUATIO CIPLA LIMITED INDIA

BECLATE-50 INHALER 50MCG CIPLA LIMITED INDIA

BECLAZONE 100 INHALER 100MCG/DOSE NORTON HEALTHCARE UNITED KINGDOM LIMITED

BECLAZONE 100 CFC-FREE INHALER 100MCG/DOSE NORTON (WATERFORD) IRELAND 482 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BECLAZONE 250 INHALER 250MCG/DOSE NORTON HEALTHCARE UNITED KINGDOM LIMITED

BECLAZONE 250 CFC-FREE INHALER 250MCG/DOSE NORTON (WATERFORD) IRELAND INHALER

BECLAZONE 50 INHALER 50MCG/DOSE NORTON HEALTHCARE UNITED KINGDOM LIMITED

BECLAZONE 50 CFC-FREE INHALER INHALER 50MCG/DOSE NORTON (WATERFORD) UNITED KINGDOM

BECLAZONE 50 EASI-BREATHE INHALER 50MCG/DOSE NORTON (WATERFORD) IRELAND CFC-FREE

BECLAZONE EASI-BREATHE INHALER 250MCG/DOSE NORTON (WATERFORD) IRELAND CFC-FREE

BECLOFORTE METERED AEROSOL N/A GLAXOWELLCOME PAKISTAN

BECLOFORTE INHALER AEROSOL 250 MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LTD T/A ALLEN & HANBURYS

BECLOFORTE INHALER AEROSOL 250MCG/DOSE GLAXO WELLCOME UK UNITED KINGDOM LIMITED

BECLOMETASONE DIPROPIONATE AQUEOUS NASAL SPRAY 0.039%W/V ASHBOURNE UNITED KINGDOM 50MCG PHARMACEUTICAL (HOLDINGS) LIMITED

BECLOMETHASONE AQUEOUS NASAL SPRAY 50MCG/DOSE NORTON HEALTHCARE UNITED KINGDOM DIPROPIONATE LIMITED

BECLOMETHASONE NASAL SPRAY 50MCG/ACTUATION GENERICS (UK) LIMITED UNITED KINGDOM DIPROPIONATE AQ. NASAL SP

BECLOMIST NASAL SPRAY FOR NASAL SPRAY 50MCG/ACTUATION PARKFIELDS UNITED KINGDOM HAYFEVER PHARMACEUTICALS LIMITED

BECONASE ALLERGY NASAL SPRAY 50MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LTD T/A ALLEN & HANDURYS

BECONASE AQUEOUS NASAL NASAL SPRAY 50MCG/AC GLAXO WELLCOME UK UNITED KINGDOM SPRAY LTD T/A ALLEN & HANBURYS

BECONASE AQUEOUS NASAL NASAL SPRAY 50UG/AC GLAXO WELLCOME UK UNITED KINGDOM SPRAY LIMITED T/A ALLEN & HANDBURYS

BECONASE AQUEOUS NASAL NASAL SPRAY 50MCG/DOSE ALLEN FARMACEUTICA SPAIN SPRAY SUSPENSION S.A.

BECONASE HAYFEVER NASAL SPRAY 50MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LIMITED

BECONASE HAYFEVER NASAL SPRAY 50UG/AC GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN & HANDBURYS

BECOTIDE AEROSOL F/INH. 50MCG/DOSE GLAXOWELLCOME PAKISTAN

BECOTIDE 100 INHALER AEROSOL 100MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LTD T/A ALLEN & HANBURYS

BECOTIDE 100 INHALER AEROSOL 100UG/AC GLAXO WELLCOME UK UNITED KINGDOM LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 483

Trade Name Dosage Form Dose MA Holder Country

BECOTIDE 50 INHALER AEROSOL 50MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LTD T/A ALLEN & HANBURYS

BECOTIDE 50 INHALER AEROSOL 50MCG/DOSE GLAXO WELLCOME UK UNITED KINGDOM LIMITED

BECOZYM FORTE SUGAR-COATED TABLET N/A ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

BEECHAM 75MG ASPIRIN TABLETS TABLET 75MG BEECHAM GROUP PLC UNITED KINGDOM T/A SMITHKLINE BEE- CHAM CONSUMER HEALTHCARE

BEECHAM DAY NURSE ORAL SOLUTION N/A BEECHAM GROUP PLC UNITED KINGDOM

BEECHAMS ALL-IN-ONE ORAL SOLUTION N/A BEECHAM GROUP PLC UNITED KINGDOM T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

BEECHAMS COLD AND FLU HOT POWDER FOR ORAL N/A BEECHAM GROUP PLC UNITED KINGDOM BLACKCURRANT SOLUTION T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

BEECHAMS COLD AND FLU HOT POWDER FOR ORAL N/A BEECHAM GROUP PLC UNITED KINGDOM LEMON SOLUTION T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

BEECHAMS COLD AND FLU HOT POWDER FOR ORAL N/A BEECHAM GROUP PLC UNITED KINGDOM LEMON AND HONEY SOLUTION T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

BEECHAMS FLU-PLUS HOT LEMON POWDER FOR ORAL NA BEECHAM GROUP PLC UNITED KINGDOM SOLUTION

BEECHAMS POWDER POWDER FOR ORAL NA BEECHAM GROUP PLC UNITED KINGDOM SOLUTION T/A GLAXOSMITHKLINE CONSUMER HEALTHCARE

BEECHAMS THROAT-PLUS BLACK- LOZENGES NA BEECHAM GROUP PLC UNITED KINGDOM CURRANT T/A GLAXOSMITHKLINE CONSUMER HEALTHCARE

BEECHAMS THROAT-PLUS LEMON LOZENGES NA BEECHAM GROUP PLC UNITED KINGDOM T/A GLAXOSMITHKLINE CONSUMER HEALTHCARE

BEECHAM'S VENO'S COUGH MIX- ORAL SOLUTION N/A BEECHAM GROUP PLC UNITED KINGDOM TURE T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

BEECHAMS VENO'S EXPECTORANT ORAL SOLUTION N/A BEECHAM GROUP PLC UNITED KINGDOM T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

BEECHAMS VENO'S HONEY AND ORAL SOLUTION N/A BEECHAM GROUP PLC UNITED KINGDOM LEMON T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE 484 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BEECHAMS WARMERS POWDER FOR ORAL N/A BEECHAM GROUP PLC UNITED KINGDOM BLACKCURRANT SOLUTION T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

BEECHAMS WARMERS LEMON POWDER FOR ORAL N/A BEECHAM GROUP PLC UNITED KINGDOM SOLUTION T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

BEECHAMS WARMERS LEMON POWDER FOR ORAL N/A BEECHAM GROUP PLC UNITED KINGDOM AND HONEY SOLUTION T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

BEGROCIT EFFERVESCENT TABLET N/A DR.GROSSMANN AG SWITZERLAND PHARMACA

BELARAMINE EXPECTORANT SYRUP N/A REMEDICA LTD CYPRUS

BELL'S CHILDRENS COUGH SYRUP ORAL LIQUID 100MG/5ML BELL SONS & CO UNITED KINGDOM (DRUGGISTS) LIMITED

BELL'S WINTERGREEN OINTMENT OINTMENT N/A BELL SONS & CO UNITED KINGDOM (DRUGGISTS) LIMITED

BENADRYL ALLERGY RELIEF CAPSULE 8MG WARNER-LAMBERT UNITED KINGDOM CONSUMER HEALTHCARE

BENDROFLUAZIDE TABLET 5MG CAMDEN INDUSTRIES (M) MALAYSIA SDN.BHD

BENDROFLUAZIDE BP 5MG TABLET 5MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMI- TED

BENDROFLUAZIDE TABLETS BP TABLET 5MG CP PHARMACEUTICALS UNITED KINGDOM 5MG LTD

BENOXYL 5 LOTION / PANOXYL 5 TOPICAL EMULSION 5% W/W STIEFEL LABORATORIES UNITED KINGDOM LOTION (UK) LIMITED

BENT 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

BENXHEXOL 2 TABLETS TABLETS 2MG REMEDICA LTD CYPRUS

BENYLIN CHESTY COUGHS SYRUP N/A WARNER-LAMBERT UNITED KINGDOM (NON-DROWSY) CONSUMER HEALTHCARE

BENYLIN CHESTY COUGHS SYRUP N/A WARNER-LAMBERT UNITED KINGDOM (ORIGINAL) CONSUMER HEALTHCARE

BENYLIN CHILDREN'S CHESTY SYRUP 50MG/5ML WARNER-LAMBERT UNITED KINGDOM COUGHS CONSUMER HEALTHCARE

BENYLIN CHILDREN'S NIGHT SYRUP N/A WARNER-LAMBERT UNITED KINGDOM COUGHS CONSUMER HEALTHCARE

BENYLIN CHILDREN'S NIGHT SYRUP N/A PFIZER CONSUMER UNITED KINGDOM COUGHS HEALTHCARE

BENYLIN DRY COUGHS (NON SYRUP 7.5MG/5ML WARNER-LAMBERT UNITED KINGDOM DROWSY) CONSUMER HEALTHCARE 23.9.2003 FR Journal officiel de l'Union européenne 485

Trade Name Dosage Form Dose MA Holder Country

BENYLIN DRY COUGHS (ORIGINAL) SYRUP N/A WARNER-LAMBERT UNITED KINGDOM CONSUMER HEALTHCARE

BENYLIN FOUR FLU LIQUID ORAL SOLUTION N/A WARNER-LAMBERT UNITED KINGDOM CONSUMER HEALTHCARE

BENYLIN FOUR FLU LIQUID ORAL SOLUTION N/A PFIZER CONSUMER UNITED KINGDOM HEALTHCARE

BENYLIN WITH CODEINE SYRUP N/A WARNER-LAMBERT UNITED KINGDOM CONSUMER HEALTHCARE

BENZAMYCIN GEL GEL N/A DERMIK LABORATORIES UNITED KINGDOM INC.

BENZET LOZENGES NA ADCOCK INGRAM SOUTH AFRICA LIMITED

BENZHEXOL BP TABLET 2MG BIOREX LABORATORIES UNITED KINGDOM LTD.

BENZOIN TINCTURE BP TOPICAL TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM SOLUTION

BENZYL BENZOATE APPLICATION TOPICAL EMULSION 25% W/V BELL SONS & CO UNITED KINGDOM BP (DRUGGISTS) LTD

BENZYL BENZOATE APPLICATION TOPICAL EMULSION N/A THORNTON & ROSS UNITED KINGDOM BP

BEPANTHEN CREAM 50MG/G ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

BEPANTHEN LOTION 25MG/ML ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

BEPANTHEN ROCHE CREAM CREAM 50MG/G HOFFMAN-LA ROCHE AG GERMANY

BEPANTHEN ROCHE OINTMENT OINTMENT 50MG/G HOFFMAN-LA ROCHE AG GERMANY

BEPROGEL TOPICAL SOLUTION 0.5MG/ML HOE PHARMACEUTICALS MALAYSIA SDN BHD

BEPROGEL TOPICAL SOLUTION N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

BEPROSONE CREAM 0.064% W/W HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

BERIATE P 1000. DRY SUBSTANCE AND N/A AVENTIS BEHRING GMBH GERMANY SOLVENT

BERMOXEL 600MG TABLET 600MG MEDOCHEMIE LTD CYPRUS

BEROCIL 4MG TABLET 4MG MEDOCHEMIE LTD CYPRUS

BEROTEC METERED AEROSOL 100MCG / PUFF BOEHRINGER INGELHEIM GERMANY PHARMA KG

BETABIOPTAL EYE DROPS N/A FARMILA FARMACEUTICI ITALY MILANO S.P.A.

BETACORTEN SCALP APPLICATION 0.1%W/W TRIMA ISRAEL ISRAEL PHARMACEUTICAL PRODUCTS LIMITED

BETADERM CRM 0.1%W/W CREAM 0.1% W/W TARO CANADA PHARMACEUTICALS INC 486 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BETADERM ONT 0.1% W/W OINTMENT 0.1% W/W TARO CANADA PHARMACEUTICALS INC

BETADINE ALCOHOLIC SOLUTION SOLUTION 10% MUNDIPHARMA CYPRUS 10% PHARMACEUTICALS LTD

BETADINE ALCOHOLIC SOLUTION TOPICAL ALCOHOLIC 10% W/V MUNDIPHARMA CYPRUS 1O% SOLUT. PHARMACEUTICALS LTD.

BETADINE ANTISEPTIC PAINT 10% ANTISEPTIC PAINT 10%W/V MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

BETADINE ANTISEPTIC SOLUTION SOLUTION 10% MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

BETADINE ANTISEPTIC SOLUTION ANTISEPTIC SOLUTION 10%W/V MUNDIPHARMA CYPRUS 10% PHARMACEUTICALS LTD

BETADINE CREAM CREAM 5%W/W MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

BETADINE CREAM CREAM 5%W/W MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

BETADINE DRY POWDER SPRAY POWDER 2.5% W/W MUNDIPHARMA CYPRUS 2.5% PHARMACEUTICALS LTD

BETADINE GARGLE AND GARGLE 1%W/V MUNDIPHARMA CYPRUS MOUTHWASH PHARMACEUTICALS LTD

BETADINE GARGLE AND GARGLE 1%W/V MUNDIPHARMA CYPRUS MOUTHWASH 1% PHARMACEUTICALS LTD.

BETADINE OINTMENT 10% OINTMENT 10%W/W MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

BETADINE OINTMENT 10% OINTMENT 10%W/W MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD.

BETADINE SCALP ANDSKIN TOPICAL LIQUID SOAP 7.5%W/V MUNDIPHARMA CYPRUS CLEANSER 7.5% PHARMACEUTICALS LTD.

BETADINE SHAMPOO 4% SHAMPOO 4%W/V MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD.

BETADINE SKIN CLEANSER 4% TOPICAL LIQUID SOAP 4%W/V MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

BETADINE SURGICAL SCRUB 7.5% TOPICAL LIQUID SOAP 7.5%W/V MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

BETADINE VAGINAL DOUCHE 10% DOUCHE 10%W/V MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

BETADINE VAGINAL DOUCHE 10% DOUCHE 10%W/V MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

BETAFERON POWDER FOR SOLN. FOR 0.25MG/ML SCHERING UNITED KINGDOM INJ. AKTIENGESELLSCHAFT

BETAFERON POWDER AND SOLVENT 0.25MG/ML SCHERING EUROPEAN COMMUNITY F/SOLUTION F/INJECTION AKTIENGESELLSCHAFT

BETAGAN (LEVOBUNOLOL HCL) TOPICAL OPHTHALMIC 0.5% W/V ALLERGAN IRELAND LIQUIFILM SOLN. PHARMACEUTICALS (IRELAND) LTD., INC.

BETAHISTINE DIHYDROCHLORIDE TABLET 8MG GENERICS (UK) LIMITED UNITED KINGDOM TABLETS 8MG

BETAKSIM STERILE POWDER FOR INJ. 1G MUSTAFA NEVZAT ILAC TURKEY SANAYII A.S. 23.9.2003 FR Journal officiel de l'Union européenne 487

Trade Name Dosage Form Dose MA Holder Country

BETAMESOL CREAM 0.05% W/W PROGE FARM S.R.L. ITALY

BETAMESOL TUBO 30G CREMA CREAM N/A PROGE FARM S.R.L ITALY 0.05%

BETAMETHASONE CREAM CREAM 0.1% W/W SM PHARMACEUTICALS MALAYSIA 0.1%W/W SDN.BHD.

BETAPLEX TABLET N/A CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD.

BETAPYN TABLET N/A ADCOCK INGRAM LTD SOUTH AFRICA

BETASERC TABLET 8MG SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

BETASERC TABLET 16MG SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

BETASONE CREAM CREAM 0.1% W/W SDN. BHD. MALAYSIA

BETAVIX SYRUP SYRUP 7.5MG/5ML GENEPHARM S.A. GREECE

BETNESOL 0.50MG EFFERVESCENT TABLET 0.5MG GLAXO WELLCOME FRANCE

BETNOVATE CREAM 1MG/G GLAXO WELLCOME PAKISTAN

BETNOVATE OINTMENT 1MG/G GLAXO WELLCOME PAKISTAN

BETNOVATE C CREAM CREAM N/A GLAXO WELLCOME UK UNITED KINGDOM LTD T/A GLAXO LABS

BETNOVATE C CREAM CREAM NA GLAXO WELLCOME UK UNITED KINGDOM LIMITED

BETNOVATE CREAM CREAM 0.122% W/W GLAXO WELLCOME UK UNITED KINGDOM LTD

BETNOVATE CREAM CREAM 0.122%W/W GLAXO WELLCOME UK UNITED KINGDOM LIMITED

BETNOVATE N CREAM CREAM N/A GLAXO WELLCOME UK UNITED KINGDOM LTD T/A GLAXO LABS

BETNOVATE N CREAM CREAM NA GLAXO WELLCOME UK UNITED KINGDOM LIMITED

BETNOVATE OINTMENT OINTMENT 0.122% W/W GLAXO WELLCOME LTD UNITED KINGDOM T/A GLAXO LABS

BETNOVATE OINTMENT OINTMENT 0.1% W/W GLAXO WELLCOME UK UNITED KINGDOM LIMITED

BETNOVATE SCALP TOPICAL SOLUTION 0.1%W/W GLAXO WELLCOME UK UNITED KINGDOM LIMITED

BETNOVATE SCALP APPLICATION TOPICAL SOLUTION 0.122% W/W GLAXO WELLCOME UK UNITED KINGDOM LTD

BETNOVATE SCALP APPLICATION SOLUTION FOR TOPICAL 0.122%W/W GLAXO WELLCOME UK GERMANY USE LIMITED

BETNOVATE SCALP APPLICATION TOPICAL SOLUTION 0.1%W/W GLAXO LABORATORIES UNITED KINGDOM LIMITED

BETOPTIC S/BETOPTIC OPHTHALMIC 2.5MG/ML S.A. ALCON-COUVREUR BELGIUM SUSPENSION SUSPENSION N.V.

BETRISS TABLET N/A MEDOCHEMIE LTD CYPRUS 488 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BETTAMOUSSE CUTANEOUS FOAM 0.12%W/W MEDEVA PHARMA UNITED KINGDOM LIMITED

BEZALIP FILM COATED TABLET 200MG HOFFMANN-LA ROCHE GERMANY AG

BEZALIP RETARD COATED SUSTAINED REL. 400MG HOFFMANN-LA ROCHE GERMANY TAB

BI PRETERAX TABLET N/A LES LABORATOIRES FRANCE SERVIER

BIAFINE EMLSION F/CUTANEOUS 0.67G/100G LABORATOIRES MEDIX FRANCE APPL.

BIO 3 CAMOMILE TEA INFUSION BAG 1.5G BIODES, S.L. SPAIN

BIO 3 HERBAL TEA INFUSION BAG 1.5G BIODES, S.L. SPAIN

BIO 3 OBESIDAD-OBESITY CAPSULES 500MG BIODES, S.L. SPAIN

BIO 3 POWDER FOR ORAL POWDER N/A BIODES S.L. SPAIN RECONSTITUTION

BIO 3 WEIGHT CONTROL INFUSION BAG N/A BIODES, S.L. SPAIN

BIOCADMIO SUSPENSION CUTANEOUS SUSPENSION 1G/100ML J.URIACH & CIA. S.A. SPAIN

BIOCALYPTOL WITH PHOLCODINE SYRUP N/A LABORATORIES LAPHAL FRANCE

BIOCARBON TABLETS NA F.TRENKA CHEMISCH- AUSTRIA PHARMAZEUTISCHE FABRIK GMBH

BIOCINE TEST PPD INTRADER. MULTIPUNC. N/A CHIRON S.P.A. ITALY TEST

BIODRAMINA CHEWING-GUM 20MG J.URIACH & CIA. S.A. SPAIN

BIODRAMINA TABLET 50MG J.URIACH & CIA. S.A. SPAIN

BIODRAMINA INFANTILE SUPPOSITORY 50MG J.URIACH & CIA. S.A. SPAIN

BIOELECTRA CALCIUM 500 EFFERVESCENT TABLETS 500MG HERMES ARZNEMEITTEL GERMANY GMBH

BIOFERON 1 M.I.U FREEZE DRIED PWR FOR 1000000 IU INSTITUTO SIDUS S.A. ARGENTINA INJ

BIOFERON 10 M.I.U. FREEZE DRIED PWR FOR 10000000 IU INSTITUTO SIDUS S.A. ARGENTINA INJ

BIOFERON 3 M.I.U FREEZE DRIED PWD FOR 3000000 IU INSTITUTO SIDUS S.A ARGENTINA INJ

BIOFERON 5 M.I.U FREEZE DRIED PWD FOR 5000000 IU INSTITUTO SIDUS S.A ARGENTINA INJ

BIOFLOR CAPSULES 250MG BIOMED AG SWITZERLAND

BIOFLOR POWDER FOR ORAL SUSP. 250MG/SACHET BIOMED AG SWITZERLAND

BIOLECTRA CALCIUM 500 EFFERVESCENT TABLET 500MG HERMES ARZNEIMITTEL GERMANY GMBH

BIOPLUS EFFERVESCENT TABLETS TABLETS N/A ADCOCK INGRAM LTD SOUTH AFRICA 23.9.2003 FR Journal officiel de l'Union européenne 489

Trade Name Dosage Form Dose MA Holder Country

BIORAL GEL OROMUCOSAL GEL 2% W/W SEVEN SEAS LIMITED T/A UNITED KINGDOM MERCK CONSUMER HEALTH

BIORINIL NASAL SPRAY, SUSPEN- N/A FARMILA FARMACEUTICI ITALY SION MILANO S.P.A.

BIOSELENIUM SUSPENSION CUTANEOUS SUSPENSION 2.5G/100ML J.URIACH & CIA. S.A. SPAIN

BIO-STAR CAPSULES 80MG LABORATORIOS NOVAG, SPAIN S.A.

BIO-STAR VIALS ORAL SOLUTION N/A LABORATORIOS NOVAG, SPAIN S.A.

BIOTONE ORAL SOLN IN AMPOULE N/A LABORATORIES LAPHAL FRANCE

BIPROFENID 150MG TABLET 150MG SPECIA LABORATORIES FRANCE

BISACODYL TABLETS 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

BISACODYL BP 5MG TABLET 5MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

BISACODYL SUPPOSITORIES BP SUPPOSITORY 10MG MARTINDALE UNITED KINGDOM 10MG PHARMACEUTICALS LTD

BISACODYL TABLET 5MG TABLET 5MG CAMDEN INDUSTRIES (M) MALAYSIA SDN BHD

BISACODYL TABLET B.P. 5MG TABLET 5MG PHARMMALAYSIA MALAYSIA BERHAD

BISACODYL TABLETS 5MG TABLET 5MG GEOFMAN PAKISTAN PHARMACEUTICALS

BISMUTH SUBNITRATE AND IMPREGNATED GAUZE N/A AURUM UNITED KINGDOM IODOFORM PASTE PHARMACEUTICALS LIMITED

BISODOL HEARTBURN RELIEF TABLETS N/A WHITEHALL UNITED KINGDOM TABLETS LABORATORIES LTD

BISODOL INDIGESTION RELIEF TABLETS N/A WHITEHALL UNITED KINGDOM TABLETS LABORATORIES LTD

BISODOL TABLETS TABLETS N/A WHITEHALL UNITED KINGDOM LABORATORIES LTD

BISOLAX 10MG SUPPOSITORY 10MG MEDOCHEMIE LTD CYPRUS

BISOLAX 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

BISOLVON SOLUTION 0.2G/100ML BOEHRINGER INGELHEIM GERMANY PHARMA KG

BISOLVON SOLUTION FOR 8MG/4ML BOEHRINGER INGELHEIM GERMANY INJECTION PHARMA KG

BISOLVON SYRUP 0.08G/100ML BOEHRINGER INGELHEIM GERMANY PHARMA KG

BISOLVON TABLETS 8MG BOEHRINGER INGELHEIM GERMANY PHARMA KG

BISOLVON TABLETS 8MG BOEHRINGER INGELHEIM PAKISTAN

BI-TILDIEM SR 120MG SR COATED TABLET 120MG LABORATOIRES FRANCE SYNTHELABO 490 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BI-TILDIEM SR 90MG SR COATED TABLET 90MG LABORATOIRES FRANCE SYNTHELABO

BLEO-KYOWA POWDER FOR INJECTION 15,000IU KYOWA HAKKO (UK) LTD UNITED KINGDOM

BLEOLEM POWDER FOR INJECTIONS 15.00U/5ML LEMERY, S.A. DE C.V. MEXICO

BLEOLEM POWDER FOR INJECTION 15U/5ML LEMERY S.A. DE C.V. MEXICO

BLISTEX RELIEF CREAM CREAM NA DDD LIMITED UNITED KINGDOM

BLISTEZE CREAM CREAM N/A D D D LIMITED UNITED KINGDOM

BLITZ 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

BLOPRESID 16/12.5MG TABLETS TABLETS NA TAKEDA ITALIA ITALY FARMACEUTICI S.P.A — ITALY

BLOPRESS TABLET 4MG TAKEDA ITALIA ITALY FARMACEUTICI S.P.A.

BLOPRESS TABLET 8MG TAKEDA ITALIA ITALY FARMACEUTICI S.P.A.

BLOPRESS TABLET 16MG TAKEDA ITALIA ITALY FARMACEUTICI S.P.A.

BONDIL URETHRAL STICK 125MCG VIVUS UK UNITED KINGDOM

BONDIL URETHRAL STICK 250MCG VIVUS UK UNITED KINGDOM

BONDIL URETHRAL STICK 500MCG VIVUS UK UNITED KINGDOM

BONDIL URETHRAL STICK 1000MCG VIVUS UK UNITED KINGDOM

BONEFOS 400MG CAPSULE 400MG LEIRAS OY FINLAND

BONEFOS 60MG/ML CONC. FOR PARENT. 60MG/ML LEIRAS OY FINLAND INFUS.

BONIDON GEL 10MG/G MEPHA PHARMA AG SWITZERLAND

BONJELA GEL N/A RECKITT & COLMAN PAKISTAN

BONJELA OROMUCOSAL GEL N/A LLOYD'S UNITED KINGDOM PHARMACEUTICALS LIMITED T/A RECKITT & COLMAN PRODUCT

BOOTS NIROLEX LOZENGES LOZENGE 2.5MG THE BOOTS COMPANY UNITED KINGDOM PLC

BORADRINE EYE DROPS NA BOURNONVILLE PHARMA BELGIUM

BOROCAINA LOZENGE N/A ALFA WASSERMANN ITALY S.P.A.

BOROCAINA GOLA TABLETS 1.5MG ALFA WASSERMANN ITALY S.P.A.

BOROCAINA GOLA TABLET 1.5MG ALFA WASSERMANN ITALY S.P.A.

BOROCAINA GOLA TABLET 1.5MG ALFA WASSERMANN ITALY S.P.A. 23.9.2003 FR Journal officiel de l'Union européenne 491

Trade Name Dosage Form Dose MA Holder Country

BOTOX POWDER SOLN INJECTION 100 UNITS ALLERGAN SALES LTD IRELAND

BOTOX POWDER F/SOLN F/INJ 100UNITS/VIAL ALLERGAN IRELAND PHARMACEUTICALS (IRELAND) LIMITED

BOTULISM ANTIOXIN BEHRING SOL. FOR INFUSION AND N/A CHIRON BEHRING GMBH GERMANY INJEC &CO

BOZAKTRAL TABLETS 10MG CHRISPA ALFA GREECE FARMAKEYTICI S.A.

BRADOSOL PLUS LOZENGE N/A NOVARTIS COMSUMER UNITED KINGDOM HEALTH UK LIMITED

BRADOSOL SUGAR FREE CHERRY LOZENGES 0.04% V/W NOVARTIS CONSUMER UNITED KINGDOM MENTHOL HEALTH UK LIMITED

BRADOSOL SUGAR FREE LOZENGE 0.04% V/W NOVARTIS CONSUMER UNITED KINGDOM ORIGINAL CITRUS HEALTH UK LIMITED

BRASIVOL FINE CREAM 38% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

BRASIVOL MEDIUM CREAM 52% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

BRAUNOL 2000 SOLUTION N/A B.BRAUN MELSUNGEN GERMANY AG

BRETYLATE SOLUTION FOR 100MG/2ML WELLCOME UNITED KINGDOM INJECTION FOUNDATION LTD.

BRETYLIUM INJ MINIJET AQUEOUS SOLUTION 50MG/ML INTERNATIONAL UNITED KINGDOM MEDICATION SYSTEMS LTD

BRETYLIUM TOSYLATE INJECTION SOLUTION FOR 50MG/ML INTERNATIONAL UNITED KINGDOM MINIJET INJECTION MEDICATION SYSTEMS (UK) LTD

BRETYLIUM TOSYLATE MINIJET SOLUTION FOR 50MG/ML INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS (UK) LIMITED

BREVIBLOC SOLUTION FOR IV 250MG/ML BAXTER UNITED STATES OF INFUSION PHARMACEUTICL AMERICA PRODUCTS

BREVIBLOC INJECTION SOLUTION FOR IV INFU- 10MG/ML BAXTER UNITED STATES OF SION PHARMACEUTICAL AMERICA PRODUCTS

BREVOXYL CREAM 4% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

BRICANYL TABLETS 2.5MG DRACO LAKEMEDEL AB SWEDEN

BRICANYL TURBUHALER INHALATION POWDER 0.5MG/DOSE DRACO LAKEMEDEL AB SWEDEN

BRINERDIN SUGAR COATED TABLETS N/A NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

BRINERDINA FILM COATED TABLETS NA NOVARTIS FARMA SPA ITALY

BROMHEXINE 8 TABLETS 8MG REMEDICA LTD CYPRUS

BROMHEXINE SYRUP ORAL SOLUTION 4MG/5ML CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD. 492 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BROMHEXINE SYRUP 4MG/5ML SYRUP 4MG/5ML CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD

BROMHEXIN-RATIOPHARM SAFT SOLUTION 4MG/5ML RATIOPHARM GMBH GERMANY

BROMOCRIPTINE TABLETS 2.5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

BRONCALENE ADULTS SYRUP N/A LABORATOIRES MARTIN- FRANCE JOHNSON & JOHNSON- MSD

BRONCALENE CHILDREN SYRUP 0.01G/100ML LABORATOIRES MARTIN FRANCE

BRONCALENE INFANT SYRUP N/A LABORATOIRES MARTIN FRANCE

BRONCATHIOL 2% CHILDREN AND SYRUP 2% W/V LABORATOIRES MARTIN FRANCE INFANTS

BRONCATHIOL ADULT ORAL SOLUTION 5G/100ML LABORATOIRES MARTIN- FRANCE EXPECTORANT JOHNSON & JOHNSON- MSD

BRONCHOPED SYRUP N/A ADCOCK INGRAM LTD SOUTH AFRICA

BRONCHOPRONT CAPSULE WITH SUST. 75MG HEINRICH MACK NACHF GERMANY ACTION

BRONCHOPRONT SYRUP 0.3G/100ML HEINRICH MACK NACHF GERMANY

BRONCHOTUSSINE SYRUP 4MG/5ML ADELCO- GREECE CHROMATOURGIA ATHINON E. COLOCOTRONIS BROS S.A.

BRONCHO-VAXOM ADULTS CAPSULE 40MG OM PHARMA SWITZERLAND

BRONCHO-VAXOM CHILDREN CAPSULE 20MG OM PHARMA SWITZERLAND

BRONCOFLUID ORAL SUSPENSION N/A PHARMARECORD S.R.L. ITALY

BRONCOLIN TABLETS 4MG TABLET 4MG GEOFMAN PAKISTAN PHARMACEUTICALS

BRONQUIMUCIL CAPSULE N/A J.URIACH & CIA., S.A. SPAIN

BRONQUIMUCIL SUSPENSION ORAL SUSPENSION N/A J.URIACH & CIA. S.A. SPAIN

BROT 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS

BRUFEN TABLET 400MG KNOLL PAKISTAN

BRULIDINE CREAM 0.15% W/W MANX PHARMA LIMITED UNITED KINGDOM

BRUMETIDINA SOLUTION FOR IM INJEC- 200MG/2ML BRUSCHETTINI SRL ITALY TION

BRUXICAM DERMATOLOGICAL 1% W/W BRUSCHETTINI SRL ITALY CREAM

BRUXICAM CAPSULE 20MG BRUSCHETTINI SRL ITALY

BRUXICAM SUPPOSITORY 20MG BRUSCHETTINI SRL ITALY

BSS 15ML/BSS ALCON INTRAOCULAR IRRIG. N/A S.A. ALCON-COUVREUR BELGIUM SOLN. N.V.

BSS PLUS INTRAOCULAR IRRIGAT. NO ACTIVE ING. ALCON LABORATORIES UNITED STATES OF SOLN INC. AMERICA 23.9.2003 FR Journal officiel de l'Union européenne 493

Trade Name Dosage Form Dose MA Holder Country

BSS PLUS 250ML AND 500ML/BSS INTRAOCULAR IRRIG. N/A S.A. ALCON-COUVREUR BELGIUM PLUS ALCON SOLN. N.V.

BUCCALIN BERNA TABLETS N/A SWISS SERUM AND SWITZERLAND VACCINE INSTITUTE

BUCCASTEM BUCCAL TABLETS 3MG RECKITT BENCKISER UNITED KINGDOM HEALTHCARE (UK) LIMITED

BUDECORT RESPULES 0.25MG CIPLA LTD. INDIA

BUDECORT 0.5MG RESPULES 0.5MG/2ML CIPLA LIMITED INDIA

BUDECORT RESPULES 0.5MG/ML RESPIRATOR SUSPENSION 1MG/2ML CIPLA LIMITED INDIA

BUDECORT-100 INHALER 100MCG CIPLA LIMITED INDIA

BUDECORT-200 INHALER 200MCG CIPLA LIMITED INDIA

BUDECORT-200 INHALER 200MCG/AC M/S CIPLA LIMITED INDIA

BUDENOFALK CAPSULES 3MG DR. FALK PHARMA GMBH GERMANY

BUDESPRAY — 200 INHALER AEROSOL CANISTER 200 MCG M/S MEDISPRAY INDIA LABORATORIES PVT. LTD —GOA

BUMETANIDE TABLETS 5MG REMEDICA LTD. CYPRUS

BUMETANIDE TABLETS 1MG REMEDICA LTD. CYPRUS

BUPIVACAINE ADRENALINE SOLUTION FOR 100MG/20ML MERCK GENERICS FRANCE MERCK INJECTION

BUPIVACAINE HCL INJECTION, USP SOLUTION FOR 0.25% W/V ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

BUPIVACAINE HCL INJECTION, USP SOLUTION FOR 0.5% W/V ABBOTT LABORATORIES UNITED STATES OF 0.5% INJECTION AMERICA

BUPIVACAINE MERCK 0.5% SOLUTION FOR INJ. 100MG/20ML MERCK GENERIQUES FRANCE

BURINEX TABLETS 5MG LEO PHARMACEUTICAL DENMARK PRODUCTS

BURINEX TABLETS 1MG LEO PHARMACEUTICAL DENMARK PRODUCTS

BURINEX SOLUTION FOR 0.5MG/ML LEO PHARMACEUTICAL DENMARK INJECTION PRODUCTS

BURINEX A TABLETS N/A LEO PHARMACEUTICAL DENMARK PRODUCTS

BURINEX K TABLETS N/A LEO PHARMACEUTICAL DENMARK PRODUCTS

BURINEX-K TABLETS TABLETS NA LEO PAKISTAN

BURNEZE SPRAY 1% W/W MUNDIPHARMA PHAR- CYPRUS MACEUTICALS LTD

BUSCOPAN SUGAR COATED TABLETS 10MG BOEHRINGER INGELHEIM GERMANY PHARMA KG

BUSCOPAN SUGAR COATED TABLET 10MG BOEHRINGER-INGELHEIM PAKISTAN

BUSCOPAN PLUS TABLETS NA BOEHRINGER INGELHEIM PAKISTAN 494 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

BUSCOPAN TABLETS TABLETS 10MG BOEHRINGER INGELHEIM PAKISTAN

BUSPAR TABLETS 10MG BRISTOL MYERS SQUIBB AUSTRALIA AUSTRALIA PTY LTD

BUSPAR TABLETS 5MG BRISTOL-MYERS SQUIBB UNITED STATES OF COMPANY AMERICA

BUSPAR TABLETS 10MG BRISTOL-MYERS SQUIBB UNITED STATES OF COMPANY AMERICA

BUTIRAN SYRUP N/A FARMACEUTICI ECOBI ITALY S.A.S

BY-VERTIN TABLETS 8MG ERGHA HEALTHCARE IRELAND LIMITED

C1 ESTERASE INHIBITOR TIM 3 POWDER FOR INJECTION 1000PU/20ML OSTERREICHISCHES AUSTRIA INSTITUT FUR HAEMODERIVATE GES.M.B.H.

CA LAC TABLET 300MG RAZA MANUFACTURING MALAYSIA BERHARD

CABASER TABLETS 2MG PHARMACIA ITALIA S.P.A. ITALY

CABASER TABLET 1MG PHARMACIA ITALIA S.P.A. ITALY

CABASER TABLET 4MG PHARMACIA ITALIA S.P.A ITALY

CABASER TABLETS 1MG PHARMACIA ITALIA SPA ITALY

CABASER TABLETS 2MG PHARMACIA ITALIA SPA ITALY

CAC 1000 EFFERVESCENT TABLET N/A NOVARTIS PAKISTAN

CAC 1000 EFFERVESCENT TABLET NA NOVARTIS PAKISTAN

CA-C 1000 SANDOZ ORANGE EFFERVESCENT TABLETS N/A NOVARTIS CONSUMER SWITZERLAND HEALTH SA

CAFLAM TABLET 50MG NOVARTIS PAKISTAN

CALADRYL LOTION TOPICAL SUSPENSION N/A WARNER-LAMBERT UNITED KINGDOM CONSUMER HEALTHCARE

CALAMINE LOTION B.P. TOPICAL SUSPENSION N/A WILLIAM RANSOM & UNITED KINGDOM SON PLC

CALAMINE LOTION BP TOPICAL SUSPENSION N/A BELL SONS & CO UNITED KINGDOM (DRUGGISTS) LIMITED

CALAMINE LOTION BP TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM

CALAMINE LOTION BP LOTION N/A PINEWOOD LABS T/A IRELAND PINEWOOD HEALTHCARE

CALAMINE LOTION BP TOPICAL SOLUTION N/A LCM UK UNITED KINGDOM

CALC. FLUOR. NEW ERA BIOCHE- TISSUE SALT NO1 TABLET NA NEW ERA UNITED KINGDOM MIC NO.1 LABORATORIES LIMITED

CALC. PHOS. NEW ERA NO.2 TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM CALC. PHOS. NO.2 LABORATORIES LIMITED

CALC. SULPH. 6X NEW ERA BIO- TISSUE SALTS NO.3 NA NEW ERA UNITED KINGDOM CHEMIC NO.3 LABORATORIES LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 495

Trade Name Dosage Form Dose MA Holder Country

CALCICARD CR TABLETS 90MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CALCICARD CR TABLETS 120MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CALCICHEW 500MG TABLETS TABLET 500MG SHIRE UNITED KINGDOM PHARMACEUTICALS LIMITED

CALCICHEW D3 FORTE TABLET N/A SHIRE UNITED KINGDOM PHARMACEUTICALS LIMITED

CALCIFEROL OIL FOR INJECTION 3 > 5UNITS/1ML EVANS MEDICAL LIMITED UNITED KINGDOM

CALCIFEROL INJECTION BP OIL FOR INJECTION 6( > 5) UNITS/2ML EVANS MEDICAL LIMITED UNITED KINGDOM

CALCIO 300 TABLET 300MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

CALCIPEN TABLETS 670MG LEO PHARMACEUTICAL DENMARK PRODUCTS

CALCITONIN NOVARTIS SOLUTION FOR 100IU NOVARTIS PHARMA AUSTRIA INJECTION GMBH

CALCIUM — SANDOZ F EFFERVESCENT TABLETS N/A NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

CALCIUM 500 WITH D TABLETS N/A AEGIS LTD. CYPRUS

CALCIUM CHLORIDE INJECTION SOLUTION FOR 10%W/V INTERNATIONAL UNITED KINGDOM MINIJET INJECTION MEDICATION SYSTEMS (UK) LIMITED

CALCIUM CHLORIDE INJECTION AQUEOUS INJECTION 10% W/V INTERNATIONAL UNITED KINGDOM MINIJET MEDICATION SYSTEMS LTD

CALCIUM GLUCONATE INJECTION SOLUTION FOR 1G/10ML F.H. FAULDING AND CO. AUSTRALIA INJECTION LTD (T/A DAVID BULL LABS)

CALCIUM GLUCONATE INJECTION SOLUTION FOR 89MG/10ML EVANS MEDICAL LIMITED UNITED KINGDOM BP INJECTION

CALCIUM LACTATE TABLETS 300MG PHARMAMED LTD. MALTA

CALCIUM LACTATE 300 TABLETS 300MG REMEDICA LTD CYPRUS

CALCIUM LACTATE BP 300MG TABLET 300MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

CALCIUM LEUCOVORIN TABLETS 15MG CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD. T/A LEDERLE LABS.

CALCIUM LEUCOVORIN TABLETS 15MG CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD

CALCIUM RESONIUM ORAL POWDER 99.934%W/W SANOFI WINTHROP UNITED KINGDOM LIMITED

CALCIUM SANDOZ EFFERVESCENT TABLET N/A SANDOZ PAKISTAN

CALGEL TEETHING GEL GINGIVAL GEL N/A GLAXO WELLCOME UK UNITED KINGDOM LIMITED 496 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CALIMAL TABLET 4MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

CALLIMON EFFERVESCENT TABLET N/A DR.GROSSMANN AG SWITZERLAND PHARMACA

CALM LIFE COATED TABLETS NA THE HERBAL RESEARCH UNITED KINGDOM COMPANY LIMITED

CALMPOSE 5MG TABLETS TABLETS 5MG RANBAXY INDIA LABORATORIES LTD.

CALMURID CREAM N/A GALDERMA (UK) LIMITED UNITED KINGDOM

CALMURID HC CREAM N/A GALDERMA (UK) LIMITED UNITED KINGDOM

CALPOL 6+ SUSPENSION ORAL SUSPENSION 250MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LIMITED

CALPOL INFANT SUSPENSION ORAL SUSPENSION 120MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LIMITED

CALPOL SIX-PLUS SUSPENSION ORAL SUSPENSION 250MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LIMITED

CALPOL SUGAR FREE INFANT ORAL SUSPENSION 120MG/5ML GLAXO WELLCOME UK UNITED KINGDOM SUSPENSION LIMITED

CALPOL SUGAR FREE INFANT ORAL SUSPENSION 120MG/5ML GLAXO WELLCOME UK GERMANY SUSPENSION LIMITED

CALSALETTES (SUGAR COATED) COATED TABLET 38MG TORBET LABORATORIES UNITED KINGDOM TABLETS LIMITED

CAMCOLIT 250 TABLETS 250MG NORGINE LIMITED UNITED KINGDOM

CAMCOLIT 400 TABLETS 400MG NORGINE LIMITED UNITED KINGDOM

CAMCOLIT 400MG TABLET 400MG BIOPHARMA PAKISTAN

CAMNOVATE CREAM CREAM 0.1% W/W CAMDEN INDUSTRIES (M) MALAYSIA SDN.BHD

CAMPTO 100MG/5ML CONCENTRATE FOR 100MG/5ML MAY & BAKER LIMITED UNITED KINGDOM INFUSION

CAMPTO 40MG/2ML CONCENTRATE FOR 20MG/ML MAY & BAKER LIMITED UNITED KINGDOM INFUSION

CANDACORT CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

CANDACORT CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

CANDACORT CREAM CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD

CANDAZOLE CREAM 1% W/W HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

CANDAZOLE CREAM 1%W/W HOE PHARMACEUTICALS MALAYSIA SDN BHD

CANDAZOLE LOTION 1% W/V HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

CANDAZOLE LOTION LOTION 1% W/V HOE PHARMACEUTICALS MALAYSIA SDN. BHD

CANDIPLAS CREAM 2%W/W MEDOCHEMIE LTD CYPRUS 23.9.2003 FR Journal officiel de l'Union européenne 497

Trade Name Dosage Form Dose MA Holder Country

CANESTEN CREAM 1G/100G BAYER VITAL GMBH & GERMANY CO. KG

CANESTEN VAGINAL TABLET 500MG BAYER PAKISTAN

CANESTEN VAGINAL TABLET 500MG BAYER PAKISTAN

CANESTEN CREAM 0.01G/G BAYER PAKISTAN

CANESTEN CREAM 1% W/W BAYER PAKISTAN

CANESTEN VAGINAL TABLET 100MG BAYER PAKISTAN(PVT) PAKISTAN LTD.

CANESTEN 1 10% CREAM VAGINAL CREAM 10%W/W BAYER VITAL GMBH GERMANY

CANESTEN 1% SOLUTION 1G/100ML BAYER VITAL GMBH & GERMANY CO. KG

CANESTEN 10% VC (POM) VAGINAL CREAM 10% W/W BAYER PLC T/A UNITED KINGDOM CONSUMER CARE DIVISION

CANESTEN COMBI VAGINAL CREAM AND N/A BAYER PLC T/A UNITED KINGDOM PESSARY CONSUMER CARE DIVISION

CANESTEN DERMATOLOGICAL TOPICAL SOLUTION 1% W/V BAYER PLC UNITED KINGDOM SPRAY

CANESTEN HC CREAM 1% CREAM N/A BAYER PLC UNITED KINGDOM

CANESTEN HYDROCORTISONE CREAM N/A BAYER PLC T/A UNITED KINGDOM CONSUMER CARE DIVISION

CANESTEN OASIS EFFERVESCENT POWDER N/A BAYER PLC UNITED KINGDOM

CANESTEN VAGINAL TABLETS VAGINAL TABLETS 100MG BAYER PAKISTAN

CANUSAL SOLUTION FOR 100IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

CANUSAL(HEPARIN SODIUM SOLUTION FOR 100IU / ML CP PHARMACEUTICALS UNITED KINGDOM 100U/ML) INJECTION LTD

CAPACE TABLETS 25MG ATCO LABORATORIES PAKISTAN (PVT) LTD

CAPACE TABLETS 12.5MG ATCO LABORATORIES PAKISTAN (PVT) LTD

CAPOCARD TABLETS 50MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

CAPOCARD TABLETS 25MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

CAPOTEN TABLETS 12.5MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

CAPOTEN TABLETS 25MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

CAPOTEN TABLETS 50MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

CAPOZIDE TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM

CAPRIN ENTERIC COATED 75MG SINCLAIR UNITED KINGDOM TABLETS PHARMACEUTICALS LIMITED 498 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CAPTIL TABLET 25MG(CAPTOPRIL) TABLET 25MG UNIMED KOREA REPUBLIC PHARMACEUTICALS INC.

CAPTIL TABLET 50MG (CAPTOPRIL) TABLET 50MG UNIMED KOREA REPUBLIC PHARMACEUTICALS INC.

CAPTOPRIL TABLETS 50MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

CAPTOPRIL TABLETS 25MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

CAPTOPRIL TABLETS 12.5MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

CAPTOPRIL TABLETS 12.5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CAPTOPRIL TABLETS 25MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CAPTOPRIL TABLETS 50MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CAPTOPRIL DENK 25 TABLETS 25MG E. DENK OHG GERMANY

CAPTOPRIL TABLETS 25MG TABLET 25MG CP PHARMACEUTICALS UNITED KINGDOM LIMITED

CAPTOPRIL TABLETS 50MG TABLET 50MG CP PHARMACEUTICALS UNITED KINGDOM LTD

CAPTOPRIL TABLETS BP 25MG TABLET 25MG WAYMADE PLC UNITED KINGDOM

CARBACHOL TABLETS 2MG NORTON UNITED KINGDOM PHARMACEUTICALS LIMITED

CARBAMAZEPINE TABLETS 100MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CARBAMAZEPINE TABLETS 200MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CARBAMAZEPINE TABLETS 400MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CARBATOL TABLETS 200MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

CARBATOL TABLETS 200MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

CARBELLON TABLETS TABLET N/A TORBET LABORATORIES UNITED KINGDOM LIMITED

CARBIMAZOLE TABLET 5MG CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD.

CARBIROID TABLET 5MG TABLET 5MG HOVID SDN BHD MALAYSIA

CARBOPLATIN SOLUTION FOR 150MG/15ML PHARMACIA & UPJOHN AUSTRALIA INJECTION (PERTH) PTY LTD.

CARBOPLATIN INJECTION SOLUTION FOR 10MG/ML FAULDING UNITED KINGDOM SOLUTION INJECTION PHARMACEUTICALS PLC

CARBOPLATIN INJECTION VIAL SOLUTION FOR 50MG/5ML F.H. FAULDING & CO. AUSTRALIA INJECTION LTD. (T/A DAVID BULL LABS) 23.9.2003 FR Journal officiel de l'Union européenne 499

Trade Name Dosage Form Dose MA Holder Country

CARBOPLATIN INJECTION VIAL SOLUTION FOR 450MG/5ML F.H. FAULDING & CO. LTD AUSTRALIA INJECTION (T/A DAVID BULL LABS)

CARBOPLATINO SOLUTION FOR 150MG/15ML PHARMACIA ITALIA SPA ITALY INJECTION

CARBOSAN GEL 2% W/W ROWA PHARMACEUTI- IRELAND CALS LTD

CARBOSIN SOLUTION FOR 10MG/ML PHARMACHEMIE BV NETHERLANDS INJECTION

CARBOTINOL SOLUTION FOR 150MG KOREA UNITED PHARM. KOREA REPUBLIC INJECTION INC.

CARDIFEN-10 CAPSULES 10MG PHARMACARE LIMITED REPUBLIC OF SOUTH AFRICA

CARDILATE MR TABLETS 20MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CARDILATE MR 10MG TABLETS TABLETS 10MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CARDIOLITE DRY SUBSTANCE FOR IV NA DUPONT PHARMA GMBH GERMANY INF

CARDIPRIL TABLETS 4.6MG BIALPORT PRODUCTOS PORTUGAL FARMACEUTICOS SA

CARDIPRIL TABLETS 9.2MG BIALPORT — PRODUTOS PORTUGAL FARMACEUTICOS SA

CARDURA TABLET 2MG PFIZER LIMITED UNITED KINGDOM

CARDURA TABLET 4MG PFIZER LIMITED UNITED KINGDOM

CARDURA TABLET 1MG PFIZER LIMITED UNITED KINGDOM

CARDURA XL MODIFIED RELEASE 4MG PFIZER LTD. UNITED KINGDOM TABLET

CARDURA XL MODIFIED RELEASE 8MG PFIZER LTD. UNITED KINGDOM TABLET

CARGOSIL CREAM 5% GENEPHARM S.A. GREECE

CARLOC-6.25 TABLETS 6.25MG CIPLA INDIA

CARTERON 5MG CAPSULE 5MG MEDOCHEMIE LTD CYPRUS

CASACOL LIQUID NA HELSINN BIREX IRELAND PHARMACEUTICALS LIMITED

CASCADE (FORMELY NATEX COATED TABLET N/A MODERN HEALTH UNITED KINGDOM NO. 1)TABLETS PRODUCTS LTD

CASODEX 150MG COATED TABLET 150MG ZENECA LIMITED UNITED KINGDOM

CASODEX TABLETS 50MG COATED TABLET 50MG ZENECA LIMITED UNITED KINGDOM

CASPOFUNGIN MSD POWD F/CONC F/SOLN F/ 50MG/VIAL MERCK SHARP AND EUROPEAN COMMUNITY INF DOHME LIMITED

CASPOFUNGIN MSD POWD. F/CONC F/SOLN F/ 70MG/VIAL MERCK SHARP & DOHME UNITED KINGDOM INF LIMITED

CASPOFUNGIN MSD POWDER FOR SOLUTION 50MG/VIAL MERCK SHARP & DOHME EUROPEAN COMMUNITY FOR INFUSION LIMITED 500 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CASTOR OIL BP ORAL SOLUTION N/A LCM LTD UNITED KINGDOM

CASTOR OIL BP ORAL SOLUTION 5ML LCM LTD UNITED KINGDOM

CATAFLAM SUGAR COATED TABLETS 50MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

CATAFLAM TABLET 50MG GEIGY PAKISTAN

CATAFLAM SUGAR COATED TABLETS 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

CATAFLAM SUGAR COATED TABLETS 50MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

CATAFLAM 1.5% DROPS 15MG/ML NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

CATAFLAM RAPID COATED TABLETS 25MG NOVARTIS UNITED KINGDOM PHARMACEUTICALS UK LIMITED

CATAFLAM RAPID COATED TABLETS 50 MG NOVARTIS UNITED KINGDOM PHARMACEUTICALS UK LIMITED

CATHAY RISING SUN/GERARD TABLET 180MG CATHAY OF UNITED KINGDOM GINGER/GINGER BOURNEMOUTH LTD T/A GERARD HOUSE

CAVERIL TABLETS 40MG REMEDICA LTD CYPRUS

CAVERIL 40 TABLETS 40MG REMEDICA LTD CYPRUS

CAVERJECT POWDER FOR INJECTION 20MCG/ML PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

C-D-CALCIUM CHEWING TABLETS N/A G.STREULI & CO. AG SWITZERLAND

C-D-CALCIUM EFFERVESCENT TABLET N/A G.STREULI & CO. AG SWITZERLAND

CEALB (ALBUMIN 20 %) SOLUTION FOR INFUSION 200G/L SANQUIN, CLB, NETHERLANDS PRODUCTS DIVISION

CEALB (ALBUMIN 20%) SOL. FOR INFUSION 200G/L CLB NETHERLANDS

CEANEL CONCENTRATE TOPICAL SOLUTION N/A QUINODERM LIMITED UNITED KINGDOM

CECENU CAPSULES 40MG MEDAC GMBH GERMANY

CECLOR MODIFIED RELEASE 375MG ELI LILLY ITALIA S.P.A. ITALY TABLET

CECLOR MODIFIED RELEASE 500MG ELI LILLY ITALIA S.P.A. ITALY TABLET

CECLOR MODIFIED RELEASE 750MG ELI LILLY ITALIA S.P.A. ITALY TABLET

CECLOR GRANULES FOR ORAL 125MG/5ML ELI LILLY ITALIA S.P.A. ITALY SUSPEN.

CECLOR GRANULES FOR ORAL 5% W/V ELI LILLY ITALIA S.P.A. ITALY SUSPEN.

CECLOR CAPSULES 500MG LILLY PAKISTAN

CECLOR MR TABLET 750MG LILLY PAKISTAN

CECLOR MR TABLET 375MG LILLY PAKISTAN 23.9.2003 FR Journal officiel de l'Union européenne 501

Trade Name Dosage Form Dose MA Holder Country

CEFACET TABLETS 500MG LABORATOIRES FRANCE NORGINE PHARMA

CEFACET TABLETS 1G LABORATOIRES FRANCE NORGINE PHARMA

CEFACET GRANULES IN SACHETS 250MG LABORATOIRES FRANCE NORGINE PHARMA

CEFALOTINE MERCK 1G POWDER FOR SOL. FOR 1G/VIAL MERCK GENERIQUES FRANCE INJ.

CEFAN POWDER FOR INJECTION 1G/VIAL DEMO ABEE GREECE

CEFARIM 750MG POWDER FOR IM/IV 750MG M/S VITAPURE INDIA CORPORATION

CEFIX-200 TABLETS 200MG CIPLA LTD INDIA

CEFRADOX 500 CAPSULES 500MG AEGIS LTD. CYPRUS

CEFTRIAXONE 500MG POWDER FOR INJECTION 500MG MEDOCHEMIE LTD CYPRUS

CEFUROXIM 750MG CURASAN POWDER FOR INJECTION 750MG/VIAL CURASAN PHARMA GERMANY GMBH

CEFUROXIME AXETILE TABLETS 250MG SHENZHEN CHINA PHARMACEUTICAL FACTORY

CEFZIL (PROCEF) TABLETS 250MG BRISTOL MYERS SQUIBB ITALY S.P.A

CEFZIL (PROCEF) POWDER FOR ORAL SUSP. 250MG/5ML BRISTOL MYERS SQUIBB ITALY S.P.A

CEFZIL (PROCEF) TABLETS 500MG BRISTOL MYERS SQUIBB ITALY S.P.A

CEGROVIT EFFERVESCENT TABLET 1G DR.GROSSMANN AG SWITZERLAND PHARMACA

CELANCE 0.05MG TABLETS TABLET 0.05MG ELI LILLY & COMPANY UNITED KINGDOM LIMITED

CELANCE 0.25MG TABLETS TABLET 0.25MG ELI LILLY & COMPANY UNITED KINGDOM LIMITED

CELANCE 1MG TABLETS TABLET 1MG ELI LILLY & COMPANY UNITED KINGDOM LIMITED

CELEBIX -200 CAPSULE 200MG OKASA PHARMA PVT INDIA LTD — INDIA

CELEBREX HARD CAPSULES 100MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

CELEBREX HARD CAPSULES 200MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

CELEBREX HARD CAPSULES 200MG PHARMACIA LIMITED UNITED KINGDOM

CELEBREX HARD CAPSULES 100MG PHARMACIA LIMITED UNITED KINGDOM

CELESTONE TABLETS 0.5MG SCHERING PLOUGH BELGIUM NV/SA

CELEVAC TABLETS 500MG MONMOUTH UNITED KINGDOM PHARMACEUTICALS LTD.

CELLCEPT CAPSULE 250MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG 502 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CELLCEPT 500MG TABLET 500MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

CELLIDRIN 100MG TABLET 100MG HENNIG ARZNEIMITTEL GERMANY GMBH & CO. KG

CELLIDRIN 300MG TABLET 300MG HENNIG ARZNEIMITTEL GERMANY GMBH & CO. KG

CELLUVISC EYE DROPS SOLUTION 1% ALLERGAN IRELAND PHARMACEUTICALS (IRELAND) LIMITED

CELLUVISC LUBRICANT EYE DROPS 1% W/V ALLERGAN UNITED STATES OF AMERICA

CEMAQUIN LOZENGES N/A CIMEX AG SWITZERLAND

CENOVIS 1000MG VIT C NATURAL TABLET 1000MG FAULDING HEALTHCARE AUSTRALIA ORANGE FLAV PTY LTD

CENOVIS 1000MG VITAMIN C TABLET N/A FAULDING HEALTHCARE AUSTRALIA NATURAL LEMON PTY LTD

CENOVIS 50 + MULTI CAPSULE CAPSULE N/A FAULDING HEALTHCARE AUSTRALIA BOTTLE PTY LTD.

CENOVIS ANTIOXIDANT TABLET TABLET N/A FAULDING HEALTHCARE AUSTRALIA BOTTLE PTY LTD.

CENOVIS ANTIOXIDANT TABLET TABLET N/A FAULDING HEALTHCARE AUSTRALIA BOTTLE PTY LTD.

CENOVIS ARTHRITIC AID TABLET N/A FAULDING HEALTHCARE AUSTRALIA PTY LTD

CENOVIS B COMPLEX TABLET N/A FAULDING HEALTHCARE AUSTRALIA PTY LTD

CENOVIS B GROUP AND C TABLET N/A FAULDING HEALTHCARE AUSTRALIA VITAMINS PTY LTD

CENOVIS B GROUP PLUS TABLET TABLETS N/A FAULDING HEALTHCARE AUSTRALIA BOTTLE PTY LTD.

CENOVIS CALCIUM 600MG AND TABLET N/A FAULDING HEALTHCARE AUSTRALIA VITAMIN D PTY LTD

CENOVIS CHILDREN'S CALCIUM TABLET N/A FAULDING HEALTHCARE AUSTRALIA PLUS PTY

CENOVIS CHILDREN'S COLD AND TABLET N/A FAULDING HEALTHCARE AUSTRALIA FLU PTY LTD

CENOVIS CHILDREN'S TABLET N/A FAULDING HEALTHCARE AUSTRALIA MULTIVITAMINS PTY

CENOVIS CHILDREN'S VIT C 100MG TABLET(CHEWABLE) 100MG FAULDING HEALHCARE AUSTRALIA ORANGE FL PTY LTD

CENOVIS COD LIVER OIL CAPSULES 275MG FAULDING HEALTHCARE AUSTRALIA PTY LTD.

CENOVIS COLD AND FLU RELIEF LOZENGE N/A FAULDING HEALTHCARE AUSTRALIA LOZENGE PTY LTD

CENOVIS CO-Q10 UBIDECARE- CAPSULE 30MG FAULDING HEALTHCARE AUSTRALIA NONE PTY LTD

CENOVIS COUGH RELIEF LOZ. LOZENGES N/A FAULDING HEALTHCARE AUSTRALIA W/ VIT. C AND ZN PTY LTD. 23.9.2003 FR Journal officiel de l'Union européenne 503

Trade Name Dosage Form Dose MA Holder Country

CENOVIS CYSTITIS AID WITH TABLET N/A FAULDING HEALTHCARE AUSTRALIA CRANBERRY PTY LTD

CENOVIS ECHINACEA COMPLEX TABLET N/A FAULDING HEALTHCARE AUSTRALIA PTY LTD

CENOVIS EVENING PRIMROSE OIL CAPSULE 600MG FAULDING HEALTHCARE AUSTRALIA 600MG PTY

CENOVIS EVINING PRIMROSE CAPSULE 1000MG FAULDING HEALTHCARE AUSTRALIA OIL1000MG PTY LTD

CENOVIS EXECUTIVE B TABLET TABLET N/A FAULDING HEALTHCARE AUSTRALIA BOTTLE PTY LTD.

CENOVIS FOLIC ACID PLUS TABLET TABLET N/A FAULDING HEALTHCARE AUSTRALIA BOTTLE PTY LTD

CENOVIS GINSENG PANAX TABLET 500MG FAULDING HEALTHCARE AUSTRALIA GINSENG 500MG PTY LTD

CENOVIS GUARANA 2000MG + FILM COATED TABLETS N/A FAULDING HEALTHCARE AUSTRALIA GINSENG 500MG PTY LTD.

CENOVIS HEALTHY HAIR, SKIN CAPSULE N/A FAULDING HEALTHCARE AUSTRALIA AND NAILS PTY LTD

CENOVIS IRON PLUS TABLET N/A FAULDING HEALTHCARE AUSTRALIA PTY LTD

CENOVIS LECITHIN 1.2G CAPSULE 1.2G FAULDING HEALTHCARE AUSTRALIA PTY LTD

CENOVIS MAGNESIUM PLUS TABLET N/A FAULDING HEALTHCARE AUSTRALIA PTY

CENOVIS MALE FORMULA TABLET N/A FAULDING HEALTHCARE AUSTRALIA PTY LTD

CENOVIS MAXEPA NATURAL FISH CAPSULE 1G FAULDING HEALTHCARE AUSTRALIA OIL CONC. PTY LTD.

CENOVIS MEGA E 500MG CAPSULE 500MG FAULDING HEALTHCARE AUSTRALIA PTY LTD

CENOVIS MEGA-MULTI EXTRA CAPSULE N/A FAULDING HEALTHCARE AUSTRALIA STRENGTH MV AND M PTY

CENOVIS MEN'S MULTI CAPSULE CAPSULE N/A FAULDING HEALTHCARE AUSTRALIA BOTTLE PTY LTD.

CENOVIS MULTIVITAMIN AND TABLET N/A FAULDING HEALTHCARE AUSTRALIA MINERALS PTY LTD

CENOVIS NATURAL E500IU CAPSULE 335MG FAULDING HEALTHCARE AUSTRALIA PTY LTD

CENOVIS ODOURLESS GARLIC CAPSULE 10MG FAULDING HEALTHCARE AUSTRALIA PTY LTD

CENOVIS OSTEO RELIEF TABLET TABLETS N/A FAULDING HEALTHCARE AUSTRALIA BOTTLE PTY LTD.

CENOVIS ST JOHN'S WORT TABLET 340MG FAULDING HEALTHCARE AUSTRALIA (HYPERICUM) PTY LTD

CENOVIS STUDENT STUDY TABLET N/A FAULDING HEALTHCARE AUSTRALIA FORMULA PTY LTD

CENOVIS SUGARLESS C 500MG TABLET N/A FAULDING HEALTHCARE AUSTRALIA ORANGE) PTY LTD 504 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CENOVIS VALERIAN FORMULA TABLET N/A FAULDING HEALTHCARE AUSTRALIA PTY LTD

CENOVIS VITAMIN B6 TABLET 50MG FAULDING HEALTHCARE AUSTRALIA PTY LTD

CENOVIS VITAMIN C 1000MG TABLET 1000MG FAULDING HEALTHCARE AUSTRALIA TABLET BOTTLE PTY LTD.

CENOVIS VITAMIN C 250MG NAT. TABLET 250MG FAULDING HEALTHCARE AUSTRALIA ORANGE FLV. PTY LTD

CENOVIS WOMEN'S MULTI CAPSULES N/A FAULDING HEALTHCARE AUSTRALIA CAPSULE BOTTLE PTY LTD.

CENOVIS YEAST 300MG TABLET 300MG FAULDING HEALTHCARE AUSTRALIA PTY LTD

CENOVIS ZINC PLUS 25MG TABLET 25MG FAULDING HEALTHCARE AUSTRALIA PTY

CENVOVIS GINKGO PLUS TABLET N/A FAULDING HEALTHCARE AUSTRALIA PTY LTD

CEPHADAR CAPSULES 250MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

CEPHADAR GRANULES FOR ORAL 125MG/5ML DAR AL DAWA JORDAN SUSP. DEVELOPMENT AND INVESTMENT CO LIMITED

CEPHADAR GRANULES FOR ORAL 125MG/5ML DAR AL DAWA JORDAN SUSP. DEVELOPMENT AND INVESTMENT CO LIMITED

CEPHALEXIN CAPSULES 250MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CEPHALEXIN CAPSULES 500MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CEPHALEXIN TABLETS 250MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CEPHALEXIN TABLETS 500MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CEPHALEXIN ORAL SUSPENSION 125MG/5ML NORTON HEALTHCARE UNITED KINGDOM LIMITED

CEPHALEXIN ORAL SUSPENSION 250MG/5ML NORTON HEALTHCARE UNITED KINGDOM LIMITED

CEPHALEXIN (TENKOREX) SUSPENSION 125MG/5ML KENT UNITED KINGDOM 125MG/5ML PHARMACEUTICALS LTD.

CEPHALEXIN (TENKOREX) SUSPENSION 250MG/5ML KENT UNITED KINGDOM 250MG/5ML PHARMACEUTICALS

CEPHALEXIN 250MG CAPSULE 250MG KENT UNITED KINGDOM PHARMACEUTICALS LTD.

CEPHALEXIN 500MG CAPSULE 500MG KENT UNITED KINGDOM PHARMACEUTICALS LTD.

CEPHALEXIN-RATIOPHARM 500 FILM COATED TABLET 500MG RATIOPHARM GMBH GERMANY

CEPHOS CAPSULE 500MG LABORATORIO ITALY FARMACEUTICO C.T.S.R.L. 23.9.2003 FR Journal officiel de l'Union européenne 505

Trade Name Dosage Form Dose MA Holder Country

CEPOREX HARD CAPSULES 500MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

CEPOREX HARD CAPSULES 500MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

CEPOREX CAPSULES 250MG CAPSULES 250MG GLAXO WELLCOME UK UNITED KINGDOM LTD

CEPOREX CAPSULES 500MG CAPSULES 500MG GLAXO WELLCOME UK UNITED KINGDOM LTD

CEPOREX SYRUP 125MG/5ML SYRUP 125MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LTD

CEPOREX SYRUP 250/5ML SYRUP 250MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LTD

CEREPAR TABLETS 75MG MEPHA PHARMA AG SWITZERLAND

CERETEC POWDER FOR INJECTION 0.5MG/VIAL NYCOMED AMERSHAM UNITED KINGDOM PLC

CEROX TOPICAL SOLUTION N/A SPA ITALIANA ITALY LABORATORI BOUTY

CEROXIM TABLETS 250MG TABLETS 250MG RANBAXY INDIA LABORATORIES LTD.

CERUMOL EAR DROPS EAR DROPS N/A LABORATORIES FOR UNITED KINGDOM APPLIED BIOLOGY LTD

CETAVLEX ANTISEPTIC CREAM 0.5% W/W ZENECA LIMITED UNITED KINGDOM

CETAVLEX CREAM CREAM 1.25% V/ W BIOGLAN LABORATORIES UNITED KINGDOM LTD

CETILSAN SUGAR FREE LOZENGES N/A LABORATORIO CHIMICO ITALY FARMACEUTICO A. SELLA S.R.L.

CETILSAN LOZENGES N/A LABORATORIO CHIMICO ITALY FARMACEUTICO A. SELLA S.R.L.

CETOMACROGOL CREAM A BP CREAM 9% W/W ADAMS HEALTHCARE UNITED KINGDOM LIMITED

CETOR PWD. FOR SOL. FOR INF. 500U SANQUIN, CLB, NETHERLANDS PRODUCTS DIVISION

CETRIMIDE ANTISEPTIC FIRST AID CREAM 0.5% W/W ANGLIAN PHARMA PLC UNITED KINGDOM CREAM

CETRIMIDE CREAM BP CREAM 0.5% W/W ADAMS HEALTHCARE UNITED KINGDOM LIMITED

CETROTIDE SOLUTION FOR 0.25MG/ML ASTA MEDICA GERMANY INJECTION.

CETROTIDE SOLUTION FOR 3MG/3ML ASTA MEDICA GERMANY INJECTION

CETROTIDE POWDER AND SOLVENT 3MG/VIAL SERONO EUROPE EUROPEAN COMMUNITY F/SOLUTION F/INJECTION LIMITED

CETROTIDE (X1VIAL) POWDER AND SOLVENT 0.25MG/VIAL SERONO EUROPE EUROPEAN COMMUNITY F/SOLUTION F/INJECTION LIMITED

CETROTIDE (X7VIALS) POWDER AND SOLVENT 0.25MG/VIAL SERONO EUROPE EUROPEAN COMMUNITY F/SOLUTION F/INJECTION LIMITED 506 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CEZIDIN POWDER FOR INJECTION 1G/VIAL DEMO ABEE GREECE

CHAPSTICK — CHERRY LIP BALM N/A WHITEHALL UNITED STATES OF INTERNATIONAL INC AMERICA

CHAPSTICK — REGULAR LIP BALM N/A WHITEHALL UNITED STATES OF INTERNATIONAL INC. AMERICA

CHAPSTICK — SUNBLOCK 15 LIP BALM N/A WHITEHALL UNITED STATES OF INTERNATIONAL INC. AMERICA

CHARCOALTABLETS 125MG TABLET 125MG G R LANE HEALTH UNITED KINGDOM PRODUCTS LTD

CHEMITRIM CAPSULES N/A BIOMEDICA FOSCAMA ITALY INDUSTRIA CHIMICO FARMACEUTICA S.P.A.

CHEMITRIM «FORTE» TABLET N/A BIOMEDICA FOSCAMA ITALY INDUSTRIA CHIMICO FARMACEUTICA S.P.A.

CHIBROXIN 0.3% DPS EYE DROPS 0.3% W/V MERCK SHARP & DOHME NETHERLANDS B.V.

CHIBROXINE EYE DROPS 0.3%W/W MSD PAKISTAN

CHIBROXINE 0.3 COLLYRE EYE DROPS 3MG/ML MERCK SHARP & DOHME NETHERLANDS B.V.

CHILBLAIN CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM

CHILDREN'S ADVIL SUSPENSION SUSPENSION NA WHITEHALL — ROBINS CANADA

CHILDREN'S DIMETAPP COLD AND ELIXIR NA WITEHALL UNITED STATES OF ALLERGY INTERNATIONAL AMERICA

CHIMAX TABLET 250MG CHIRON BV NETHERLANDS

CHLORAMPHENICAL EYE DROPS EYE DROPS 0.5% W/V SCHERING-PLOUGH UNITED KINGDOM LIMITED

CHLORAMPHENICOL BP 250MG CAPSULE 250MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

CHLORAMPHENICOL EYE EYE OINTMENT 1% W/W PL 00156/0049 UNITED KINGDOM OINTMENT 1% BP

CHLORASEPT 2000 ANTISEPTIC TOPICAL SOLUTION N/A BAXTER HEALTHCARE UNITED KINGDOM SOL. LIMITED

CHLORHEXIDINE GLUCONATE OROMUCOSAL SOLUTION 0.2% W/V ADAMS HEALTHCARE UNITED KINGDOM NATURAL FLAVOUR LIMITED

CHLOROQUINE PHOSPHATE TABLETS 100MG PHARMAMED LTD. MALTA

CHLOROQUINE PHOSPHATE TABLETS 250MG PHARMAMED LTD. MALTA

CHLOROQUINE PHOSPHATE SOLUTION FOR 40MG/ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

CHLOROQUINE PHOSPHATE SOLUTION FOR 80MG/2ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

CHLOROQUINE PHOSPHATE BP TABLET 250MG SUSSEX UNITED KINGDOM 250MG PHARMACEUTICAL LIMITED

CHLORPAMIDE BP 250MG TABLET 250MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 507

Trade Name Dosage Form Dose MA Holder Country

CHLORPHENIRAMINE BP 4MG TABLET 4MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

CHLORPROMAZINE COATED TABLETS 25MG CLONMEL HEALTHCARE IRELAND LIMITED

CHLORPROMAZINE TABLETS 25MG REMEDICA LTD. CYPRUS

CHLORPROMAZINE BP 25MG TABLETS 25MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

CHLORPROPAMIDE TABLET 250MG MEDOCHEMIE LTD CYPRUS

CHLORPROPAMIDE TABLETS 250MG PHARMAMED LTD. MALTA

CHLORPROPAMIDE BP 100MG TABLET 100MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

CHLORURE DE THALLIUM SOLUTION FOR 37 MBQ/ML CIS BIO INTERNATIONAL FRANCE [(201)TI] CIS BIO INJECTION

CHOLECIS INTRAVENEOUS NA CIS BIO INTERNATIONAL FRANCE SOLUTION

CHOLERA VACCINE BEHRING SUSPENSION FOR N/A CHIRON BEHRING GMBH GERMANY INJECTION &CO

CHORAGEN 5000 POW. FOR INJ. AND 5000 I.E. FERRING GMBH GERMANY SOLVENT

CHYMOL EMOLLIENT BALM OINTMENT NS ANGLIAN PHARMA PLC UNITED KINGDOM

CIBACEN FILM C. TABLETS 5MG NOVARTIS PHARMA SWITZERLAND DIVISIBLE SCHWEIZ AG

CIBACEN TABLETS 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

CICATRIN POWDER N/A WELLCOME UNITED KINGDOM FOUNDATION LTD.

CICATRIN CREAM N/A WELLCOME UNITED KINGDOM FOUNDATION LTD.

CICATRIN POWDER POWDER NA GLAXOWELLCOME PAKISTAN

CICLOFOSFAMIDA FILAXIS LYOPHILIZED POWDER 1G LABORATORIOS FILAXIS ARGENTINA FOR INJECTION SA

CICLOFOSFAMIDA FILAXIS LYOPHILIZED POWDER 200MG LABORATORIOS FILAXIS ARGENTINA FOR INJECTION SA

CIDOMYCIN EYE/EAR DROPS EYE/EAR DROPS 0.3% W/V ROUSSEL LABORATORIES UNITED KINGDOM LIMITED

CIDOMYCIN INJECTION ADULT — SOLUTION FOR 80MG/2ML ROUSSEL LABORATORIES UNITED KINGDOM 80MG/2ML INJECTION LIMITED

CIDOMYCIN PAEDIATRIC SOLUTION FOR 20MG/2ML ROUSSEL LABORATORIES UNITED KINGDOM INJECTABLE 20MG/2ML INJECTION LIMITED

CIFEX ORAL SUSPENSION 100MG/5ML AEGIS LTD. CYPRUS

CIFEX 200 TABLETS 200MG AEGIS LTD. CYPRUS

CIFEX 400 TABLETS 400MG AEGIS LTD. CYPRUS

CIFLURON 250MG FILMCOATED FILM COATED TABLETS NA IL KO ILAC VE KOZMETIK TURKEY TABLETS SAN. A.S. — TURKEY 508 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CIFRAN SOLUTION FOR 200MG RANBAXY INDIA INJECTION LABORATORIES LTD.

CILEST TABLET N/A JANSSEN-CILAG AG SWITZERLAND

CILOPRIN CUM ANAESTHETICO DROPS N/A JANSSEN-CILAG AG SWITZERLAND

CILOXAN OPHTHALMIC SOLUTION 3MG/ML S.A. ALCON-COUVREUR BELGIUM N.V.

CIMEDINE TABLETS 800MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LIMITED

CIMET (CIMETIDINE TABLETS USP) TABLET 200MG IPCA LABORATORIES INDIA LIMITED

CIMET-400 (CIMETIDINE TABLETS TABLET 400MG IPCA LABORATORIES INDIA USP) LIMITED

CIMETIDINE TABLETS 200MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CIMETIDINE TABLETS 400MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CIMETIDINE TABLETS 800MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CINAZYN TABLETS 25MG ITALCHIMICI SPA ITALY

CINAZYN CAPSULE 75MG ITALCHIMICI SPA ITALY

CINNARIZINE TABLETS 15MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CIPLIN (COTRIMOXAZOLE TABLET N/A CIPLA LTD INDIA TABLETS IP)

CIPLIN SUSPENSION SUSPENSION N/A CIPLA LTD — INDIA INDIA

CIPLOX SOLUTION FOR 2MG/ML CIPLA LTD. INDIA INJECTION

CIPLOX-250 TABLETS TABLETS 250MG CIPLA LTD. INDIA

CIPRAM TABLET 20MG H. LUNDBECK A/S DENMARK

CIPRAM TABLET 20MG LUNDBECK PAKISTAN

CIPRO HC OTIC SUSPENSION N/A ALCON LABORATORIES UNITED STATES OF INC. AMERICA

CIPRO HC OTIC SUSPENSION EAR DROPS N/A ALCON CUSI S.A. SPAIN

CIPROBAY 100 INFUSION SOLUTION 100MG/50ML BAYER VITAL GMBH & GERMANY CO. KG

CIPROBAY 200 INFUSION SOLUTION 200MG/100ML BAYER VITAL GMBH & GERMANY CO. KG

CIPROBAY 250 FILM-COATED TABLET 250MG BAYER VITAL GMBH & GERMANY CO. KG

CIPROBAY 500 FILM-COATED TABLET 500MG BAYER VITAL GMBH & GERMANY CO. KG

CIPROBID-250 TABLETS 250MG CADILA HEALTHCARE INDIA LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 509

Trade Name Dosage Form Dose MA Holder Country

CIPRODAR FILM-COATED 250MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

CIPRODAR TABLETS 500MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LIMITED

CIPROFLOXACIN INJECTION USP SOL FOR INJ 2MG/ML VYSALI INDIA PHARMACEUTICALS LIMITED

CIPROFLOXACIN TABLETS USP FILM COATED TABLET 250MG TABLETS (INDIA) LIMITED INDIA CIFROTIL

CIPROXIN TABLET 250MG BAYER PAKISTAN

CIPROXIN 100 INFUSION SOLUTION 100MG/50ML BAYER VITAL GMBH & GERMANY CO. KG

CIPROXIN 200 INFUSION SOLUTION 200MG/100ML BAYER VITAL GMBH & GERMANY CO. KG

CIPROXIN 250 FILM-COATED TABLET 250MG BAYER VITAL GMBH & GERMANY CO. KG

CIPROXIN 250 FILM COATED TABLET 250MG BAYER PAKISTAN

CIPROXIN 400 INFUSION SOLUTION 400MG/200ML BAYER VITAL GMBH & GERMANY CO. KG

CIPROXIN 500 FILM-COATED TABLET 500MG BAYER VITAL GMBH & GERMANY CO. KG

CIPROXIN 750 FILM-COATED TABLET 750MG BAYER VITAL GMBH & GERMANY CO. KG

CIROK SOLUTION FOR 2MG/ML KOREA UNITED PHARM. KOREA REPUBLIC INJECTION INC.

CIRRUS CAPSULE N/A U.C.B. S.A. BELGIUM

CISPLATIN 100MG/100ML SOLUTION FOR 1MG/ML PHARMACIA & UPJOHN AUSTRALIA INJECTION (PERTH) PTY LTD.

CISPLATIN 10MG/10ML SOLUTION FOR 1MG/ML PHARMACIA & UPJOHN AUSTRALIA INJECTION (PERTH) PTY LTD.

CISPLATIN 50MG/50ML SOLUTION FOR 1MG/ML PHARMACIA & UPJOHN AUSTRALIA INJECTION (PERTH) PTY LTD.

CISPLATIN INJECTION B.P SOLUTION FOR N/A SERUM INSTITUTE OF INDIA INJECTION INDIA LTD.

CISPLATIN INJECTION SOLUTION SOLUTION FOR INFUSION 1MG/ML FAULDING UNITED KINGDOM PHARMACEUTICALS PLC

CISPLATINE MERCK 10MG/10ML SOL. TO DILUTE FOR 10MG/10ML MERCK GENERIQUES FRANCE PERFUS

CISPLATINE MERCK 50MG/50ML SOL. TO DILUTE FOR 50MG/50ML MERCK GENERIQUES FRANCE PERFUS

CISPLATINO SOLUTION FOR 50MG/50ML PHARMACIA ITALIA SPA ITALY INJECTION

CISPLATINO SOLUTION FOR 10MG/10ML PHARMACIA ITALIA SPA ITALY INJECTION

CITANEST OCTAPRESSIN SOLUTION FOR N/A ASTRA LAKEMEDEL AB SWEDEN INJECTION 510 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CITOMID RU SOLUTION FOR 1MG/2ML LEMERY S.A. MEXICO INJECTION

CITOMID RU SOLUTION FOR 2MG/2ML LEMERY S.A. MEXICO INJECTION

CITRAMAG POWDER EFFERVESCENT POWDER N/A BOIGLAN UNITED KINGDOM LABORATORIES

CITRATO ESPRESSO S PELLEGRINO ORAL POWDER 7.12G / 40G SYNTHELABO S.P.A. ITALY

CITROVENOT TABLET 250MG BROS LTD GREECE

CITROVENOT TABLET 500MG BROS LTD GREECE

CLABAT DRY SYRUP N/A PT INTERBAT INDONESIA

CLABAT 500 FILM COATED CAPLET N/A PT INTERBAT INDONESIA

CLABAT 500 FILM-COATED TABLET N/A PT INTERBAT INDONESIA

CLABAT DRY SYRUP SYRUP N/A PT INTERBAT INDONESIA

CLABAT FORTE DRY SYRUP N/A PT INTERBAT INDONESIA

CLABAT FORTE DRY SYRUP 60 ML DRY SYRUP N/A PT INTERBAT INDONESIA

CLACIN CAPSULES 150MG KOREA UNITED PHARM. KOREA REPUBLIC INC.

CLAFORAN 0.5G POWDER FOR IV-IM 0.5G LABORATOIRES AVENTIS FRANCE INJECT.

CLAFORAN 1G POWDER FOR IV-IM 1G LABORATOIRES AVENTIS FRANCE INJECT.

CLAFORAN 1G IM POWDER FOR INJECTION 1G LABORATOIRES AVENTIS FRANCE

CLAMIDE TABLET 5MG TABLET 5MG HOVID SDN BHD MALAYSIA

CLARICIDE TABLETS 250MG BILIM ILAC SANAYII VE TURKEY TICARET A.S.

CLARICIDE FILM COATED TABLETS 500MG BILIM ILAC SANAYII VE TURKEY TICARET A.S.

CLARIDAR FILM-COATED TABLETS 250MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

CLARINASE REPETABS N/A SCHERING-PLOUGH S.A. BELGIUM

CLARITHROMYCIN/GENEPHARM TABLETS 500MG GENEPHARM S.A. GREECE

CLARITHROMYCIN/GENEPHARM TABLETS 250MG GENEPHARM S.A. GREECE

CLARITINE TABLETS 10MG SCHERING-PLOUGH NV/ BELGIUM SA

CLARITINE SYRUP 1MG/ML SCHERING-PLOUGH S.A. BELGIUM

CLAVAMOX DT 400 POWDER F/ORAL SUSP. NA LABORATORIOS BIAL PORTUGAL

CLENASMA TABLET 0.02MG BIOMEDICA FOSCAMA ITALY INDUSTRIA CHIMICO FARMACEUTICA S.P.A.

CLENASMA SYRUP 0.1MG/100ML BIOMEDICA FOSCAMA ITALY INDUSTRIA CHIMICO FARMACEUTICA S.P.A. 23.9.2003 FR Journal officiel de l'Union européenne 511

Trade Name Dosage Form Dose MA Holder Country

CLEXANE SOLUTION FOR 20MG/0.2ML LABORATOIRES AVENTIS FRANCE INJECTION

CLEXANE SOLUTION FOR 40MG/0.4ML LABORATOIRES AVENTIS FRANCE INJECTION

CLEXANE SOLUTION FOR 60MG/0.6ML BELLON, RHONE- FRANCE INJECTION POULENC RORER

CLEXANE SOLUTION FOR 80MG/0.8ML BELLON, RHONE- FRANCE INJECTION POULENC RORER

CLEXANE SOLUTION FOR 100MG/1ML BELLON, RHONE- FRANCE INJECTION POULENC RORER

CLEXANE 100MG/ML (FOR SC USE) INJECTABLE SOLN. IN PFS 100MG/ML BELLON, RHONE- FRANCE POULENC RORER

CLEXANE 20MG/0.2ML INJECTABLE SOLN. IN PFS 20MG/0.2ML BELLON, RHONE- FRANCE POULENC RORER

CLEXANE 40MG/0.4ML INJECTABLE SOLN. IN PFS 40MG/0.4ML BELLON, RHONE- FRANCE POULENC RORER

CLEXANE 60MG/0.6ML (FOR SC INJECTABLE SOLN. IN PFS 60MG/0.6ML BELLON, RHONE- FRANCE USE) POULENC RORER

CLEXANE 80MG/0.8ML (FOR SC INJECTABLE SOLN. IN PFS 80MG/0.8ML BELLON, RHONE- FRANCE USE) POULENC RORER

CLINDAZYN INJECTABLE SOLUTION 300MG/2ML LEMERY, S.A. DE C.V. MEXICO

CLINOMEL N4-550 SOLUTION FOR INFUSION NA BAXTER HEALTHCARE UNITED KINGDOM LIMITED

CLINOMEL N5-800 SOLUTION FOR INFUSION N/A BAXTER HEALTHCARE UNITED KINGDOM LIMITED

CLINOMEL N5-800 SOLUTION FOR INFUSION NA BAXTER HEALTHCARE UNITED KINGDOM LIMITED

CLINOMEL N6-900 SOLUTION FOR INFUSION N/A BAXTER HEALTHCARE UNITED KINGDOM LIMITED

CLINOMEL N6-900 SOLUTION FOR INFUSION NA BAXTER HEALTHCARE UNITED KINGDOM LIMITED

CLINOMEL N7-1000 EMULSION FOR INFUSION N/A BAXTER HEALTHCARE UNITED KINGDOM LIMITED

CLINOMEL N7-1000 SOLUTION FOR INFUSION NA BAXTER HEALTHCARE UNITED KINGDOM LIMITED

CLINT 100MG TABLET 100MG MEDOCHEMIE LTD CYPRUS

CLISMA LAX RECTAL SOLUTION N/A SOFAR SPA ITALY

CLOBAZAM 10MG CAPSULE 10MG MEDOCHEMIE LTD CYPRUS

CLOBEDERM-E CREAM 0.05G/100G ATCO LABORATORIES PAKISTAN (PVT) LTD

CLOBETASOL PROPIONATE TOPICAL SOLUTION 0.5MG/G TARO UNITED STATES OF TOPICAL SOLUTION PHARMACEUTICALS USA AMERICA

CLOCIP 1% W/W/ CREAM CREAM 1% CIPLA LTD. INDIA

CLOFENAC-25 ENTERIC COATED 25MG HOVID SDN.BHD. MALAYSIA TABLETS 512 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CLOFENAC-25 ENTERIC COATED TABLET 25MG HOVID SDN. BHD MALAYSIA (FORMERLY HO YAN HOR SDN.BHD)

CLOMFRANIL 10MG TABLET 10MG NOVARTIS PAKISTAN

CLOMFRANIL 25MG TABLETS 25MG NOVARTIS PAKISTAN

CLOMID 50MG TABLET 50MG LABORATOIRES MARION FRANCE MERRELL DOW

CLOMID TABLETS 50 MG TABLETS 50 MG AVENTIS PHARMA UNITED KINGDOM LIMITED

CLOMIFENE TABLETS BP 50MG CP PHARMACEUTICALS UNITED KINGDOM LIMITED

CLOMIPHENE CITRATE TABLET 50MG TEVA PHARMACEUTICAL ISRAEL (SEROPHENE) 50MG INDUSTRIES LIMITED

CLOMIPRAMINE CAPSULES 10MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CLOMIPRAMINE CAPSULES 25MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CLOMIPRAMINE CAPSULES 50MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CLOMIPRAMINE CAPSULE 10 MG APPROVED PRESCRIPTION UNITED KINGDOM SERVICES LIMITED

CLOMIPRAMINE BP CAPSULES 25MG APPROVED PRESCRIPTION UNITED KINGDOM SERVICES LIMITED

CLOMIPRAN 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

CLOMIPRAN 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

CLONEA CREAM 10MG/G ALPHAPHARM PTY AUSTRALIA LIMITED

CLONIL TABLETS 25MG INTAS INDIA PHARMACEUTICALS LTD.

CLONIL-10 TABLETS 10MG INTAS INDIA PHARMACEUTICALS LTD.

CLOPERAN 10MG TABLETS REMEDICA LTD. CYPRUS

CLOPIXOL TABLET 25MG H. LUNDBECK A/S DENMARK

CLOPIXOL TABLET 10MG H. LUNDBECK A/S DENMARK

CLOPIXOL TABLET 2MG H. LUNDBECK A/S DENMARK

CLOPIXOL DROPS 20MG/ML H. LUNDBECK A/S DENMARK

CLOPIXOL DEPOT INJECTION SOLUTION FOR 200MG/ML H. LUNDBECK A/S DENMARK 200MG/ML INJECTION

CLOPIXOL-ACUPHASE INJECTION SOLUTION FOR 50MG/ML H. LUNDBECK A/S DENMARK 50MG/ML INJECTION

CLOTAM (CLOTAN) CAPSULE 200MG GEA FARMACEUTISK DENMARK FABRIK

CLOTRI-DENK 1% CREAM CREAM 10MG/G E. DENK OHG GERMANY 23.9.2003 FR Journal officiel de l'Union européenne 513

Trade Name Dosage Form Dose MA Holder Country

CLOTRI-DENK 100 VAGINAL VAGINAL TABLET 100MG E. DENK OHG GERMANY

CLOTRIMADERM CREAM 1% W/W CREAM 1% W/W TARO CANADA PHARMACEUTICALS INC.

CLOVE OIL BP DENTAL SOLUTION 100%V/V LCM LTD UNITED KINGDOM

CLOXACILLIN 250 CAPSULES 250MG REMEDICA LTD CYPRUS

CLOXACILLIN 250 CAPSULES 250MG AEGIS LTD. CYPRUS

CLOXACILLIN 500 CAPSULES 500MG AEGIS LTD. CYPRUS

CLOZAPINE TABLETS 25MG MYLAN UNITED STATES OF PHARMACEUTICALS INC AMERICA

CLOZAPINE TABLETS 100MG MYLAN UNITED STATES OF PHARMACEUTICALS INC AMERICA

CLOZOLE CREAM 1% W/W CREAM 1% W/W SM PHARMACEUTICALS MALAYSIA SDN BHD

CO-AMILOFRUSE TABLETS NA CP PHARMACEUTICALS UNITED KINGDOM LIMITED

CO-AMILOZIDE TABLETS N/A CP PHARMACEUTICALS UNITED KINGDOM LTD.

CO-AMILOZIDE TABLETS N/A CP PHARMACEUTICALS UNITED KINGDOM LTD.

COAPROVEL 150/12.5MG TABLETS TABLET N/A SANOFI PHARMA EUROPEAN COMMUNITY BRISTOL-MYERS SQUIBB SNC

COAPROVEL 300/12.5MG TABLET N/A SANOFI PHARMA EUROPEAN COMMUNITY BRISTOL-MYERS SQUIBB SNC

CO-CODAMOL TABLETS N/A CP PHARMACEUTICALS UNITED KINGDOM LTD.

CO-CODAMOL TABLETS N/A HN NORTON & CO LTD UNITED KINGDOM

CO-CODAMOL TABLETS 8/500MG M & A PHARMACHEM UNITED KINGDOM LIMITED

COCOIS OINTMENT N/A BIOGLAN LABORATORIES UNITED KINGDOM LTD

CO-DANTHRAMER SUSPENSION SUSPENSION N/A NAPP LABORATORIES UNITED KINGDOM LIMITED

CODEINE LINCTUS BP ORAL SOLUTION 15MG/5ML WILLIAM RANSOM & UNITED KINGDOM SON PLC

CODEINE LINCTUS BP ORAL SOLUTION N/A LCM LTD UNITED KINGDOM

CODEINE PHOSPHATE TABLETS BP TABLETS 15MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

CODEINE PHOSPHATE TABLETS BP TABLETS 30MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

CODEINE PHOSPHATE TABLETS BP TABLETS 60MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

CODEINE PHOSPHATE TABLETS BP TABLET 30MG CP PHARMACEUTICALS UNITED KINGDOM 30MG LTD 514 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CO-DIOVAN FILM-COATED TABLETS N/A NOVARTIS SPAIN FARMACEYTICA S.A. - SPAIN

CO-DIOVAN 80/12.5MG FILM COATED TABLETS N/A NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

CODIPRONT CAPSULES WITH SUST N/A HEINRICH MACK NACHF GERMANY ACTION

CODIPRONT SYRUP N/A HEINRICH MACK NACHF GERMANY

CODIPRONT CUM EXPECTORANS CAPSULES N/A PFIZER AG SWITZERLAND

CODIPRONT CUM EXPECTORANS SYRUP N/A PFIZER AG SWITZERLAND

CODIPRONT CUM EXPECTORANS ORAL SUSPENSION NA PFIZER AG SWITZERLAND

CODIPRONT CUM EXPECTORANS CAPSULES NA PFIZER AG SWITZERLAND

CODIS TABLETS TABLET N/A RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

CO-DYDRAMOL TABLETS N/A NORTON HEALTHCARE UNITED KINGDOM LIMITED

COFLOX-500 TABLETS 500MG MACLEODS INDIA PHARMACEUTICALS LTD

COFSED LINCTUS ORAL SOLUTION N/A GALEN LIMITED UNITED KINGDOM

COFSED PAEDIATRIC LINCTUS ORAL SOLUTION N/A GALEN LIMITED UNITED KINGDOM

COLCHICINE TABLETS BP TABLETS 500MCG CP PHARMACEUTICALS UNITED KINGDOM LTD.

COLCHICINE TABLETS BP 500 TABLET 500MCG CP PHARMACEUTICALS UNITED KINGDOM MICROGRAMS LTD

COLD CREAM SALICYLE CREAM N/A LABORATOIRES LA FRANCE ROCHE-POSAY

COLESTID GRANULES 5G PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

COLIRCUSI PILOCARPINA 2% EYE EYE DROPS 2% ALCON CUSI SA SPAIN DROPS

COLLOMACK SOLUTION N/A HEINRICH MACK NACHF. GERMANY GMBH & CO. KG

COLLU-HEXTRIL 0.2% SPRAY SOLUTION 0.2% W/V PARKE DAVIS FRANCE

COLOFAC SUGAR COATED TABLET 135MG SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

COLOFAC RETARD CAPSULE 200MG SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

COLOMYCIN TABLETS 1.5MU PHARMAX LIMITED UNITED KINGDOM

COLOMYCIN SYRUP 250,000 U/5ML PHARMAX LIMITED UNITED KINGDOM

COLOMYCIN INJECTION POWDER FOR 0.5MU PHARMAX LIMITED UNITED KINGDOM RECONSTITUTION

COLOMYCIN INJECTION POWDER FOR 1MU PHARMAX LIMITED UNITED KINGDOM RECONSTITUTION

COLOMYCIN STERILE POWDER STERILE POWDER 1G PHARMAX LIMITED UNITED KINGDOM 23.9.2003 FR Journal officiel de l'Union européenne 515

Trade Name Dosage Form Dose MA Holder Country

COLOSPASMIN FORTE TABLETS 135MG EGYPTIAN EGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO (EIPICO)

COLPOCINT-T SOLUTION FOR 500MG/1000ML DEMO ABEE GREECE INJECTION

COLPOSEPTINE GYNAECOLOGICAL N/A LABORATOIRE FRANCE TABLETS THERAMEX

COLPOTROPHINE VAGINAL CAPSULE 0.01G LABORATOIRE MONACO THERAMEX

COLPOTROPHINE 1% CREAM 1G/100G LABORATOIRE MONACO THERAMEX

COLSOR CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM

COLSOR LOTION TOPICAL SOLUTION N/A J PICKLES & SONS UNITED KINGDOM

COLTRAMYL 4MG TABLET 4MG LABORATOIRES ROUSSEL FRANCE

COLTRAMYL 4MG/2ML SOLUTION FOR IM 4MG/2ML LABORATOIRES ROUSSEL FRANCE INJECTION

COLYTE POWDER FOR ORAL N/A SCHWARZ PHARMA INC. UNITED STATES OF SOLUTION AMERICA

COMAZOL CREAM 1% W/W CREAM 1% W/W CAMDEN INDUSTRIES (M) MALAYSIA SDN BHD

COMBACID N GEL N/A G.STREULI & CO. AG SWITZERLAND

COMBINATION Q-BIOCHEMIC TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM LABORATORIES LIMITED

COMBIVENT UDVS INHALATION SOLUTION N/A BOEHRINGER INGELHEIM UNITED KINGDOM LTD

COMPOUND BENZOIN TINCTURE CONC. FOR INHALATION N/A WILLIAM RANSOM & UNITED KINGDOM BP SOLN SON PLC

COMPOUND SOD.LACTATE WITH INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY 5%W/V GLUCOSE AG

COMPOUND SODIUM LACTATE IV SOLUTION FOR N/A BAXTER HEALTHCARE UNITED KINGDOM INFUSION INJECTION LIMITED

COMPOUND SODIUM LACTATE IVI INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY BP -HARTMANN AG

COMPOUND THYMOL GLYCERIN OROMUCOSAL SOLUTION N/A WILLIAM RANSOM & UNITED KINGDOM BP SON PLC

COMTAN FILM COATED TABLETS 200MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

COMTAN FILM COATED TABLETS 200MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

COMTAN FILM-COATED TABLETS 200MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

CONCAVIT SOFT GELATINE N/A WALLACE UNITED KINGDOM CAPSULES MANUFACTURING CHEMISTS LIMITED

CONCAVIT DROPS N/A WALLACE UNITED KINGDOM MANUFACTURING CHEMISTS LIMITED 516 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CONDYLINE SOLUTION 5MG/ML YAMANOUCHI PHARMA NETHERLANDS B.V.

CONOTRANE CREAM N/A YAMANOUCHI PHARMA UNITED KINGDOM LIMITED

CONTAC 12 CAPSULE 50MG MENLEY & JAMES UNITED KINGDOM LIMITED

CONTAC 400 CAPSULES GASTRO-RESISTANT N/A MENLEY & JAMES LTD UNITED KINGDOM GRANULES T/A SMITHKLINE BEECHAM CONSUMER HEALTHCAR

CONTACT ADMINISTRATOR XXX XXX GERMANY

CONTRACIDE ORAL SUSPENSION N/A LABORATOIRES FRANCE NORGINE PHARMA

CONTRACIDE ORAL SUSPENSION N/A LABORATOIRES FRANCE NORGINE PHARMA

CONTRATUBEX GEL N/A MERZ+CO. GMBH & CO. GERMANY

COOL MINT LISTERINE SOLUTION N/A WARNER-LAMBERT S.A. SOUTH AFRICA (PTY) LTD

CO-PROXAMOL TABLETS COATED TABLET N/A SANOFI WINTHROP LTD UNITED KINGDOM

CO-PROXAMOL TABLETS BP TABLET N/A M & A PHARMACHEM UNITED KINGDOM LIMITED

CORACTEN RETARD CAPSULE 20MG SMITHKLINE BEECHAM GERMANY PHARMA GMBH

CORADAY MR 20MG TABLET TABLET 20MG GENERICS (UK) LIMITED UNITED KINGDOM

CORDARONE 150MG/3ML IV INJECTABLE SOLUTION 150MG/3ML SANOFI WINTHROP FRANCE

CORDARONE 200MG SCORED TABLET 200MG SANOFI WINTHROP FRANCE

CORDARONE X/AMIODARONE HCL TABLET 100MG SANOFI WINTHROP UNITED KINGDOM 100MG TABLETS LIMITED

CORDICANT CAPSULES 5MG MUNDIPHARMA GMBH GERMANY

CORDICANT CAPSULE 10MG MUNDIPHARMA GMBH GERMANY

CORDICANT RETARD TABLETS 20MG MUNDIPHARMA GMBH GERMANY

CORDICANT RETARD PROLONGED RELEASE 20MG MUNDIPHARMA GMBH GERMANY TABLETS

CORDILOX SR TABLETS 240MG NORTON HEALTHCARE UNITED KINGDOM LTD

CORDIMEDIL FILM COATED TABLETS 300MG KLEVA LIMITED GREECE

CORGARD TABLETS 40MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

CORGARD TABLETS 80MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

CORGARETIC 40MG/5MG TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM

CORGARETIC 80MG/5MG TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM

CORICIDIN-D EXTRA STRENGTH TABLETS N/A S-P CANADA CANADA

CORITUSSAL CAPSULES N/A HEINRICH MACK NACHF GERMANY 23.9.2003 FR Journal officiel de l'Union européenne 517

Trade Name Dosage Form Dose MA Holder Country

CORITUSSAL SYRUP SUSPENSION N/A HEINRICH MACK NACHF GERMANY

CORN REMOVAL PLASTERS PLASTER 40%W/W SCHOLL CONSUMER UNITED KINGDOM PRODUCTS

CORN REMOVAPADS PLASTER 40%W/W SCHOLL CONSUMER UNITED KINGDOM PRODUCTS

CORPRILOR TABLETS 20MG LABORATORIOS RUBIO SPAIN S.A

CORSODYL DENTAL GEL 1% W/W DENTAL GEL 1% W/W BEECHAM GROUP PLC UNITED KINGDOM T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

CORSODYL MINT MOUTHWASH DENTAL SOLUTION 0.2% W/V BEECHAM GROUP PLC UNITED KINGDOM 0.2% W/V T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

CORSODYL MOUTHWASH DENTAL SOLUTION 0.2% W/V BEECHAM GROUP PLC UNITED KINGDOM 0.2% W/V T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

CORTEF TABLETS 10MG PHARMACIA & UPJOHN UNITED STATES OF COMPANY AMERICA

CORTEF HYDROCORTISONE TABLETS 20MG PHARMACIA AND UNITED STATES OF TABLETS UPJOHN COMPANY AMERICA

CORTIFOAM RECTAL FOAM N/A SCHWARZ PHARMA INC. UNITED STATES OF AMERICA

CORTISONE ACETATE TABLET 25MG REKAH ISRAEL LTD

CORTODERM ONT 1% W/W OINTMENT 1% W/W TARO CANADA PHARMACEUTICALS INC.

CORTOPIN HYDROCORTISONE CREAM 1% W/W PINEWOOD UNITED KINGDOM CREAM LABORATORIES LIMITED

CORTOPIN HYDROCORTISONE CREAM 1% W/W PINEWOOD UNITED KINGDOM CREAM LABORATORIES LTD T/A PINEWOOD HEALTHCARE

CORTOPIN HYDROCORTISONE OINTMENT 1% W/W PINEWOOD UNITED KINGDOM OINTMENT LABORATORIES LTD T/A PINEWOOD HEALTHCARE

CORVASAL 2MG TABLET 2MG LABORATOIRES FRANCE HOECHST

CORVASAL 4MG TABLET 4MG LABORATOIRES FRANCE HOECHST

COSOPT EYEDROPS N/A MERCK SHARP AND UNITED KINGDOM DOHME LIMITED

COSTI 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

CO-TENIDONE TABLETS 100MG/25MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CO-TENIDONE TABLETS 50MG/12.5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED 518 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

COTRIM SUSPENSION N/A MEDOCHEMIE LTD CYPRUS

COTRIM 480MG TABLET N/A MEDOCHEMIE LTD CYPRUS

COTRIM D.S. TABLET N/A MEDOCHEMIE LTD CYPRUS

COTRIMHEXAL FORTE TABLET N/A HEXAL AG GERMANY

CO-TRIMOXAZOLE TABLETS 960MG PHARMAMED LTD. MALTA

CO-TRIMOXAZOLE TABLETS 960MG PHARMAMED LTD. MALTA

CO-TRIMOXAZOLE TABLETS N/A MACLEODS INDIA

CO-TRIMOXAZOLE BP 400/80MG TABLET N/A SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

COTRIMOXAZOLE TABLETS UNCOATED TABLET N/A MEDICORP INDIA B.P.480MG TECHNOLOGIES INDIA LTD.,

COUMADIN TABLETS 1MG DUPONT PHARMA UNITED STATES OF AMERICA

COUMADIN TABLETS 2.5MG DUPONT PHARMA UNITED STATES OF AMERICA

COUMADIN TABLETS 5MG DUPONT PHARMA UNITED STATES OF AMERICA

COUMADIN TABLETS 2MG DUPONT UNITED STATES OF PHARMACEUTICALS AMERICA COMPANY (DUPONT PHARMA)

COUMADIN TABLETS 3MG DUPONT UNITED STATES OF PHARMACEUTICALS AMERICA COMPANY

COUMADIN TABLETS 6MG DUPONT UNITED STATES OF PHARMACEUTICALS AMERICA COMPANY

COUMADIN TABLETS 4MG DUPONT UNITED STATES OF PHARMACEUTICALS AMERICA COMPANY

COUMADIN TABLETS 7.5MG DUPONT UNITED STATES OF PHARMACEUTICALS AMERICA COMPANY

COUMADIN TABLETS 10MG DUPONT UNITED STATES OF PHARMACEUTICALS AMERICA COMPANY

COVERSYL TABLET 4MG SERVIER PAKISTAN

COVERSYL TABLETS 4MG LES LABORATOIRES FRANCE SERVIER

COVERSYL 2MG TABLET 2MG LES LABORATOIRES FRANCE SERVIER

COVONIA BRONCHIAL BALSAM ORAL SOLUTION N/A THORNTON & ROSS LTD UNITED KINGDOM

COVONIA MENTHOLATED COUGH ORAL SOLUTION N/A LCM LTD UNITED KINGDOM MIXTURE

COVONIA NIGHT TIME FORMULA ORAL SOLUTION N/A THORNTON & ROSS UNITED KINGDOM 23.9.2003 FR Journal officiel de l'Union européenne 519

Trade Name Dosage Form Dose MA Holder Country

COXERIN CAPSULES 250MG MACLEODS INDIA PHARMACEUTICALS LTD

COZAAR TABLET 100MG MERCK SHARP AND UNITED KINGDOM DOHME LIMITED

COZAAR 50MG TABLET 50MG MERCK SHARP & DOHME NETHERLANDS B.V.

COZAAR TABLETS TABLETS 50MG MSD PAKISTAN

CRAMPEX TABLETS TABLET N/A SETON PRODUCTS UNITED KINGDOM LIMITED

CREON 10 000 CAPSULE 150MG SOLVAY ARZNEIMITTEL GERMANY GMBH

CREON 25 000 CAPSULE 300MG SOLVAY ARZNEIMITTEL GERMANY GMBH

CRIXIVAN HARD CAPSULE 400MG MERCK SHARP & DOHME UNITED KINGDOM

CROMABAK EYEDROPS 2% N/A LABORATOIRES THEA FRANCE

CROMAL EYE DROPS 2%W/V CIPLA LTD INDIA

CROMAL-5 INHALER N/A CIPLA LIMITED INDIA

CROMOGEN INHALER 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

CROMOGEN EASI BREATHE INHALER 5MG NORTON HEALTHCARE UNITED KINGDOM INHALER LIMITED

CROMOGEN STERI-NEB SOLUTION FOR 20MG/2ML STERIPAK LIMITED UNITED KINGDOM NEBULISATION

CRYSTACIDE CREAM 1% CREAM 1% W/ W BIOGLAN LABORATORIES UNITED KINGDOM LTD

CUATRODERM CREAM N/A SCHERING PLOUGH S.A. SPAIN

CUPAL HONEY AND LEMON ORAL SOLUTION 50MG/5ML CUPAL LTD UNITED KINGDOM MELTUS COUGH LINCTUS

CUPROFEN COATED TABLETS 400 MG CUPAL LIMITED UNITED KINGDOM

CUPROFEN IBUPROFEN COATED TABLETS 200 MG CUPAL LIMITED UNITED KINGDOM

CURAM TABLET N/A BIOCHEMIE GMBH AUSTRIA

CURZON TABLETS TABLET N/A CATHAY OF UNITED KINGDOM BOURNEMOUTH LTD T/A GERARD HOUSE

CUSIMOLOL 0.25% EYE DROPS 0.25% W/V ALCON CUSI, S.A. SPAIN

CUSIMOLOL 0.5% EYE DROPS 0.5% W/V ALCON CUSI, S.A. SPAIN

CUSIMOLOL 0.5% EYE DROPS 0.5% W/V LABORATORIOS CUSI SPAIN S.A.

CUTIVATE CREAM CREAM 0.05%W/W GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A GLAXO LABORATORIES

CUTIVATE CREAM 0.05% CREAM 0.05% W/W GLAXO WELLCOME UK UNITED KINGDOM LTD 520 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

CUTIVATE OINTMENT OINTMENT 0.05%W/W GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A GLAXO LABORATORIES

CUTIVATE OINTMENT 0.005% OINTMENT 0.005% GLAXO WELLCOME UK UNITED KINGDOM LTD

CYCLIMORPH 10 SOLUTION FOR N/A WELLCOME UNITED KINGDOM INJECTION FOUNDATION LTD.

CYCLIMORPH 15 SOLUTION FOR N/A WELLCOME UNITED KINGDOM INJECTION FOUNDATION LTD.

CYCLOGYL 0.5% OPHTHALMIC SOLUTION 0.5% W/V S.A. ALCON-COUVREUR BELGIUM N.V.

CYCLOSPORINE (IMUSPORIN-100) CAPSULES 100MG CIPLA LIMITED INDIA

CYCLOSPORINE (IMUSPORIN-25) SOFT GELATIN CAPSULES 25MG CIPLA LIMITED INDIA

CYCLOSPORINE (IMUSPORIN-50) SOFT GELATIN CAPSULE 50MG CIPLA LIMITED INDIA

CYKLOKAPRON SOLUTION FOR 100MG/ML PHARMACIA & UPJOHN SWEDEN INJECTION SVERIGE AB

CYKLOKAPRON TABLETS 500MG PHARMACIA & UPJOHN ITALY SVERIGE SA

CYKLOKAPRON SOLUTION FOR 100MG/ML PHARMACIA & UPJOHN BELGIUM INJECTION N.V./S.A.

CYKLOKAPRON SOLUTION F/PARENTERAL 100MG/ML PHARMACIA NV/SA BELGIUM USE

CYKLOKAPRON SOL. FOR PARENTERAL 100MG/ML PHARMACIA NV/SA BELGIUM USE

CYKLOKAPRON SOL. FOR PARENTERAL 100MG/ML PHARMACIA NV/SA BELGIUM USE

CYMALON GRANULES FOR ORAL N/A SETON PRODUCTS UNITED KINGDOM SOLN. LIMITED

CYMALON GRANULES FOR ORAL N/A SETON PRODUCTS UNITED KINGDOM SUSPE. LIMITED

CYMEX CREAM CREAM N/A PL 00083/0026 UNITED KINGDOM

CYNT 0.2 FILM-COATED TABLET 0.2MG BEIERSDORF-LILLY GMBH GERMANY

CYNT 0.3 FILM-COATED TABLET 0.3MG BEIERSDORF-LILLY GMBH GERMANY

CYNT 0.4 FILM-COATED TABLET 0.4MG BEIERSDORF-LILLY GMBH GERMANY

CYPROCUR TABLETS 50 MG CIPLA LTD — INDIA INDIA

CYPROTERONE ACETATE TABLETS 50 MG GENERICS (UK) LIMITED UNITED KINGDOM —UK

CYPROTERONE ACETATE TABLETS 50MG CP PHARMACEUTICALS UNITED KINGDOM LIMITED

CYSTOCALM GRANULES FOR ORAL 4G GALPHARM HEALTHCARE UNITED KINGDOM SOL. LIMITED

CYSTOFEM CYSTITIS RELIEF GRANULES N/A SUSSEX UNITED KINGDOM GRANULES PHARMACEUTICAL LIMITED

CYSTRIN 5MG TABLET 5MG LEIRAS OY FINLAND 23.9.2003 FR Journal officiel de l'Union européenne 521

Trade Name Dosage Form Dose MA Holder Country

CYTARABINE INJECTION VIAL SOLUTION FOR 100MG/5ML F.H. FAULDING & CO. LTD UNITED KINGDOM INJECTION (T/A DAVID BULL LABS)

CYTOBLASTIN AQUEOUS SOLUTION FOR 10MG/ML CIPLA LIMITED INDIA INJECTION

CYTOCRISTIN AQUEOUS SOLUTION FOR 1MG/1ML CIPLA LIMITED INDIA INJECTION

CYTODROX CAPSULES 500MG CIPLA LTD INDIA

CYTOPLATIN-10 AQUEOUS SOLUTION FOR 10MG/20ML CIPLA LIMITED INDIA INJECTION

CYTOPLATIN-50 AQUEOUS SOLUTION FOR 50MG/50ML CIPLA LIMITED INDIA INJECTION

CYTOSAR POWDER FOR INJECTION 100MG/VIAL PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

CYTOSAR POWDER FOR INJECTION 500MG PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

CYTOTAM-20 TABLETS 20MG CIPLA LTD INDIA

CYTOTEC TABLETS 200MCG MONSANTO PLC UNITED KINGDOM

CYTOTEC TABLETS 200MCG MONSANTO PLC T/A UNITED KINGDOM SEARLE

CYTOTEC TABLETS 200MCG MONSANTO PLC T/A UNITED KINGDOM SEARLE

CYTOTEC 200 MCG TABLETS TABLETS 200 MCG PHARMACIA LIMITED UNITED KINGDOM

CYTOTREX TABLETS 2.5MG CIPLA LTD. INDIA

CZARTAN TABLET 25MG MACLEODS INDIA PHARMACEUTICALS LTD

D.D.D. MEDICATED LOTION TOPICAL SOLUTION N/A D D D LIMITED UNITED KINGDOM

D.T. COQ INJECTABLE SUSPENSION N/A (IN PFS) PASTEUR MERIEUX FRANCE

D.T. POLIO VACCINE VACCINE N/A PASTEUR MERIEUX FRANCE

D.T. VAX INJECTABLE N/A PASTEUR MERIEUX FRANCE PREPARATION

DACARBAZINE FOR INJECTION POWDER FOR INJECTION 20MG/ML FAULDING UNITED KINGDOM PHARMACEUTICALS PLC

DADCROME EYE DROPS 220MG/10ML DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

DAFLON TABLET 150MG SERVIER PAKISTAN

DAFLON 500MG TABLET LES LABORATOIRES FRANCE SERVIER

DAFLON 375MG COATED TABLET 375MG LES LABORATOIRES FRANCE SERVIER

DAFLON 500MG COATED TABLET 500MG LABORATOIRES SERVIER FRANCE

DAIVONEX CREAM 50MCG/G LEO PHARMACEUTICAL DENMARK PRODUCTS LIMITED 522 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DAIVONEX SCALP SOLUTION 50MCG/ML LEO PHARMACEUTICAL DENMARK PRODUCTS

DAIVONEX OINTMENT 50MCG/G LEO PHARMACEUTICAL DENMARK PRODUCTS

DAKTACORT CREAM N/A JANSSEN-CILAG N.V. BELGIUM

DAKTACORT CREAM N/A JANSSEN PAKISTAN

DAKTARIN CREAM 20MG/G JANSSEN-CILAG N.V. BELGIUM

DAKTARIN LOTION 20MG/G JANSSEN-CILAG N.V. BELGIUM

DAKTARIN LOTION 20MG/G JANSSEN FARMACEUTICA PORTUGAL PORTUGAL

DAKTARIN CUTANEOUS SOLUTION 20MG/ML JANSSEN FARMACEUTICA PORTUGAL PORTUGAL

DAKTARIN 2% ORAL GEL 2% W/W JANSSEN-CILAG N.V. BELGIUM

DAKTARIN 2% TINCTURE 2% W/V JANSSEN-CILAG N.V. BELGIUM

DAKTARIN 2% POWDER 20MG/G JANSSEN-CILAG N.V. BELGIUM

DALACIN TOPICAL SOLUTION 10MG/ML PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

DALACIN VAGINAL CREAM 2%W/W PHARMACIA LIMITED UNITED KINGDOM

DALACIN C CAPSULE 150MG UPJOHN PAKISTAN

DALACIN C SOLUTION FOR 300MG/2ML PHARMACIA & UPJOHN BELGIUM INJECTION N.V. / S.A.

DALACIN C SOLUTION FOR 600MG/4ML PHARMACIA & UPJOHN BELGIUM INJECTION N.V. / S.A.

DALACIN C ORAL CAPSULES 150MG PHARMACIA NV/AS BELGIUM

DALACIN C 150MG ORAL CAPSULES 150MG PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

DALACIN C 75MG ORAL CAPSULES 75MG PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

DALACIN C 75MG/5ML SYRUP 75MG/5ML PHARMACIA & UPJOHN BELGIUM N.V./ S.A

DALACIN T LOTION N/A UPJOHN PAKISTAN

DALACIN T TOPICAL SOLUTION 10MG/1ML PHARMACIA NV/AS BELGIUM

DALACIN VAGINAL OVULES VAGINAL OVULES 100MG PHARMACIA & UPJOHN UNITED STATES OF COMPANY AMERICA

DALIVIT DROPS ORAL EMULSION N/A EASTERN UNITED KINGDOM PHARMACEUTICALS LIMITED

DALMANE CAPSULES CAPSULES 15MG ICN PHARMACEUTICALS UNITED KINGDOM LIMITED

DALMANE CAPSULES CAPSULES 30MG ICN PHARMACEUTICALS UNITED KINGDOM LIMITED

DANATROL 200MG CAPSULE 200MG SANOFI WINTHROP FRANCE

DANOGEN-200 CAPSULES 200MG CIPLA LTD. INDIA 23.9.2003 FR Journal officiel de l'Union européenne 523

Trade Name Dosage Form Dose MA Holder Country

DANOL 200MG CAPSULES CAPSULE 200MG SANOFI WINTHROP UNITED KINGDOM LIMITED

DAONIL TABLET 5MG HOECHST PAKISTAN

DAONIL TABLET 5MG HOECHST MARION PAKISTAN ROUSSEL

DAONIL 5MG TABLET 5MG LABORATOIRES FRANCE HOECHST

DAONIL FAIBLE 1.25MG TABLET 1.25MG LABORATOIRES FRANCE HOECHST

DAPA-TABS TABLETS 2.5MG ALPHAPHARM PTY AUSTRALIA LIMITED

DAPRIL 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

DAPRIL 20MG TABLET 20MG MEDOCHEMIE LTD CYPRUS

DAPRIL 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

DARAPRIM TABLETS 25MG WELLCOME UNITED KINGDOM FOUNDATION LTD.

DARAZIO TABLETS NA DELTA HF ICELAND

DAREN TABLETS 2.5MG DELTA HF ICELAND

DAREN TABLETS 5MG DELTA HF ICELAND

DAREN TABLETS 10MG DELTA HF ICELAND

DAREN TABLETS 20MG DELTA HF ICELAND

DAUNOBLASTINA POWDER FOR INJECTION 20MG/VIAL PHARMACIA & UPJOHN ITALY S.P.A.

DAUNOBLASTINA POWDER FOR SOLN FOR 20MG/10ML PHARMACIA ITALIA S.P.A ITALY INJECTION

DAY NURSE ORAL SOLUTION NA BEECHAM GROUP PLC UNITED KINGDOM T/A GLAXOSMITHKLINE CONSUMER HEALTHCARE

DAY NURSE HARD CAPSULES NA BEECHAM GROUP PLC UNITED KINGDOM T/A GLAXOSMITHKLINE CONSUMER HEALTHCARE

DAY NURSE CAPSULES CAPSULE N/A BEECHAM GROUP PLC UNITED KINGDOM T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

DAY NURSE CAPSULES CAPSULE N/A BEECHAM GROUP PLC UNITED KINGDOM T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

DAYTIME COLD AND FLU LIQUID CAPSULE N/A STANLEY CANADA CAPSULES PHARMACEUTICALS LTD

DAZIL 30 TABLETS 30MG AEGIS LTD. CYPRUS

DAZIL 60 TABLETS 60MG AEGIS LTD. CYPRUS

DAZIL 90 TABLETS 90MG AEGIS LTD CYPRUS 524 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DBL CARBOPLATIN INJECTION SOLUTION FOR 150MG/15ML F.H. FAULDING & CO LTD AUSTRALIA VIAL INJECTION (T/A DAVID BULL LABS)

DBL CISPLATIN INJECTION VIAL SOLUTION FOR 50MG/50ML F.H. FAULDING & CO LTD AUSTRALIA INJECTION (T/A DAVID BULL LABS)

DBL DAUNORUBICIN 20MG/4ML SOLUTION FOR 20MG/4ML F.H. FAULDING & CO LTD AUSTRALIA INJECTION

DBL HYOSCINE HYDROBROMIDE SOLUTION FOR 400MCG F.H FAULDING & CO. AUSTRALIA INJECTION LIMITED T/A DAVID BULL LABORATORIES

DBL METHOTREXATE INJECTION SOLUTION FOR 50MG/2ML F.H. FAULDING & CO LTD AUSTRALIA VIAL INJECTION (T/A DAVID BULL LABS)

DBL MORPHINE SULPHATE SOLUTION FOR 10MG/ML F.H. FAULDING & CO LTD AUSTRALIA INJECTION

DBL MORPHINE SULPHATE SOLUTION FOR 15MG/1ML F.H. FAULDING & CO LTD AUSTRALIA INJECTION

DBL PETHIDINE HYDROCHLORIDE SOLUTION FOR 50MG/ML F.H. FAULDING & CO LTD AUSTRALIA INJECTION

DDAVP INTRANASAL SOL. NASAL DROPS 0.01% FERRING UNITED KINGDOM PHARMACEUTICALS LIMITED

DDAVP TABLETS TABLET 0.1MG FERRING UNITED KINGDOM PHARMACEUTICALS LTD

DDD MEDICATED LOTION TOPICAL SOLUTION NA DDD LIMITED UNITED KINGDOM

DE WITTS ANTACID TABLETS TABLET N/A E C DE WITT & CO LTD UNITED KINGDOM

DE WITTS THROAT LOZENGES LOZENGE N/A E C DE WITT & CO LTD UNITED KINGDOM

DEANXIT SUGAR-COATED TABLET N/A LUNDBECK AUSTRIA ARZNEIMITTEL GESELLSCHAFT M.B.H.

DECADRON 4MG/ML INJECTION FLUID 4MG/ML MERCK SHARP & DOHME NETHERLANDS B.V.

DECADRON EAR + NEOMYCIN EAR DROPS N/A MERCK SHARP & DOHME NETHERLANDS 0.1% DPS B.V.

DECADRON EYE + NEOMYCIN 0.1% EYE DROPS N/A MERCK SHARP & DOHME NETHERLANDS DPS B.V.

DECA-DURABOLIN SOLUTION FOR 25MG/ML ORGANON UNITED KINGDOM INJECTION LABORATORIES

DECA-DURABOLIN 25MG/ML SOLUTION FOR 25MG/ML ORGANON UNITED KINGDOM INJECTION LABORATORIES LIMITED

DECA-DURABOLIN 50MG/ML SOLUTION FOR 50MG/ML ORGANON UNITED KINGDOM INJECTION INJECTION LABORATORIES LIMITED

DECAPEPTYL 0.1MG POWDER FOR INJEC. 0.1MG LABORATOIRES IPSEN FRANCE SUSPEN. BIOTECH

DECAVIT CAPSULE N/A ROWA IRELAND PHARMACEUTICALS LTD

DECLOVIR CREAM 5% W/W HOE PHARMACEUTICALS MALAYSIA SDN.BHD.

DECLOVIR CREAM CREAM 5% W/W HOE PHARMACEUTICALS MALAYSIA SDN. BHD 23.9.2003 FR Journal officiel de l'Union européenne 525

Trade Name Dosage Form Dose MA Holder Country

DECOCORT CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

DECOCORT CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

DECOCORT CREAM CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD

DECONGESTANT NASAL SPRAY AEROSOL 0.1% W/V STANLEY CANADA 0.1% W/V PHARMACEUTICALS LTD

DECOZOL CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD

DECOZOL CREAM 2% W/W HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

DECUTAN SOFT GELATIN CAPSULES 10MG DELTA LIMITED ICELAND

DECUTAN SOFT GELATIN CAPSULES 20MG DELTA LIMITED ICELAND

DEEP FREEZE AEROSOL SPRAY TOPICAL SPRAY N/A THE MENTHOLATUM UNITED KINGDOM COMPANY LIMITED

DEEP HEAT MAXIMUM STRENGTH CREAM N/A THE MENTHOLATUM UNITED KINGDOM CREAM COMPANY LIMITED

DEEP RELIEF GEL N/A THE MENTHOLATUM UNITED KINGDOM COMPANY LIMITED

DEFAROL TABLET 10MG PROEL S.A. CORONIS E.G. GREECE

DEFFERINE GEL 0.1% W/W LABORATOIRE FRANCE GALDERMA

DEHYDRATED ALCOHOL BP FOR SOLUTION FOR 100%V/V MACARTHYS UNITED KINGDOM INJECTION INJECTION LABORATORIES LTD

DEHYDROBENZPERIDOL AMPOULE 2.5MG/ML JANSSEN-CILAG N.V. BELGIUM

DELIMON GEL FOR EXTERNAL USE 11.6MG/1G PHARMATHEN LTD. GREECE

DELTACOTRIL ENTERIC COATED TABLET 2.5MG PFIZER LIMITED UNITED KINGDOM

DEMOCINETIC CREAM N/A GEYMONAT SPA ITALY

DENAVIR 1% (VECTAVIR) CREAM 1% W/W LABORATOIRES FRANCE SMITHKLINE BEECHAM

DENEREL 0.2MG/ML SYRUP 0.2MG/ML MEDOCHEMIE LTD CYPRUS

DENEREL 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS

DENEX TABLET 100MG MEDOCHEMIE LTD CYPRUS

DE-NOL TABLETS 120MG YAMANOUCHI PHARMA NETHERLANDS B.V.

DENTINOX CRADLE CAP SHAMPOO N/A D D D LIMITED UNITED KINGDOM TREATMENT SHAMPOO

DENTINOX INFANT COLIC DROPS ORAL SUSPENSION N/A D D D LIMITED UNITED KINGDOM

DENTINOX TEETHING GEL DENTAL GEL N/A D D D LIMITED UNITED KINGDOM

DEPACON SOLUTION FOR 500MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA 526 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DEPAKINE 400MG/4ML FREEZE-DRIED POWDER 400MG/4ML SANOFI-SYNTHELABO FRANCE FRANCE

DEPAKOTE DELAYED RELEASE 500MG ABBOTT LABORATORIES UNITED STATES OF TABLETS AMERICA

DEPO-MEDROL STERILE AQ. SUSP. FOR 40MG/ML PHARMACIA & UPJOHN BELGIUM INJ N.V./ S.A

DEPO-MEDROL STERILE AQ. SUSP. FOR 80MG/2ML PHARMACIA & UPJOHN BELGIUM INJ N.V. / S.A.

DEPO-PROVERA STERILE AQ. SUSP. FOR 500MG/VIAL PHARMACIA & UPJOHN BELGIUM INJ N.V. / S.A.

DEPO-PROVERA STERILE AQ. SUSP. FOR 1000MG/VIAL PHARMACIA & UPJOHN BELGIUM INJ N.V. / S.A.

DEPO-PROVERA STERILE AQUEOUS 150MG/ML PHARMACIA N.V./S.A. BELGIUM SUSPENS.

DEPRIM TABLETS N/A REMEDICA LTD CYPRUS

DEQUACAINE LOZENGE N/A CROOKES HEALTHCARE UNITED KINGDOM LIMITED

DEQUADIN LOZENGE 0.25MG CROOKES HEALTHCARE UNITED KINGDOM LIMITED

DERM-AID CREAM 5MG/G EGO PHARMACEUTICALS AUSTRALIA

DERMAID SOFT 0.5% CREAM CREAM 0.5% EGO PHARMACEUTICALS AUSTRALIA PTY LTD.

DERMAID SOFT 1% CREAM CREAM 1% EGO PHARMACEUTICALS AUSTRALIA PTY LTD.

DERMATIN SHAMPOO 20MG/ML DELTA HF ICELAND

DERMESONE CREAM N/A DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

DERMESONE SKIN OINTMENT 1MG/G DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO. LTD

DERMIDEX DERMATOLOGICAL CREAM N/A PHARMALAB LTD UNITED KINGDOM CREAM

DERMOBACTER SOLN FOR CUTANEOUS N/A INNOTECH FRANCE APPLIC INTERNATIONAL

DERMOCINETIC CREAM N/A GEYMONAT SPA ITALY

DERMOVATE CREAM CREAM 0.053% W/W GLAXO WELLCOME UK UNITED KINGDOM LTD T/A GLAXO LABSS

DERMOVATE CREAM CREAM 0.05%W/W GLAXO WELLCOME UK UNITED KINGDOM LIMITED

DERMOVATE OINTMENT OINTMENT 0.05% W/W GLAXO WELLCOME UK UNITED KINGDOM LTD

DERMOVATE OINTMENT OINTMENT 0.05%W/W GLAXO WELLCOME UK UNITED KINGDOM LIMITED

DERMOVATE SCALP APPLICATION SOLUTION FOR TOPICAL 0.5MG/G GLAXO WELLCOME GERMANY USE GMBH & CO

DERMOVATE SCALP APPLICATION TOPICAL SOLUTION 0.05%W/W GLAXO WELLCOME UK UNITED KINGDOM LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 527

Trade Name Dosage Form Dose MA Holder Country

DERMOVATE SCALP APPLICATION SOLTN. FOR SCALP APPL. 0.05% W/W GLAXO WELLCOME GERMANY 0.05% GMBH & CO

DESAL 40MG 50 TABLET TABLET 40MG BIOFARMA ILAC SAN. VE TURKEY TIC.A.S.

DESFERAL SUBSTANCE FOR INJEC- 500MG NOVARTIS PHARMA SWITZERLAND TION SCHWEIZ AG

DESFERAL DRY SUBSTANCE FOR INJ. 500MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

DESFERAL SOLUTION FOR 500MG NOVARTIS PHARMA GERMANY INJECTION GMBH

DE-SPASM 135MG FILM COATED FILM COATED TABLETS 135MG ELSAAD PHARMA — SYRIA TABLETS SYRIA

DETACORTIL ENTERIC COATED TABLET 5MG PFIZER LIMITED UNITED KINGDOM

DETADERM NM CREAM NA ATCO LABORATORIES PAKISTAN (PVT) LTD

DETIMEDAC POWDER F/SOLN FOR IV 200MG/VIAL GESELLSCHAFT FUR GERMANY INJ KLINISCHE SPEZIALPREPARATE MBH

DETRUSITOL FILM COATED TABLET 1MG PHARMACIA & UPJOHN ITALY S.P.A.

DETRUSITOL FILM COATED TABLET 2MG PHARMACIA & UPJOHN ITALY S.P.A.

DETRUSITOL FILM-COATED TABLETS 1MG PHARMACIA ITALIA SPA ITALY

DETRUSITOL FILM-COATED TABLETS 2MG PHARMACIA ITALIA SPA ITALY

DETTOL ANTISEPTIC CREAM CREAM N/A RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

DEXA RHINASPRAY N NASAL SPRAY SOLUTION N/A BOEHRINGER INGELHEIM GREECE ELLAS A.E

DEXA-GENTAMICIN EYE OINTMENT N/A URSAPHARM GERMANY ARZNEIMITTEL GMBH

DEXA-GENTAMICIN EYE DROPS N/A URSAPHARM GERMANY ARZNEIMITTEL GMBH

DEXAMED 0.5MG TABLET 0.5MG MEDOCHEMIE LTD CYPRUS

DEXAMED 1.5MG TABLET 1.5MG MEDOCHEMIE LTD CYPRUS

DEXAMED 8MG/2ML LIQUID FOR INJECTION 8MG/2ML MEDOCHEMIE LTD CYPRUS

DEXAMETHASONE PHOSPHATE SOLUTION FOR 8MG/2ML F.H. FAULDING & CO. LTD UNITED KINGDOM INJECTION INJECTION (T/A DAVID BULL LABS)

DEXAMETHASONE SODIUM SOL. FOR INJ. 8MG/2ML EGYPTIAN EGYPT PHOSPHATE INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO.

DEXAMETHASONE SODIUM SOLUTION FOR 4MG/ML CIPLA LTD INDIA PHOSPHATE INJECTION

DEXAMETHASONE/GAP INJECTABLE SOLUTION 8MG/2ML GAP S.A. GREECE 528 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DEXAMYTREX EYE DROPS EYE DROPS N/A DR.GERHARD MANN, GERMANY CHEM.-PHARM. FABRIK GMBH

DEXAMYTREX EYE OINTMENT EYE OINTMENT N/A DR. GERHARD MANN, GERMANY CHEM.-PHARM. FABRIK GMBH

DEXA-RHINOSPRAY PUMP SPRAY N/A BOEHRINGER GERMANY INGELHEIM PHARMA KG

DEXTRAN 40 10% W/V IN SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA PORTUGAL DEXTROSE 5% W/V FARMACEUTICA S.A.

DEXTRAN 40 10% W/V IN NACL SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA PORTUGAL 0.9% W/V FARMACEUTICA S.A.

DEXTRAN 40 IV INFUSION IN SOLUTION FOR N/A BAXTER HEALTHCARE UNITED KINGDOM SODIUM CHLOR. INJECTION LIMITED

DEXTRAN 70 6% W/V IN DEX- SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA PORTUGAL TROSE 5% W/V FARMACEUTICA S.A.

DEXTRAN 70 6%W/V IN NACL SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA PORTUGAL 0.9%W/V FARMACEUTICA S.A.

DEXTROSE SOLUTION FOR 10% W/V BP GALEN RESEARCH UNITED KINGDOM INJECTION LABORATORIES LIMITED

DEXTROSE 10% W/V SOL. FOR INJ./INF. 10% W/V PARACELCIA INDUSTRIA PORTUGAL FARMACEUTICA S.A.

DEXTROSE 20% W/V SOL. FOR INJ./INF. 20%W/V PARACELCIA INDUSTRIA PORTUGAL FARMACEUTICA S.A.

DEXTROSE 3.33% W/V IN NACL SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA PORTUGAL 0.3% W/V FARMACEUTICA S.A.

DEXTROSE 30% W/V SOL. FOR INJ./INF. 30%W/V PARACELCIA INDUSTRIA PORTUGAL FARMACEUTICA S.A.

DEXTROSE 4% W/V IN NACL SOL. FOR INJ./INF N/A PARACELCIA INDUSTRIA PORTUGAL 0.18% W/V FARMACEUTICA S.A.

DEXTROSE 5% (W/V) SOL. FOR INJ./INFUSION 5%W/V PARACELCIA INDUSTRIA PORTUGAL FARMACEUTICA SA

DEXTROSE 5% W/V IN NACL SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA PORTUGAL 0.3% W/V FARMACEUTICA S.A.

DEXTROSE 5% W/V IN NACL SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA PORTUGAL 0.9% W/V FARMACEUTICA S.A.

DEXTROSE 5%W/V IN NACL SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA PORTUGAL 0.15%W/V FARMACEUTICA S.A.

DEXTROSE 5%W/V IN NACL SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA PORTUGAL 0.45% W/V FARMACEUTICA S.A.

DEXTROSE 50% SOLUTION FOR 25G/50ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

DEXTROSE 50% HYPERTONIC INJECTABLE SOLUTION 50% LABORATOIRE FRANCE AGUETTANT AGUETTANT

DEXTROSE DEMO 20% SOLUTION FOR IV 20% W/V DEMO SA GREECE INFUSION

DEXTROSE INFUSION SOLUTION FOR INFUSION N/A DEMO ABEE GREECE SOLUTION/DEMO 5% 23.9.2003 FR Journal officiel de l'Union européenne 529

Trade Name Dosage Form Dose MA Holder Country

DEXTROSE SOLN F/INFUSION SOLUTION FOR INFUSION 5% DEMO SA GREECE DEMO

DEXTROSE SOLUTION FOR SOLUTIONFOR INFUSION 10% DEMO SA GREECE INFUSION DEMO 10%

DEXTROSE/DEMO 35% SOLUTION FOR N/A DEMO SA GREECE INJECTION

DEZOR CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

DEZOR SHAMPOO 2% W/V HOE PHARMACEUTICALS MALAYSIA SDN BHD

DEZOR CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

DEZOR SHAMPOO LIQUID N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

DEZOR SHAMPOO SHAMPOO 2% W/V HOE PHARMACEUTICALS MALAYSIA SDN. BHD

DHC CONTINUS TABLETS 120MG MODIFIED RELEASE 120MG NAPP LABORATORIES UNITED KINGDOM TABLET LIMITED

DHC CONTINUS TABLETS 90 MG MODIFIED RELEASE 90MG NAPP LABORATORIIES UNITED KINGDOM TABLET LIMITED

DHC-CONTINUS TABLETS 60MG MODIFIED RELEASE 60MG NAPP LABORATORIES UNITED KINGDOM TABLETS LIMITED

DIA COLON SYRUP 66.7G/100ML VECCHI & C PIAM S.A.P.A. ITALY

DIABENESE TABLET 250MG PFIZER UNITED KINGDOM

DIABINESE TABLETS 100MG PFIZER LIMITED UNITED KINGDOM

DIABITOL TABLET 5MG TABLET 5MG SM PHARMACEUTICALS MALAYSIA SDN BHD

DIAGLIC TABLET 80MG OKAS PHARMA PVT LTD INDIA — INDIA

DIAMICRON TABLETS 80MG SERVIER PAKISTAN

DIAMICRON TABLETS 80MG SERVIER EGYPT EGYPT INDUSTRIES LTD

DIAMICRON 80MG SCORED TABLET 80MG LES LABORATOIRES FRANCE SERVIER

DIAMICRON 80MG TABLET 80MG LABORATORIOS SPAIN SERVIER, S.A.

DIAMICRON MR MODIFIED RELEASE 30MG LES LABORATOIRES FRANCE TABLET SERVIER

DIAMICRON TABLET TABLET 80MG SERVIER PAKISTAN

DIAMORPHINE HYDROCHLORIDE POWDER FOR 500MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM BP RECONSTITUTION

DIAMORPHINE HYDROCHLORIDE POWDER FOR 30MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM BP RECONSTITUTION

DIAMORPHINE HYDROCHLORIDE POWDER FOR 10MG/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM BP RECONSTITUTION 530 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DIAMORPHINE HYDROCHLORIDE POWDER FOR 5MG/VIAL EVANS MEDICAL UNITED KINGDOM BP RECONSTITUTION LIMITED

DIAMORPHINE HYDROCLORIDE BP POWDER FOR 100MG/VIAL EVANS MEDICAL UNITED KINGDOM RECONSTITUTION LIMITED

DIAMOX TABLET 250MG LEDERLE PAKISTAN

DIAMOX TABLET 250MG WYETH-LEDERLE PAKISTAN

DIAMOX TABLET 250MG CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD

DIAMOX SODIUM PARENTERAL POWDER FOR INJECTION 500MG/VIAL CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD

DIANE 35 TABLET NA SCHERING PAKISTAN

DIANE-35 COATED TABLET N/A SCHERING AG GERMANY

DIANEAL PD1 1,36% SOLUTION FOR NA SALUS SLOVENIA INJECTION

DIANEAL PD1 GLUCOSE 1.36% SOLUTION FOR 13.6MG/1ML BAXTER HEALTHCARE UNITED KINGDOM INJECTIONS LIMITED

DIANEAL PD1 GLUCOSE 2.27%W/V SOLUTION FOR 22.7MG/1ML BAXTER HEALTHCARE UNITED KINGDOM INJECTION LIMITED

DIANEAL PD1 GLUCOSE 3.86%W/V SOLUTION FOR 38.6MG/ML BAXTER HEALTHCARE UNITED KINGDOM INJECTION LIMITED

DIANEAL PD4 PERIT. DIALYSIS SOL. F/INTRAPERITONEAL N/A BAXTER HEALTHCARE UNITED KINGDOM SOL. 1.36 AD LIMITED

DIANEAL PD4 PERIT. DIALYSIS SOL. F/INTRAPERITONEAL N/A BAXTER HEALTHCARE UNITED KINGDOM SOL. 2.27 AD LIMITED

DIANEAL PD4 PERIT. DIALYSIS SOL. F/INTRAPERITONEAL N/A BAXTER HEALTHCARE UNITED KINGDOM SOL. 3.86 AD LIMITED

DIARREST SYRUP ORAL SOLUTION N/A GALEN LIMITED UNITED KINGDOM

DIAZEM 60MG TABLET 60MG MEDOCHEMIE LTD CYPRUS

DIAZEPAM TABLET 5MG RANBAXY IRELAND IRELAND LIMITED

DIAZEPAM TABLETS 50MG PHARMAMED LTD. MALTA

DIAZEPAM BP 10MG TABLET 10MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

DIAZEPAM BP 2MG TABLET 2MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

DIAZEPAM BP 5MG TABLET 5MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

DIAZEPAM DESITIN RECTAL SOLUTION 5MG DESITIN ARZNEIMITTEL GERMANY GMBH

DIAZEPAM INJECTION BP SOLUTION FOR 5MG/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.)

DIAZEPAM INJECTION BP SOLUTION FOR 0.5% W/V PHOENIX UNITED KINGDOM INJECTION PHARMACEUTICALS LTD 23.9.2003 FR Journal officiel de l'Union européenne 531

Trade Name Dosage Form Dose MA Holder Country

DIAZEPAM INJECTION BP 5MG/ML SOLUTION FOR 5MG/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD

DIAZEPAM RECTAL TUBES 10MG RECTAL SOLUTION 4MG/ML CP PHARMACEUTICALS UNITED KINGDOM LTD.

DIAZEPAM RECTAL TUBES 10MG RECTAL SOLUTION 10MG / TUBE CP PHARMACEUTICALS UNITED KINGDOM LTD

DIAZEPAM RECTAL TUBES 2.5MG RECTAL SOLUTION 2MG/ML CP PHARMACEUTICALS UNITED KINGDOM LTD.

DIAZEPAM RECTAL TUBES 5MG RECTAL SOLUTION 2MG/ML CP PHARMACEUTICALS UNITED KINGDOM LTD.

DIAZEPAM RECTAL TUBES 5MG RECTAL SOLUTION 5MG / TUBE CP PHARMACEUTICALS UNITED KINGDOM LTD

DIAZOL SUSPENSION 320MG/5ML ATCO LABORATORIES PAKISTAN (PVT) LTD

DIAZOL TABLETS 200MG ATCO LABORATORIES PAKISTAN (PVT) LTD

DIAZOL TABLETS 400MG ATCO LABORATORIES PAKISTAN (PVT) LTD

DIBENYLINE CAPSULES 10MG CAPSULE 10MG FORLEY LIMITED UNITED KINGDOM

DICALCI SOFT CAPSULES 1MCG KOREA UNITED PHARM. KOREA REPUBLIC INC.

DICETEL 100MG FILM-COATED TABLET 100MG LABORATOIRES SOLVAY FRANCE PHARMA

DICETEL 50MG FILM-COATED TABLET 50MG LABORATOIRES SOLVAY FRANCE PHARMA

DICLAC 50 ENTERIC-COATED TABLET 50MG HEXAL AG GERMANY

DICLO 25 TABLET ENTERIC-COATED TABLET 25MG CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD.

DICLO-DENK 100 RECTAL SUPPOSITORIES 100MG E. DENK OHG GERMANY

DICLO-DENK 100 RETARD TABLETS 100MG E. DENK OHG GERMANY

DICLO-DENK 50 ENTERIC COATED TABLET 50MG E. DENK OHG GERMANY

DICLOFENAC SUPPOSITORIES 50MG GLAXO WELLCOME POLAND POZNAN S.A.

DICLOFENAC SUPPOSITORIES 100MG GLAXO WELLCOME POLAND POZNAN S.A.

DICLOFENAC GASTRO-RESISTANT TABLETS 25MG PHARMAMED LTD. MALTA TABLETS

DICLOFENAC PROLONGED RELEASE 100MG RATIOPHARM GMBH GERMANY RETARD-RATIOPHARM CAPSULE

DICLOFENAC SODIUM OPHTHALMIC SOLUTION 0.1% W/V ALCON LABORATORIES UNITED STATES OF INC. AMERICA

DICLOFENAC SODIUM ENTERIC COATED 25MG NORTON HEALTHCARE UNITED KINGDOM TABLETS LIMITED

DICLOFENAC SODIUM ENTERIC COATED 50MG NORTON HEALTHCARE UNITED KINGDOM TABLETS LIMITED 532 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DICLOFENAC SODIUM TABLET 25MG DEXCEL-PHARMA UNITED KINGDOM LIMITED

DICLOFENAC SODIUM SOLUTION FOR 75MG/3ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

DICLOFENAC SODIUM EC TABLETS GASTRO-RESISTANT 25MG GENERICS (UK) LIMITED UNITED KINGDOM 25MG TABLET

DICLOFENAC SODIUM EC TABLETS GASTRO-RESISTANT 25MG GENERICS (UK) LIMITED UNITED KINGDOM 25MG TABLET

DICLOFENAC SODIUM TABLETS GASTRO-RESISTANT 25MG SANOFI WINTHROP UNITED KINGDOM 25MG TABLET LIMITED T/A STERWIN MEDICINES

DICLOFENAC SODIUM TABLETS TABLET 50MG SANOFI WINTHROP UNITED KINGDOM 50MG LIMITED T/A STERWIN MEDICINES

DICLOFENAC SR 100MG MODIFIED RELEASE 100MG SANOFI WINTHROP UNITED KINGDOM TABLET LIMITED T/A STERWIN MEDICINES

DICLOFENAC SR 75MG MODIFIED RELEASE 75MG SANOFI WINTHROP UNITED KINGDOM TABLET LIMITED T/A STERWIN MEDICINES

DICLOFENAC STADA 100 RETARD SUSTAINED RELEASE 100MG STADAPHARM GMBH GERMANY TABLETS

DICLOFENAC STADA 100 RETARD SUSTAINED RELEASE 100MG STADAPHARM GMBH GERMANY TABLETS

DICLOFENAC STADA 50 FILM COATED TABLETS 50MG STADAPHARM GMBH GERMANY

DICLOFENAC STADA N INJECTABLE SOLUTION 75MG STADAPHARM GMBH GERMANY

DICLOFENAC-RATIOPHARM 100 SUPPOSITORY 100MG RATIOPHARM GMBH GERMANY ZAPFCHEN

DICLOFENAC-RATIOPHARM 25 GASTRO-RESISTANT 25MG RATIOPHARM GMBH GERMANY TABLETTEN TABLET

DICLOFENAC-RATIOPHARM 50 GASTRO-RESISTANT 50MG RATIOPHARM GMBH GERMANY TABLETTEN TABLET

DICLOFENAC-RATIOPHARM UNO SUSTAINED RELEASE 150MG RATIOPHARM GMBH GERMANY TABLET

DICLOGESIC SUPPOSITORES 50MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LIMITED

DICLOGESIC EYE DROPS 5MG/5ML DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO. LTD

DICLOGESIC 100 SUPPOSITORIES SUPPOSITORIES 100MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO. LTD

DICLOGESIC 12.5 SUPPOSITORIES SUPPOSITORIES 12.5MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO. LTD

DICLOGESIC 25 ENTERIC COATED 25MG DAR AL DAWA JORDAN TABLETS DEVELOPMENT AND INVESTMENT CO LTD

DICLOMELAN FILM COATED TABLETS 50MG LANNACHER HEILMITTEL AUSTRIA GES.M.B.H. 23.9.2003 FR Journal officiel de l'Union européenne 533

Trade Name Dosage Form Dose MA Holder Country

DICLOMELAN SUPPOSITORY 100MG LANNACHER HEILMITTEL AUSTRIA GMBH

DICLOMELAN RETARD FILM COATED TABLETS 100MG LANNACHER HEILMITTEL AUSTRIA GES.M.B.H.

DICLORAN SR FILM COATED TABLET 100MG LEKAR PHARMA LIMITED INDIA

DICLORENGEL GEL 1%W/W TRIMA ISRAEL ISRAEL PHARMACEUTICAL PRODUCTS LIMITED

DICLOXIL 250 CAPSULES 250MG AEGIS LTD CYPRUS

DICLOXIL 500 CAPSULES 500MG AEGIS LTD CYPRUS

DICORTEN CREAM 0.05%W/W TRIMA ISRAEL ISRAEL PHARMACEUTICAL PRODUCTS LIMITED

DICTON COUGH SYRUP SYRUP 220MG/100ML DOLORGIET GMBH & CO GERMANY KG

DICTON COUGH CAPSULES RETARD CAPSULE 30MG DOLORGIET GMBH & CO. GERMANY KG

DICTON COUGH RETARD RETARD CAPSULES 30MG DOLORGIET GMBH & CO GERMANY CAPSULES KG

DICTON COUGH SYRUP SOLUTION 220MG/100ML DOLORGIET GMBH & CO. GERMANY KG

DICYNONE 250 TABLET 250MG OM PHARMA SA SWITZERLAND

DICYNONE 500 TABLET 500MG OM PHARMA SA SWITZERLAND

DIDRALIN TABLET 50MG MEDOCHEMIE LTD CYPRUS

DIESPOR POWDER FOR INJECTION 1000MG BIOMEDICA FOSCAMA ITALY INDUSTRIA CHIMICO FARMACEUTICA S.P.A

DIFENAC TABLETS 25MG TABLET 25MG DRUG HOUSES OF SINGAPORE AUSTRALIA(ASIA) PTE LTD

DIFFERIN CREAM 0.1% GALDERMA(UK) LIMITED UNITED KINGDOM

DIFFLAM COUGH LOZENGES N/A 3M PHARMACEUTICALS AUSTRALIA PTY LTD

DIFFLAM ANTI-INFLAMMATORY LOZENGES N/A 3M PHARMACEUTICALS AUSTRALIA LOZENGES PTY LTD

DIFFLAM 5% GEL GEL 5% W/W 3M PHARMACEUTICALS AUSTRALIA PTY LTD

DIFFLAM ANTI-INFLAMMATORY LOZENGE N/A 3M PHARMACEUTICALS AUSTRALIA LOZENGES PTY LTD

DIFFLAM BLACKCURRANT S.F. LOZENGES N/A 3M PHARMACEUTICALS AUSTRALIA COUGH LOZENGES PTY LTD.

DIFFLAM CREAM CREAM 3% W/W 3M HEALTH CARE UNITED KINGDOM LIMITED

DIFFLAM HONEY AND LEMON LOZENGES NA 3M PHARMACEUTICALS AUSTRALIA SUGAR FRE LIMITED

DIFFLAM LOZENGES RASBERRY LOZENGES N/A 3M PHARMACEUTICALS AUSTRALIA SUGAR FREE LIMITED 534 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DIFFLAM MOUTH GEL GEL N/A 3M PHARMACEUTICALS AUSTRALIA PTY LTD

DIFFLAM ORAL RINSE GARGLE 0.15% W/V 3M HEALTH CARE UNITED KINGDOM LIMITED

DIFFLAM ORANGE SUGAR FREE LOZENGES NA 3M PHARMACEUTICALS AUSTRALIA LIMITED

DIFFLAM SPRAY 0.15%W/V OROMUCOSAL SPRAY 0.15% W/V 3M HEALTH CARE UNITED KINGDOM LIMITED

DIFFLAM-C ANTI-INFLAMMATORY SOLUTION N/A 3M PHARMACEUTICALS AUSTRALIA ANTISEPTIC PTY LTD

DIFFLAM-C ANTI-INFLAMMATORY SOLUTION N/A 3M PHARMACEUTICALS AUSTRALIA ANTISEPTIC PTY LTD

DIFLERIX 2.5MG CAPSULE 2.5MG MEDOCHEMIE LTD CYPRUS

DIFLUCAN CAPSULE 150MG PFIZER UNITED KINGDOM

DIFLUCAN CAPSULE 200MG PFIZER LIMITED UNITED KINGDOM

DIFLUCAN CAPSULE 50MG PFIZER LIMITED UNITED KINGDOM

DIFLUCAN INTAVENOUS SOLUTION N/A PFIZER LIMITED UNITED KINGDOM

DIFLUCAN INTAVENOUS SOLUTION N/A PFIZER LIMITED UNITED KINGDOM

DIFLUCAN POWDER FOR ORAL 50MG/5ML PFIZER LIMITED UNITED KINGDOM SUSPENS.

DIFLUCAN POWDER FOR ORAL N/A PFIZER LIMITED UNITED KINGDOM SUSPEN.

DIGESTIVO ANTONETTO TABLETS N/A MARCO ANTONETTO SPA ITALY

DIGESTIVO ANTONETTO TABLET N/A MARCO ANTONETTO SPA ITALY

DIGIBIND DIGOXIN ANTIBODY POWDER FOR INJECTION 38MG THE WELLCOME UNITED KINGDOM (F(AB)) FOUNDATION LIMITED

DIGOXIN SOLUTION FOR 0.5MG/2ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

DIGOXIN INJECTION USP SOLUTION FOR 0.25MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

DIGOXIN TABLETS B.P. 0.25MG UNCOATED TABLET 0.25MG MEDICORP INDIA TECHNOLOGIES INDIA LTD

DIHYDERGOT NASAL SPRAY 4MG/ML NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

DIHYDROCODEINE TABLETS 30MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

DIHYDROCODEINE 30MG TABLET 30MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

DIHYDROCODEINE TABLETS 30MG TABLETS 30MG GENERICS (UK) LIMITED UNITED KINGDOM

DIHYDROCODEINE TABLETS BP TABLETS 30MG CP PHARMACEUTICALS UNITED KINGDOM 30MG 23.9.2003 FR Journal officiel de l'Union européenne 535

Trade Name Dosage Form Dose MA Holder Country

DIHYDROCODEINE TABLETS BP TABLET 30MG CP PHARMACEUTICALS UNITED KINGDOM 30MG LTD

DILAPAN CAPSULES 150MG REMEDICA LTD CYPRUS

DILAPROST 5MG 30 FILM COATED FILM-COATED TABLET 5MG BIOFARMA ILAC SAN.VE TURKEY TABLET TIC. A.S.

DILATREND TABLETS 12.5MG ROCHE DIAGNOSTICS GERMANY GMBH

DILATREND 25MG TABLET 25MG HOFFMANN-LA ROCHE GERMANY AG

DILATREND 6.25MG TABLET 6.25MG HOFFMANN-LA ROCHE GERMANY AG

DILGARD TABLET 60MG CIPLA LTD. INDIA

DILTIAZEM HCL MODIFIED TABLETS 60MG NORTON HEALTHCARE UNITED KINGDOM RELEASE LIMITED

DILTIAZEM HYDROCHLORIDE MODIFIED RELEASE 60MG CP PHARMACEUTICALS UNITED KINGDOM TABLETS 60MG TABLET LTD

DILTIAZEM HYDROCHLORIDE TABLETS 60MG CP PHARMACEUTICALS UNITED KINGDOM TABLETS BP 60MG LTD.

DILTIZEM TABLET 30 MG MUSTAFA NEVZAT ILAC TURKEY SANAYII A.S.

DILTIZEM TABLET 60MG MUSTAFA NEVZAT ILAC TURKEY SANAYII A.S.

DILZACARD 60 MG TABLETS TABLETS 60MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO. LTD

DIMA 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

DINDEVAN TABLET 50MG GOLDSHIELD GROUP PLC UNITED KINGDOM T/A GOLDSHIELD PHARMACEUTICALS

DINEX-100 TABLET 100MG CIPLA LIMITED INDIA

DINIKET SOLUTION FOR INFUSION 10MG SCHWARZ PHARMA ITALY S.P.A.

DIOCALM TABLETS N/A SETON PRODUCTS UNITED KINGDOM LIMITED

DIOCIMEX TABLETS 100MG CIMEX AG SWITZERLAND

DIORALYTE (BLACKCURRANT) POWDER FOR ORAL N/A RORER UNITED KINGDOM POWDER SOLUTION PHARMACEUTICALS LIMITED T/A RPR FAMILY HEALTH DIVISION

DIORALYTE NATURAL POWDER FOR ORAL N/A RORER UNITED KINGDOM SOLUTION PHARMACEUTICALS LIMI- TED

DIORALYTE RELIEF POWDER FOR ORAL N/A MAY & BAKER LIMITED UNITED KINGDOM SOLUTION (T/A RHONE-POULENC RORER)

DIORALYTE SACHETS FOR POWDER FOR ORAL N/A RORER UNITED KINGDOM SOLUTION (CITRUS) SOLUTION PHARMACEUTICALS LTD. T/A RPR FAMILY HEALTH DIVISION 536 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DIOSPER FILM COATED TABLETS NA KLEVA LIMITED GREECE

DIOVAN CAPSULES 80MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

DIOVAN CAPSULES 160MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

DIOVAN FILM COATED TAB 80MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

DIOVAN FILM COATED TABLET 160MG NOVARTIS PHARMA SWITZERLAND SCHWIEZ AG

DIOVAN FILM-COATED TABLETS 160 MG NOVARTIS SPAIN FARMACEUTICA S.A. — SPAIN

DIOVAN FILM-COATED TABLETS 80MG NOVARTIS SPAIN FARMACEUTICA S.A. — SPAIN

DIOVENOR FILM-COATED TABLETS 600MG LABORATOIRES FRANCE INNOTHERA

DIPALAN 150 CAPSULES 150MG REMEDICA LTD CYPRUS

DIPENTUM CAPSULES 250MG PHARMACIA & UPJOHN SWEDEN SVERIGE AB

DIPENTUM TABLET 500 MG TABLET 500MG PHARMACIA SVERIGE AB SWEDEN

DIPHENHYDRAMINE CO COUGH ORAL SOLUTION N/A ROSEMONT UNITED KINGDOM LINCT. 14MG/5ML PHARMACEUTICALS LIMITED

DIPHENHYDRAMINE CO COUGH ORAL SOLUTION 14MG/5ML ROSEMONT UNITED KINGDOM LINCTUS PHARMACEUTICALS LTD.

DIPHTERIA AND TETANUS SOLUTION FOR N/A EVANS MEDICAL UNITED KINGDOM VACCINE (ADSORBED) INJECTION LIMITED

DIPHTERIA AND TETANUS SOLUTION FOR 0.5ML/DOSE SERUM INSTITUTE OF INDIA VACCINE ADSORBED INJECTION INDIA LTD

DIPHTERIA AND TETANUS SOLUTION FOR N/A M/S SERUM INSTITUTE OF INDIA VACCINE PEDIATRIC INJECTION INDIA

DIPHTERIA-TETANUS-PERTUSSIS SOLUTION FOR N/A M/S SERUM INSTITUTE OF INDIA VACCINE ADS. INJECTION INDIA LIMITED

DIPHTHERIA-TETANUS-PERTUSSIS SOLUTION FOR NA SERUM INSTITUTE OF INDIA VACCINE INJECTION INDIA LTD

DIPHTHERIA AND TETANUS SOLUTION FOR N/A SERUM INSTITUTE OF INDIA VACCINE ADSORBED INJECTION INDIA LTD

DIPHTHERIA VACCINE (ADSORBED) SOLUTION FOR N/A EVANS MEDICAL UNITED KINGDOM INJECTION LIMITED

DIPRIVAN EMULSION FOR 1% W/V ZENECA LIMITED UNITED KINGDOM INJECTION

DIPRIVAN EMULSION FOR 20MG/ML ZENECA LIMITED UNITED KINGDOM INJECTION

DIPRIVAN 2% EMULSION FOR 20MG / ML ZENECA LIMITED UNITED KINGDOM INJECTION

DIPROPHOS/DIPROFOS SOLUTION FOR N/A SCHERING-PLOUGH S.A. BELGIUM INJECTION 23.9.2003 FR Journal officiel de l'Union européenne 537

Trade Name Dosage Form Dose MA Holder Country

DIPROSALIC OINTMENT N/A SCHERING-PLOUGH BELGIUM NV/SA

DIPROSALIC LOTION N/A SCHERING-PLOUGH S.A. BELGIUM

DIPROSONE CREAM 0.64MG/G SCHERING-PLOUGH BELGIUM NV/SA

DIPROSONE OINTMENT 0.64MG/G SCHERING-PLOUGH BELGIUM NV/SA

DIPROSONE LOTION 0.64MG/G SCHERING-PLOUGH BELGIUM NV/SA

DIPYRIDAMOLE TABLETS 25MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

DIPYRIDAMOLE TABLETS 100MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

DIPYRIDAMOLE COATED TABLET 100MG GENERICS(UK) LIMITED UNITED KINGDOM

DISFLATYL DROPS ORAL EMULSION 40MG/ML SOLCO BASLE LTD. SWITZERLAND

DISFLATYL TABLETS CHEWABLE TABLETS 40MG SOLCO BASLE LTD. SWITZERLAND

DISIPAL TABLETS 50MG YAMANOUCHI PHARMA NETHERLANDS B.V.

DISOPHROL SUSTAINED-ACTION N/A SCHERING-PLOUGH UNITED STATES OF TABLETS CORPORATION AMERICA

DISOPYRAMIDE PHOSPHATE CAPSULE 100MG GENERICS[UK] LIMITED UNITED KINGDOM CAPSULES BP 100MG

D-ISO-RATIOPHARM SACHET N/A RATIOPHARM GMBH GERMANY

DISPERSIBLE ASPIRIN TABLET 75MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

DISPRIN TABLETS TABLET 300MG RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

DISPROL PARACETAMOL SUSPENSION 120MG/5ML RECKITT & COLMAN UNITED KINGDOM SUSPENSION PRODUCTS LIMITED

DISPROL SOLUBLE PARACETAMOL TABLET 120MG RECKITT & COLMAN UNITED KINGDOM TABLETS PRODUCTS LIMITED

DISTALGESIC TABLETS COATED TABLET N/A ELI LILLY & COMPANY UNITED KINGDOM LIMITED

DISTILLED WITCH HAZEL BPC TOPICAL SOLUTION 100% V/V BELL SONS & CO UNITED KINGDOM 1973 (DRUGGISTS) LIMITED

DITROPAN SCORED TABLET 5MG LABORATOIRES FRANCE SYNTHELABO

DITROPAN ELIXIR 2.5MG/5ML SYRUP 2.5MG/5ML LOREX SYNTHELABO UK UNITED KINGDOM & IRELAND LIMITED

DITROPAN XL MODIFIED RELEASE 15MG SANOFI WINTHROP LTD UNITED KINGDOM TABLETS T/A SANOFI SYNTHELABO

DITROPAN XL MODIFIED RELEASE 5MG SANOFI WINTHROP UNITED KINGDOM TABLETS LIMITED T/A SANOFI SYNTHELABO 538 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DITROPAN XL MODIFIED RELEASE 10MG SANOFI WINTHROP LTD UNITED KINGDOM TABLETS T/A SANOFI SYNTHELABO

DIUMIDE-K CONTINUS TABLETS MODIFIED RELEASE N/A NAPP LABORATORIES UNITED KINGDOM TABLETS LIMITED

DIUREMID 20MG INJECTION SOLUTION FOR 20MG HOVID SDN BHD MALAYSIA INJECTION

DIVIDOL TABLETS 10MG REMEDICA LTD. CYPRUS

DIVIR-100 TABLETS 100MG CIPLA LIMITED INDIA

DNCG STADA AUGENTROPFEN SOLUTION 20MG/ML STADAPHARM GMBH GERMANY

DOBUJECT 50MG/ML CONC. FOR PARENT. 50MG/ML LEIRAS OY FINLAND INFUS.

DOBUTAMINE INJECTION SOLUTION FOR 12.5MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

DOBUTREX LIQUID CONC FOR INF CONC. FOR INF. 250MG/VIAL LILLY DEUTSCHLAND GERMANY GMBH

DOBUTREX SOLUTION CONCENTRATE FOR 250MG/20ML LILLY DEUTSCHLAND GERMANY INFUSION GMBH

DOCUSATE CALCIUM CAP 240MG CAPSULE 240MG TARO CANADA PHARMACEUTICALS INC.

DOCUSATE SOD CAP 100MG CAPSULE 100MG TARO CANADA PHARMACEUTICALS INC.

DOGMATIL 200MG TABLET 200MG LABORATOIRES FRANCE SYNTHELABO

DOGMATIL 50MG CAPSULE 50MG LABORATOIRES FRANCE SYNTHELABO

DOLAL LINIMENT N/A LABORATOIRES FRANCE BIOCODEX

DOLGIT 600 SUGAR COATED TABLETS 600MG DOLORGIET GMBH & CO. GERMANY KG

DOLGIT CREAM CREAM 5G/100G DOLORGIET GMBH & CO. GERMANY KG

DOLGIT CREAM CREAM 5G/100G DOLORGEIT GMBH & GERMANY COKG

DOLOBENE GEL N/A MEPHA PHARMA AG SWITZERLAND

DOLOBID 250MG TABLET 250MG MERCK SHARP & DOHME NETHERLANDS B.V.

DOLOFEN-500 LACTAB 500MG MEPHA PHARMA AG SWITZERLAND

DOLO-GESIC FILM COATED TABLET 50MG ALFARES SYRIA PHARMACEUTICALS

DOLO-GESIC, FILM-COATED FILM-COATED TABLET 50MG ALFARES SYRIA TABLET PHARMACEUTICALS

DOLVAN TABLETS TABLETS N/A NORMA CHEMICALS UNITED KINGDOM LIITED

DOMAR CAPSULE 5MG POLIPHARM CO. LTD. THAILAND

DONA CAPSULE 250MG ROTTAPHARM S.R.L. ITALY 23.9.2003 FR Journal officiel de l'Union européenne 539

Trade Name Dosage Form Dose MA Holder Country

DONORMYL 15MG SCORED FILM-COATED 15MG LABORATOIRES FRANCE TABLET OBERLIN

DONORMYL 15MG SCORED EFF. TABLETS 15MG LABORATOIRES FRANCE OBERLIN

DOPAMET 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

DOPAMINE 200 PIERRE FABRE INJ. SOL. FOR INFUSION 200MG/5ML PIERRE FABRE FRANCE 200MG/5ML MEDICAMENT

DOPAMINE 50 PIERRE FABRE INJECT. SOL. FOR 50MG/10ML PIERRE FABRE FRANCE 50MG/10ML INFUSION MEDICAMENT

DOPAMINE CONC. SELECTAJET SOLUTION FOR 40MG/ML INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS LTD

DOPATAB M250 TABLET 250MG HOVID SDN BHD MALAYSIA

DOPEGYT TABLETS 250MG EGIS PHARMACEUTICALS HUNGARY LTD

DOPERGIN TABLET 0.2MG LABORATOIRE FRANCE SCHERING

DOPERGIN TABLETS 0.2MG SCHERING PAKISTAN

DORMICUM FILM-COATED TABLET 7.5MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

DORMICUM AMPOULE 5MG/5ML ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

DORMONOCT TABLET 1MG HOECHST MARION UNITED KINGDOM ROUSSEL LIMITED

DORYX 100 CAPSULE 100MG FAULDING AUSTRALIA PHARMACEUTICALS

DORYX 50 CAPSULE 50MG FAULDING AUSTRALIA PHARMACEUTICALS

DOSTINEX TABLETS 0.5MG PHARMACIA & UPJOHN ITALY S.P.A

DOSTINEX TABLETS 0.5MG PHARMACIA & UPJOHN ITALY S.P.A

DOTHIEPIN CAPSULES 25MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

DOTHIEPIN TABLETS 75MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

DOXAT 100 TABLETS F.C. 100MG AEGIS LTD CYPRUS

DOXAT 100 CAPSULE 100MG AEGIS LTD CYPRUS

DOXAT 50 TABLETS F.C. 50MG AEGIS LTD. CYPRUS

DOXEPIN HDROCHLORIDE CAPSULES 25MG DANBURY PHARMACAL UNITED STATES OF INC. AMERICA

DOXIBIOTIC CAPSULES 100MG CTS CHEMICAL ISRAEL INDUSTRIES LTD

DOXIBIOTIC CAPSULES 100MG CTS CHEMICAL ISRAEL INDUSTRIES

DOXIPROCT OINTMENT N/A LABORATOIRES OM S.A. SWITZERLAND 540 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DOXIPROCT SUPPOSITORY N/A LABORATOIRES OM S.A. SWITZERLAND

DOXIPROCT PLUS OINMENT N/A LABORATOIRES OM S.A. SWITZERLAND

DOXIPROCT PLUS SUPPOSITORY N/A LABORATOIRES OM S.A. SWITZERLAND

DOXIUM TABLET 250MG LABORATOIRES OM S.A. SWITZERLAND

DOXIUM 500 CAPSULE 500MG LABORATOIRES OM S.A. SWITZERLAND

DOXIVENIL GEL N/A LABORATOIRES OM S.A. SWITZERLAND

DOXOLEM (WITHOUT POWDER FOR INJECTION 50MG/10ML LEMERY, S.A. DE C.V. MEXICO METHYLPARABEN)

DOXORUBICIN HCL FOR INJ. USP LYOPHILISED CAKE FOR 10MG M/S SERUM INSTITUTE OF INDIA LYOPHILISED INJ INDIA LIMITED

DOXORUBICIN HYDROCHLORIDE SOLUTION FOR 10MG/5ML F.H. FAULDING & CO. AUSTRALIA INJ. VIAL INJECTION LTD. (T/A DAVID BULL LABS)

DOXORUBICIN HYDROCHLORIDE SOLUTION FOR 50MG/25ML F.H. FAULDING & CO. AUSTRALIA INJECTION VIAL INJECTION LTD. (T/A DAVID BULL LABS)

DOXORUBICIN HYDROCLORIDE LYOPHILISED CAKE FOR 50MG M/S SERUM INSTITUTE OF INDIA INJ LYOPHILISED INJ INDIA LIMITED

DOXYCYCLIN STADA 100 FILM COATED TABLETS 100MG STADAPHARM GMBH GERMANY

DOXYCYCLINE CAPSULES 50MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

DOXYCYCLINE CAPSULES 100MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

DOXYCYCLINE TABLETS 100MG PHARMAMED LTD. MALTA

DOXYDAR 100 CAPSULES 100MG DAR AL SAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

DOXYHEXAL CAPSULE 100MG HEXAL AG GERMANY

DOXYHEXAL 200 CAPSULE 200MG HEXAL AG GERMANY

DOXYHEXAL TABS TABLET 100MG HEXAL AG GERMANY

DOXYLIN TABLET 50MG ALPHAPHARM PTY AUSTRALIA LIMITED

DOXYLIN 100 TABLET 100MG ALPHAPHARM PTY AUSTRALIA LIMITED

DOXYN CAPSULES 100MG ATCO LABORATORIES PAKISTAN (PVT) LTD

DRAMAMINE TABLETS 50MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

DRAPOLENE CREAM N/A GLAXO WELLCOME POLAND GROUP

DRAPOLENE CREAM CREAM N/A GLAXO WELLCOME UK UNITED KINGDOM LIMITED

DRICLOR TOPICAL SOLUTION 20% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 541

Trade Name Dosage Form Dose MA Holder Country

DRIED FACTOR VIII FRACTION, POWDER FOR INJECTION N/A BPL, BIO PRODUCTS UNITED KINGDOM TYPE 8Y, LABORATORY

DRIN TABLETS N/A ALFA WASSERMANN ITALY S.P.A.

DRIPTANE 5MG SCORED TABLET 5MG LABORATOIRES DEBAT FRANCE

DRISTAN NASALSPRAY 0.05% W / W WHITEHALL UNITED KINGDOM LABORATORIES LTD

DRISTAN DECONGESTANT TABLETS N/A WHITEHALL UNITED KINGDOM LABORATORIES LTD

DROPSTAR TG EYE DROPS NA FARMIGEA S.P.A. ITALY

DROPTIMOL OPHTHALMIC DROPS 0.5% W/V FARMIGEA SPA ITALY

DROPTIMOL OPHTHALMIC DROPS 0.25% W/V FARMIGEA SPA ITALY

D-STOP-RATIOPHARM FILM COATED TABLET 2MG RATIOPHARM GMBH GERMANY

DUAL LAX EXTRA STRONG COATED TABLETS N/A G R LANE HEALTH UNITED KINGDOM TABLETS PRODUCTS LTD

DUAL LAX NORMAL TABLETS COATED TABLET N/A G R LANE HEALTH UNITED KINGDOM PRODUCTS LTD

DUBAM CREAM CREAM N/A NORMA CHEMICALS UNITED KINGDOM LIMITED

DUBAM SPRAY AEROSOL SPRAY N/A NORMA CHEMICALS UNITED KINGDOM LIMITED

DUINUM 50MG TABLET 50MG MEDOCHEMIE LTD CYPRUS

DUKORAL ORAL LIQ & EFF. NA SBL VACCIN AB SWEDEN GRANULES

DULCOLAX S.C. TABLETS 5MG BOEHRINGER GERMANY INGELHEIM PHARMA KG

DULCOLAX SUPPOSITORY 5MG BOEHRINGER GERMANY INGELHEIM PHARMA KG

DULCOLAX SUPPOSITORY 10MG BOEHRINGER GERMANY INGELHEIM PHARMA KG

DULCOLAX TABLET 5MG BOEHRINGER PAKISTAN INGELHEIM

DULCOLAX ENTERIC COATED TABLET 5MG BOEHRINGER PAKISTAN INGELHEIM

DUOFILM TOPICAL SOLUTION N/A STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

DUOGAS EFFERVESCENT GRANULES N/A BRACCO S.P.A ITALY

DUPHALAC SYRUP 667G/L SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

DUPHALAC DRY POWDER >=95% W/W SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

DUPHASTON TABLET 10MG SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

DUPHASTON FILM-COATED TABLET 10MG SOLVAY NETHERLANDS PHARMACEUTICALS B.V. 542 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

DURACEF SUSPENSION 5% W / V BRISTOL-MYERS SQUIBB ITALY S.P.A

DURACEF CAPSULES 500MG BRISTOL-MYERS SQUIBB ITALY HOLDINGS LTD

DURACEF POWDER FOR ORAL SUSP. 500MG/5ML (10%) BRISTOL MYERS SQUIBB ITALY S.P.A.

DURACEF SUSPENSION 5%(250MG/5ML) BRISTOL MYERS SQUIBB ITALY S.P.A.

DURACEF SUSPENSION POWDER FOR ORAL 250MG/5ML BRISTOL-MYERS SQUIBB UNITED KINGDOM 250MG/5ML SUSPENSIO HOLDINGS LTD

DURAKINASE INJECTION POWDER FOR INJECTION 750000 UI DONG KOOK PHARM. KOREA REPUBLIC CO. LTD

DURAKINASE INJECTION POWDER FOR INJECTION 1500000 IU DONG KOOK PHARM. KOREA REPUBLIC CO. LTD

DUR-ELIX PLUS ORAL LIQUID NA 3M PHARMACEUTICALS AUSTRALIA LIMITED

DUROAMINE CAPSULES 30MG MODIFIED RELEASE 30MG 3M HEALTH CARE UNITED KINGDOM CAPSULES LIMITED

DUROGESIC 25MCG/H PATCH 25MCG/H JANSSEN-CILAG N.V. BELGIUM

DUROGESIC TTS 100MCG/H PATCH 100MCG/H JANSSEN-CILAG N.V. BELGIUM

DUROGESIC TTS 50MCG/H PATCH 50MCG/H JANSSEN-CILAG N.V. BELGIUM

DUROGESIC TTS 75MCG/H PATCH 75MCG/H JANSSEN-CILAG N.V. BELGIUM

DURO-TUSS COUGH LOZENGES LOZENGE N/A 3M PHARMACEUTICALS AUSTRALIA PTY LTD

DURO-TUSS COUGH LOZENGES LOZENGES N/A 3M PHARMACEUTICALS AUSTRALIA PTY LTD

DURO-TUSS DECONGESTANT ORAL LIQUID N/A 3M PHARMACEUTICALS AUSTRALIA PTY LTD

DURO-TUSS EXPECTORANT ORAL LIQUID N/A 3M PHARMACEUTICALS AUSTRALIA PTY LTD

DURO-TUSS FORTE ORAL LIQUID 3MG/ML 3M PHARMACEUTICALS AUSTRALIA PTY LTD

DURO-TUSS MUCOLYTIC COUGH ORAL LIQUID 0.8MG/ML 3M PHARMACEUTICALS AUSTRALIA LIQUID LIMITED

DURO-TUSS REGULAR ORAL LIQUID 1MG/ML 3M PHARMACEUTICALS AUSTRALIA PTY LTD

DURO-TUSS SINUS ORAL LIQUID N/A AUST R 54130 AUSTRALIA

DUSPATALIN LIQUID SUSPENSION 10MG/ML SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

DUXIL COATED TABLET N/A LES LABORATOIRES FRANCE SERVIER

DUXIL ORAL SUSPENSION N/A LES LABORATOIRES FRANCE SERVIER

DUXIMA IM VIAL 1G ECOBI FARMACEUTICI ITALY S.A.S

DYAZIDE TABLETS TABLET N/A SMITHKLINE & FRENCH UNITED KINGDOM LABORATORIES LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 543

Trade Name Dosage Form Dose MA Holder Country

DYCLOMAX 100MG DELAYED RELEASE 100MG SMITHKLINE BEECHAM GERMANY TABLET PHARMA GMBH

DYCLOMAX 100MG SUPPOSITORY 100MG SMITHKLINE BEECHAM GERMANY PHARMA GMBH

DYCLOMAX 50MG ENTERIC COATED TABLET 50MG SMITHKLINE BEECHAM GERMANY PHARMA GMBH

DYCLOMAX 75MG/3ML SOLUTION FOR 75MG/3ML SMITHKLINE BEECHAM GERMANY INJECTION PHARMA GMBH

DYNASTAT POWDER FOR SOLUTION 20MG PHARMACIA EUROPE EUROPEAN COMMUNITY FOR INJECTION EEIG

DYNASTAT POWDER FOR SOLUTION 40MG PHARMACIA EUROPE EUROPEAN COMMUNITY FOR INJECTION EEIG

DYSPAMET SUSPENSION ORAL SUSPENSION 4%W/V GOLDSHIELD UNITED KINGDOM PHARMACEUTICALS LIMITED

DYSPAMET SUSPENSION ORAL SUSPENSION 200MG/5ML SMITHKLINE & FRENCH UNITED KINGDOM 200MG/5ML LABORATORIES LIMITED

DYSPORT INJECTION POWDER FOR INJECTION 500 UNITS IPSEN LIMITED UNITED KINGDOM

E45 CREAM CREAM N/A CROOKES HEALTHCARE UNITED KINGDOM LIMITED

E45 ITCH RELIEF CREAM CREAM N/A CROOKES HEALTHCARE UNITED KINGDOM LIMITED

EAREX EAR DROPS EAR DROPS N/A PHARMALAB LTD UNITED KINGDOM

EAU PRECIEUSE TOPICAL SOLUTION N/A PARKE-DAVIS FRANCE

EBRILON TABLETS 250MG MEDOCHEMIE LTD CYPRUS

ECHINACEA TABLETS COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

ECOCAIN SOLUZIONE INIETTABILE 20MG/ML MOLTENI DENTAL SRL ITALY

ECOCAIN 8704 FLAC. NEBULIZZATORE NS MOLTENI DENTAL SRL ITALY

ECOCAIN A50 SOLUTION FOR N/A MOLTENI DENTAL S.R.L. ITALY INJECTION

ECOCAIN A80 SOLUTION FOR N/A MOLTENI DENTAL S.R.L. ITALY INJECTION

ECOCAIN CON ADRENALINA SOLUZIONE INIETTABILE 20MG/ML MOLTENI DENTAL SRL ITALY 1:100,000

ECOCAIN CON ADRENALINA SOLUZIONE INIETTABILE 20MG/ML MOLTENI DENTAL SRL ITALY 1:80,000

ECOCILLIN CAPSULE MOLLI VAGINALI NA PROGE FARM S.R.L. ITALY

ECOCILLIN, CAPSULE MOLLI CAPSULE MOLLI VAGINALI 100000000 UFF PROGE FARM S.R.L ITALY VAGINALI

ECOCORT CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

ECOCORT CREAM CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD

ECODERGIN VAGINAL CREAM 1% W/W FARMIGEA SPA ITALY 544 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ECODERGIN VAGINAL OVULE 150MG FARMIGEA SPA ITALY

ECODERGIN CREAM NA FARMIGEA SPA ITALY

ECOMI' VAGINAL OVULES 150MG GEYMONAT SPA ITALY

ECOMI' TOPICAL SOLUTION N/A GEYMONAT SPA ITALY

ECOMI' CREAM N/A GEYMONAT SPA ITALY

ECONEX-400 TABLETS N/A MACLEODS INDIA PHARMACEUTICALS LTD

ECONEX-800 TABLET N/A MACLEODS INDIA PHARMACEUTICALS LTD

ECOX-800 TABLET 800MG MACLEODS INDIA

EDRONAX TABLETS 4MG PHARMACIA & UPJOHN ITALY S.P.A

EDRONAX TABLETS 4MG PHARMACIA ITALIA S.P.A ITALY

EFEXOR TABLETS 37.5MG LEDERLE PAKISTAN

EFEXOR — TAB 50 MG TABLETS 50MG WYETH-AYERST CANADA CANADA INC.

EFEXOR — TAB 75 MG TABLET 75MG WYETH-AYERST CANADA CANADA INC.

EFEXOR TAB 37.5 MG TABLETS 37.5MG WYETH-AYERST CANADA CANADA INC.

EFEXOR TAB 50MG TABLETS 50MG WYETH-AYERST CANADA CANADA INC.

EFEXOR TAB 75MG TABLETS 75MG WYETH-AYERST CANADA CANADA INC

EFEXOR TABLETS TABLET 37.5MG JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES —UK

EFEXOR TABLETS TABLETS 75MG JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES UK

EFEXOR XL CAPSULE 75MG JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES —UK

EFEXOR XL 150MG CAPSULES 150MG JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES

EFEXOR XL CAPSULES CAPSULES 75MG JOHN WYETH AND IRELAND BROTHER LIMITED T/A WYETH LABORATORIES

EFEXOR XR CAPSULE SUSTAINED RELEASE 75MG WYETH-AYERST CANADA CANADA CAPSULE INC.

EFEXOR XR CAPSULES SUSTAINED RELEASE 150MG WYETH-AYERST CANADA CANADA CAPSULE INC. 23.9.2003 FR Journal officiel de l'Union européenne 545

Trade Name Dosage Form Dose MA Holder Country

EFEXORXL 150 MG MODIFIED CAPSULE 150MG JOHN WYETH AND UNITED KINGDOM RELEASECAPSULE BROTHER LIMITED T/A WYETH LABORATORIES- UK

EFFACNE 5 TOPICAL GEL 5G/100G LABORATOIRES LA FRANCE ROCHE-POSAY

EFFERALGAN PAEDIATRIC 3% ORAL SOLUTION 3% W / V LABORATOIRES UPSA FRANCE

EFFERALGAN VITAMIN C SCORED EFF. TABLETS N/A LABORATOIRES UPSA FRANCE

EFFERCITRATE TABLETS EFFERVESCENT TABLET N/A TYPHARM LIMITED UNITED KINGDOM

EFFEXOR TAB 37.5MG TABLET 37.5MG WERTH-AYERST CANADA CANADA INC.

EFFICO TONIC ORAL SOLUTION 0.18MG/5ML PHARMAX LIMITED UNITED KINGDOM

EFFORTIL DROPS SOLUTION 0.75G/100G BOEHRINGER GERMANY INGELHEIM PHARMA KG

EFLORAN SOLUTION FOR INFUSION 500MG/100ML KRKA, D.D., NOVO SLOVENIA MESTO

EFUDIX CREAM 5% W/W ICN PHARMACEUTICALS UNITED KINGDOM LTD

EGOCORT CREAM 10MG/G EGO PHARMACEUTICALS AUSTRALIA

ELBAT TABLET 250MG GENEPHARM S.A. GREECE

ELDOPAQUE FORTE CREAM 4 % ICN PHARMACEUTICALS UNITED STATES OF INC. AMERICA

ELDOPAQUE FORTE 4% CREAM 4% W/W ICN PHARMACEUTICALS, UNITED STATES OF INC. AMERICA

ELDOQUIN FORTE 4% CREAM ICN PHARMACEUTICALS UNITED STATES OF INC. AMERICA

ELDOQUIN FORTE 4% CREAM 4% W/W ICN PHARMACEUTICALS UNITED STATES OF INC. AMERICA

ELECTROLADE BANANA POWDER FOR ORAL N/A EASTERN UNITED KINGDOM SOLUTION PHARMACEUTICALS LIMITED

ELECTROLADE BANANA POWDER FOR ORAL N/A EASTERN UNITED KINGDOM SOLUTION PHARMACEUTICALS LIMITED

ELECTROLADE BLACKCURRANT POWDER FOR ORAL N/A EASTERN UNITED KINGDOM SOLUTION PHARMACEUTICALS LIMITED

ELECTROLADE BLACKCURRANT POWDER FOR ORAL N/A EASTERN UNITED KINGDOM SOLUTION PHARMACEUTICALS LIMITED

ELECTROLADE LEMON AND LIME POWDER FOR ORAL N/A EASTERN UNITED KINGDOM SOLUTION PHARMACEUTICALS LIMITED

ELECTROLADE MELON POWDER FOR ORAL N/A EASTERN UNITED KINGDOM SOLUTION PHARMACEUTICALS LIMITED

ELECTROLADE ORANGE POWDER FOR ORAL N/A EASTERN UNITED KINGDOM SOLUTION PHARMACEUTICALS LIMITED 546 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ELECTROLADE ORANGE POWDER FOR ORAL N/A EASTERN UNITED KINGDOM SOLUTION PHARMACEUTICALS LIMITED

ELIDIL CREAM 1% NOVARTIS HEALTHCARE DENMARK A/S

ELINAP TABLETS 100MG KLEVA LIMITED GREECE

ELITAN TABLET 10MG MEDOCHEMIE LTD CYPRUS

ELITAN 10MG SUPPOSITORY 10MG MEDOCHEMIE LTD CYPRUS

ELITAN 10MG/2ML LIQUID FOR INJECTION 10MG/2ML MEDOCHEMIE LTD CYPRUS

ELITAN 20MG SUPPOSITORY 20MG MEDOCHEMIE LTD CYPRUS

ELMETIN 100MG TABLET 100MG MEDOCHEMIE LTD CYPRUS

ELMETIN 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS

ELOCOM CREAM 0.1% W/W S-P CANADA CANADA

ELOCOM OINTMENT 0.1% W/W S-P CANADA CANADA

ELOCOM LOTION 1MG/G S-P CANADA CANADA

ELOQUINE 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

ELOXATIN 5MG/ML POWDER FOR POWDER FOR SOL. FOR 5MG/ML SANOFI WINTHROP FRANCE SOL FOR INF. INF. LIMITED

ELPEGON ORAL SUSPENSION 5MG/5ML ELPEN PHARM CO. INC. GREECE

ELPEGON TABLET 5MG ELPEN S.A. GREECE

ELPEGON TABLET 10MG ELPEN S.A. GREECE

ELTROXIN TABLETS 100MCG GOLSHIELD GROUP PLC UNITED KINGDOM T/A GOLDSHIELD PHARMACEUTICALS

ELTROXIN TABLET 50MCG GOLDSHIELD GROUP PLC UNITED KINGDOM T/A GOLDSHIELD PHARMACEUTICALS

ELTROXIN TABLETS 100MCG TABLET 100MCG GOLDSHIELD UNITED KINGDOM PHARMACEUTICALS LTD

ELTROXIN TABLETS 50 MCG TABLET 50MCG GOLDSHIELD UNITED KINGDOM PHARMACEUTICALS LTD

ELUMATIC III SOLUTION FOR NA CIS BIO INTERNATIONAL FRANCE INJECTION

EMADINE EYE DROPS, SOLUTION 0.5MG/ML ALCON LABORATORIES UNITED KINGDOM (UK) LTD

EMESET SOLUTION FOR 2MG/4ML CIPLA LTD INDIA INJECTION

EMESET INJECTION SOLUTION FOR 2ML CIPLA INDIA INJECTION

EMESET-4 TABLETS 4MG CIPLA LTD INDIA

EMLA CREAM N/A ASTRA LAKEMEDEL AB SWEDEN

EMOCLOT D.I. SOLUTION FOR 1000I.U. KEDRION S.P.A. ITALY INJECTION 23.9.2003 FR Journal officiel de l'Union européenne 547

Trade Name Dosage Form Dose MA Holder Country

EMOCLOT D.I. SOLUTION FOR 1000I.U. KEDRION S.P.A. ITALY INJECTION

EMTHEXATE TABLETS 2.5MG PHARMACHEMIE B.V. NETHERLANDS

EMULSIFYING OINTMENT BP OINTMENT N/A ADAMS HEALTHCARE UNITED KINGDOM LIMITED

E-MYCIN POWDER FOR ORAL 200MG/5ML ALPHAPHARM PTY AUSTRALIA LIQUID LIMITED

E-MYCIN TABLET 400MG ALPHAPHARM PTY AUSTRALIA LIMITED

ENACE TABLETS 10MG ATCO LABORATORIES PAKISTAN (PVT) LTD

ENACE TABLETS 5MG ATCO LABORATORIES PAKISTAN (PVT) LTD

ENALAPRIL MALEATE TABLET 20MG RANBAXY INDIA LABORATORIES LTD.

ENALAPRIL MALEATE TABLETS 20MG VYSALI INDIA PHARMACEUTICALS LIMI- TED

ENALAPRIL MALEATE TABLETS 20MG NORTON HEALTHCARE UNITED KINGDOM LTD

ENALAPRIL MALEATE TABLETS TABLET 5MG SANOFI WINTHROP UNITED KINGDOM 5MG LIMITED T/A STERWIN MEDICINES

ENANTONE POWDER FOR IM/SC 3.75MG TAKEDA ITALIA ITALY INJECT. FARMACEUTICI S.P.A.

ENANTONE POWDER FOR IM/SC 11.25MG TAKEDA ITALIA ITALY INJECT. FARMACEUTICI S.P.A.

ENAP TABLET 5MG KRKA, D.D., NOVO SLOVENIA MESTO

ENATEC 10 TABLETS 10MG MEPHA PHARMA AG SWITZERLAND

ENATEC 20 TABELTS 20MG MEPHA PHARMA AG SWITZERLAND

ENATEC 5 TABLETS 5MG MEPHA PHARMA AG SWITZERLAND

ENBREL SOLUTION FOR 25MG WYETH EUROPA LTD UNITED KINGDOM INJECTION

ENBREL POWDER FOR INJECTION 25MG IMMUNEX CORPORATION UNITED STATES OF AMERICA

ENDEKAY FLOUTABS 2-4 YEARS TABLET 1.1MG MANX PHARMA LIMITED UNITED KINGDOM

ENDEKAY FLUORINSE DENTAL SOLUTION 2% W/V MANX PHARMA LIMITED UNITED KINGDOM

ENDEKAY FLUOTABS 4+ YEARS TABLET 2.2MG MANX PHARMA LIMITED UNITED KINGDOM

ENDOBULIN S/D 500MG POWDER FOR INJECTION NS BAXTER AG AUSTRIA

ENDOXAN SUGAR-COATED TABLETS 50MG ASTA MEDICA GERMANY

ENDOXAN POWDER FOR INJECTION 200MG ASTA MEDICA GERMANY

ENDOXAN POWDER FOR INJECTION 500MG ASTA MEDICA GERMANY

ENDOXAN POWDER FOR INJECTION 1G ASTA MEDICA GERMANY 548 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ENELFA 125 SUPPOSITORIES 125MG DOLORGEIT GMBH & CO GERMANY KG

ENELFA 125MG SUPPOSITORY 125MG DOLORGIET GMBH & CO. GERMANY KG

ENELFA 250 SUPPOSITORIES SUPPOSITORIES 250MG DOLORGEIT GMBH & CO GERMANY KG

ENELFA 250MG SUPPOSITORY 250MG DOLORGIET GMBH & CO, GERMANY KG

ENELFA 500 SUPPOSITORY 500MG DOLORGIET GMBH & CO. GERMANY KG

ENELFA SYRUP SOLUTION 2G/100ML DOLORGIET GMBH & CO. GERMANY KG

ENELFA SYRUP SOLUTION SYRUP 100ML DOLORGEIT GMBH & CO GERMANY KG

ENGERIX B SUSPENSION FOR 10MCG/0.5ML SMITHKLINE BEECHAM BELGIUM INJECTION BIOLOGICALS

ENGERIX B SUSPENSION FOR 20MCG/ML SMITHKLINE BEECHAM BELGIUM INJECTION BIOLOGICALS

ENGERIX B SUSPENSION FOR NA SMITHKLINE BEECHAM BELGIUM INJECTION BIOLOGICALS

ENGERIX B JUNIOR SUSPENSION FOR NA GLAXOSMITHKLINE BELGIUM INJECTION BIOLOGICALS SA

ENO POWDER FOR ORAL N/A BEECHAM GROUP PLC UNITED KINGDOM SOLUTION T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

ENPRIN GASTRO-RESISTANT 75MG HEALTHY IDEAS LIMITED UNITED KINGDOM TABLET

ENPRIN GASTRO-RESISTANT 75MG HEALTHY IDEAS LIMITED UNITED KINGDOM TABLET

ENTOCORT SOLUBLET AND SOL FOR 0.02MG/ML TIKA LAKEMEDEL AB SWEDEN ENEMA

ENTOCORT PROLONGED RELEASE 3MG TIKA LAKEMEDEL AB SWEDEN CAPSULE

ENTOX-P TABLET 500MG CYNAMID (PAKISTAN) PAKISTAN LIMITED

ENTROCALM LOPERAMIDE CAPSULES 2MG GALPHARM UNITED KINGDOM HEALTHCARE LIMITED

ENTROCALM REPLACE GRANULES FOR ORAL N/A HEALTHY IDEAS LIMITED UNITED KINGDOM SOLN.

ENTROCALM REPLACE GRANULES FOR ORAL N/A HEALTHY IDEAS LIMITED UNITED KINGDOM SOL.

ENZIFLUR TABLET 5MG BROS LTD GREECE

EOLARIX POWDER FOR INJECTION N/A SMITHKLINE BEECHAM BELGIUM BIOLOGICALS

EPADOREN SOLUTION FOR INECTION N/A DEMO ABEE SA GREECE

EPADOREN COATED TABLET 150MG DEMO ABEE GREECE 23.9.2003 FR Journal officiel de l'Union européenne 549

Trade Name Dosage Form Dose MA Holder Country

EPADOREN SYRUP 75MG/5ML DEMO ABEE GREECE

EPANUTIN CAPSULE 100MG PARKE-DAVIS GMBH GERMANY

EPANUTIN CAPSULES 25MG CAPSULE 25MG WARNER LAMBERT (UK) UNITED KINGDOM LIMITED

EPANUTIN CAPSULES 300MG CAPSULE 300MG WARNER LAMBERT (UK) UNITED KINGDOM LIMITED

EPANUTIN CAPSULES 50MG CAPSULE 50MG WARNER LAMBERT (UK) UNITED KINGDOM LIMITED

EPANUTIN PARENTERAL SOLUTION FOR 250MG/5ML PARKE-DAVIS GMBH GERMANY INJECTION

EPANUTIN SUSPENSION ORAL SUSPENSION 30MG/5ML WARNER LAMBERT (UK) UNITED KINGDOM LIMITED

EPAXAL BERNA SOLUTION FOR N/A ISTITUTO ITALY INJECTION SIEROTERAPICO BERNA S.R.L.

EPHEDRINE AGUETTANT 3% INJECTABLE SOLUTION 3% W/V LABORATOIRE FRANCE AGUETTANT

EPHEDRINE HYDROCHLORIDE BP TABLET 30MG SUSSEX UNITED KINGDOM 30MG PHARMACEUTICAL LIMITED

EPHEDRINE HYDROCHLORIDE BP SOLUTION FOR 3%W/V MACARTHYS LABORAT. UNITED KINGDOM 30MG/ML INJECTION LTD. T/A MARTINDALE PHARMACEUTICALS LTD

EPHEDRINE HYDROCHLORIDE TABLETS 15MG CP PHARMACEUTICALS UNITED KINGDOM TABLETS BP 15MG LTD.

EPHEDRINE HYDROCHLORIDE TABLETS 30MG CP PHARMACEUTICALS UNITED KINGDOM TABLETS BP 30MG LTD.

EPHEDRINE SULFATE INJECTION SOLUTION FOR 50MG/ML ABBOTT LABORATORIES UNITED STATES OF USP INJECTION AMERICA

EPIFOAM TOPICAL AEROSOL N/A SCHWART PHARMA INC UNITED STATES OF AMERICA

EPILAT SOFT GELATIN CAPSULES 10MG EGYPTIAN EGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO (EIPICO)

EPILIM 100MG CRUSHABLE TABLET 100MG SANOFI WINTHROP UNITED KINGDOM LIMITED

EPILIM 200MG ENTERIC COATED TABLET 200MG SANOFI WINTHROP UNITED KINGDOM LIMITED

EPILIM 500MG ENTERIC COATED TABLET 500MG SANOFI WINTHROP UNITED KINGDOM LIMITED

EPILIM CHRONO 300MG MODIFIED RELEASE 300MG SANOFI SYNTHELABO UNITED KINGDOM TABLET LIMITED

EPILIM INTRAVENOUS POWDER POWDER FOR INJECTION 400MG/VIAL SANOFI WINTHROP UNITED KINGDOM FOR INJECTION LIMITED

EPILIM/SODIUM VALPROATE ORAL SOLUTION 200MG/5ML SANOFI WINTHROP UNITED KINGDOM 200MG/5ML LIQUID LIMITED

EPINEPHRINE (ADRENALINE) INJ AQUEOUS SOLUTION 1MG/10ML INTERNATIONAL UNITED KINGDOM MINIJET MEDICATION SYSTEMS LTD 550 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

EPINEPHRINE (ADRENALINE) INJ. SOLUTION FOR 1:10,000 INTERNATIONAL UNITED KINGDOM MINIJET INJECTION MEDICATION SYSTEMS (UK) LIMITED

EPIRAZOLE CAPSULE 20MG EGYPTIAN EGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO (EIPICO)

EPIVIR ORAL SOLUTION 10MG/ML GLAXO GROUP LTD. UNITED KINGDOM

EPIVIR COATED TABLETS 150MG GLAXO GROUP LTD. UNITED KINGDOM

EPOKELAN SCALP LOTION 2% W/W MEDOCHEMIE LTD CYPRUS

EPPY EYE DROPS 1% W/V CHAUVIN UNITED KINGDOM PHARMACEUTICALS LIMI- TED

EPREX INJECTION SOLUTION SEE REMARKS JANSSEN-CILAG AG SWITZERLAND

EPREX 10000U/ML INJECTION PREFILLED SYRINGE 10000 IU/ML JANSSEN-CILAG AG SWITZERLAND SOLUTION

EPREX 10000U/ML INJECTION VIAL 10000 IU/ML JANSSEN-CILAG AG SWITZERLAND SOLUTION

EPREX 1000U/0.5ML INJECTION PREFILLED SYRINGE 1000 IU/0.5ML JANSSEN-CILAG AG SWITZERLAND SOLUTION

EPREX 2000U/0.5ML INJECTION PREFILLED SYRINGE 2000 IU/0.5ML JANSSEN-CILAG AG SWITZERLAND SOLUTION

EPREX 2000U/ML INJECTION VIAL 2000 IU/ML JANSSEN-CILAG AG SWITZERLAND SOLUTION

EPREX 3000U/0.3ML INJECTION PREFILLED SYRINGE 3000 IU/0.3ML JANSSEN-CILAG AG SWITZERLAND SOLUTION

EPREX 4000U/0.4ML INJECTION PREFILLED SYRINGE 4000 IU/0.4ML JANSSEN-CILAG AG SWITZERLAND SOLUTION

EPREX 4000U/ML INJECTION VIAL 4000 IU/ML JANSSEN-CILAG AG SWITZERLAND SOLUTION

EPSOM SALTS BP ORAL POWDER 100%W/W LCM LTD UNITED KINGDOM

ERCEFURYL 200MG CAPSULE 200MG LABORATOIRES FRANCE SYNTHELABO

ERCEFURYL 4% ORAL SUSPENSION 4% W/W LABORATOIRES FRANCE SYNTHELABO

ERIOS SUSPENSION 200MG/5ML MEPHA PHARMA AG SWITZERLAND

ERIOS-250 LACTAB 250MG MEPHA PHARMA AG SWITZERLAND

ERIOS-500 LACTAB 500MG MEPHA PHARMA AG SWITZERLAND

ERITROPIU TABLETS 80MG FARMA UNO SRL ITALY

ERMYCED 125 ORAL SUSPENSION 125MG/5ML REMEDICA LTD CYPRUS

ERVEVAX POWDER FOR INJECTION >=10(3) TCID50 SMITHKLINE BEECHAM BELGIUM BIOLOGICALS

ERYACNE 4 GEL 4% W/W GALDERMA (UK) LIMITED UNITED KINGDOM

ERYC CAPSULE 250MG FAULDING AUSTRALIA PHARMACEUTICALS 23.9.2003 FR Journal officiel de l'Union européenne 551

Trade Name Dosage Form Dose MA Holder Country

ERYCYTOL DEPOT SOLUTION FOR N/A LANNACHER HEILMITTEL AUSTRIA INJECTION GMBH.

ERYHEXAL 500 FILM-COATED TABLET 500MG HEXAL AG GERMANY

ERYHEXAL FORTE SAFT GRANULES FOR 400MG /5ML HEXAL AG GERMANY SUSPENSION

ERYHEXAL SAFT GRANULES FOR 235MG/5ML HEXAL AG GERMANY SUSPENSION

ERYTHRO 125 GRANULES GRANULES FOR 125MG/5ML CAMDEN INDUSTRIES (M) MALAYSIA SUSPENSION SDN. BHD

ERYTHRO 125 GRANULES GRANULES F/ORAL SUSP. 125MG/5ML CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD.

ERYTHRO-250 TABLET TABLET 250MG CAMDEN INDUSTRIES (M) MALAYSIA SDN.BHD

ERYTHROCIN LYOPHILIZED POWDER F/ 1G ABBOTT FRANCE FRANCE INJ.

ERYTHROCIN 250MG TABLETS COATED TABLETS 250MG ABBOTT LABORATORIES UNITED KINGDOM LIMITED

ERYTHROCIN LACTOBIONATE 1G POWDER FOR IV 1G ABBOTT LABORATORIES UNITED KINGDOM VIAL INFUSION LIMITED

ERYTHROMYCIN (ERYTHRO-TEVA) TABLET 250MG TEVA PHARMACEUTICAL ISRAEL TABLETS INDUSTRIES LTD

ERYTHROMYCIN INJECTION VIAL POWDER FOR INJECTION 1G/VIAL F.H. FAULDING & CO. UNITED KINGDOM LTD. (T/A DAVID BULL LABS)

ERYTHROMYCIN STEARATE TABLET 250MG PHARMAMED LTD. MALTA

ERYTHROMYCIN STEARATE TABS FILM COATED TABLET 250MG TABLETS (INDIA) INDIA ESTYMICIN LIMITED

ERYTHROPED PI 125MG/5ML GRANULES FOR ORAL 125MG/5ML ABBOTT LABORATORIES UNITED KINGDOM SOL. LIMITED

ESELAN ENTERIC CAPSULE 20MG ANFARM HELLAS S.A. GREECE

ESKORNADE SPANSULE CAPSULES MODIFIED RELEASE N/A SMITHKLINE & FRENCH UNITED KINGDOM CAPSULE LABORATORIES LIMITED

ESKORNADE SYRUP ORAL SOLUTION N/A SMITHKLINE & FRENCH UNITED KINGDOM LABORATORIES LIMITED

ESMERON 100MG=10ML SOLUTION FOR 10MG/ML ORGANON TEKNIKA B.V. NETHERLANDS INJECTION (PART OF AKZO NOBEL)

ESMERON 250MG=25ML SOLUTION FOR 10MG/ML ORGANON TEKNIKA B.V. NETHERLANDS INJECTION (PART OF AKZO NOBEL)

ESMERON 50MG=5ML SOLUTION FOR 10MG/ML ORGANON TEKNIKA B.V. NETHERLANDS INJECTION (PART OF AKZO NOBEL)

ESONIDE CREAM 0.025%W/W KLEVA LIMITED GREECE

ESONIDE METER DOSE NASAL 50MCG/DOSE KLEVA LIMITED GREECE SPRAY

ESONIDE METER DOSE NASAL 100MCG/DOSE KLEVA LIMITED GREECE SPRAY

ESTRACOMB TTS TRANSDERMAL PATCH N/A NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG 552 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ESTRACOMB TTS TRANSDERMAL PATCHES N/A NOVARTIS SPAIN FARMACEUTICA S.A. SPAIN

ESTRADERM TTS TRANSDERMAL PATCH 2MG NOVARTIS PHARMA ITALY S.P.A.

ESTRADERM TTS TRANSDERMAL PATCHES 4MG NOVARTIS PHARMA ITALY S.P.A.

ESTRADERM TTS 100 TRANSDERMAL PATCH 8MG/20CM(2) NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

ESTRADERM TTS 25 TRANSDERMAL PATCH 2MG/5CM(2) NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

ESTRADERM TTS 50 TRANSDERMAL PATCH 4MG/10CM(2) NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

ESTREVA TRANSDERMAL GEL 0.1G/100G LABORATOIRE FRANCE THERMAX

ESTROFEM — 28 TABLETS TABLET 2MG NOVO NORDISK A/S DENMARK

ESTROFEM FORTE 28 -TABLETS TABLET 4MG NOVO NORDISK DENMARK

ETHAMBUTOL TABLETS 400MG PHARMAMED LTD. MALTA

ETHAMBUTOL HCL TABLET 400MG MACLEODS INDIA

ETHANOLAMINE OLEATE BP SOLUTION FOR N/A EVANS MEDICAL UNITED KINGDOM INJECTION LIMITED

ETHOMID TABLET 250MG MACLEODS INDIA

ETHRANE SOLN F/INHALATION 99G/100ML ABBOTT S.P.A ITALY

ETHYL CHLORIDE «DR. HENNING» SPRAY LIQUID N/A DR. GEORG FRIEDRICH GERMANY HENNING

ETILTOX TABLETS 200MG A.F.O.M. MEDICAL SPA ITALY

ETINILESTRADIOLO AMSA TABLETS 0.01MG A.M.S.A. S.R.L. ITALY

ETOMIDATE LIPURO EMULSION FOR IV 20MG/10ML B.BRAUN MELSUNGEN GERMANY INJECTION AG

ETOPOS INJECTABLE SOLUTION SEE REMARKS LEMERY S.A. DE C.V. MEXICO

ETOPOSIDE INJECTION VIAL SOLUTION FOR 100MG/5ML PHARMACIA (PERTH) PTY AUSTRALIA INJECTION LIMITED

ETOPOSIDE MERCK 20MG/ML SOLUTION FOR 20MG/ML MERCK GENERIQUES FRANCE PERFUSION

ETOPOSIDE PHARMACIA CONCENTRATE FOR 20MG/ML PHARMACIA OY FINLAND SOLUTION FOR INFUSION

ETOPOSIDE PIERRE FABRE INJ. SOL. FOR I.V. INF. 100MG/5ML PIERRE FABRE MEDICA- FRANCE 100MG/5ML MENT

ETOPUL SOLUTION FOR 100MG KOREA UNITED PHARM. KOREA REPUBLIC INJECTION INC.

ETOSID CAPSULES 50MG CIPLA LTD INDIA

ETOSID CAPSULE 50 MG CIPLA LTD INDIA

EUCARBON TABLETS N/A F.TRENKA CHEM-PHARM AUSTRIA FABRIK G.M.B.H 23.9.2003 FR Journal officiel de l'Union européenne 553

Trade Name Dosage Form Dose MA Holder Country

EUCYCLINE SYRUP 1MG/5ML DEMO ABEE GREECE

EUGLUCON TABLET 5MG ROCHE PAKISTAN

EUGLUCON TABLET 5MG BOEHRINGER-INGELHEIM PAKISTAN

EUGLUCON 5MG TABLET 5MG HOFFMANN-LA ROCHE GERMANY AG

EULEXIN TABLETS TABLETS 250MG SCHERING-PLOUGH BELGIUM NV/SA

EUMOVATE CREAM CREAM 0.05% W/W GLAXO WELLCOME UK UNITED KINGDOM LTD

EUMOVATE CREAM CREAM 0.05%W/W GLAXO WELLCOME UK UNITED KINGDOM LIMITED

EUMOVATE ECZEMA AND CREAM 0.005% GLAXO WELLCOME UK UNITED KINGDOM DERMATITIS CREAM LIMITED

EUMOVATE OINTMENT OINTMENT 0.05% W/W GLAXO WELLCOME UK UNITED KINGDOM LTD

EUPEN CAPSULE 500MG J.URIACH & CIA. S.A. SPAIN

EUPEN BRONQUIAL CAPSULE N/A J.URIACH & CIA. S.A. SPAIN

EUPEN DROPS ORAL SUSPENSION 100MG/ML J.URIACH & CIA. S.A. SPAIN

EUPEN SACHETS 250MG GRANULES 250MG J.URIACH & CIA. S.A. SPAIN

EURAX CREAM 100MG/G NOVARTIS CONSUMER SWITZERLAND HEALTH SA

EURAX LOTION 100MG/G NOVARTIS CONSUMER SWITZERLAND HEALTH SA

EUROCEFIX CAPSULES 500MG FARMA UNO SRL ITALY

EUROCEFIX ORAL SUSPENSION 250MG/5ML FARMA UNO SRL ITALY

EVISTA FILM COATED TABLETS 60MG ELI LILLY NEDERLAND NETHERLANDS B.V.

EVOREL 100 TRANSDERMAL PATCH 100MCG/24 JANSSEN-CILAG LIMITED SWITZERLAND

EVOREL 50 TRANSDERMAL PATCH 50MCG/24 JANSSEN-CILAG LIMITED SWITZERLAND

EVOREL 75 TRANSDERMAL PATCH 75MCG/24 JANSSEN-CILAG LIMITED SWITZERLAND

EXACYL 0.5MG/5ML SOLUTION FOR 0.5MG/5ML SANOFI WINTHROP FRANCE INJECTION

EXELON ORAL SOLUTION 2MG/ML NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

EXELON ORAL SOLUTION 2MG/ML NOVARTIS EUROPHARMA UNITED KINGDOM LIMITED

EXELON HARD GELATIN CAPSULE NA NOVARTIS PHARMA SWITZERLAND SCHWIEZ AG

EXELON HARD CAPSULES 1.5MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

EXELON HARD CAPSULES 3MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

EXELON HARD CAPSULES 4.5MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED 554 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

EXELON HARD CAPSULES 6MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

EXELON 0.5MG CAPSULES 0.5MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

EXELON 1.5MG CAPSULES 1.5MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

EXELON 1MG CAPSULES 1MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

EXELON 3MG CAPSULES 3MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

EXELON 4.5MG CAPSULES 4.5MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

EXELON 6MG CAPSULES 6MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

EXOLIT 4MG/5ML ELIXIR 4MG/5ML MEDOCHEMIE LTD CYPRUS

EXOLIT 8MG TABLET 8MG MEDOCHEMIE LTD CYPRUS

EXOSURF NEONATAL POWDER FOR INJECTION 108MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

EXPECTORAN SYRUP N/A DR.GROSSMANN AG SWITZERLAND PHARMACA

EXPECTORAN WITH CODEIN SYRUP N/A DR.GROSSMANN AG SWITZERLAND PHARMACA

EXPULIN CHILDREN'S COUGH ORAL SOLUTION (SUGAR N/A MONMOUTH UNITED KINGDOM LINCTUS FREE PHARMACEUTICALS LIMI- TED

EXPULIN COUGH LINCTUS SUGAR ORAL SOLUTION N/A MONMOUTH UNITED KINGDOM FREE PHARMACEUTICALS LTD.

EXPULIN DECONGESTANT- BABIES ORAL SOLUTION N/A MONMOUTH UNITED KINGDOM AND CHILDREN PHARMACEUTICALS LTD.

EXPUTEX ORAL LIQUID 250MG/5ML MONMOUTH UNITED KINGDOM PHARMACEUTICALS LTD.

EXTRA STRENGTH COLD MED TABLET N/A STANLEY CANADA NIGHTTIME RELIEF PHARMACEUTICALS LTD

EXTRA STRENGTH COLD MEDI. TABLET N/A STANLEY CANADA DAYTIME RELIEF PHARMACEUTICALS LTD

EXTRAFER ORAL SOLUTION 113.5MG/10ML SO.SE.PHARM S.R.L. SOC. ITALY DI SERVIZ. PER L'INDUS. FARM. ED AFF

EXTRANEAL (ICODEXTRIN 7.5%) SOL F/INTRAPERITONEAL N/A BAXTER HEALTHCARE UNITED KINGDOM ADM LIMITED

EZIPOL ENTERIC COATED 20MG KLEVA LIMITED GREECE CAPSULES

FADOL POWDER FOR INJ. 100MG/250MG/500 LEMERY S.A. DE C.V. MEXICO OLUTION

FALICARD I.V. INJECTION SOLUTION 5MG/2ML ARZNEIMITTELWERK GERMANY DRESDEN GMBH

FAM-LAX PHENOLPHTHALEIN TABLETS N/A TORBET LABORATORIES UNITED KINGDOM LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 555

Trade Name Dosage Form Dose MA Holder Country

FAM-LAX SENNA LAXATIVE TABLETS N/A MODERN HEALTH UNITED KINGDOM PRODUCTS LIMITED

FAMO FILM COATED TABLETS 40MG CTS CHEMICAL ISRAEL INDUSTRIES LTD.

FAMO 40 FILM COATED TABLET 40MG CTS CHEMICAL ISRAEL INDUSTRIES LTD

FAMODAR TABLET 40MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

FAMVIR TABLETS 125MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

FAMVIR TABLETS 250MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

FAMVIR TABLETS 125MG NOVARTIS SPAIN FARMACEUTICA S.A

FAMVIR TABLETS 250MG NOVARTIS SPAIN FARMACEUTICA S.A

FAMVIR 125MG TABLET COATED TABLET 125MG SMITHKLINE BEECHAM UNITED KINGDOM PLC

FAMVIR TABLETS 125 MG FILM-COATED TABLETS 125 MG NOVARTIS UNITED KINGDOM PHARMACEUTICALS UK LIMITED

FAMVIR TABLETS 250 MG FILM-COATED TABLETS 250 MG NOVARTIS UNITED KINGDOM PHARMACEUTICALS UK LIMITED

FAMVIR TABLETS 250MG COATED TABLET 250MG SMITHKLINE BEECHAM UNITED KINGDOM PLC

FARMORUBICINA POWDER FOR INJECTION 10MG/VIAL PHARMACIA & UPJOHN ITALY S.P.A.

FARMORUBICINA POWDER FOR INJECTION 50MG/VIAL PHARMACIA & UPJOHN ITALY S.P.A.

FARMORUBICINA POWDER AND SOLVENT N/A PHARMACIA ITALIA S.P.A ITALY F/SOLN F/INJ.

FARMORUBICINA SOLUTION FOR IV 10MG/5ML PHARMACIA ITALIA S.P.A ITALY INFUSION

FARMORUBICINA SOLUTION FOR IV 50MG/25ML PHARMACIA ITALIA S.P.A ITALY INFUSION

FARMORUBICINA POWDER FOR SOLUTION 50MG PHARMACIA ITALIA SPA ITALY FOR INJECTION

FARVIRAN VAGINAL DOUCHE, 3.3G/100ML FARMIGEA SPA ITALY SOLUTION

FASIGYN TABLET 500MG PFIZER LIMITED UNITED KINGDOM

FAST POWDER N/A MEDOCHEMIE LTD CYPRUS

FASTUM GEL 2.5G/100G A.MENARINI INDUSTRIE ITALY FARMACEUTICHE RIUNITE S.R.L.

FASTUM, TUBO CON DISPENSER GEL 2.5% A. MENARINI INDUSTRIE ITALY FARMACEUTICHE RIUNITE S.R.L. 556 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FAVE DI FUCA TABLETS N/A ROCHE S.P.A. ITALY

FAVERIN 100 TABLET 100MG SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

FAVERIN 50 TABLET 50MG SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

FEFOL SPANSULE SUSTAINED RELEASE N/A SMITH KLINE & PAKISTAN CAPSULE BEECHAM

FEFOL SPANSULE CAPSULE MODIFIED RELEASE N/A SMITHKLINE & FRENCH UNITED KINGDOM CAPSULE LABORATORIES LIMITED

FEFOL Z SPANSULE CAPSULES MODIFIED RELEASE N/A SMITHKLINE & FRENCH UNITED KINGDOM CAPSULE LABORATORIES LIMITED

FEIBA S-TIM 4 FAKTOR VIII INHIBI- DRY SUBS IN VIAL + 500U/20ML BAXTER AG AUSTRIA TOR SOLV.

FELDENE CAPSULE 20MG PFIZER LIMITED UNITED KINGDOM

FELDENE CAPSULES 10MG PFIZER LIMITED UNITED KINGDOM

FELDENE TOPICAL GEL N/A PFIZER LIMITED UNITED KINGDOM

FELDENE TABLETS 20MG PFIZER LIMITED UNITED KINGDOM

FELDENE TABLETS 20MG PFIZER LIMITED UNITED KINGDOM

FELDENE CAPSULE 20MG PFIZER PAKISTAN

FELDENE GEL 5MG/G PFIZER PAKISTAN

FELDENE 0.5% GEL GEL N/A PFIZER SA BELGIUM

FELDENE 20MG DISPERSIBLE TABLET 20MG PFIZER PAKISTAN

FEMARA TABLETS 2.5MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

FEMARA COATED TABLET 2.5 MG NOVARTIS UNITED KINGDOM PHARMACEUTICALS UK LIMITED

FEMINAX TABLET SEE REMARKS ROCHE PRODUCTS UNITED KINGDOM LIMITED

FEMOSTON 1/10 TABLET N/A SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

FEMOSTON 2/10 TABLET N/A SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

FEMOSTON 2/20 TABLET N/A SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

FEMOSTON CONTI TABLET N/A SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

FEMULEN TABLETS 0.5MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

FEMULEN TABLETS 0.5MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

FENADOL SOLUTION FOR 75MG/3ML PROGE FARM S.R.L. ITALY INJECTION

FENADOL SUPPOSITORY 100MG PROGE FARM S.R.L. ITALY 23.9.2003 FR Journal officiel de l'Union européenne 557

Trade Name Dosage Form Dose MA Holder Country

FENADOL «RETARD» COMPRESSE 100MG PROGE FARM S.R.L ITALY

FENADOL 5 FIALE 75MG/3ML FIALE 75MG / 3ML PFOGE FARM S.R.L ITALY

FENADOL RETARD SLOW RELEASE TABLET 100MG PROGE FARM S.R.L. ITALY

FENAMIDE TABLETS 50MG FARMIGEA SPA ITALY

FENAMON 10MG CAPSULE 10MG MEDOCHEMIE LTD CYPRUS

FENAMON 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

FENAMON S.R. 20MG TABLET 20MG MEDOCHEMIE LTD CYPRUS

FENAZIL CREAM 2% LABORATORIO CHIMICO ITALY FARMACEUTICO A. SELLA S.R.L

FENBID GEL 5% W/W GOLDSHIELD GROUP PLS UNITED KINGDOM

FENBID SPANSULE MODIFIED RELEASE 300MG GOLDSHIELD GROUP PLC UNITED KINGDOM CAPSULE

FENBID SPANSULE CAPSULES MODIFIED RELEASE 300MG MENLEY & JAMES UNITED KINGDOM CAPSULE LIMITED

FENBUFEN CAPSULES 300MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

FENBUFEN TABLETS 300MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

FENBUFEN TABLETS 450MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

FENBUFEN 450MG TABLETS COATED TABLET 450MG SANOFI WINTHROP UNITED KINGDOM LIMITED T/A STERWIN MEDICINES

FENBUFEN TABLETS 300MG TABLET 300MG SANOFI WINTHROP UNITED KINGDOM LIMITED T/A STERWIN MEDICINES

FENESTIL PROLONGED RELEASE 4MG NOVARTIS CONSUMER SWITZERLAND CAPSULE HEALTH SA

FENISTIL GEL 1MG/G NOVARTIS CONSUMER SWITZERLAND HEALTH SA

FENISTIL DROPS 1MG/ML NOVARTIS CONSUMER SWITZERLAND HEALTH SA

FENISTIL SYRUP 0.5MG/5ML NOVARTIS CONSUMER SWITZERLAND HEALTH SA

FENNINGS CHILDREN'S COOLING ORAL POWDER 50MG ANGLIAN PHARMA PLC UNITED KINGDOM POWDER

FENTANYL CITRATE SOLUTION FOR 0.05MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

FENTANYL CITRATE SOLUTION FOR 100MG//PER 2ML ANITGEN IRELAND INJECTION PHARMACEUTICALS LTD

FENTANYL CITRATE SOLUTION FOR 500MC/10ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS

FENTANYL CITRATE INJECTION SOLUTION FOR 100MCG/2ML ANTIGEN IRELAND INJECTIONS PHARMACEUTICALS LIMITED 558 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FENTANYL CITRATE INJECTION SOLUTION FOR 500MCG/10ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

FENTANYL-JANSSEN 0.05MG/ML AMPOULE 0.05MG/ML JANSSEN-CILAG N.V. BELGIUM 10ML AMP

FENTANYL-JANSSEN 0.05MG/ML AMPOULE 0.05MG/ML JANSSEN-CILAG N.V BELGIUM 2ML AMP

FENULIN TABLETS TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

FERR. PHOS. 6X NEW ERA TISSUE SALTS TABLETS NA NEW ERA UNITED KINGDOM BIOCHEMIC NO.4 NO.4 LABORATORIES LIMITED

FERROGRAD MODIFIED RELEASE 325MG ABBOTT LABORATORIES UNITED KINGDOM TABLETS LIMITED

FERROGRAD FOLIC MODIFIED RELEASE N/A ABBOTT LABORATORIES UNITED KINGDOM TABLETS LIMITED

FERROGRADUMET MODIFIED RELEASE 325MG ABBOTT LABORATORIES UNITED KINGDOM TABLETS LIMITED

FERROGYN 80MG EFFERVESCENT TABLETS 80MG SOCIETA' DI SERVIZIO ITALY PER L'INDUSTRIA FARMACEUTICA

FERRONAL TABLETS 300MG CTS CHEMICAL ISRAEL INDUSTRIES

FERRONAL TABLETS TABLET 300MG CTS CHEMICAL ISRAEL INDUSTRIES LTD

FERROUS FUMARATE 200 TABLETS 200MG REMEDICA LTD CYPRUS

FERROUS GLUCONATE 30MG TABLET 300MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

FERROUS SULPHATE TABLETS BP COATED TABLET 200MG RANBAXY IRELAND IRELAND 200MG LIMITED

FIBERCON CAPLETS 500MG LEDERLE UNITED STATES OF PHARMACEUTICAL AMERICA DIVISION OF AMERICA CYANAMID CO.

FIBER-CON CAPLETS CAPLETS NS WYETH CONSUMER UNITED STATES OF HEALTHCARE AMERICA

FIBRA 3 PWD FOR ORAL RECON- N/A BIODES, S.L. SPAIN STITUTI

FIERY JACK CREAM CREAM N/A RUDGE ROBERTS UNITED KINGDOM LIMITED

FILAIR 100 INHALER AEROSOL 100MCG/ACTUAT. 3M HEALTH CARE UNITED KINGDOM LIMITED

FILAIR 50 INHALER AEROSOL 50MCG/ACTUAT. 3M HEALTH CARE UNITED KINGDOM LIMITED

FILAIR FORTE INHALER AEROSOL 250MCG/ACTUAT. 3M HEALTH CARE UNITED KINGDOM LIMITED

FILICINE TABLET 5MG ADELCO- GREECE CHROMATOURGIA ATHINON E.COLOCOTRONIS BROS S.A. 23.9.2003 FR Journal officiel de l'Union européenne 559

Trade Name Dosage Form Dose MA Holder Country

FINCAR TABLETS 5MG CIPLA LTD INDIA

FLAGENTYL 500MG TABLETS 500MG SPECIA LABORATORIES FRANCE

FLAGYL TABLET 400MG RHONE POULENC RORER PAKISTAN

FLAGYL TABLET 200MG RHONE POULENC RORER PAKISTAN

FLAGYL FILM COATED TABLET 200MG RHONE-POULENC-RORER PAKISTAN

FLAGYL FILM COATED TABLET 400MG RHONE-POULENC-RORER PAKISTAN

FLAGYL SUPPOSITORIES 500MG HAWGREEN LIMITED UNITED KINGDOM

FLAGYL INJECTION 0.5% W/V SOLUTION FOR 0.5% W/V MAY & BAKER LIMITED UNITED KINGDOM (100ML) INJECTION

FLAGYL S SUSPENSION N/A HAWGREEN UNITED KINGDOM LIMITED(IRELAND)

FLAGYL S SUSPENSION ORAL SUSPENSION 200MG/5ML HAWGREEN LIMITED IRELAND

FLAGYL TABLETS 200MG FILM COATED TABLET 200MG HAWGREEN LIMITED IRELAND

FLAGYL TABLETS 400MG TABLET 400MG HAWGREEN LIMITED IRELAND

FLAMAZINE 1% CREAM 1%W/W SMITH & NEPHEW UNITED KINGDOM PHARMACEUTICALS LIMITED

FLAREX OPHTHALMIC SOLUTION 1MG/ML S.A. ALCON-COUVREUR BELGIUM N.V.

FLEET ADULT GLYCERIN SUPPOSITORIES 2G/SUPPOSITORY C.B. FLEET COMPANY UNITED STATES OF SUPPOSITORIES AMERICA

FLEET BABYLAX LIQ. GLYCERIN LIQUID GLYCERIN SUPP. 2.3G/2.3ML C.B. FLEET COMPANY UNITED STATES OF SUPP. AMERICA

FLEET CHILD GLYCERIN SUPPOSITORIES 1G/SUPPOSITORY C.B. FLEET COMPANY UNITED STATES OF SUPPOSITORIES AMERICA

FLEET PHOSPHO-SODA ORAL ORAL SOLUTION N/A E C DE WITT & CO LTD UNITED KINGDOM SOLUTION

FLEET READY TO USE ENEMA RECTAL SOLUTION N/A E C DE WITT & CO LTD UNITED KINGDOM

FLEET READY-TO-USE ENAMA ENEMA N/A C.B. FLEET COMPANY UNITED STATES OF F/CHILDREN AMERICA

FLEET READY-TO-USE ENEMA ENEMA N/A C.B. FLEET COMPANY UNITED STATES OF AMERICA

FLEMOXIN DROPS POWDER FOR 100MG/ML YAMANOUCHI PHARMA NETHERLANDS SUSPENSION B.V.

FLEMOXIN SOLUTAB 250 TABLETS 250MG YAMANOUCHI PHARMA NETHERLANDS B.V.

FLEMOXIN SOLUTAB 500 TABLETS 500MG YAMANOUCHI PHARMA NETHERLANDS B.V.

FLEMOXIN SUSPENSION POWDER FOR 125MG/5ML YAMANOUCHI PHARMA NETHERLANDS SUSPENSION B.V.

FLEMOXIN SUSPENSION FORTE POWDER FOR 250MG/5ML YAMANOUCHI PHARMA NETHERLANDS SUSPENSION B.V.

FLETCHERS' ARACHIS OIL LIQUID EVACUATION 130ML PHARMAX LIMITED UNITED KINGDOM RETENTION ENEMA ENEMA 560 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FLETCHERS' ENEMETTE LIQUID ENEMA SINGLE N/A PHARMAX LIMITED UNITED KINGDOM DOSE

FLETCHERS' PHOSPHATE ENEMA LIQUID EVACUATION N/A PHARMAX LIMITED UNITED KINGDOM ENEMA

FLEXIN-25 CONTINUS TABLETS MODIFIED RELEASE 25MG NAPP LABORATORIES UNITED KINGDOM TABLET LIMITED

FLEXIN-50 CONTINUS TABLETS MODIFIED RELEASE 50MG NAPP LABORATORIES UNITED KINGDOM TABLET LIMITED

FLEXIN-75 CONTINUS TABLETS MODIFIED RELEASE 75MG NAPP LABORATORIES UNITED KINGDOM TABLETS LIMITED

FLIXONASE AQUEOUS NASAL SPRAY N/A ALLEN & HANDBURY'S IRELAND LIMITED UK

FLIXONASE NASULE DROPS NASAL DROPS 400MCG GLAXO WELLCOME AUSTRALIA AUSTRALIA LTD

FLIXONASE AQUEOUS NASAL NASAL SPRAY 0.05% W/W GLAXO WELLCOME UK UNITED KINGDOM SPRAY LTD T/A ALLEN & HANBURYS

FLIXONASE AQUEOUS NASAL NASAL SPRAY 0.05%W/W GLAXO WELLCOME UK UNITED KINGDOM SPRAY LIMITED

FLIXONASE AQUEOUS NASAL NASAL SPRAY 50MCG GLAXO WELLCOME SPAIN SPRAY SUSPENSION S.A.-SPAIN

FLIXONASE NASULE DROPS NASAL DROPS 1MG/ML GLAXO WELLCOME UK UNITED KINGDOM LTD T/A ALLEN & HANBURYS

FLIXOTIDE ACCUHALER INHALATION POWDER 50MCG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

FLIXOTIDE ACCUHALER INHALATION POWDER 100MCG/DOSE GLAXO WELLCOME UK UNITED KINGDOM LIMITED

FLIXOTIDE ACCUHALER 250MCG INHALATION POWDER 250MCG/BLISTER GLAXO WELLCOME UK UNITED KINGDOM LIMITED

FLIXOTIDE ACCUHALER 50MCG INHALATION POWDER 50MCG/BLISTER GLAXO WELLCOME UK UNITED KINGDOM LIMITED

FLIXOTIDE DISKUS INHALATION POWDER 100MCG GLAXO WELLCOME UK FRANCE LTD T/A ALLEN & HANDBURYS

FLIXOTIDE DISKUS POWDER F/ORAL 50UG/DOSE LABORATOIRE GLAXO FRANCE INHALATION WELLCOME

FLIXOTIDE DISKUS POWDER F/ORAL 100UG/DOSE LABORATOIRE GLAXO FRANCE INHALATION WELLCOME

FLIXOTIDE DISKUS POWDER F/ORAL 250UG/DOSE LABORATOIRES GLAXO FRANCE INHALATION WELLCOME

FLIXOTIDE DISKUS INHALATION POWDER 250MCG GLAXO WELLCOME UK FRANCE LIMITED

FLIXOTIDE DISKUS INHALTION POWDER 100MCG ALLEN AND HANBURY'S UNITED KINGDOM LTD -UK

FLIXOTIDE DISKUS INHALTION POWDER 250 MCG ALLEN AND HANBURY'S UNITED KINGDOM LTD — UK

FLIXOTIDE DISKUS 250MCG INHALATION POWDER 250MCG GLAXO WELLCOME UK UNITED KINGDOM LTD 23.9.2003 FR Journal officiel de l'Union européenne 561

Trade Name Dosage Form Dose MA Holder Country

FLIXOTIDE DISKUS 50MCG INHALATION POWDER 50MCG GLAXO WELLCOME UK UNITED KINGDOM LTD

FLIXOTIDE DISKUS 50MCG INHALATION POWDER 50MCG GLAXO WELLCOME UK FRANCE LIMITED

FLIXOTIDE EVOHALER AEROSOL 125UG/AC GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN AND HANDBURYS

FLIXOTIDE EVOHALER AEROSOL 250UG/AC GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN AND HANDBURYS

FLIXOTIDE EVOHALER AEROSOL 50MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN AND HANDBURYS

FLIXOTIDE EVOHALER PRESSURISED 250MCG/AC ALLEN & HANDBURY'S IRELAND INHALATION LIMITED SUSPENSION

FLIXOTIDE EVOHALER 50MCG AEROSOL 50MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LTD T/A ALLEN & HANBURYS

FLIXOTIDE INHALER AEROSOL 125MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN AND HANDBURYS

FLIXOTIDE INHALER AEROSOL 250MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN AND HANDBURYS

FLIXOTIDE INHALER 125 AEROSOL 125MCG/AC GLAXO WELLCOME UK UNITED KINGDOM MICROGRAMS LTD

FLIXOTIDE INHALER 250 AEROSOL 250MCG/AC GLAXO WELLCOME UK UNITED KINGDOM MICROGRAMS LTD

FLIXOTIDE INHALER 50 AEROSOL 50MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN AND HANDBURYS

FLIXOTIDE INHALER 50 AEROSOL 50MCG/AC GLAXO WELLCOME UK UNITED KINGDOM MICROGRAMS LTD

FLIXOTIDE INHALER 50MCG AEROSOL 50MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LIMITED

FLIXOTIDE NEBULES SUSPENSION FOR 0.5MG/2ML GLAXO WELLCOME AUSTRALIA INHALATION AUSTRALIA LTD

FLIXOTIDE NEBULES SUSPENSION FOR 2MG/2ML GLAXO WELLCOME AUSTRALIA INHALATION AUSTRALIA LTD

FLIXOTIDE NEBULES INHALATION SUSPENSION 0.5MG/2ML GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN AND HANDBURYS

FLIXOTIDE NEBULES INHALATION SUSPENSION 2MG/2ML GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN AND HANDBURYS

FLIXOTIDE NEBULES 0.5MG/2ML INHALATION SUSPENSION 0.5MG/2ML GLAXO WELLCOME UK UNITED KINGDOM LTD T/A ALLEN & HANBURYS

FLIXOTIDE NEBULES 2MG/2ML INHALATION SUSPENSION 2MG/2ML GLAXO WELLCOME UK UNITED KINGDOM LTD T/A ALLEN & HANBURYS 562 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FLODOL CAPSULES 20MG FARMA UNO SRL ITALY

FLODOL 1% GEL 1%W/W FARMA UNO SRL ITALY

FLOGOFENAC GEL 1%W/W ECOBI FARMACEUTICI ITALY S.A.S

FLOGOFENAC SUPPOSITORIES 100MG FARMACEUTICI ECOBI ITALY S.A.S

FLOGOFENAC SOLUTION FOR 75MG/3ML FARMACEUTICI ECOBI ITALY INJECTION SAS

FLOGOFENAC RETARD CAPSULE 100MG FARMACEUTICI ECOBI ITALY SAS

FLOGOPROFEN GEL 5G/100G CHIESI WASSERMANN SPAIN S.A.

FLOGOPROFEN SOLUTION 5G/100ML CHIESI WASSERMANN SPAIN S.A.

FLOGOPROFEN SOLUTION 5G/100ML CHIESI ESPANA S.A. SPAIN

FLOGOPROFEN GEL GEL 5G/100G CHIESI ESPANA S.A. SPAIN

FLOLAN SOLUTION FOR 0.5MG/2ML THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION LTD.

FLOLAN POW AND SOL F/IV INF. 0.5MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

FLOMIST SPRAY N/A CIPLA LTD INDIA

FLONITAL CAPSULE 20MG ANFARM HELLAS S.A. GREECE

FLORINEF TABLETS 0.1MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

FLOXAPEN CAPSULES 250MG CAPSULE 250MG BEECHAM GROUP PLC UNITED KINGDOM

FLOXAPEN CAPSULES 500MG CAPSULE 500MG BEECHAM GROUP PLC UNITED KINGDOM

FLOXAPEN SYRUP POWDER FOR ORAL 250MG/5ML BEECHAM GROUP PLC UNITED KINGDOM SOLUTION

FLOXAPEN SYRUP POWDER F/SOL 125MG/5ML BEECHAM GROUP PLC UNITED KINGDOM F/INJECTIONI

FLOXAPEN SYRUP 125MG/5ML POWDER FOR ORAL 125MG/5ML BEECHAM GROUP PLC UNITED KINGDOM SOLUTION

FLOXAPEN VIALS FOR INJECTION POWDER FOR INJECTION 250MG BEECHAM GROUP PLC UNITED KINGDOM 250MG

FLU RELIEF CAPSULES WITH CAPSULE N/A GALPHARM HEALTHCARE UNITED KINGDOM DECONGESTANT LIMITED

FLUANXOL TABLET 0.5MG H. LUNDBECK A/S DENMARK

FLUANXOL DEPOT INJECTION SOLUTION FOR 100MG/ML H. LUNDBECK A/S DENMARK 100MG/ML INJECTION

FLUANXOL DEPOT INJECTION SOLUTION FOR 20MG/ML H. LUNDBECK A/S DENMARK 20MG/ML INJECTION

FLUARIX (INFLUENZA SPLIT SUSP. FOR IM/SC N/A SACHSISCHES GERMANY VACCINE) INJECTION SERUMWERK DRESDEN (SMITHKLINE BEECHAM PHARMA) 23.9.2003 FR Journal officiel de l'Union européenne 563

Trade Name Dosage Form Dose MA Holder Country

FLUARIX INFLUENZA SPLIT SUSPENSION F IM SC INJ. NA SACHSISCHES GERMANY VACCINE SERUMWERK DRESDEN

FLUCLOXACILLIN ORAL ELIXIR 125MG/5ML KENT UNITED KINGDOM PHARMACEUTICALS LIMITED

FLUCLOXACILLIN CAPSULES 250MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

FLUCLOXACILLIN CAPSULES 500MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

FLUCLOXACILLIN ELIXIR 125MG/5ML NORTON HEALTHCARE UNITED KINGDOM LIMITED

FLUCLOXACILLIN CAPSULES B.P. CAPSULES 250MG ATHLONE IRELAND LABORATORIES LIMITED

FLUCORAL 150MG CAPSULES CAPSULES 150MG BILIM ILAC SANAYII VE TURKEY TICARET A.S.

FLUCOZAL 100 CAPSULES 100MG AEGIS LTD CYPRUS

FLUCOZAL 150 CAPSULE 150MG AEGIS LTD. CYPRUS

FLUCOZAL 200 CAPSULES 200MG AEGIS LTD CYPRUS

FLUCOZAL 50 CAPSULES 50MG AEGIS LTD CYPRUS

FLUDARA POWDER FOR INJECTION 50MG SCHERING AG GERMANY

FLUDARA ORAL FILM COATED TABLET 10MG SCHERING HEALTH CARE UNITED KINGDOM LIMITED

FLUDITEC 5% EXPECTORANT, ORAL SUSPENSION 5% INNOTECH FRANCE SYRUP F/ADULTS INTERNATIONAL

FLUIFORT SYRUP N/A DOMPE FARMACEUTICI ITALY

FLUMETOL EYE DROPS N/A FARMILA FARMACEUTICI ITALY MILANO S.P.A.

FLUMETOL 'ANTIBIOTICO' EYE DROPS, POWD.+ N/A FARMILA FARMACEUTICI ITALY SOLVENT MILANO S.P.A.

FLUMETOL 'SEMPLICE' EYE DROPS 0.2% W/V FARMILA FARMACEUTICI ITALY MILANO S.P.A.

FLUNIL-10 CAPSULES 10MG INTAS INDIA PHARMACEUTICALS LIMITED

FLUNIL-10 10MG CAPSULES INTAS INDIA PHARMACEUTICALS LTD

FLUNIL-20 CAPSULE 20MG INTAS INDIA PHARMACEUTICALS LTD

FLUNIL-20 CAPSULES 20MG INTAS INDIA PHARMACEUTICALS LTD

FLUOCIM CAPSULES 20MG CIMEX AG SWITZERLAND

FLUORESCEIN SODIUM 2% EYE DROPS 2% CHAUVIN UNITED KINGDOM PHARMACEUTICALS LIMITED

FLUORESCEINE 10% SOLUTION FOR 100MG/ML NOVARTIS SWITZERLAND INJECTION OPHTHALMICS AG 564 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FLUORESCEINE SODIQUE FAURE SOLUTION FOR 10% W/V CIBA VISION FRANCE INJECTION OPHTHALMICS

FLUORETS OPHTHALMIC STRIPS 1MG/STRIP CHAUVIN UNITED KINGDOM PHARMACEUTICALS LTD.

FLUORORINIL NASAL SPRAY, SUSPEN- N/A FARMILA ITALY SION FARMACEUTICI MILANO S.P.A.

FLUOROURACIL INJECTION BP SOLUTION FOR 25MG/ML FAULDING UNITED KINGDOM INJECTION PHARMACEUTICALS PLC

FLUOROURACIL INJECTION BP SOLUTION FOR 50MG/ML FAULDING UNITED KINGDOM INJECTION PHARMACEUTICALS PLC

FLUOROURACIL INJECTION VIAL SOLUTION FOR 250MG/10ML F.H. FAULDING & CO. UNITED KINGDOM INJECTION LTD. (T/A DAVID BULL LABS)

FLUOTHANE LIQUID FOR INHALATION 0.01% W/W ZENECA LIMITED UNITED KINGDOM

FLUOTHANE CONCENTRATE FOR INH. 100% W/W ZENECA LIMITED UNITED KINGDOM SOL.

FLUOXETIN DELTA 10MG CAPSULES DELTA HF — ICELAND ICELAND CAPSULES

FLUOXETIN DELTA 20 MG CAPSULE 20MG DELTA HF ICELAND

FLUPHENAZINE DECANOATE SOLUTION FOR 25MG/1ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

FLUPHENAZINE DECANOATE INJ. SOLUTION FOR 100MG/ML FAULDING UNITED KINGDOM BP 100MG/ML INJECTION PHARMACEUTICALS PLC

FLUPHENAZINE DECANOATE SOLUTION FOR 25MG/1ML ANTIGEN IRELAND INJECTION INJECTION PHARMACEUTICALS LIMITED

FLUPHENAZINE DECANOATE SOLUTION FOR 100MG/1ML ANTIGEN IRELAND INJECTION INJECTION PHARMACEUTICALS LIMITED

FLUPHENAZINE DECANOATE SOLUTION FOR 100MG/1ML ANTIGEN IRELAND INJECTION BP INJECTION PHARMACEUTICALS LIMITED

FLUSEMINAL F.C. TABLET 400MG ANFARM HELLAS S.A. GREECE

FLUSENIL CAPSULE 50MG ANFARM HELLAS S.A. GREECE

FLUSENIL CAPSULE 150MG ANFARM HELLAS S.A. GREECE

FLUSOLV SOLUTION FOR 12500IU/0.5ML FARMACEUTICI ECOBI ITALY INJECTION SAS

FLUTAMIDA TABLETS 250MG LEMERY S.A. MEXICO

FLUTAMIDE TAB 250MG TABLET 250MG PHARMASCIENCE INC. CANADA

FLUTAMIDE TABLETS 250MG TABLET 250MG GENERICS (UK) LIMITED UNITED KINGDOM

FLUTAN 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

FLUVIRAL S/F SUS IM SUSPENSION FOR INJEC- N/A BIOCHEM VACCINES INC. CANADA TION

FLUVOXAMINE TABLETS 100MG CP PHARMACEUTICALS UNITED KINGDOM LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 565

Trade Name Dosage Form Dose MA Holder Country

FLUVOXAMINE TABLETS BP 100MG TABLET 100MG CP PHARMACEUTICALS UNITED KINGDOM LTD

FLUXIL 20 CAPSULES 20MG AEGIS LTD, CYPRUS

FLUZOLE 50MG 7 CAPSULE CAPSULE 50MG BIOFARMA ILAC SAN.VE TURKEY TIC.A.S.

FML LIQUIFILM STERILE OPHTHAL. 1MG/ML ALLERGAN IRELAND SUSPEN. PHARMACEUTICALS (IRELAND) LTD., INC.

FOBAN OINTMENT 2% W/W HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

FOBAN CREAM 2% W/W HOE PHARMCEUTICALS MALAYSIA SDN. BHD.

FOBAN CREAM 2% W/W HOE PHARMACEUTICALS MALAYSIA SDN BHD

FOBAN OINTMENT 2% W/W HOE PHARMACEUTICALS MALAYSIA SDN BHD

FOBAN CREAM CREAM 2%W/W HOE PHARMACEUTICALS MALAYSIA SDN. BHD

FOBAN OINTMENT OINTMENT 2% W/W HOE PHARMACEUTICALS MALAYSIA SDN. BHD

FOBANCORT OINTMENT N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

FOBANCORT CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

FOBANCORT CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN BHD

FOBANCORT OINTMENT N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

FOBANCORT OINTMENT OINTMENT N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD

FOLIC ACID TABLETS 5MG REMEDICA LTD CYPRUS

FOLIC ACID TABLETS 5MG PHARMAMED LTD. MALTA

FOLIC ACID BP 5MG TABLET 5MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMI- TED

FOLIC ACID TABLETS TABLET 5MG CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD

FOLIC ACID TABLETS BP 5MG TABLETS 5MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

FOLIC ACID TABLETS BP 5MG TABLET 5MG CP PHARMACEUTICALS UNITED KINGDOM LTD

FOLIFER PROLONGED RELEASE NA LABORATORIOS BIAL — PORTUGAL TABLET PORTELA & CA, S.A.

FOLIFER PROLONGED RELEASE NA LABORATORIOS BIAL — PORTUGAL TABLET PORTELA & CA, S.A.

FORADIL POWDER CAPS. FOR 12MCG NOVARTIS PHARMA SWITZERLAND INHAL. SCHWEIZ AG 566 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FORADIL POWDER FOR 12MCG NOVARTIS PHARMA ITALY INHALATION S.P.A.

FORAL LOZENGE N/A DR.GROSSMANN AG SWITZERLAND PHARMACA

FORANE CONC. FOR INHALATION 99.9% W/W ABBOTT LABORATORIES UNITED KINGDOM SOL. LIMITED

FORCEVAL CAPSULES CAPSULE N/A UNIGREG LIMITED UNITED KINGDOM

FORCEVAL JUNIOR CAPSULES CAPSULE N/A UNIGREG LIMITED UNITED KINGDOM

FORCEVAL PROTEIN POWDER POWDER FOR ORAL N/A UNIGREG LIMITED UNITED KINGDOM SOLUTION

FORCID SOLUTAB TABLETS 125/31,25 YAMANOUCHI PHARMA NETHERLANDS B.V.

FORCID SOLUTAB TABLETS 250/62,50 YAMANOUCHI PHARMA NETHERLANDS B.V.

FORCID SOLUTAB TABLETS 375/93,75 YAMANOUCHI PHARMA NETHERLANDS B.V.

FORCID SOLUTAB TABLETS 500/125 YAMANOUCHI PHARMA NETHERLANDS B.V.

FORECOX TABLETS N/A MALCEODS INDIA PHARMACEUTICALS LTD

FORECOX-TRAC TABLET N/A MACLEODS INDIA PHARMACEUTICALS LTD

FORMOMICIN OPTHALMIC DROPS N/A FARMIGEA SPA ITALY

FORMOMICIN OPHTHALMIC OINTMENT N/A FARMIGEA SPA ITALY

FORSEF 1G IM POWDER F/SOLUTION F/ 1G BILIM ILAC SANAYII VE TURKEY INJ TICARET A.S

FORSEF 1G IV POWDER F/SOLUTION F/ 1G BILIM ILAC SANAYII VE TURKEY INJ TICARET A.S.

FORTOVASE CAPSULE 200MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

FORTRAL CAPSULES 50MG CAPSULE 50MG SANOFI WINTHROP UNITED KINGDOM LIMITED

FORTRAL INJECTION 30MG/ML SOLUTION FOR 3.947% W/V SANOFI WINTHROP UNITED KINGDOM INJECTION LIMITED

FORTUM 1G/3ML POWDER AND SOL FOR 1164MG GLAXOSMITHKLINE S.P.A ITALY INJ.

FORTUM 500MG/1.5ML POWDER AND SOL FOR 582MG GLAXOSMITHKLINE S.P.A ITALY INJ.

FORTUM FOR INJECTION POWDER FOR INJECTION 1G GLAXO OPERATIONS UK UNITED KINGDOM LIMITED

FORTUM FOR INJECTION POWDER FOR INJECTION 500MG GLAXO OPERATIONS UK UNITED KINGDOM LIMITED

FORTUM INJECTION 1G POWDER FOR INJECTION 1G GLAXO OPERATIONS UK UNITED KINGDOM LTD

FORTUM INJECTION 250MG POWDER FOR INJECTION 250MG GLAXO OPERATIONS UK UNITED KINGDOM LTD

FORTUM INJECTION 2G POWDER FOR INJECTION 2G GLAXO OPERATIONS UNITED KINGDOM 23.9.2003 FR Journal officiel de l'Union européenne 567

Trade Name Dosage Form Dose MA Holder Country

FORTUM INJECTION 500MG POWDER FOR INJECTION 500MG GLAXO OPERATIONS UK UNITED KINGDOM LTD

FORTZAAR 100/25MG TABLETS 100/25MG MERCK SHARP & DOHME NETHERLANDS B.V.

FOSAMAX 10MG TABLET 10MG MERCK SHARP & DOHME NETHERLANDS B.V.

FOSAMAX, ONCE WEEKLY TABLETS 70MG MERCK SHARP & DOHME UNITED KINGDOM LTD.

FRAGMIN SOLUTION FOR 25,000IU PHARMACIA & UPJOHN SWEDEN INJECTION SVERIGE AB

FRAGMIN SOLUTION FOR 2500IU/ML PHARMACIA & UPJOHN SWEDEN INJECTION SVERIGE AB

FRAGMIN SOLUTION FOR 10000IU/1ML PHARMACIA & UPJOHN SWEDEN INJECTION SVERIGE AB

FRAGMIN SOLUTION FOR 2500IU/ML PHARMACIA NV/SA BELGIUM INJECTION

FRAGMIN SOLUTION FOR 12 500IU/ML PHARMACIA SVERIGE AB SWEDEN INJECTION

FRAGMIN SOLUTION FOR 7500IU/0.3ML PHARMACIA NV/SA BELGIUM INJECTION

FRAGMIN 2500IU (ANTI-XA)/ML SOLUTION FOR 2500IU/ML PHARMACIA NV/SA BELGIUM INJECTION

FRAGMIN 2500IU/0.2ML SOLUTION FOR 2500IU/02ML PHARMACIA NV/SA BELGIUM INJECTION

FRAGMIN 5000IU/0.2ML SOLUTION FOR 5000IU/0.2ML PHARMACIA NV/SA BELGIUM INJECTION

FRAXIPARINE 2850 UI AXA/0.3ML SOLUTION FOR 2850 IU/0.3ML SANOFI WINTHROP FRANCE INJECTION

FRAXIPARINE 3800 IU AXA/0.4ML INJ. SOLUTION 3800IU SANOFI SYNTHALABO FRANCE FRANCE

FRAXIPARINE 5700 UI AXA/0.6ML SOLUTION FOR 5700 IU/0.6ML SANOFI WINTHROP FRANCE INJECTION

FRAXIPARINE 7600 UI/AXA/0.8ML SOLUTION FOR 7600 IU/0.8ML SANOFI WINTHROP FRANCE INJECTION

FRAXIPARINE FORTE INJECTABLE SOLUTION 11400 IU/0.6ML SANOFI WINTHROP FRANCE (PFS)

FRAXIPARINE FORTE INJECTABLE SOLUTION 15200 IU/0.8ML SANOFI WINTHROP FRANCE (PFS)

FRAXIPARINE FORTE INJECTABLE SOLUTION 19000IU/1ML SANOFI WINTHROP FRANCE (PFS)

FRIARS BALSAM BP TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM

FROMILID FILM-COATED TABLET 250MG KRKA, D.D., NOVO SLOVENIA MESTO

FROXIME TABLETS 250MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

FROXIME SUSPENSION 125MG/5ML DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT 568 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FRU-CO TABLETS N/A NORTON HEALTHCARE UNITED KINGDOM LIMITED

FRUMIL TABLET N/A HELIOS HEALTHCARE GREECE LIMITED

FRUMIL TABLET N/A HELIOS HEALTHCARE UNITED KINGDOM LIMITED

FRUSEMIDE TABLET 40MG GENERICS (UK) LIMITED UNITED KINGDOM —UK

FRUSEMIDE INJECTION BP SOLUTION FOR 50MG/ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

FRUSEMIDE BP TABLET 40MG CP PHARMACEUTICALS UNITED KINGDOM LIMITED

FRUSEMIDE INJ MINIJET AQUEOUS SOLUTION 10MG/ML INTERNATIONAL UNITED KINGDOM MEDICATION SYSTEMS LTD

FRUSEMIDE INJECTION SOLUTION FOR 20MG/2ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

FRUSEMIDE INJECTION BP SOLUTION FOR 250MG/25ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LTD

FRUSEMIDE INJECTION BP SOLUTION FOR 20MG/2ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

FRUSEMIDE INJECTION BP SOLUTION FOR 250MG/ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

FRUSEMIDE INJECTION BP MINIJET SOLUTION FOR 10MG/ML INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS (UK) LIMITED

FRUSEMIDE TABLET 40MG TABLET 40MG CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD

FRUSEMIDE TABLET BP 40MG TABLET 40MG TABLETS (INDIA) INDIA AMEDOSIX LIMITED

FRUSEMIDE TABLETS BP TABLET 40MG IPCA LABORATORIES INDIA LIMITED

FRUSEMIDE TABLETS BP 40MG TABLET 40MG CP PHARMACEUTICALS UNITED KINGDOM LTD

FUCICORT CREAM N/A LEO PHARMACEUTICAL DENMARK PRODUCTS

FUCICORT CREAM N/A LEO PAKISTAN

FUCICORT CREAM N/A LEO PAKISTAN

FUCIDIN SUSPENSION 50MG/ML LEO PHARMACEUTICAL DENMARK PRODUCTS

FUCIDIN CREAM 20MG/G LEO PHARMACEUTICAL DENMARK PRODUCTS

FUCIDIN GEL 20MG/G LEO PHARMACEUTICAL DENMARK PRODUCTS

FUCIDIN OINTMENT 20MG/G LEO PHARMACEUTICAL DENMARK PRODUCTS 23.9.2003 FR Journal officiel de l'Union européenne 569

Trade Name Dosage Form Dose MA Holder Country

FUCIDIN TABLETS 250MG LEO PHARMACEUTICAL DENMARK PRODUCTS

FUCIDIN CREAM N/A LEO PAKISTAN

FUCIDIN OINTMENT 20MG/G LEO PAKISTAN

FUCIDIN CREAM 20MG/G LEO PAKISTAN

FUCIDIN OINTMENT 20MG/G LEO PAKISTAN

FUCIDIN H CREAM N/A LEO LABORATORIES UNITED KINGDOM LIMITED

FUCIDIN H CREAM N/A LEO PHARMACEUTICAL DENMARK PRODUCTS

FUCIDIN H CREAM CREAM NA LEO PAKISTAN

FUCIDIN I.V. POWDER FOR INFUSION N/A LEO PHARMACEUTICAL DENMARK PRODUCTS

FUCIDIN INTERTULLE GAUZE INPREG. 20MG/100CM2 LEO PHARMACEUTICAL DENMARK W/OINTMENT PRODUCTS

FUCIDIN INTERTULLE GAUZE IMP. WITH 30MG/100CM2 LEO PHARMACEUTICAL DENMARK OINTMENT PRODUCTS

FUCIDIN-H CREAM N/A LEO PAKISTAN

FUCITHALMIC VISCOUS EYE DROPS 10MG/G LEO PHARMACEUTICAL DENMARK PRODUCTS

FUCITHALMIC VISCOUS EYE DROPS 10MG/G LEO PAKISTAN

FUCITHALMIC DROPS EYE DROPS 1%W/W LEO PAKISTAN

FUGENTIN TABLET N/A ELPEN S.A. GREECE

FUGENTIN POWD. ORAL N/A ELPEN S.A. GREECE SUSPENSION

FUGENTIN POWD. FOR ORAL N/A ELPEN PHARM. CO. INC. GREECE SUSPENSION

FULCIN TABLET 125MG ZENECA LIMITED UNITED KINGDOM

FULCIN TABLET 500MG ZENECA LIMITED UNITED KINGDOM

FULCIN ORAL SUSPENSION 2.5%W/V ZENECA LIMITED UNITED KINGDOM

FULL MARKS LOTION TOPICAL SOLUTION 0.2% W/V SETON PRODUCTS UNITED KINGDOM LIMITED

FUNGILIN LOZENGES 10MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

FUNGILIN ORAL TABLETS 100MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

FUNGILIN ORAL SUSPENSION 100MG/ML E.R. SQUIBB & SONS LTD UNITED KINGDOM

FUNGO POWDER POWDER 2% W/W EGO PHARMACEUTICALS AUSTRALIA

FUNGO SOLUTION SOLUTION 2% W/W EGO PHARMACEUTICALS AUSTRALIA

FUNGO SOOTHING BALM BALM N/A EGO PHARMACEUTICALS AUSTRALIA

FUNGO VAGINAL CREAM CREAM 2% W/W EGO PHARMACEUTICALS AUSTRALIA

FUNGOCORT CREAM N/A EGO PHARMACEUTICALS AUSTRALIA

FUNGOTOX CREAM 10MG/G MEPHA PHARMA AG SWITZERLAND 570 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

FURANTOINA TABLET 50MG J.URIACH & CIA. S.A. SPAIN

FUROSEMIDE SOLUTION FOR 10MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

FUROSEMIDE SOLUTION FOR 20MG/2ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

FUROSEMIDE INJECTION USP SOLUTION FOR 10MG/1ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

FUROSEMIDE/FRUSEMIDE (FUSID) TABLET 40MG TEVA PHARMACEUTICAL ISRAEL TABLETS INDUSTRIES LTD

FUROSEMID-SLOVAKOFARMA TABLET 40 MG SLOVAKOFARMA A.S. SLOVAK REPUBLIC TABLETS HLOHOVEC

FYBOGEL LEMON GRANULES FOR ORAL 3.5G RECKITT & COLMAN UNITED KINGDOM SOLN. PRODUCTS LIMITED

FYBOGEL LEMON GRANULES F/ORAL SOL. 3.5G RECKITT BENCKISER UNITED KINGDOM HEALTHCARE(UK) LIMITED

FYBOGEL MEBEVERINE EFF.GRANULES F/ORAL N/A RECKITT & COLMAN UNITED KINGDOM SUSP. PRODUCTS LIMITED

FYBOGEL ORANGE EFFERVESCENT GRANULES 3.5G RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

FYBOGEL ORANGE EFF.GRANULES 3.5GM RECKITT BENCKISER UNITED KINGDOM HEATHCARE(UK) LIMITED

G.P.O. (4% ALBUMIN) SOLUTION FOR INFUSION 40G/L CLB NETHERLANDS

GADIN TABLETS 150MG UNIMED KOREA REPUBLIC PHARMACEUTICALS INC.

GADIN (RANITIDINE SOLUTION FOR 50MG/2ML UNIMED KOREA REPUBLIC HYDROCHLORIDE) INJECTION PHARMACEUTICALS INC

GADOVIST 1.0MMOL/ML SOLUTION FOR 1.0MMOL/ML SCHERING AG GERMANY INJECTION

GALENAMOX CAPSULES 250MG BP GALEN LIMITED UNITED KINGDOM

GALENAMOX GRANULES FOR ORAL 125MG/5ML GALEN LIMITED UNITED KINGDOM SOL.

GALENAMOX GRANULES FOR ORAL 250MG/5ML GALEN LIMITED UNITED KINGDOM SOL.

GALENOMOX CAPSULES 500MG BP GALEN LIMITED UNITED KINGDOM

GALFER ORAL SOLUTION 140MG/5ML GALEN LIMITED UNITED KINGDOM

GALFER FA CAPSULES N/A GALEN LIMITED UNITED KINGDOM

GALLIUM CITRATE (67GA) SOLUTION FOR 37MBQ/ML NYCOMED AMERSHAM UNITED KINGDOM INJECTIONS PLS

GALPAMOL ORAL SUSPENSION 120MG/5ML HEALTHY IDEAS LIMITED UNITED KINGDOM

GALPHARM HAYFEVER AND FILM COATED TABLET 10MG APPROVED PRESCRIPTION UNITED KINGDOM ALLERGY RELIEF SERVICES LIMITED

GALPROFEN IBUPROFEN COLD COATED TABLET 200MG GALPHARM UNITED KINGDOM AND FLU HEALTHCARE LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 571

Trade Name Dosage Form Dose MA Holder Country

GALPROFEN LONG LASTING MODIFIED RELEASE 200MG HEALTHY IDEAS LIMITED UNITED KINGDOM IBUPROFEN CAPSULE CAPSULE

GAMALATE B6 COATED TABLETS N/A LABORATORIOS NOVAG, SPAIN S.A.

GAMALATE B6 SOLUTION N/A LABORATORIOS NOVAG, SPAIN S.A.

GAMIMUNE N, 10% SOLUTION FOR IV 10% W/V BAYER CORPORATION, UNITED STATES OF INJECTION PHARMACEUTICAL AMERICA DIVISION

GAMIMUNE N, 5% SOLUTION FOR IV 5% W/V BAYER CORPORATION, UNITED STATES OF INJECTION PHARMACEUTICAL AMERICA DIVISION

GAMMAGLOBULIN PHARMACIA SOLUTION FOR 165MG/1ML PHARMACIA & UPJOHN SWEDEN INJECTION AB

GAMMAGLOBULIN PHARMACIA SOLUTION FOR 165MG/ML BIOVITRUM AB SWEDEN INJECTION

GAMMONATIV POWDER FOR INFUSION (I+II) 2.5G PHARMACIA & UPJOHN SWEDEN AB

GAMMONATIV POWDER FOR INFUSION (I+II) 5G PHARMACIA & UPJOHN SWEDEN AB

GAMMONATIV POWDER AND POWDER AND SOLVENT 2.5G BIOVITRUM SWEDEN SOLVENT

GANAZOLO VAGINAL CREAM 1% W/W ISTITUTO GANASSINI ITALY S.P.A DI RICERCHE BIOCHIMICHE

GANAZOLO VAGINAL OVULES 150MG ISTITUTO GANASSINI ITALY S.P.A. DI RICERCHE BIOCHIMICHE

GARAMYCIN OINTMENT 0.1% W/W S-P CANADA CANADA

GARAMYCIN 0.1% CREAM 0.1% W/W S-P CANADA CANADA

GARASONE EYE OINTMENT N/A SCHERING-PLOUGH BELGIUM NV/SA

GARASONE EYE/EAR DROPS N/A SCHERING-PLOUGH S.A. BELGIUM

GASTROBID CONTINUS TABLETS MODIFIED RELEASE 15MG NAPP LABORATORIES UNITED KINGDOM 15MG TABLETS LIMITED

GASTROFAIT TABLETS 1G EGYPTIAN EGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO.

GASTROGRAFIN SOLUTION N/A SCHERING ESPANA, S.A. SPAIN

GASTRONERTON TABLET 8.92MG DOLORGIET GMBH & CO. GERMANY KG

GASTRONERTON TABLET 8.92MG/TABLET DOLORGEIT GMBH & CO GERMANY KG

GASTRONERTON SYRUP SOLUTION 116.2MG/100ML DOLORGIET GMBH & CO. GERMANY KG

GASTROPRIDE SUSPENSION 5MG/5ML DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD 572 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

GAVISCON LIQUID N/A RECKITT & COLMAN PAKISTAN

GAVISCON ADVANCE ORAL SUSPENSION N/A RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

GAVISCON INFANT POWDER FOR ORAL N/A RECKITT & COLMAN UNITED KINGDOM SOLUTION PRODUCTS LIMITED

GAVISCON LIQUID LIQUID N/A RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

GAVISCON LIQUID LIQUID NA RECKITT & BENCKISER PAKISTAN

GAVISCON LIQUID PEPPERMINT ORAL SUSPENSION N/A RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

GAVISCON LIQUID SACHETS ORAL SUSPENSION N/A RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

GAVISCON PEPPERMINT FLAVOUR CHEWABLE TABLET N/A RECKITT & COLMAN PAKISTAN

GAVISCON TABLETS TABLET N/A RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

GAVISCON TABLETS TABLETS NA RECKITT & BENCKISER PAKISTAN

GAVISCON TOFFEE FLAVOUR CHEWABLE TABLET N/A RECKITT & COLMAN PAKISTAN

GEE'S LINCTUS BP/SQUILL OPIATE ORAL SOLUTION N/A LCM LTD UNITED KINGDOM LINQTUS

GELAFUNDIN INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY AG

GELCOTAR LIQUID SHAMPOO N/A QUINODERM LIMITED UNITED KINGDOM

GEL-LARMES OPHTHALMIC GEL 0.3G / 100G LABORATOIRES THEA FRANCE

GELOFUSINE SOLUTION FOR INFUSION 4% W/V B.BRAUN MELSUNGEN GERMANY AG

GELOMYRTOL CAPSULES 120MG G. POHL-BOSKAMP GMBH GERMANY &CO

GELOMYRTOL FORTE CAPSULE 300MG G. POHL-BOSKAMP GMBH GERMANY &CO

GEMZAR POWDER FOR IV 200MG LABORATOIRES LILLY FRANCE INJECTION FRANCE

GEMZAR POWDER FOR IV 1000MG LABORATOIRES LILLY FRANCE INJECTION FRANCE S.A.

GENELAC ORAL SOLUTION 100%W/V GENERICS (UK) LTD. UNITED KINGDOM

GENOTROPIN (I + II) 16IU POWDER FOR INJECTION N/A PHARMACIA & UPJOHN SWEDEN SVERIGE AB

GENOTROPIN (I + II) 36IU POWDER FOR INJECTION N/A PHARMACIA & UPJOHN SWEDEN SVERIGE AB

GENOTROPIN, POWDER AND POWDER AND SOLVENT 16IU(5.3MG) PHARMACIA SVERIGE AB SWEDEN SOLVENT

GENOVOX FILM COATED TABLETS 30MG KLEVA LTD. GREECE

GENOVOX FILM COATED TABLETS 30MG KLEVA LIMITED GREECE 23.9.2003 FR Journal officiel de l'Union européenne 573

Trade Name Dosage Form Dose MA Holder Country

GENTADAR EYE/EAR DROPS N/A DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LIMITED

GENTAMED 80MG/2ML LIQUID FOR INJECTION 80MG/2ML MEDOCHEMIE LTD CYPRUS

GENTAMICIN SOLUTION FOR 80MG/2ML KRKA, D.D., NOVO SLOVENIA INJECTION MESTO

GENTAMICIN INJECTION IP 40MG CIPLA LTD — INDIA INDIA

GENTAMICIN - POS EYEDROPS EYE DROPS N/A URSAPHARM GERMANY ARZNEIMITTEL GMBH AND CO KG — GERMANY

GENTAMICIN SULFATE SOLUTION FOR 80MG/2ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

GENTAMICIN SULFATE INJECTION SOLUTION F/INJECTION 40MG/ML ABBOTT LABORATORIES UNITED STATES OF USP AMERICA

GENTAMICIN SULPHATE SOL. FOR SOLUTION FOR 40MG/ML TABLETS (INDIA) LIMITED INDIA INJECTION INJECTION

GENTAMICINE (ESSEX GENTA) SOLUTION FOR 80MG/2ML SCHERING-PLOUGH S.A. BELGIUM INJECTION

GENTAMYCIN INJECTION 80MG/2ML WAN WEI YAO ZHUNZI CHINA

GENTAMYCIN INJECTION SOLUTION FOR 80MG/2ML FAULDING UNITED KINGDOM INJECTION PHARMACEUTICALS

GENTAMYTREX OPHTHALMIC OINTMENT 3MG/1G DR. GERHARD MANN GERMANY CHEM-PHARM FABRIK GMBH

GENTAMYTREX IN DER OPHTIOLE EYE DROPS 5MG/ML DR. GERHARD MANN, GERMANY CHEM.-PHARM.FABRIK GMBH

GENTATRIM OINTMENT 0.1%W/W TRIMA ISRAEL ISRAEL PHARMACEUTICAL PRODUCTS LIMITED

GENTIBIOPTAL EYE DROPS 441MG/100ML FARMILA FARMCEUTICI ITALY MILANO S.P.A.

GENTRAN 70 INTRAVENOUS SOLUTION FOR N/A BAXTER HEALTHCARE UNITED KINGDOM INFUSION INJECTION LIMITED

GEOERYTHCIN TABLET 250MG GEOFMAN PAKISTAN PHARMACEUTICALS

GEOMOXIN SUSPENSION 125MG/5ML GEOFMAN PAKISTAN PHARMACEUTICALS

GEOMYCIN/GARAMYCIN EYE/EAR DROPS 3MG/ML SCHERING-PLOUGH S.A. BELGIUM

GERARD BLUE FLAG ROOT TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM COMPOUND TABLETS

GERARD BUCHU COMPOUND TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM TABLETS

GERARD HELONIAS COMPOUND COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM TABLETS

GERARD HOUSE SOMNUS COATED TABLET N/A CATHAY OF BOURNE- UNITED KINGDOM MOUTH LIMITED 574 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

GERARD HOUSE CATARRH EEZE TABLET N/A PETER BLACK UNITED KINGDOM HEALTHCARE

GERARD HOUSE ECHINACEA + COATED TABLET N/A CATHAY OF UNITED KINGDOM GARLIC TABLETS BOURNEMOUTH LTD

GERARD HOUSE REUMALEX COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM TABLETS

GERARD HOUSE SERENITY COATED TABLET N/A CATHAY OF UNITED KINGDOM BOURNEMOUTH LIMITED

GERARD HOUSE SLIMMERS AID TABLETS N/A GERARD HOUSE LIMITED UNITED KINGDOM

GERARD HOUSE WATER RELIEF COATED TABLETS N/A PETER BLACK UNITED KINGDOM TABLETS HEALTHCARE LIMITED

GERARD KELP TABLETS 360MG TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

GERARD PAPAYA PLUS TABLETS COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

GERARD SLIPPERY ELM TABLETS TABLET 400MG GERARD HOUSE LIMITED UNITED KINGDOM

GERIAVIT PHARMATON CAPSULE N/A PHARMATON SA SWITZERLAND (PHARMATON CAPSULES)

GERMACID OINTMENT 2% W/W RAZA MANUFACTURING MALAYSIA BERHAD

GERMOLENE ANTISEPTIC OINTMENT N/A BAYER PLC T/A BAYER UNITED KINGDOM OINTMENT PLC CONSUMER DIVISION

GERMOLOIDS OINTMENT N/A BAYERPLC/BAYERPLC UNITED KINGDOM CONSUMER CARE DIVISION

GERMOLOIDS COMPLETE SUPPOSITORY N/A BAYER PLC T/A BAYER UNITED KINGDOM SUPPOSITORY PLC CONSUMER CARE DIVISION

GERMOLOIDS SUPPOSITORIES SUPPOSITORY N/A BAYER PLCT/A BAYER UNITED KINGDOM PLC CONSUMER CARE DIVISION

GESTONE 100MG/2ML SOLUTION FOR 100MG/2ML FERRING UNITED KINGDOM INJECTION PHARMACEUTICALS LIMITED

GESTONE 25MG/ML SOLUTION FOR 25MG/ML FERRING UNITED KINGDOM INJECTION PHARMACEUTICALS LIMITED

GESTONE 50MG/ML SOLUTION FOR 50MG/ML FERRING UNITED KINGDOM INJECTION PHARMACEUTICALS LIMITED

GF-125 TABLETS 125MG CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD

GINCOSAN HARD GELATINE CAPSU- N/A PHARMATON SA SWITZERLAND LES

GINESAL VAGINAL SOLUTION NA FARMIGEA SPA ITALY

GINGIVITOL N SOLUTION 8.78MG/1G HENNIG ARZNEIMITTEL GERMANY GMBH & CO. KG

GINORECTOL FILM COATED TABLETS 250MG KLEVA LIMITED GREECE

GINORECTOL FILM COATED TABLETS 500MG KLEVA LIMITED GREECE 23.9.2003 FR Journal officiel de l'Union européenne 575

Trade Name Dosage Form Dose MA Holder Country

GINSANA CAPSULE 100MG BOEHRINGER UNITED KINGDOM INGELHEIM LIMITED

GIVALEX MOUTH WASH N/A LABORATOIRES FRANCE NORGINE PHARMA

GIVALEX MOUTHWASH N/A LABORATOIRES FRANCE NORGINE PHARMA

GIVALEX MOUTHWASH N/A LABORATOIRES FRANCE NORGINE PHARMA

GLABINOL TABLET 5MG GEOFMAN PAKISTAN PHARMACEUTICALS

GLADLAX TABLETS TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

GLIBENCLAMIDE TABLETS 2.5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

GLIBENCLAMIDE TABLETS 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

GLIBENCLAMIDE TABLETS 5MG PHARMAMED LTD. MALTA

GLIBENCLAMIDE TABLETS 5MG EGYPTIAN EGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO (EIPICO)

GLIBENCLAMIDE TABLETS BP TABLETS 2.5MG CP PHARMACEUTICALS UNITED KINGDOM 2.5MG LTD.

GLIBENCLAMIDE TABLETS BP TABLET 2.5MG CP PHARMACEUTICALS UNITED KINGDOM 2.5MG LTD

GLIBENCLAMIDE TABLETS BP 5MG TABLETS 5MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

GLIBENCLAMIDE TABLETS BP 5MG TABLET 5MG CP PHARMACEUTICALS UNITED KINGDOM LTD

GLIBESYN 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

GLIBOMET FILM-COATED TABLETS NA LABORATORI GUIDOTTI ITALY SPA

GLICEROLO SUPPOSITORIES 2500MG PIETRASANTA PHARMA ITALY S.R.L.

GLICEROLO SUPPOSITORIES 2250MG LABORATORIO CHIMICO ITALY FARMACEUTICO A. SELLA S.R.L.

GLIMICRON 80MG TABLET 80MG HOVID SDN. BHD MALAYSIA

GLITISOL TABLETS 5MG REMEDICA LTD CYPRUS

GLIVEC HARD CAPSULES 50MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

GLIVEC HARD CAPSULES 100MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

GLIVEC HARD CAPSULES 50MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

GLIVEC HARD CAPSULES 100MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

GLORYFEN DR.PD.INJ. 1G/VIAL HELP A.B.E.E. GREECE 576 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

GLUCAGEN 1MG HYPOKIT POWDER F/INJ AND SOL- 1MG/1ML NOVO DORDISK A/S DENMARK INJECTION VENT

GLUCAGEN INJECTION POWDER F/INJ AND SOL- 1MG/1ML NOVO NORDISK A/S DENMARK VENT

GLUCOBAY 100 TABLET 100MG BAYER VITAL GMBH & GERMANY CO. KG

GLUCOBAY 100MG TABLETS 100MG BAYER PAKISTAN

GLUCOBAY 50 TABLET 50MG BAYER VITAL GMBH & GERMANY CO. KG

GLUCOBAY 50MG TABLET 50MG BAYER PAKISTAN

GLUCOMET FILM COATED TABLETS 500MG,850MG DOUGLAS NEW ZEALAND PHARMACEUTICALS LIMITED

GLUCOPHAGE 500MG FILM-COATED TABLET 500MG LIPHA SANTE FRANCE

GLUCOPHAGE 850MG FILM-COATED TABLET 850MG LIPHA SANTE FRANCE

GLUCOSE SOLUTION FOR 20% W/VBP GALEN RESEARCH UNITED KINGDOM INJECTION LABORATORIES LIIMITED

GLUCOSE SOLUTION FOR 50% W/V BP IVEX UNITED KINGDOM INJECTION PHARMACEUTICALS LIMITED

GLUCOSE 20%W/V INTRAVENOUS SOLUTION FOR 20%W/V GALEN RESEARCH UNITED KINGDOM INFUSION BP INJECTION LABORATORIES

GLUCOSE 50% W/V INTRAVENOUS SOLUTION FOR 50%W/V IVEX UNITED KINGDOM INFUSION INJECTION PHARMACEUTICALS LIMITED

GLUCOSE INJECTION MINIJET AQUEOUS SOLUTION 500MG/ML INTERNATIONAL UNITED KINGDOM 50%W/V MEDICATION SYSTEMS LTD

GLUCOSE INJECTION BP MINIJET SOUTION FOR INJECTION 50%W/V INTERNATIONAL UNITED KINGDOM MEDICATION SYSTEMS (UK) LIMITED

GLUCOSE INTRAVENOUS SOLUTION FOR INFUSION 50%W/V BAXTER HEALTHCARE UNITED KINGDOM INFUSION LIMITED

GLUCOSE INTRAVENOUS SOLUTION FOR 10%W/V BAXTER HEALTHCARE UNITED KINGDOM INFUSION INJECTION LIMITED

GLUCOSE INTRAVENOUS SOLUTION FOR 20%W/V BAXTER HEALTHCARE UNITED KINGDOM INFUSION INJECTION LIMITED

GLUCOSE IV INFUSION SOLUTION FOR INFUSION 5%W/V BAXTER HEALTHCARE UNITED KINGDOM LIMITED

GLUMET-500 TABLET 500MG CIPLA LIMITED INDIA

GLYCERIN (GLYCEROL BP) ORAL SOLUTION 100% V/V WILLIAM RANSOM & UNITED KINGDOM SON PLC

GLYCERIN BP ORAL SOLUTION 100% V/V LVM LTD UNITED KINGDOM

GLYCERIN BP ORAL SOLUTION ORAL SOLUTION 100%V/V LCM LIMITED UNITED KINGDOM

GLYCERIN SUPPOSITORIES BP 1G SUPPOSITORY 70%W/W THORNTON & ROSS LTD UNITED KINGDOM INFANTS'

GLYCERIN, LEMON, HONEY WITH ORAL SOLUTION N/A LCM LTD UNITED KINGDOM GLUCOSE LINC 23.9.2003 FR Journal officiel de l'Union européenne 577

Trade Name Dosage Form Dose MA Holder Country

GLYCERINE SUPP. B.P.2G SUPPOSITORY 70%W/W THORNTON & ROSS LTD UNITED KINGDOM MOULD-CHILDREN'S

GLYCERINE SUPPOSITORIES BP SUPPOSITORY 70%W/W MARTINDALE UNITED KINGDOM PHARMACEUTICALS LTD

GLYCERINE SUPPOSITORIES BP 4G SUPPOSITORY 70%W/W LCM LTD UNITED KINGDOM ADULT SIZE

GLYCERYL TRINITRATE BP TABLET 500MCG A.H. COX & COMPANY UNITED KINGDOM LIMITED

GLYCOMIN TABLET 5MG PHARMACARE LIMITED SOUTH AFRICA — SOUTH AFRICA

GLYFORMIN TABLETS 500MG REMEDICA LTD. CYPRUS

GLYTRIN SPRAY SUBLIGUAL SPRAY 400 UG/AC BIOGLAN UNITED KINGDOM SOLUTION LABORATORIES LTD

GLYVENOL SOFT CAPSULE 400MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

GLYVENOL 400 CAPSULES 400MG NOVARTIS PHARMA NV BELGIUM

GNOSTOCARDIN TABLET 20MG BROS LTD GREECE

GOANNA ARTHRITIS CREAM CREAM TUBE 100MG/G HERRON AUSTRALIA PHARMACEUTICALS PTY LTD

GOCCE ODONTALGICHE DENTAL SOLUTION 4ML LABORATORIO CHIMICO ITALY FARMACEUTICO A.SELLA S.R.L

GOLDEN EYE DROPS EYE DROPS 0.1% W/V TYPHARM LIMITED UNITED KINGDOM

GOLDEN EYE OINTMENT 0.15% EYE OINTMENT 0.15% W/W TYPHARM LIMITED UNITED KINGDOM

GOLDEN SEAL COMPOUND COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM TABLETS

GONAL-F SOLUTION FOR 150 IU SERONO EUROPE UNITED KINGDOM INJECTION LIMITED

GONAL-F SOLUTION FOR 150 IU SERONO EUROPE UNITED KINGDOM INJECTION LIMITED

GONAL-F SOLUTION FOR 150 IU SERONO EUROPE UNITED KINGDOM INJECTION LIMITED

GONAL-F SOLUTION FOR 150 IU SERONO EUROPE UNITED KINGDOM INJECTION LIMITED

GONAL-F 75 POWDER FOR INJECTION 75 IU/3ML ARES SERONO (EUROPE) UNITED KINGDOM LIMITED

GONAL-F 75IU INJECTABLE SOLUTION 75IU R-HFSH/ML LABORATOIRES SERONO SWITZERLAND SA

GONASI HP SOLUTION FOR 1000 IU A.M.S.A. S.R.L. ITALY INJECTION

GONASI HP SOLUTION FOR 5000 IU A.M.S.A. S.R.L. ITALY INJECTION

GONIF DRY POWDER FOR 750MG/VIAL KLEVA LIMITED GREECE INJECTION

GONNE BALM CREAM N/A G R LANE HEALTH UNITED KINGDOM PRODUCTS LTD 578 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

GRECOTENS GEL. EXT. US. GEL 0.5% GENEPHARM S.A. GREECE

GREGODERM OINTMENT OINTMENT N/A UNIGREG LIMITED UNITED KINGDOM

GRENIS-CIPRO TABLETS 250MG GENEPHARM S.A. GREECE

GRENIS-CIPRO TABLETS 500MG GENEPHARM S.A. GREECE

GRENOVIX TABLETS 30MG GENEPHARM S.A. GREECE

GRENOVIX SYRUP 30MG/5ML GENEPHARM S.A. GREECE

GRETHER'S BLACKCURRANT PASTILLES NA DOETSCH GRETHER AG SWITZERLAND

GRETHER'S BLACKCURRANT PASTILLES NS DOETSCH GRETHER AG SWITZERLAND SUGARLESS

GRETHER'S REDCURRANT PASTILLES NA DOETSCH GRETHER AG SWITZERLAND

GRETHER'S REDCURRANT PASTILLES NA DOETSCH GRETHER AG SWITZERLAND SUGARLESS WITH VITC

GRETHER'S SWIISS ALP FRUITS PASTILLES NA DOETSCH GRETHER AG SWITZERLAND SUGARLESS

GRIPPOSTAD C CAPSULES N/A STADA ARZNEIMITEL AG GERMANY

GRISEOFULVIN TABLETS 125MG PHARMAMED LTD. MALTA

GRISEOFULVIN TABLETS 125MG REMEDICA CYPRUS

GRISOVIN TABLET 125MG COATED TABLET 125MG GLAXO WELLCOME UK UNITED KINGDOM LTD T/A GLAXO LABS

GRISOVIN TABLETS 500MG COATED TABLET 500MG GLAXO WELLCOME UK UNITED KINGDOM LTD

GROFENAC EMULSION GEL 10MG/G DR.GROSSMANN AG SWITZERLAND PHARMACA

GROFENAC AMPOULE 75MG DR.GROSSMANN AG SWITZERLAND PHARMACA

GROFENAC SUPPOSITORY 100MG DR.GROSSMANN AG SWITZERLAND PHARMACA

GROFENAC TABLET 50MG DR.GROSSMANN AG SWITZERLAND PHARMACA

GROFENAC RETARD TABLET 100MG DR.GROSSMANN AG SWITZERLAND PHARMACA

GROMAZOL SPRAY 10MG DR.GROSSMANN AG SWITZERLAND PHARMACA

GROMAZOL CREAM 10MG DR.GROSSMANN AG SWITZERLAND PHARMACA

GUANOR CHESTY COUGH ORAL SOLUTION N/A ROSEMONT UNITED KINGDOM LINCTUS PHARMACEUTICALS LIMITED

GUARINA GRANULES 100% W/W NORGINE LIMITED UNITED KINGDOM

GUASTIL CAPSULE 50MG J.URIACH & CIA. S.A. SPAIN

GUASTIL CHILDREN ORAL SUSPENSION 500MG/100ML J.URIACH & CIA. S.A. SPAIN

GUTTALAX ORAL DROPS 0.75G/100ML BOEHRINGER ITALY INGELHEIM ITALIA S.P.A. 23.9.2003 FR Journal officiel de l'Union européenne 579

Trade Name Dosage Form Dose MA Holder Country

GUTTALAX SOFT CAPSULE (PERLA) 1.5MG BOEHRINGER ITALY INGELHEIM ITALIA S.P.A.

GYNERA COATED TABLET N/A SCHERING AG GERMANY

GYNO CANESTEN 1 VAGINAL TABLET 0.5G BAYER VITAL GMBH & GERMANY CO. KG

GYNO CANESTEN 6 VAGINAL TABLET 0.1G BAYER VITAL GMBH & GERMANY CO. KG

GYNO-DAKTARIN VAGINAL CAPSULE 400MG JANSSEN-CILAG N.V. BELGIUM

GYNO-DAKTARIN VAGINAL CAPSULE 1200MG JANSSEN-CILAG N.V. BELGIUM

GYNO-DAKTARIN VAGINAL CREAM 20MG/G JANSSEN-CILAG N.V. BELGIUM

GYNO-DAKTARIN CREAM N/A JANSSEN PAKISTAN

GYNODEL TABLETS 2.5MG IL-KO ILAC VE TURKEY KOZMETIK SAN.TIC.A.S

GYNODEL TABLET 2.5MG IL-KO ILAC VE TURKEY KOZMETIK SAN.A.S.

GYNO-PEVARYL VAGINAL CREAM 10MG/G JANSSEN-CILAG AG SWITZERLAND

GYNO-PEVARYL VAGINAL CREAM 1G/100G JANSSEN-CILAG NV BELGIUM

GYNO-PEVARYL 150MG VAGINAL OVULE 150MG JANSSEN-CILAG AG SWITZERLAND

GYNO-PEVARYL DEPOT VAGINAL OVULE 150MG JANSSEN-CILAG AG SWITZERLAND

GYNO-TRAVOGEN OVULA PESSARY 600MG SCHERING SPA ITALY

GYNO-TRAVOGEN OVULUM OVULUM FOR VAGINAL 0.6G SCHERING AG GERMANY USE

GYRABLOCK 400MG TABLET 400MG MEDOCHEMIE LTD CYPRUS

HAEMOCORTIN OINTMENT N/A G.STREULI & CO. AG SWITZERLAND

HAEMOCTIN SDH 1000 FRZ.DRD. SUBS.+DILUENT N/A BIOTEST PHARMA GMBH GERMANY

HAEMOCTIN SDH 250 FRZ. DRD. SUBS. & DIL. N/A BIOTEST PHARMA GMBH GERMANY

HAEMOCTIN SDH 500 FRZ. DRD. SUBS+DIL. N/A BIOTEST PHARMA GMBH GERMANY

HAEMOLAN OINTMENT N/A G.STREULI & CO. AG SWITZERLAND

HAIRGROW SOLUTION N/A DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO. LIMITED

HAIRSCIENCE ANTI-DANDRUFF SHAMPOO 20MG/G EGO PHARMACEUTICALS AUSTRALIA TREATMENT

HALCION TABLETS 0.125MG PHARMACIA N.V. / S.A. BELGIUM

HALCION TABLETS 0.25MG PHARMACIA N.V. / S.A. BELGIUM

HALDOL 0.5MG TABLET 0.5MG JANSSEN-CILAG N.V. BELGIUM

HALDOL 5MG TABLET 5MG JANSSEN-CILAG N.V. BELGIUM

HALDOL 5MG/ML AMPOULES INJECTABLE SOLUTION 5MG/ML JANSSEN-CILAG N.V. BELGIUM

HALDOL DECANOAS 100MG/ML SOLUTION FOR 100MG/ML JANSSEN-CILAG N.V. BELGIUM INJECTION 580 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

HALDOL DECANOAS 50MG/ML SOLUTION FOR 50MG/ML JANSSEN-CILAG N.V. BELGIUM INJECTION

HALDOL DROPS DROPS 2MG/ML JANSSEN-CILAG N.V. BELGIUM

HALFAN 100MG/5ML ORAL SOLUTION 100MG/5ML LABORATOIRES SMITH FRANCE KLINE & BEECHAM

HALFAN 250MG TABLET 250MG LABORATOIRES SMITH FRANCE KLINE & BEECHAM

HALLS MENTHOLYPTUS LOZENGE NA WARNER LAMBERT UK UNITED KINGDOM BLACKCURRANT LIMITED T/A ADAMS

HALLS MENTHOLYPTUS EXTRA LOZENGE NA WARNER LAMBERT UK UNITED KINGDOM STRONG LIMITED T/A ADAMS

HALLS MENTHOLYPTUS HONEY LOZENGE NA WARNER LAMBERT UK UNITED KINGDOM AND LEMON LIMITED T/A ADAMS

HALLS MENTHOLYPTUS ORIGINAL LOZENGE NA WARNER LAMBERT UK UNITED KINGDOM LIMITED T/A ADAMS

HALLS MENTHOLYPTUS ORIGINAL LOZENGE NA WARNER LAMBERT UK UNITED KINGDOM S/F LIMITED T/A ADAMS

HALOPER TABLETS 0.5MG CTS CHEMICAL ISRAEL INDUSTRIES LTD.

HALOPER 0.5MG TABLETS TABLET 0.5MG CTS CHEMICAL ISRAEL INDUSTRIES LTD

HALOPERIDOL TABLETS 1.5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

HALOPERIDOL TABLETS 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

HALOPERIDOL TABLETS 10MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

HALOPERIDOL TABLETS 20MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

HALOPERIDOL ORAL SOLUTION ORAL SOLUTION 10MG/5ML ROSEMONT UNITED KINGDOM BP PHARMACEUTICALS LTD.

HALOPERIDOL ORAL SOLUTION ORAL SOLUTION 10MG/5ML ROSEMONT UNITED KINGDOM BP 10MG/5ML PHARMACEUTICALS LIMITED

HAMAMELIS WATER B.P.C.(DIST. TOPICAL SOLUTION 20.7% V/V WILLIAM RANSOM & UNITED KINGDOM WITCH HAZEL SON PLC

HAPPINOSE OINTMENT 0.3%W/W DIOMED DEVELOPMENTS UNITED KINGDOM LIMITED T/A DERMAL LABORATORIES

HAVRIX 1440 SUSPENSION FOR 1440 ELISA U/ML SMITHKLINE BEECHAM BELGIUM INJECTION BIOLOGICALS

HAVRIX JUNIOR 720 SUSPENSION FOR 720 ELU/0.5ML SMITHKLINE BEECHAM BELGIUM INJECTION BIOLOGICALS

HAVRIX VACCINE (JUNIOR 360) SUSPENSION FOR 360 ELISA UNITS SMITHKLINE BEECHAM BELGIUM INJECTION BIOLOGICALS

HAY-CROM AQUEOUS EYE DROPS 2%W/V NORTON HEALTHCARE UNITED KINGDOM LIMITED

HAY-CROM HAYFEVER EYE DROPS 2% W/V NORTON HEALTHCARE UNITED KINGDOM LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 581

Trade Name Dosage Form Dose MA Holder Country

HAYMINE MODIFIED RELEASE N/A PHARMAX LIMITED UNITED KINGDOM TABLETS

HB-VAX DNA 10MCG VACCINE SUSPENSION FOR 10MCG MERCK SHARP & DOHME NETHERLANDS INJECTION B.V.

HB-VAX DNA 5MCG VACCINE SUSPENSION FOR 5MCG MERCK SHARP & DOHME NETHERLANDS INJECTION B.V.

HC45 HYDROCORTISONE CREAM CREAM 1%W/W CROOKES HEALTHCARE UNITED KINGDOM LIMITED

HEALIT SKIN OINTMENT OINTMENT NA ATCO LABORATORIES PAKISTAN (PVT) LTD

HEALTHY FEET CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM

HEEMEX OINTMENT N/A G R LANE HEALTH UNITED KINGDOM PRODUCTS LTD

HEMATOCIS KIT POWDER FOR INJECTION N/A CIS BIO INTERNATIONAL FRANCE

HEMAX 1000 I.U. FREEZE DRIED PWR FOR 1000 I.U. INSTITUTO SIDUS S.A ARGENTINA INJ

HEMAX 10000 IU FREEZE DRIED PWR FOR 10000 IU INSTITUTO SIDUS S.A ARGENTINA INJ

HEMAX 2000 I.U FREEZE DRIED PWR FOR 2000 IU INSTITUTO SIDUS S.A ARGENTINA INJ

HEMAX 3000 I.U FREEZE DRIED PWR FOR 3000 IU INSTITUTO SIDUS S.A ARGENTINA INJ

HEMAX 4000 IU FREEZE DRIED PWR FOR 4000 IU INSTITUTO SIDUS S.A. ARGENTINA INJ

HEMI-DAONIL 2.5MG TABLET 2.5MG LABORATOIRES FRANCE HOECHST

HEMINEVRIN CAPSULES 300MG ASTRA LAKEMEDEL AB SWEDEN

HEMOCANE CREAM RECTAL CREAM N/A EASTERN UNITED KINGDOM PHARMACEUTICALS LIMITED

HEMOCANE RECTAL CREAM RECTAL CREAM N/A EASTERN UNITED KINGDOM PHARMACEUTICALS LIMITED

HEMOFIL M - AHF MONOCLONAL POWDER FOR INJECTION 500IU/VIAL BAXTER HEALTHCARE UNITED KINGDOM PURIFIED NOM. LIMITED

HEMOFIL M AHF (HUMAN) — SEE POWDER FOR INJECTION 1000 IU BAXTER HEALTHCARE UNITED KINGDOM REMARKS LTD

HEMOFIL M AHF MONOCLONAL POWDER FOR INJECTION 250IU/BOTTLE BAXTER HEALTHCARE UNITED KINGDOM PURIFIED LIMITED

HEPA-MERZ GRANULES 3 G MERZ+CO. GMBH & CO. GERMANY

HEPA-MERZ INFUSION CONCENTRATE 5.0 G MERZ+CO. GMBH & CO. GERMANY

HEPAPLUS 30 EMGEL GEL 30000IU/100G HEXAL AG GERMANY

HEPARIN SOLUTION FOR 100IU/ML LEO PHARMACEUTICAL UNITED KINGDOM INJECTION PRODUCTS

HEPARIN «LEO» SOLUTION FOR 5,000IU/ML LEO PHARMACEUTICAL DENMARK INJECTION PRODUCTS 582 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

HEPARIN CALCIUM INJECTION INECTION SOLUTION 5000 IU/0.5ML B.BRAUN MELSUNGEN GERMANY 5000 IU/0.5ML AG

HEPARIN INJECTION BP SOLUTION FOR 5000UNITS/ML ROTEXMEDICA GMBH, GERMANY 5,000UNITS/ML INJECTION ARZNEIMITTELWERK

HEPARIN SODIUM 100IU/ML AMPOULE SOLN F/INFU- 1000IU/ML LEO LABORATORIES LTD UNITED KINGDOM SION

HEPARIN SODIUM 2000U/L IN SOLUTION FOR N/A BAXTER HEALTHCARE UNITED KINGDOM 0.9% SOD. CHL. INJECTION LIMITED

HEPARIN SODIUM BP 1000IU/L IN SOLUTION FOR N/A BAXTER HEALTHCARE UNITED KINGDOM 0.9% NACL INJECTION LIMITED

HEPARIN SODIUM BP 1000U/L IN SOL. FOR INJ NA BAXTER HEALTHCARE UNITED KINGDOM 0.9% NACL LTD

HEPARIN SODIUM INJECTION INJECTION SOLUTION 5000 IU/ML B.BRAUN MELSUNGEN GERMANY 5000 IU/ML AG

HEPARIN SODIUM INJECTION INJECTION SOLUTION 5000IU/0.2ML B.BRAUN MELSUNGEN GERMANY 5000IU/0.2ML AG

HEPARIN SODIUM INJECTION USP SOLUTION FOR 5000 USP U/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

HEPARIN SODIUM IV FLUSH SOLN. SOLUTION FOR 10IU/ML LEO LABORATORIES LTD UNITED KINGDOM INJECTION

HEPARINISED SALINE, 50IU IN 5ML SOLUTION FOR 10IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD

HEPARINOL-5000 (5MI) SOLUTION FOR 5000IU/ML AIN MEDICARE SDN. MALAYSIA INJECTION BHD.

HEPATECT SOL. FOR IV INJ. N/A BIOTEST PHARMA GMBH GERMANY

HEPAVAX-GENE POWDER FOR INJ 20UG GREEN CROSS VACCINE KOREA (DEM PEOPLE'S CORP. REP)

HEPAVAX-GENE 20MCG LIQUID FOR INJECTION N/A KOREA GREEN CROSS KOREA REPUBLIC CORP.,

HEP-FLUSH SOLUTION N/A LEO LABORATORIES UNITED KINGDOM LIMITED

HEP-FLUSH INJECTION SOLUTION FOR 100IU/ML LEO PHARMACEUTICAL DENMARK INJECTION PRODUCTS

HEPLOK FORMERLY HEPARIN SOLUTION FOR 10 UNITS/ML LEO LABORATORIES UNITED KINGDOM MUCOUS INJECTION INJECTIONS LIMITED

HEPSAL SOLUTION FOR 50IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

HEPSAL INJECTION 10IU/ML SOLUTION FOR 10IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

HEPSAL INJECTION 10IU/ML SOLUTION FOR 10IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD

HERBALUX COATED TABLET N/A PETER BLACK UNITED KINGDOM HEALTHCARE LTD. T/A ENGLISH GRAINS HEALTHCARE

HERBALUX/GERARD HOUSE COATED TABLET N/A PETER BLACK UNITED KINGDOM HERBALUX HEALTHCARE LIMITED

HERECEPTIN POWDER FOR INFUSION 150MG ROCHE REGISTRATION UNITED KINGDOM LTD. — UK (EMEA) 23.9.2003 FR Journal officiel de l'Union européenne 583

Trade Name Dosage Form Dose MA Holder Country

HERPILEM POWDER FOR INJECTION 250MG LEMERY, S.A. DE C.V. MEXICO

HERRON BABY TEETHING GEL TUBE 87MG/G HERRON AUSTRALIA PHARMACEUTICALS PTY LTD

HEXEDIN, GENERICON TABLET N/A GENERICON PHARMA GERMANY GES.M.B.H

HEXIGEL DENTAL GEL 0.5% W/W PARKE DAVIS FRANCE

HHT 4 I.U. FREEZE DRIED PWR FOR 4 IU INSTITUTO SIDUS S.A. ARGENTINA INJ

HIBERIX POWDER FOR INJECTION NA GLAXOSMITHKLINE BELGIUM BIOLOGICALS

HIBERIX (HAEMOPHILUS FREEZE-DRIED VACCINE 10MCG SMITHKLINE BEECHAM BELGIUM INFLUENZAE TYPE B) BIOLOGICALS

HIBICET HOSPITAL CONCENTRATE TOPICAL SOLUTION N/A ZENECA LIMITED UNITED KINGDOM

HIBICET HOSPITAL CONCENTRATE TOPICAL SOLUTION NA TUBIFOAM LIMITED UNITED KINGDOM

HIBISCRUB TOPICAL SOLUTION 4% W/V ZENECA LIMITED UNITED KINGDOM

HIBISCRUB TOPICAL SOLUTION 4%W/V TUBIFOAM LIMITED UNITED KINGDOM

HIBISOL SOLUTION 0.5% W/V ZENECA LIMITED UNITED KINGDOM

HIBISOL SOLUTION TOPICAL SOLUTION 2.5% V/V ZENECA LIMITED UNITED KINGDOM

HIBISOL SOLUTION TOPICAL SOLUTION 2.5%V/V TUBIFOAM LIMITED UNITED KINGDOM

HIBITANE OBSTETRIC CREAM 1% W/W ZENECA LIMITED UNITED KINGDOM

HIBITANE 5% CONCENTRATE TOPICAL SOLUTION 5%W/V TUBIFOAM LIMITED UNITED KINGDOM

HIBITANE CONCENTRATE TOPICAL SOLUTION 25% V/V ZENECA LIMITED UNITED KINGDOM SOLUTION 5%

HIBITANE OBSTETRIC CREAM CREAM 5% V/ W BIOGLAN UNITED KINGDOM LABORATORIES LTD

HIBTITER SOLUTION FOR N/A WYETH PHARMA GMBH GERMANY INJECTION

HIBTITER SOLUTION FOR NA CYANAMID OF GREAT UNITED KINGDOM INJECTION BRITAIN LTD

HIBTITER SOLUTION FOR NA WYETH LEDERLE SPA ITALY INJECTION

HIBTITER HAEMOPHILUS B SOLUTION FOR N/A CYANAMID OF GREAT UNITED KINGDOM CONJUGATE VACCINE INJECTION BRITAIN LTD.

HIDRASEC CAPSULE 100MG LABORATOIRES FRANCE BIOPROJET PHARMA

HIDRASEC 18MG PAEDIATRIC ORAL POWDER 18MG LABORATOIRE FRANCE BIOPROJET PHARMA

HIDRASEC 30MG PAEDIATRIC ORAL POWDER 30MG LABORATOIRE FRANCE BIOPROJET PHARMA

HIDRASEC 6MG PAEDIATRIC ORAL POWDER 6MG LABORATOIRE FRANCE BIOPROJET PHARMA 584 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

HIKMA-HEPARIN 25000 VIALS SOLUTION FOR 25000IU/ML HIKMA JORDAN INJECTION PHARMACEUTICALS

HILL'S BALSAM CHESTY COUGH ORAL LIQUID N/A EASTERN UNITED KINGDOM LIQ F/CHILD. PHARMACEUTICALS LIMITED

HILL'S BALSAM CHESTY COUGH ORAL LIQUID 100MG/5ML EASTERN UNITED KINGDOM LIQUID PHARMACEUTICALS LIMITED

HIRIDOID GEL GEL 0.3%W / W SANKYO PHARMA UK UNITED KINGDOM LIMITED

HIRUDOID CREAM 300MG/100G SANKYO PHARMA GMBH GERMANY

HIRUDOID GEL 300MG/100G SANKYO PHARMA GMBH GERMANY

HIRUDOID CREAM CREAM 0.3% W/W SANKYO PHARMA UK UNITED KINGDOM LIMITED

HISTALIX SYRUP N/A WALLACE UNITED KINGDOM MANUFACTURING CHEMISTS LIMITED

HISTASIN TABLET 10MG DELTA HF ICELAND

HISTERGAN CREAM CREAM 2%W/W NORMA CHEMICALS UNITED KINGDOM LIMITED

HIVOTEX SYRUP 30MG/5ML KLEVA LIMITED GREECE

HOLOXAN POWDER FOR INJECTION 500MG ASTA MEDICA GERMANY

HOLOXAN POWDER FOR INJECTION 1G ASTA MEDICA GERMANY

HOLOXAN POWDER FOR INJECTION 2G ASTA MEDICA GERMANY

HONEY AND LEMON MELTUS FOR ORAL SOLUTION 50 MG CUPAL LIMITED UNITED KINGDOM DEEP CHESTY COU

HONEY AND MOLASSES MIXTURE ORAL SOLUTION N/A G R LANE HEALTH UNITED KINGDOM PRODUCTS LTD

HONVAN TABLETS 120MG ASTA MEDICA GERMANY

HONVAN SOLUTION FOR 300MG/5ML ASTA MEDICA GERMANY INJECTION

HORESTYL TABLETS 10MG KLEVA LTD GREECE

HORESTYL SYRUP 5MG/5ML KLEVA LTD. GREECE

HORESTYL TABLETS 10MG KLEVA LIMITED GREECE

HORESTYL SYRUP 5MG/5ML KLEVA LIMITED GREECE

HOT LEMON COLD RELIEF POWDER FOR ORAL N/A SUSSEX UNITED KINGDOM POWDER SOLUTION PHARMACEUTICALS LIMITED

HRI NIGHT TABLETS COATED TABLETS NA JESSUP HEALTH LIMITED UNITED KINGDOM

HRI WATER BALANCE TABLETS COATED TABLETS NA JESSUP HEALTH LIMITED UNITED KINGDOM

HUMALOG CARTRIDGE SOLUTION FOR 100UNITS/ML ELI LILLY NEDERLAND NETHERLANDS INJECTION B.V.

HUMALOG CARTRIDGE SOLUTION FOR 100UNITS/ML ELI LILLY NEDERLAND NETHERLANDS INJECTION B.V. 23.9.2003 FR Journal officiel de l'Union européenne 585

Trade Name Dosage Form Dose MA Holder Country

HUMALOG VIALS SOLUTION FOR 100 UNITS/ML ELI LILLY NEDERLAND NETHERLANDS INJECTION B.V.

HUMAN ALBUMIN SOLUTION FOR INFUSION 182.4-210MG/ML OCTAPHARMA AUSTRIA «OCTAPHARMA» 20% PHARMAZEUTIKA PRODUKTIONSGES.M.B.H.

HUMAN ALBUMIN 20% BIOTEST SOL. FOR I.V. USE 200G/1000ML BIOTEST PHARMA GMBH GERMANY

HUMAN ALBUMIN 20% IMMUNO SOLUTION FOR N/A BAXTER AG AUSTRIA SOL FOR INJ INJECTION

HUMAN ALBUMIN 5% BIOTEST SOL. FOR INTRAVENOUS 50G/1000ML BIOTEST PHARMA GMBH GERMANY USE

HUMAN ALBUMIN 5% BIOTEST ISOT.SOL.FOR IV USE 50G/1000ML BIOTEST PHARMA GMBH GERMANY ISOTONIC

HUMAN ALBUMIN 5% IMMUNO SOLUTION FOR INJESTION N/A BAXTER AG AUSTRIA SOL FOR INJ

HUMAN ANTI-D (RHO) IMMUNO- SOLUTION FOR 500IU/VIAL BIOPRODUCTS UNITED KINGDOM GLOBULIN 15%SOL INJECTION LABORATORY (BPL)

HUMAN HEP B IMMUNOGLOBULIN SOLUTION FOR 15% W/V BPL, BIO PRODUCTS UNITED KINGDOM PROTEIN SOL INJECTION LABORATORY

HUMAN HEP B IMMUNOGLOBULIN SOLUTION FOR 15% W/V BPL, BIO PRODUCTS UNITED KINGDOM PROTEIN SOL INJECTION LABORATORY

HUMAN IMMUNOGLOBULIN SOLUTION FOR INFUSION 45.6-52.5MG/ML OCTAPHARMA AUSTRIA «OCTAPHARMA» 5% PHARMAZEUTIKA PRODUKTIONSGES.M.B.H

HUMAN RABIES SOLUTION FOR 15% W/V BPL, BIO PRODUCTS UNITED KINGDOM IMMUNOGLOBULIN FOR IM INJ INJECTION LABORATORY

HUMAN TETANUS IMMUNOGLO. SOLUTION FOR 15%V/W BIOPRODUCTS UNITED KINGDOM PROTEIN SOLUT. INJECTION LABORATORY (BPL)

HUMATROPE POWDER FOR INJECTION 4IU(1.33MG)/2ML LABORATOIRES LILLY FRANCE FRANCE

HUMATROPE POWDER FOR INJECTION 18IU(6MG)/3ML LABORATOIRES LILLY FRANCE FRANCE

HUMATROPE POWDER FOR INJECTION 16IU(5.3MG)/8ML LABORATOIRES LILLY FRANCE FRANCE

HUMATROPE POWDER FOR INJECTION 36IU(12MG)/3ML LABORATOIRES LILLY FRANCE FRANCE

HUMATROPE POWDER FOR INJECTION 72IU(24MG)/3ML LABORATOIRES LILLY FRANCE FRANCE

HUMEX FOURNIER INHALER N/A URGO SA FRANCE

HUMULIN 70/30 SUSPEN. FOR SC/IM 300IU/3ML LILLY FRANCE S.A. FRANCE INJECT.

HUMULIN 70/30 (30% RAPID SUSPENSION FOR 100IU/ML LILLY DEUTSCHLAND GERMANY ACTING 70% NPH) INJECTION GMBH

HUMULIN L (HUMULIN INSULIN SUSPENSION FOR 100IU/ML LILLY DEUTSCHLAND GERMANY LONG ACTING) INJECTION GMBH

HUMULIN N (HUMAN INSULIN SUSPENSION FOR 100IU/ML LILLY DEUTSCHLAND GERMANY NPH) INJECTION GMBH

HUMULIN NPH SUSPEN. FOR SC/IM INJEC. 300IU/3ML LILLY FRANCE S.A. FRANCE 586 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

HUMULIN R SOLUTION FOR SC/IM 300IU/3ML LILLY FRANCE S.A. FRANCE INJEC.

HUMULIN R (HUMAN INSULIN LIQUID FOR INJECTION 100IU/ML LILLY DEUTSCHLAND GERMANY RAPID ACTING) GMBH

HUMULIN U (HUMAN INSULIN SUSPENSION FOR 100IU/ML LILLY DEUTSCHLAND GERMANY ULTRA LONG ACT) INJECTION GMBH

HYALASE DRIED POWDER FOR INJ. 1500IU/ML CP PHARMACEUTICALS UNITED KINGDOM LTD.

HYALASE (HYALURONIDASE FOR POWDER FOR INJECTION 1500IU/AMPOULE CP PHARMACEUTICALS UNITED KINGDOM INJECTION BP) LTD

HYALGAN SOLUTION FOR 20MG/ML FIDIA SPA ITALY INJECTION

HYALGAN SOLUTION FOR 10MG/ML FIDIA SPA ITALY UNITED KINGDOM INJECTION

HYCAMTIN FOR INJECTION POWDER FOR INJECTION 4MG SMITHKLINE BEECHAM UNITED STATES OF PHARMACEUTICALS AMERICA

HYCROCORTISONE TABLET 10MG REKAH ISRAEL PHARMACEUTICAL INDUSTRY LTD

HYDERGIN ORAL DROPS (SOL.) 1MG/ML NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

HYDERM CREAM 1% W/W CREAM 1% W/W TARO CANADA PHARMACEUTICALS INC.

HYDRACORT CREAM 0.5% W/W LABORATOIRES FRANCE GALDERMA

HYDRALAZINE TABLETS 25MG REMEDICA LTD. CYPRUS

HYDRALAZINE TABLET 25MG GENERICS (UK) LIMITED UNITED KINGDOM —UK

HYDREA CAPSULES 500MG BRISTOL MYERS SQUIBB ITALY

HYDREX SURGICAL TOPICAL SOLUTION 4% W/V ADAMS HEALTHCARE UNITED KINGDOM SCRUB-CHLORHEXIDINE LIMITED

HYDROCORTISONE CREAM 1% HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

HYDROCORTISONE CREAM 1%W/W CAMDEN INDUSTRIES (M) MALAYSIA SDN BHD

HYDROCORTISONE 1% OINTMENT 1% W/W BIOREX LABORATORIES UNITED KINGDOM LTD.

HYDROCORTISONE 1% B.P. CREAM 1% W/W BIOREX LABORATORIES UNITED KINGDOM LTD.

HYDROCORTISONE CREAM CREAM 1% W/V NORTON UNITED KINGDOM PHARMACEUTICALS LIMITED

HYDROCORTISONE CREAM 1% CREAM 1% W/V NORTON UNITED KINGDOM OTC PHARMACEUTICALS LIMITED

HYDROCORTISONE CREAM 1% CREAM 1% W/W CAMDEN INDUSTRIES (M) MALAYSIA W/W SDN BHD

HYDROCORTISONE CREAM B.P 1% CREAM 1% W / W BIOREX LABORATORIES UNITED KINGDOM LTD 23.9.2003 FR Journal officiel de l'Union européenne 587

Trade Name Dosage Form Dose MA Holder Country

HYDROCORTISONE EYE EYE OINTMENT 1%W/W MARTINDALE UNITED KINGDOM OINTMENT BPC 1% PHARMACEUTICALS LTD

HYDROCORTISONE/HYDRODERM OINTMENT 10MG/G SCHERING-PLOUGH S.A. BELGIUM

HYDROCORTISONE-MEDO 100MG POWDER FOR INJECTION 100MG MEDOCHEMIE LTD CYPRUS

HYDROCORTISYL SKIN CREAM CREAM 1% W/W ROUSSEL UNITED KINGDOM LABORATORIES LIMITED

HYDROCORTISYL SKIN OINTMENT OINTMENT 1% W/W ROUSSEL UNITED KINGDOM LABORATORIES LIMITED

HYDROGEN PEROXIDE TOPICAL SOLUTION 6%V/V LCM LTD UNITED KINGDOM

HYDROGEN PEROXIDE SOLUTION SOLUTION 6%BP 20 VOLS LCM LIMITED UNITED KINGDOM

HYDROGEN PEROXIDE SOLUTION TOPICAL SOLUTION 9% 30 VOLS LCM LTD UNITED KINGDOM

HYDROGEN PEROXIDE SOLUTION TOPICAL SOLUTION 9%V/V LCM LTD UNITED KINGDOM 9% 30 VOLS

HYDROMOL CREAM CREAM N/A QUINODERM LIMITED UNITED KINGDOM

HYDROXOCOBALAMIN INJECTION BP 1MG ROTEXMEDICA GMBH, GERMANY ARZNEIMITTELWERK - GERMANY

HYDROXOCOBALAMIN INJECTION SOLUTION FOR 1MG/1ML GOLDSHIELD GROUP PLC UNITED KINGDOM INJECTION

HYGROTON TABLETS 50MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

HYOSCINE BUTYLBROMIDE FILM-COATED TABLETS 10MG PHARMAMED LTD. MALTA

HYOSCINE BUTYLBROMIDE FILM-COATED TABLETS 20MG PHARMAMED LTD. MALTA

HYOSCINE BUTYLBROMIDE SOLUTION FOR 20MG/1ML ROTEXMEDICA GMBH GERMANY INJECTION INJECTION

HYOSCINE INJECTION BP SOLUTION FOR 400MCG/1ML EVANS MEDICAL LIMITED UNITED KINGDOM INJECTION

HYPERIUM 1MG TABLET 1MG LES LABORATOIRES FRANCE SERVIER

HYPNOMIDATE 10ML AMPOULE 2MG/ML JANSSEN-CILAG N.V. BELGIUM

HYPOVASE TABLET N/A PFIZER LIMITED UNITED KINGDOM

HYPOVASE TABLET 500MCG PFIZER LIMITED UNITED KINGDOM

HYPOVASE TABLETS 1MG PFIZER LIMITED UNITED KINGDOM

HYPOVASE TABLET 5MG PFIZER LIMITED UNITED KINGDOM

HYPOVASE TABLET 2MG PFIZER LIMITED UNITED KINGDOM

HYPRIN BOVINE ISOPHANE SUSPENSION FOR INJEC- 100IU/ML CP PHARMACEUTICALS UNITED KINGDOM TION LTD.

HYPROMELLOSE EYE DROPS BPC EYE DROPS 0.3%W/V MARTINDALE UNITED KINGDOM 0.3% PHARMACEUTICALS LTD

HYPURIN BOVINE LENTE SUSPENSION FOR INJEC- 100IU/ML CP PHARMACEUTICALS UNITED KINGDOM TION LTD.

HYPURIN BOVINE NEUTRAL SOLUTION FOR 100IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD. 588 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

HYPURIN BOVINE PROTAMINE SUSPENSION FOR 100IU/ML CP PHARMACEUTICALS UNITED KINGDOM ZINC INJECTION LTD.

HYPURIN PORCIN NEUTRAL SOLUTION FOR 100IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

HYPURIN PORCINE BIPHASIC SUSPENSION FOR N/A CP PHARMACEUTICALS UNITED KINGDOM ISOPHANE INJECTION LTD.

HYPURIN PORCINE ISOPHANE SUSPENSION FOR 100IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

HYTRIN 1MG TABLETS 1MG ABBOTT LABORATORIES UNITED KINGDOM LIMITED

HYTRIN 2MG TABLETS 2MG ABBOTT LABORATORIES UNITED KINGDOM LIMITED

HYTRIN 5MG TABLETS 5MG ABBOTT LABORATORIES UNITED KINGDOM LIMITED

HYTRIN BPH 10MG TABLETS 10MG ABBOTT LABORATORIES UNITED KINGDOM LTD.

HYTRIN BPH 1MG STARTER KIT TABLETS 1MG ABBOTT LABORATORIES UNITED KINGDOM LTD.

HYTRIN BPH 2MG TABLETS 2MG ABBOTT LABORATORIES UNITED KINGDOM LTD

HYTRIN BPH 5MG TABLETS 5MG ABBOTT LABORATORIES UNITED KINGDOM LTD.

HYZAAR 50/12.5MG TABLET N/A MERCK SHARP & DOHME NETHERLANDS B.V.

IBUFEN TABLET 200 MG DELTA HF ICELAND

IBUFEN TABLET 400MG DELTA HF ICELAND

IBUFEN TABLET 600MG DELTA HF ICELAND

IBUGESIC 200 FILM COATED TABLETS 200MG DAR AL DAWA DEV. & JORDAN INV. CO. LTD.

IBUGESIC-200 TABLET 200MG CIPLA LIMITED INDIA

IBUHEXAL 200 FILM COATED TABLET 200MG HEXAL AG GERMANY

IBUKOD TABLETS N/A DELTA HF ICELAND

IBUKOD STERKAR TABLETS TABLET N/A DELTA HF ICELAND

IBULEVE/IBULEVE GEL 5% W/W DIOMED DEVELOPMENTS UNITED KINGDOM SPORT GEL5%W/W / IBUDERM LIMITED T/A DERMAL LABORATORIES

IBUPROFEN TABLETS 200MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

IBUPROFEN TABLETS 400MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

IBUPROFEN COATED TABLETS 200MG PHARMAMED LTD. MALTA

IBUPROFEN TABLETS 400MG PHARMAMED LTD. MALTA

IBUPROFEN 200MG COATED TABLETS 200MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMI- TED 23.9.2003 FR Journal officiel de l'Union européenne 589

Trade Name Dosage Form Dose MA Holder Country

IBUPROFEN 400MG COATED TABLET 400MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

IBUPROFEN 5% GEL GEL 5% W/W GOLDSHIELD UNITED KINGDOM PHARMACEUTICALS LTD

IBUPROFEN BP 200MG TABLET 200MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

IBUPROFEN BP 400MG TABLET 400MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

IBUPROFEN BP 600MG TABLET 600MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

IBUPROFEN DENK 400 FILM COATED TABLET 400MG E.DENK OHG GERMANY

IBUPROFEN TABLETS COATED TABLETS 200MG HEALTHY IDEAS LIMITED UNITED KINGDOM

IBUPROFEN TABLETS BP 200 MG TABLET 200 MG CIPLA LTD INDIA

IBUSPAN TABLETS 200MG SM PHARMACEUTICALS MALAYSIA SDN. BHD.

IBUTOP CUPROFEN IBUPROFEN GEL 5% W/W SETON PRODUCTS UNITED KINGDOM GEL LIMITED

IBUTOP GEL GEL 5G/100G DOLORGIET GMBH & CO. GERMANY KG

ICTHTAMMOL OINTMENT BP 1980 OINTMENT 10%W/W THORNTON & ROSS LTD UNITED KINGDOM

IDEOS CHEWABLE TABLET N/A LABORATOIRE INNO- FRANCE THERA

IDRACEMI OPHTHALMIC DROPS 0.335G FARMIGEA SPA ITALY

IDRACEMI OPHTHALMIC OINTMENT N/A 014438030 ITALY

IDUCHER OPHTHALMIC DROPS 0.2G FARMIGEA SPA ITALY

IDUCHER OPHTHALMIC OINTMENT 0.2G/100G FARMIGEA SPA ITALY

IETAPAR CAPSULE N/A ROTTAPHARM S.R.L ITALY

IETEPAR INJECTABLE IM SOLN. N/A ROTTAPHARM SRL ITALY

IFICIPRO SOL. FOR INJECTION 200MG IFIUNIK INDIA PHARMACEUTICALS LIMITED

IFICIPRO — CIPROFLOXACIN SOLUTION FOR 200MG (2MG/ML) UNIQUE INDIA INJECTION 200MG INJECTION PHARMACEUTICAL LABORATORIES

IKOREL TABLETS 10MG MAY & BAKER LIMITED UNITED KINGDOM

ILOMEDIN SOLUTION FOR IV 0.05MG/0.5ML SCHERING AG GERMANY INFUSION

ILOSONE 125MG/5ML SUSPENSION 125MG/5ML DISTA S.A. SPAIN

ILOSONE 500MG COATED TABLET 500MG LILLY, S.A. SPAIN

IMDUR PROLONGED RELEASE 60MG HASSLE LAKEMEDEL AB SWEDEN TABLETS 590 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

IMIGRAN COATED TABLETS 50MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

IMIGRAN 100MG FILM COATED TABLETS 100MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

IMIGRAN INJECTION SOLUTION FOR 12MG/ML GLAXO WELLCOME UK UNITED KINGDOM INJECTION LIMITED

IMIGRAN TABLETS 100MG FILM COATED TABLET 100MG GLAXO WELLCOME UK UNITED KINGDOM LTD

IMIGRAN TABLETS 50MG TABLET 50MG GLAXO WELLCOME UK UNITED KINGDOM LTD

IMIPRAMINE BP 10MG TABLET 10MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

IMIPRAMINE BP 25MG TABLET 25MG SUSSEX UNITED KINGDOM PHARMACEUITICAL LIMITED

IMMUBRON TABLET 50MG BRUSCHETTINI SRL ITALY

IMMUCYST — PWS-LIQ ITV PRC POWDER FOR SOLUTION 27MG/ML CONNAUGHT CANADA LIQUID LABORATORIES LIMITED

IMMUCYST -PWS LIQ ITV PRC POWDER FOR SOLUTION 81MG/3ML CONNAUGHT CANADA LIQUID LABORATORIES LTD

IMMULEM SOLUTION 5G/50ML LEMERY S.A MEXICO

IMMUNATE 1000 I.E POWDER FOR INJECTION N/A BAXTER AG AUSTRIA

IMMUNATE 250 I.E POWDER FOR INJECTION N/A BAXTER AG AUSTRIA

IMMUNATE 500 I.E POWDER FOR INJECTION N/A BAXTER AG AUSTRIA

IMMUNOGLOBULINE I.V. (NRM. I.V. PWD. FOR SOL. FOR. INF. N/A CLB NETHERLANDS IMMUNOG)

IMMUNOVIR CREAM 5%W/W FARMA UNO SRL ITALY

IMOCAP CAPSULE 2MG RAZA MANUFACTURING MALAYSIA BERHAD

IMODIUM CAPSULE 2MG JANSSEN-CILAG N.V. BELGIUM

IMODIUM CAPSULE 2MG JANSSEN PAKISTAN

IMODIUM CAPSULE 2MG JANSSEN PAKISTAN

IMOGRAM RAGE 150UI/ML INJECTABLE SOLUTION 150IU/1ML PASTEUR MERIEX FRANCE SERUMS ET VACCINS

IMOVAX POLIO INJECTABLE SOLUTION N/A PASTEUR MERIEUX FRANCE CONNAUGHT

IMOX(AMOXICILLIN CAPSULES BP) CAPSULE 250MG IPCA LABORATORIES INDIA LIMITED

IMPLANON IMPLANT (SUB-DERMAL 68MG ORGANON UNITED KINGDOM USE) LABORATORIES LIMITED

IMPORTAL ORAL POWDER IN 10G NOVARTIS CONSUMER SWITZERLAND SACHETS HEALTH SA

IMUPRIN TABLETS 50MG REMEDICA LTD. CYPRUS 23.9.2003 FR Journal officiel de l'Union européenne 591

Trade Name Dosage Form Dose MA Holder Country

IMURAN TABLETS 50MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

IMURAN FILM COATED TABLETS 25MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

IMURAN COATED TABLETS 50MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

IMURAN FILM-COATED TABLETS 25MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

INAPROL TABLETS 250MG BILIM ILAC SANAYII VE TURKEY TICARET A.S.

INCIDAL TABLET N/A BAYER PAKISTAN

INDERAL COATED TABLET 10MG ZENECA LIMITED UNITED KINGDOM

INDERAL COATED TABLET 40MG ZENECA LIMITED UNITED KINGDOM

INDERAL INJECTION SOLUTION FOR 0.1% W/V ZENECA LIMITED UNITED KINGDOM INJECTION

INDERAL LA MODIFIED RELEASE 160MG ZENECA LIMITED UNITED KINGDOM CAPSULES

INDERAL LA-80 CAPSULE 80MG ZENECA LIMITED UNITED KINGDOM

INDOCEM 25 CAPSULES 25MG AEGIS LTD. CYPRUS

INDOCID 100MG SUPPOSITORY 100MG MERCK SHARP & DOHME NETHERLANDS B.V.

INDOCID 25MG CAPSULE 25MG MERCK SHARP & DOHME NETHERLANDS B.V.

INDOCID RETARD 75MG CAPSULE 75MG MERCK SHARP & DOHME NETHERLANDS B.V.

INDOGESIC SUPPOSITORIES 100MG DAR AL DAWA DEVELOP- JORDAN MENT AND INVESTMENT CO LTD

INDOGESIC 25 CAPSULE 25MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO. LTD

INDOLGINA CAPSULE 25MG J.URIACH & CIA. S.A. SPAIN

INDOLGINA SUPPOSITORY 100MG J.URIACH & CIA. S.A. SPAIN

INDOMELAN CAPSULE 25MG LANNACHER HEILMITTEL AUSTRIA GMBH.

INDOMELAN SUPPOSITORY 100MG LANNACHER HEILMITTEL AUSTRIA GMBH.

INDOMETHACIN SUPPOSITORIES 100MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

INDOMETHACIN BP 25MG CAPSULE 25MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

INDOMETHACIN BP 50MG CAPSULE 50MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

INDOMETHACIN CAPSULES BP CAPSULE 25MG IPCA LABORATORIES INDIA LIMITED 592 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

INDOPREX EYE DROPS SOLUTION 2% DEMO S.A GREECE

INDOREM 25 TABLETS 25MG REMEDICA LTD CYPRUS

INDYLON 100MG SUPPOSITORIES 100MG MEDOCHEMIE LTD CYPRUS

INDYLON 25MG CAPSULE 25MG MEDOCHEMIE LTD CYPRUS

INFACOL ORAL LIQUID 4% W/V PHARMAX LIMITED UNITED KINGDOM

INFANRIX SUSPENSION FOR N/A SMITHKLINE BEECHAM BELGIUM INJECTION BIOLOGICALS

INFANRIX HEPB SUSPENSION FOR N/A SMITHKLINE BEECHAM BELGIUM INJECTION BIOLOGICALS S.A.

INFANRIX HEXA SEE REMARKS NA SMITHKLINE BEECHAM EUROPEAN COMMUNITY BIOLOGICALS S.A.

INFANRIX IPV (DTPA-IPV) SUSPENSION FOR SEE REMARKS GLAXOSMITHKLINE BELGIUM INJECTION BIOLOGICALS S.A.

INFANRIX IPV+HIB SUSPENSION FOR N/A SMITHKLINE BEECHAM BELGIUM INJECTION BIOLOGICALS

INFANRIX-HIB SUSPENSION FOR N/A SMITHKLINE BEECHAM BELGIUM INJECTION BIOLOGICALS

INFECTOFLAM EYE OINTMENT N/A CIBA VISION AG SWITZERLAND

INFECTOFLAM EYE DROPS N/A CIBA VISION AG SWITZERLAND

INFECTOFLAM EYE OINTMENT NA NOVARTIS SWITZERLAND OPHTHALMICS AG

INFECTOFLAM EYE DROPS NA NOVARTIS OPHTHAMICS SWITZERLAND AG

INFED (IRON DEXTRAN SOLN F/IM IV USE 50MG/ML SCHEIN UNITED STATES OF INJECTION USP) PHARMACEUTICAL INC. AMERICA

INFLEXAL BERNA V SUSPENSION FOR N/A ISTITUTO ITALY INJECTION SIEROTERAPICO BERNA S.R.L.

INFLORAN BERNA CAPSULES N/A SWISS SERUM AND SWITZERLAND VACCINE INSTITUTE BERNE

INFLUVAC 2000/2001 SUSPENSION FOR 15MCG/0.5ML SOLVAY NETHERLANDS INJECTION PHARMACEUTICALS B.V.

INFLUVAC 2001/2002 SUSPENSION FOR 15 MCG/0.5 SOLVAY NETHERLANDS INJECTION PHARMACEUTICALS B.V.

INFLUVAC 2002/2003 SUSPENSION FOR 15MCG/ML SOLVAY NETHERLANDS INJECTION PHARMACEUTICALS B.V.

INHALANT CAPSULES INHALATION LIQUID N/A INDUSTRIAL PHARMA- UNITED KINGDOM CEUTICAL SERVICE LIMI- TED

INNOHEP SOLUTION FOR 3500IU/0.35ML LEO PHARMACEUTICAL DENMARK INJECTION PRODUCTS

INNOHEP SOLUTION FOR 4500IU/0.45ML LEO PHARMACEUTICAL DENMARK INJECTION PRODUCTS

INNOHEP SOLUTION FOR 10,000IU/ML LEO PHARMACEUTICAL DENMARK INJECTION PRODUCTS 23.9.2003 FR Journal officiel de l'Union européenne 593

Trade Name Dosage Form Dose MA Holder Country

INNOHEP SOLUTION FOR 20,000IU/ML LEO PHARMACEUTICAL DENMARK INJECTION PRODUCTS

INNOHEP SOLUTION FOR 20000IU/ML LEO PHARMACEUTICAL DENMARK INJECTION PRODUCTS

INNOHEP SOLUTION FOR 2,500 IU/0.25ML LEO PHARMACEUTICAL DENMARK INJECTION PRODUCTS

INNOHEP 10,000IU/ML SOLUTION FOR 10,000IU/ML LEO LABORATORIES LTD DENMARK INJECTION

INNOHEP 20,000IU/ML SOLUTION FOR 20,000IU/ML LEO LABORATORIES LTD UNITED KINGDOM INJECTION

INNOHEP SYRINGE 10,000IU/ML SOLUTION FOR 10,000IU/ML LEO LABORATORIES LTD UNITED KINGDOM INJECTION

INNOHEP SYRINGE 20,000IU/ML SOLUTION FOR 20,000IU/ML LEO LABORATORIES LTD DENMARK INJECTION

INPANOL TABLETS 10MG TABLET 10MG DRUG HOUSES OF SINGAPORE AUSTRALIA(ASIA) PTE LTD

INSTILLAGEL GEL N/A FARCO-PHARMA GMBH GERMANY

INSULATARD HM PENFILL SUSPENSION FOR 100IU/ML NOVO NORDISK A/S DENMARK 100 IU/ML X10ML INJECTION

INSULATARD HM PENFILL SUSPENSION FOR NA NOVO NORDISK A/S DENMARK 100 IU/ML.1.5ML INJECTION

INTAFEN - 200 TABLETS 200MG INTAS- INDIA PHARMACEUTICALS LTD.

INTAL 1MG/DOSE INHALER MET. DOSE PRESS. 1MG/ACTUATION FISONS LIMITED T/A UNITED KINGDOM AEROSOL RHONE-POULENC RORER

INTAL 1MG/DOSE INHALER AEROSOL 1MG/ACTUATION FISONS LTD T/A UNITED KINGDOM RHONE-POULENC RORER

INTAL INHALER (5MG) MET. DOSE PRESS. 5MG/ACTUATION FISONS LIMITED T/A UNITED KINGDOM AEROSOL RHONE-POULENC RORER

INTAL INHALER (5MG) AEROSOL 5MG/ACTUATION FISONS LTD T/A UNITED KINGDOM RHONE-POULENC RORER

INTAL NEBULISER SOL. AMPOULE NASAL SPRAY 1% W/V FISONS LIMITED T/A UNITED KINGDOM 20MG/2ML RHONE-POULENC RORER

INTAL NEBULISER SOLUTION NASAL SPRAY 1%W/V FISONS LTD T/A UNITED KINGDOM AMPOULE RHONE-POULENC RORER

INTAL SPINCAPS CAPSULES 20MG INHALATION POWDER 20MG FISONS LIMITED T/A UNITED KINGDOM RHONE-POULENC RORER

INTAL SPINCAPS CAPSULES 20MG 20MG CAPSULE(POWDER) FISONS LTD T/A UNITED KINGDOM RHONE-POULENC RORER

INTALGIN GEL GEL N/A 3M HEALTH CARE UNITED KINGDOM LIMITED

INTERMOXIL DRY SYRUP 125MG/5ML PT INTERBAT INDONESIA

INTERPRIL 10 TABLETS 10MG PT INTERBAT INDONESIA

INTERPRIL 5 TABLET 5MG PT INTERBAT INDONESIA

INTRAFER LIQUID FOR I.M. USE 100MG/2ML GEYMONAT ITALY

INTRAFER ORAL SOLUTION N/A GEYMONAT SPA ITALY 594 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

INTRAFER ORAL DROPS N/A GEYMONAT SPA ITALY

INTRAGLOBIN F SOL FOR INTRAVENOUS 50MG/ML BIOTEST PHARMA GMBH GERMANY ADM.

INTRALIPID 20% EMULSION FOR INJEC- 20%W/V FRESENIUS KABI LIMITED UNITED KINGDOM TION

INTRAMED TRICHAZOLE SOLUTION FOR INFUSION 500MG/100ML BODENE (PROPIETARY) SOUTH AFRICA LIMITED T/A INTRAMED — SOUTH AFRICA

INTRAVEN GV 101 SOLUTION FOR IV INFU- 0.9% W/V BP GALEN RESEARCH UNITED KINGDOM SION LABORATORIES LIMITED

INTRAVEN GV 102 SOLUTION FOR IV INFU- 0.9% W/V BP GALEN RESEARCH UNITED KINGDOM SION LABORATORIES LIMITED

INTRAVEN GV 112 SOLUTION FOR INFUSION 0.45% W/V BP GALEN RESEARCH UNITED KINGDOM LABORATORIES LIMITED

INTRAVEN GV 121 SOLUTION FOR IV 5% W/V BP GALEN RESEARCH UNITED KINGDOM INFUSION LABORATORIES LIMITED

INTRAVEN GV 122 SOLUTION FOR IV 5% W/V BP GALEN RESEARCH UNITED KINGDOM INFUSION LABORATORIES LIMITED

INTRAVEN GV 152 SOLUTION FOR IV N/A GALEN RESEARCH UNITED KINGDOM INFUSION LABORATORIES LIMITED

INTRAVEN GV 172 SOLUTION FOR IV N/A GALEN RESEARCH UNITED KINGDOM INFUSION LABORATORIES LIMITED

INTRAVEN GV 202 SOLUTION FOR IV N/A GALEN RESEARCH UNITED KINGDOM INFUSION LABORATORIES LIMITED

INTRAVEN GV 262 SOLUTION FOR IV N/A IVEX PHARMACEUTICALS UNITED KINGDOM INFUSION LIMITED

INTRAVEN GV 352 SOLUTION FOR IV N/A GALEN RESEARCH UNITED KINGDOM INFUSION LABORATORIES LIMITED

INTRAVEN GV104 SOLUTION FOR IV 0.9% W/VBP GALEN RESEARCH UNITED KINGDOM INFUSION LABORATORIES LIMITED

INTRON A POWDER FOR INJECTION 5×10(6) IU\VIAL SCHERING-PLOUGH LTD. IRELAND

INTRON A POWDER FOR INJECTION 3×10(6)IU/VIAL SCHERING-PLOUGH LTD. IRELAND

INTRON A SOLUTION FOR 18 MILLION IU SP EUROPE IRELAND INJECTION

INTRON A SOLUTION FOR 25 MILLION IU SP EUROPE IRELAND INJECTION

INTROPIN SOLUTION FOR 40MG/ML FAULDING HOSPITAL UNITED STATES OF INJECTION PRODUCTS AMERICA

INVANZ POWD. F/CONC F/SOLN F/ 1G/VIAL MERCK SHARP & DOHME EUROPEAN COMMUNITY INF LIMITED

INVIRASE CAPSULE 200MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

IODINE SOLUTION STRONG BP TOPICAL SOLUTION N/A THORNTON & ROSS LTD UNITED KINGDOM 1958

IODINE TINCTURE BP TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM

IODIO, ALCOHOLIC CUTANEOUS ALCOHOLIC CUTANEOUS N/A LABORATORIO CHIMICO ITALY SOLUTION SOL FARMACEUTIC A. SELLA S.R.L 23.9.2003 FR Journal officiel de l'Union européenne 595

Trade Name Dosage Form Dose MA Holder Country

IOPAMIRO (100ML) SOLUTION FOR IV NA BRACCO S.P.A ITALY INFUSION

IOPAMIRO (50ML) SOLUTION FOR IV NA BRACCO S.P.A ITALY INFUSION

IOPIDINE 0.5% OPHTHALMIC SOLUTION 0.5% W/V S.A. ALCON-COUVREUR BELGIUM N.V.

IPECAVOM SYRUP 1000MG/15ML ELPEN S.A GREECE

IPERTON TABLETS N/A KLEVA LTD GREECE

IPOLIPID 600MG TABLET 600MG MEDOCHEMIE LTD CYPRUS

IPRACIP - 20 INHALER AEROSOL CANISTER 20 MCG M/S. MEDISPRAY INDIA LABORATORIES PVT. LTD —GOA

IPRAGOCCE OPHTHALMIC SOLUTION NA PROGE FARMA SRL ITALY

IPRATROPIUM STERI-NEB SOLUTION FOR 250MCG/1ML STERIPAK LIMITED UNITED KINGDOM NEBULISATION

IPRATROPIUM STERI-NEB SOLUTION FOR 500MCG/2ML STERIPAK LIMTIED UNITED KINGDOM 500MCG/2ML NEBULISATION

IPRAVENT INHALER INHALER 20MCG CIPLA LIMITED INDIA

IPRAVENT INHALER INHALER 4MG CIPLA LTD — INDIA INDIA

IPROBEN 200 LACTAB 200MG MEPHA PHARMA AG SWITZERLAND

IRFEN LACTAB 200MG MEPHA PHARMA AG SWITZERLAND

IRONORM CAPSULES N/A WALLACE UNITED KINGDOM MANUFACTURING CHEMISTS LIMITED

ISLA-MINT HERBAL LOZENGES 100,00MG ENGELHARD GERMANY ARZNEIMITTEL GMBH & CO. KG

ISLA-MOOS HERBAL LOZENGES LOZENGES 80MG ENGELHARD GERMANY ARZNEIMITTEL GMBH & CO. KG

ISMELIN EYE DROPS 50MG/ML CIBA VISION AG SWITZERLAND

ISMO TABLETS 20MG ROCHE PRODUCTS UNITED KINGDOM LIMITED

ISMO 20 TABLET 20MG HOFFMANN-LA ROCHE GERMANY AG

ISMO 20 TABLET 20MG ROCHE PAKISTAN

ISMO 20 TABLET 20MG ROCHE PAKISTAN PAKISTAN LIMITED

ISMONIT 20 TABLET 20MG HEXAL AG GERMANY

ISO MACK RETARD 20MG CAPSULE WITH SUST. 20MG HEINRICH MACK NACHF GERMANY ACTION

ISO MACK RETARD 40MG CAPSULE WITH SUST 40MG HEINRICH MACK NACHF GERMANY RELEASE

ISO MACK SPRAY SOLUTION 1.25MG/0.09ML HEINRICH MACK NACHF GERMANY 596 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ISOCARD TABLETS 10MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

ISOFLURANE LIQUID FOR INHALATION >99.9% HALOCARBON UNITED STATES OF LABORATORIES AMERICA

ISOGEL GRANULES FOR ORAL 90% W/W UNICLIFFE LIMITED T/A UNITED KINGDOM SOLN. PFIZER CONSUMER HEALTHCARE

ISOKET SOLUTION 0.1% SOLUTION FOR INFUSION 0.1% SCHWARZ PHARMA AG GERMANY

ISONIAZID 100MG TABLETS PHARMAMED LTD. MALTA

ISONIAZID TABLETS 300MG PHARMAMED LTD. MALTA

ISOPRENALINE HCL INJECTION SOLUTION FOR 20MCG/ML INTERNATIONAL UNITED KINGDOM MINIJET INJECTION MEDICATION SYSTEMS (UK) LIMITED

ISOPRENALINE HCL MINIJET SOLUTION FOR 0.002%W/V INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS (UK) LIMITED

ISOPRENALINE INJ MINIJET AQUEOUS SOLUTION 20MCG/ML INTERNATIONAL UNITED KINGDOM 0.002%W/V MEDICATION SYSTEMS LTD

ISOPRINOSINE TABLET 500MG NEWPORT SYNTHESIS IRELAND LTD.

ISOPRINOSINE SYRUP 250MG/5ML NEWPORT SYNTHESIS IRELAND LTD.

ISOPROTERENOL SOLUTION FOR 0.2MG/ML ABBOTT LABORATORIES UNITED STATES OF HYDROCHLORIDE USP.1:5000 INJECTION AMERICA

ISOPTO CARPINE 1% OPHTHALMIC SOLUTION 10MG/ML S.A. ALCON-COUVREUR BELGIUM N.V.

ISOPTO CARPINE 2% OPHTHALMIC SOLUTION 2% W/V S.A. ALCON-COUVREUR BELGIUM N.V.

ISOPTO CARPINE 4% OPHTHALMIC SOLUTION 4% W/V S.A. ALCON-COUVREUR BELGIUM N.V.

ISOPTO FENICOL 0.5% OPHTHALMIC SOLUTION 5MG/ML S.A. ALCON-COUVREUR BELGIUM N.V.

ISOPTO FENICOL OPHTHALMIC SOLUTION 0.5% W/V S.A. ALCON-COUVREUR BELGIUM 0.5%/CHLORAMPHENICOL 0.5% N.V.

ISORDIL TABLET 10MG WYETH LEDERLE PAKISTAN

ISORDIL TABLET 10MG WYETH-LEDERLE PAKISTAN

ISORDIL TAB 10MG TABLET 10MG WYETH-AYERST CANADA CANADA INC.

ISORDIL TAB 5MG SUBLINGUAL TABLET 5MG WYETH-AYERST CANADA CANADA INC.

ISOSORBIDE DINITRATE TABLETS 10MG PHARMAX LIMITED UNITED KINGDOM

ISOSORBIDE DINITRATE TABLET 20MG PHARMAX LIMITED UNITED KINGDOM

ISOSORBIDE MONONITRATE TABLETS 10MG PHARMAX LIMITED UNITED KINGDOM

ISOSORBIDE MONONITRATE TABLET 20MG PHARMAX LIMITED UNITED KINGDOM 23.9.2003 FR Journal officiel de l'Union européenne 597

Trade Name Dosage Form Dose MA Holder Country

ISOSORBIDE MONONITRATE TABLET 40MG PHARMAX LIMITED UNITED KINGDOM

ISOSORBIDE MONONITRATE TABLETS 10MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

ISOSORBIDE MONONITRATE TABLETS 20MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

ISOSORBIDE MONONITRATE TABLETS 40MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

ISOTREX GEL GEL 0.05% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

ISOVIST-300 SOLN FOR INJ. AND ORAL 640.75MG/ML SCHERING AG GERMANY USE

ISPAGEL POWDER FOR ORAL NA RICHMOND UNITED KINGDOM SUSPENSION PHARMACEUTICALS LIMITED

ISTIN TABLET 10MG PFIZER LIMITED UNITED KINGDOM

ISTIN TABLET 5MG PFIZER LIMITED UNITED KINGDOM

ITASPOR CAPSULES 100MG INTAS INDIA PHARMACEUTICALS LTD

ITASPOR (ITRACONAZOLE CAPSULE 100MG INTAS INDIA CAPSULES 100MG) PHARMACEUTICALS LTD

IV-GLOBULIN (1,000MG) POWDER FOR N/A KOREA GREEN CROSS KOREA REPUBLIC RECONSTITUTION CORP.

IV-GLOBULIN (2,500MG) POWDER FOR N/A KOREA GREEN CROSS KOREA REPUBLIC RECONSTITUTION CORP.

IXEL CAPSULE 25MG LABORATOIRES PIERRE FRANCE FABRE MEDICAMENT

IXEL CAPSULE 50MG LABORATOIRES PIERRE FRANCE FABRE MEDICAMENT

IXENSE SUBLINGUAL TABLETS 2MG TAKEDA EUROPE R&D UNITED KINGDOM CENTRE LIMITED

IXENSE SUBLINGUAL TABLETS 3MG TAKEDA EUROPE R&D UNITED KINGDOM CENTRE LIMITED

JACKSON'S HERBAL LAXATIVE SYRUP N/A ANGLIAN PHARMA PLC UNITED KINGDOM

JECTOFER SOLUTION FOR 50MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION

JODOPLEX LIQUID SOAP N/A G.STREULI & CO. AG SWITZERLAND

JODOPLEX OINTMENT N/A G.STREULI & CO.AG SWITZERLAND

JODOPLEX SOLUTION 10MG/ML G.STREULI & CO. AG SWITZERLAND

JOINT AND MUSCLE BALSAM OINTMENT N/A AH EHRLICH GMBH & CO GERMANY KG

JOINT AND MUSCLE BALSAM, OINTMENT NA AH EHRLICH GMBH & GERMANY EHRLICH BALSAM OI CO. KG

JOY RIDES TABLETS 0.075%W/W STAFFORD MILLER UNITED KINGDOM LIMITED

JOY-RIDES TABLET 0.075 W/W STAFFORD-MILLER UNITED KINGDOM LIMITED 598 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

JUMEX 5MG TABLET 5MG SEARLE PAKISTAN

JUNIFEN SUSPENSION ORAL SUSPENSION 100MG/5ML CROOKES HEALTHCARE UNITED KINGDOM LIMITED

JUNIOR IBUPROFEN SUPENSION ORAL SUSPENSION 100MG/5ML GALPHARM UNITED KINGDOM HEALTHCARE LIMITED

JUNIOR MELTUS FOR CHESTY ORAL SOLUTION N/A CUPAL LIMITED UNITED KINGDOM COUGHS AND CATARR

JUNIOR MELTUS FOR DRI TICKLY ORAL SOLUTION N/A CUPAL LIMITED UNITED KINGDOM COUGHS AND CA

JUNIOR MELTUS NIGHT TIME SYRUP N/A CUPAL LIMITED UNITED KINGDOM

JUNIOR MELTUS SUGAR AND ORAL LIQUID N/A CUPAL LIMITED UNITED KINGDOM COLOR FREE EXPECTO

JUNIOR PARAPAED PARACETAMOL ORAL SUSPENSION 120MG/5ML PINEWOOD UNITED KINGDOM SUSPENSION LABORATORIES LIMITED T/A PINEWOOD HEALTHCARE LIMITED

KABIKINASE POWDER FOR INFUSION 25000IU/VIAL PHARMACIA & UPJOHN SWEDEN SVERIGE AB

KABIKINASE POWDER FOR INFUSION 1500000IU/VIAL PHARMACIA & UPJOHN SWEDEN SVERIGE AB

KALETRA CAPSULES NA ABBOTT LABORATORIES UNITED STATES OF AMERICA

KALETRA ORAL SOLUTION NA ABBOTT LABORATORIES EUROPEAN COMMUNITY LIMITED

KALETRA SOFT GELATIN CAPSULES NA ABBOTT LABORATORIES EUROPEAN COMMUNITY LIMITED

KALI SULPH 6X NEW ERA TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM BIOCHEMIC NO.7 NO.7 LABORATORIES LIMITED

KALI. MUR. 6X NEW ERA TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM BIOCHEMIC NO.5 NO.5 LABORATORIES LIMITED

KALMIREN 10 TABLETS 10MG AEGIS LTD. CYPRUS

KALMIREN 5 TABLETS 5MG AEGIS LTD. CYPRUS

KALMS TABLETS COATED TABLET N/A G R LANE HEALTH UNITED KINGDOM PRODUCTS LTD

KALPIREN TABLET 5MG MEDOCHEMIE LTD CYPRUS

KALPIREN 20MG TABLET 20MG MEDOCHEMIE LTD CYPRUS

KALTEN CAPSULE N/A ZENECA LIMITED UNITED KINGDOM

KAMAGRA-100 FILM COATED TABLET 100MG AJANTA PHARMA LTD. INDIA

KAMAGRA-50 FILM COATED TABLET 50MG AJANTA PHARMA LTD. INDIA

KAMILLOSAN OINTMENT 10.5%W/W NORGINE LIMITED UNITED KINGDOM

KAMILLOSAN OINTMENT 10.5%W/W GOLDSHIELD UNITED KINGDOM PHARMACEUTICALS LIMITED

KAMISTAD-GEL GEL N/A STADAPHARM GERMANY 23.9.2003 FR Journal officiel de l'Union européenne 599

Trade Name Dosage Form Dose MA Holder Country

KANAMYCIN-POS EYE DROPS 6.2MG/ML URSAPHARM GERMANY ARZNEIMITTEL GMBH

KANAMYCIN-POS EYE OINTMENT 6.2MG/G URSAPHARM GERMANY ARZNEIMITTEL GMBH

KAOLIN AND MORPHINE MIXTURE ORAL SOLUTION N/A WILLIAM RANSOM & UNITED KINGDOM BP SON PLC

KAOLIN AND MORPHINE MIXTURE ORAL SOLUTION N/A LCM LTD UNITED KINGDOM BP

KAPARLON-S TAB. 5MG TABLET 5MG ANFARM HELLAS S.A.- GREECE PHARMACEUTICALS

KAPARLONS-S TABLETS 20MG ANFARM HELLAS S.A. GREECE

KARDEGIC 160MG POWDER FOR ORAL 160MG LABORATOIRES FRANCE SOLUTION SYNTHELABO

KARDEGIC 300MG POWDER FOR ORAL 300MG LABORATOIRES FRANCE SOLUTION SYNTHELABO

KARVOL DECONGESTANT POWD. FOR INHALATION N/A CROOKES HEALTHCARE UNITED KINGDOM CAPSULES SOLN LIMITED

KATAVAL CREAM NA FARMIGEA SPA ITALY

KATOXYN POWDER SPRAY N/A DEVERGE' MEDICINA E ITALY MEDICALIZZAZIONE SRL

K-COR-5 TABLET 5MG MACLEODS INDIA

KEFLEX CAPSULE 250MG ELI LILLY ITALIA S.P.A. ITALY

KEFLEX CAPSULE 500MG ELI LILLY ITALIA S.P.A. ITALY

KEFLEX GRANULES FOR ORAL 125MG/5ML ELI LILLY ITALIA S.P.A. ITALY SUSPEN.

KEFLIN NEUTRO POWDER FOR INJECTION 1000MG ELI LILLY ITALIA S.P.A. ITALY

KEFORAL HARD CAPSULE 250MG ELI LILLY ITALIA S.P.A. ITALY

KEFORAL HARD CAPSULE 500MG ELI LILLY ITALIA S.P.A. ITALY

KEFTID POWDER FOR ORAL SUS- 125MG/5ML GALEN LIMITED UNITED KINGDOM PENSIO

KEFTID POWDER FOR ORAL SUS- 250MG/5ML GALEN LIMITED UNITED KINGDOM PENSIO

KEFTID CAPSULES 500MG GALEN LIMITED UNITED KINGDOM

KEFTID CAPSULES 250MG GALEN LIMITED UNITED KINGDOM

KEFUROX POWDER FOR INJECTION 1500MG ELI LILLY ITALIA S.P.A. ITALY

KEFUROX POWDER FOR INJECTION 750MG ELI LILLY ITALIA S.P.A. ITALY

KEFUROX POWDER FOR INJECTION 250MG ELI LILLY ITALIA S.P.A. ITALY

KEMADRIN TABLETS 5MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

KEMADRIN SOLUTION FOR 5MG/ML THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION LTD.

KEMADRIN TABLETS 5MG GLAXOSMITHKLINE GERMANY GMBH & CO KG 600 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

KEMADRIN INJECTION 10MG/2ML SOLUTION FOR 0.5% W/V THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION LIMITED

KENACOMB CREAM N/A BRISTOL-MYERS SQUIBB ITALY S.P.A

KENACOMB OINTMENT N/A BRISTOL-MYERS SQUIBB ITALY S.P.A

KENACORT INJECTABLE SUSPENSION 40MG/ML BRISTOL MYERS SQUIBB ITALY S.P.A.

KENACORT «A RETARD» SOLUTION FOR 40MG/ML BRISTOL MYERS SQUIBB ITALY INJECTION S.P.A

KENALOG IN ORABASE PASTE 0.1G/100G SQUIBB INDUSTRIA FAR- SPAIN MACEUTICA, S.A.

KEPPRA FILM-COATED TABLETS 250MG UCB S.A.(PHARMA EUROPEAN COMMUNITY SECTOR)

KEPPRA FILM-COATED TABLETS 500MG UCB S.A.(PHARMA EUROPEAN COMMUNITY SECTOR)

KEPPRA FILM-COATED TABLETS 1000MG UCB S.A.(PHARMA EUROPEAN COMMUNITY SECTOR)

KESTIN 10MG FILM COATED TABLET 10MG LABS SPECIA FRANCE

KETEK TABLETS 400MG AVENTIS PHARMA S.A. FRANCE

KETESSE TABLET 25MG MENARINI ITALY INTERNATIONAL OPERATIONS LUXEMBOURG S.A.

KETODOL TABLET N/A ALFA WASSERMANN ITALY S.P.A.

KETOFTIL EYE DROPS 0.05% FARMIGEA SPA ITALY

KETOFTIL OPHTHALMIC GEL 0.05% FARMIGEA SPA ITALY

KETOFTIL OPHTHALMIC GEL 0.05% FARMIGEA SPA ITALY

KETORAL MEDICAL SHAMPOO N/A BILIM ILAC SANAYII VE TURKEY TICARET A.S.

KETORAL MEDICAL SHAMPOO SHAMPOO N/A BILIM ILAC SANAYII VE TURKEY TICARET A.S

KETRAX TABLETS 47.2MG ZENECA LIMITED UNITED KINGDOM

KETRAX SYRUP 0.944% W/V ZENECA LIMITED UNITED KINGDOM

KETRAX COATED TABLETS 40MG ZENECA LIMITED UNITED KINGDOM

KETRAX SYRUP ORAL SOLUTION 40MG/5ML ZENECA LIMITED UNITED KINGDOM

KIDDI PHARMATON SYRUP N/A PHARMATON SA SWITZERLAND

KIDDI PHARMATON EFFERVESCENT TABLET N/A PHARMATON SA SWITZERLAND (KIDDI PHARMATON FIZZ)

KINUSSEN TABLETS 10MG KLEVA LTD GREECE

KLACID GRANULES FOR ORAL 125MG/5ML ABBOTT AG ITALY SUSP.

KLACID FILMTAB TABLETS 250MG ABBOTT AG SWITZERLAND 23.9.2003 FR Journal officiel de l'Union européenne 601

Trade Name Dosage Form Dose MA Holder Country

KLACID TABLETS 250MG ABBOTT S.P.A ITALY

KLACID GRANULES FOR 125MG/5ML ABBOTT S.P.A. ITALY SUSPENSION

KLACID COATED TABLET 500MG ABBOTT SPA ITALY

KLACID LA MODIFIED RELEASE 500MG ABBOTT LABORATORIES IRELAND TABLETS (IRELAND) LTD

KLACID RM SR COATED TABLETS 500MG ABBOTT S.P.A. ITALY

KLACID XL TABLETS 500MG ABBOTT LABORATORIES SOUTH AFRICA S.A (PTY)

KLACID XL TABLETS MODIFIED RELEASE 500MG ABBOTT LABORATORIES SOUTH AFRICA TABLETS S.A (PTY) LIMITED

KLAMOKS 156.25MG PED. POWDER FOR N/A BILIM ILAC SANAYII VE TURKEY O.SUSPEN TICARET A.S

KLAMOKS 156.25MG PAEDIATRIC DRY POWDER FOR ORAL N/A BILIM ILAC SANAYII VE TURKEY SUSP. TICARET A.S.

KLAMOKS 625MG FILM COATED TABLETS N/A BILIM ILAC SANAYII VE TURKEY TICARET A.S.

KLAMOKS 625MG FILM COATED TABLET N/A BILIM ILAC SANAYII VE TURKEY TICARET A.S

KLAMOKS BID TABLETS 1000MG BILIM ILAC SANAYII VE TURKEY TICARET A.S

KLAMOKS BID 200/28MG DRY POWDER FOR ORAL N/A BILIM ILAC SANAYII VE TURKEY SUSP. TICARET A.S.

KLAMOKS BID FORTE 200/28MG POWDER FOR OR. N/A BILIM ILAC SANAYII VE TURKEY SUSPENSION TICARET A.S

KLAMOKS BID FORTE 400/57MG DRY POWDER FOR ORAL N/A BILIM ILAC SANAYII VE TURKEY SUSP. TICARET A.S.

KLAMOKS BID FORTE 400/57MG POWDER FOR OR. N/A BILIM ILAC SANAYII VE TURKEY SUSPENSION TICARET A.S.

KLAMOKS-BID 1000MG FILM COATED TABLET N/A BILIM ILAC SANAYI VE TURKEY TICARET A.S

KLARICID TABLET 250MG ABBOTT PAKISTAN

KLARICID COATED TABLETS 500MG ABBOTT LABORATORIES UNITED KINGDOM LIMITED

KLARICID 500MG IV POWDER FOR IV 500MG ABBOTT LABORATORIES UNITED KINGDOM INJECTION LTD.

KLARICID XL TABLET 500MG ABBOTT PAKISTAN

KLARICID XL 500MG MODIFIED RELEASE 500MG ABBOTT LABORATORIES UNITED KINGDOM TABLETS LIMITED

KLEAN PREP POWDER N/A NORGINE LIMITED UNITED KINGDOM

KLEAN-PREP ORAL POWDER N/A HELSINN BIREX IRELAND PHARMACEUTICALS LTD.

KLERIMED TABLETS 250MG MEDOCHEMIE LIMITED CYPRUS

KLEVASIN CAPSULE 500MG KLEVA LTD. GREECE 602 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

KLEVASIN POWDER FOR ORAL SUSP. 500MG/5ML KLEVA LTD GREECE

KLEVISTAMIN TABLET 1MG KLEVA GREECE PHARMACEUTICAL LABORATORIES LTD

KLEVISTAMIN SYRUP 1MG/5ML KLEVA GREECE PHARMACEUTICAL LABORATORIES LTD

KLEVISTAMIN TABLETS 1MG KLEVA LIMITED GREECE

KLEVISTAMIN SYRUP 1MG/5ML KLEVA LIMITED GREECE

KLIACEF GRANULES FOR ORAL 5% W/V FONTEN FARMACEUTICI ITALY SUSP. S.R.L.

KLIACEF CAPSULE 500MG FONTEN FARMACEUTICI ITALY S.R.L.

KLIACEF TABLET 500MG FONTEN FARMACEUTICI ITALY S.R.L.

KLINDAM CAPSULE 150MG PRIME PHARMACEUTICAL MALAYSIA SDN.BHD.

KLINDAN CAPSULE 150MG BILIM ILAC CANAYII VE TURKEY TICARET SA

KLINDAN 300MG AMPUL SOLUTION FOR 300MG/2ML BILIM ILAC SANAYII VE TURKEY INJECTION TICARET A.S

KLIOGEST -28 TABLETS TABLET NA NOVO NORDISK A/S DENMARK

KLISMACORT RECTAL CAPSULES 100MG BENE-ARZNEIMITTEL GERMANY GMBH

KLONT 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

KLOVIREKS 250MG POWDER FOR INJECTION 250MG MUSTAFA NEVZAT ILAC TURKEY SANAYII A.S.

KLOVIREKS-L ENJEKTABL FREEZE-DRIED POW.F/INJ. 250MG MUSTAFA NEVZAT ILAC TURKEY SANAYII A.S.

KOATE-DVI (ANTIHEMOPHILIC POWDER FOR INJECTION 9-22IU/MG PROT. BAYER CORPORATION, UNITED STATES OF FACTOR, HUMAN) PHARMACEUTICAL DIV. AMERICA

KONSYL-ORANGE SUGAR FREE POWDER FOR ORAL SUSP. 60.3% W/W EASTERN UNITED KINGDOM PHARMACEUTICALS LIMITED

KRATIUM 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS

KRATIUM 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

KROTER CREAM CREAM 10% W/W CAMDEN INDUSTRIES (M) MALAYSIA SDN BHD

KYTRIL FILM COATED TABLETS 1MG ROCHE PHARMA SWITZERLAND SCHWEIZ LTD.

KYTRIL INFUSION 3MG/3ML SOLUTION FOR 3MG/3ML SMITHKLINE BEECHAM UNITED KINGDOM INJECTION PLC

KYTRIL PAEDIATRIC LIQUID ORAL LIQUID 200MCG/ML SMITHKLINE BEECHAM UNITED KINGDOM PLC

KYTRIL TABLETS 1MG COATED TABLET 1MG SMITHKLINE BEECHAM UNITED KINGDOM PLC 23.9.2003 FR Journal officiel de l'Union européenne 603

Trade Name Dosage Form Dose MA Holder Country

LABETALOL TABLETS 200MG COATED TABLET 200MG GENERICS (UK) LIMITED UNITED KINGDOM

LABOSEPT PASTILLES 0.25MG LOZENGE 0.25MG LABORATORIES FOR UNITED KINGDOM APPLIED BIOLOGY LTD

LACIPIL TABLETS 4MG GALXO WELLCOME S.A. SPAIN

LACIPIL 4MG TABLETS FILM COATED TABLET 4MG GLAXO WELLCOME S.A. SPAIN

LACRIGEL OPHTHALMIC GEL N/A FARMIGEA SPA ITALY

LACRINORM OPHTHALMIC GEL N/A FARMIGEA SPA ITALY

LACTATED RINGERS AND 5% SOLUTION FOR NA ABBOTT LABORATORIES UNITED STATES OF DEXTROSE INJ. INJECTION AMERICA

LACTATED RINGER'S INJECTION SOLUTION FOR IV N/A DEMO SA GREECE INFUSION

LACTATED RINGERS INJECTION SOLUTION FOR INFUSION NA DEMO SA GREECE DEMO

LACTATED RINGERS INJECTION SOLUTION FOR NA ABBOTT LABORATORIES UNITED STATES OF USP INJECTION AMERICA

LACTATED RINGER'S INJECTION, SOLUTION FOR IV N/A ABBOTT LABORATORIES UNITED STATES OF USP INFUSION AMERICA

LACTEOL FORT CAPSULE N/A LABORATOIRE DU FRANCE LACTEOL DU DOCTEUR BOUCARD

LACTEOL FORT SACHET POWDER FOR ORAL N/A LABORATOIRE DU FRANCE SUSPEN. LACTEOL DU DOCTEUR BOUCARD

LACTICARE (FORMERLY K/A TOPICAL EMULSION N/A STIEFEL LABORATORIES UNITED KINGDOM OILATUM LOTION) (UK) LIMITED

LACTO CALAMINE LOTION TOPICAL SUSPENSION N/A SCHERING-PLOUGH UNITED KINGDOM LIMITED

LACTULOSE SOLUTION (LAXOSE) ORAL SOLUTION 3.35G/5ML APPROVED UNITED KINGDOM PRESCRIPTION SERVICES LIMITED

LAMETEC-100 TABLET 100MG CIPLA INDIA

LAMICTAL TABLETS 25MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

LAMICTAL TABLETS 50MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

LAMICTAL TABLETS 100MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

LAMICTAL TABLETS 100MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

LAMICTAL TABLET 25MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

LAMICTAL TABLETS 50MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

LAMICTAL DISPERSIBLE TABLET FOR ORAL 5MG THE WELLCOME UNITED KINGDOM SOLUTION FOUNDATION LIMITED

LAMICTAL DISPERSIBLE 25MG TABLET FOR ORAL 25MG THE WELLCOME UNITED KINGDOM TABLETS SOLUTION FOUNDATION LIMITED 604 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LAMICTAL DISPERSIBLE 5MG TABLETS FOR ORAL 5MG THE WELLCOME UNITED KINGDOM TABLETS SOLUTION FOUNDATION LIMITED

LAMICTAL TABLETS TABLETS 25MG GLAXOWELLCOME PAKISTAN

LAMICTAL TABLETS TABLETS 100MG GLAXOWELLCOME PAKISTAN

LAMIFEN TABLETS 250 MG TABLET 250MG ALFARES SYRIA PHARMACEUTICALS

LAMIFIN TABLET 250MG ALFARES SYRIA PHARMACEUTICALS

LAMIFIN 1% CREAM 1% W/W ALFARES SYRIA PHARMACEUTICALS

LAMIFIN CREAM 1% CREAM 10MG/G ALFARES SYRIA PHARMACEUTICALS

LAMISIL TOPICAL SOLUTION 10MG/G NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LAMISIL SPRAY 10MG/G NOVARTIS PHARMA SWITZERLAND (SCHWEIZ) AG

LAMISIL DERMGEL 10MG/G NOVARTIS PHARMA SWITZERLAND (SCHWEIZ) AG

LAMISIL TABLETS 250MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LAMISIL CREAM 1% W/W NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LAMISIL CREAM 10MG/G NOVARTIS PAKISTAN

LAMISIL TABLETS 125MG NOVARTIS PAKISTAN

LAMISIL TOPICAL SOLUTION 10MG/G NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LAMISIL SPRAY 10MG/G NOVARTIS PHARMA SWITZERLAND (SCHWEIZ) AG

LAMISIL CREAM 1% W/W NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LAMISIL TABLETS 250MG NOVARTIS FARMA SPA ITALY

LAMOTRIGINE DISPERSIBLE TABLET FOR ORAL 25MG THE WELLCOME UNITED KINGDOM SOLUTION FOUNDATION LTD.

LANACANE CREME CREAM 3%W/W COMBE INTERNATIONAL UNITED KINGDOM LIMITED

LANES MOD. HERB. COLD AND COATED TABLET N/A MODERN HEALTH UNITED KINGDOM CATARRH TABLETS. PRODUCTS

LANES MOD. HERB. RHEUMATIC COATED TABLET N/A MODERN HEALTH UNITED KINGDOM PAIN TABLETS PRODUCTS LTD

LANES MOD. HERB. TRAPPED TABLET 125MG G R LANE HEALTH UNITED KINGDOM WIND AND INDIGEST PRODUCTS LTD

LANES MOD. HERB. WATER COATED TABLET N/A MODERN HEALTH UNITED KINGDOM RETENTION TABS. PRODUCTS LTD

LANES MOD. HERBALS SLEEP AID TABLET 22MG G R LANE HEALTH UNITED KINGDOM PASSIFLORA PRODUCTS

LANES MOD. HERBALS STRESS COATED TABLET N/A METABASIC PRODUCTS UNITED KINGDOM TABLETS LTD 23.9.2003 FR Journal officiel de l'Union européenne 605

Trade Name Dosage Form Dose MA Holder Country

LANES MODERN HERBALS COLD ORAL SOLUTION N/A G R LANE HEALTH UNITED KINGDOM AND CONGESTION PRODUCTS LTD

LANES MODERN HERBALS COUGH ORAL SOLUTION N/A G R LANE HEALTH UNITED KINGDOM MIXTURE PRODUCTS LTD

LANES MODERN HERBALS FOOT OINTMENT N/A G R LANE HEALTH UNITED KINGDOM BALM PRODUCT LTD

LANES MODERN HERBALS COATED TABLET N/A G R LANE HEALTH UNITED KINGDOM LAXATIVE TABLETS PRODUCTS LTD

LANES MODERN HERBALS COATED TABLET N/A METABASIC PRODUCTS UNITED KINGDOM MENOPAUSE TABLET LTD

LANES MODERN HERBALS CREAM N/A G R LANE HEALTH UNITED KINGDOM MUSCULAR PAIN CREAM PRODUCTS LTD

LANES MODERN HERBALS PILE OINTMENT N/A G R LANE HEALTH UNITED KINGDOM OINTMENT PRODUCTS

LANES MODERN HERBALS PILE COATED TABLET N/A GR LANE HEALTH UNITED KINGDOM TABLETS PRODUCTS LTD

LANOXIN TABLETS 250MCG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

LANOXIN ELIXIR N/A GLAXO WELLCOME GERMANY GMBH & CO

LANOXIN — PG TABLETS TABLETS 62.5MCG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

LANOXIN INJECTION 1.25MG/5ML SOLUTION FOR 0.025% W/V THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION LIMITED

LANOXIN PAEDIATRIC ELIXIR ELIXIR 0.05G/1000ML THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

LANOXIN PG DIGOXIN 62.5MCG TABLET 62.5MCG SIGMA AUSTRALIA TABLETS PHARMACEUTICALS PTY LTD.

LANOXIN TABLET 250 MCG TABLET 0.25MG GLAXOSMITHKLINE GERMANY GMBH & CO. LTD

LANSOX CAPSULE 15MG TAKEDA ITALIA ITALY FARMACEUTICI S.P.A.

LANSOX CAPSULE 30MG TAKEDA ITALIA ITALY FARMACEUTICI S.P.A.

LANSOYL 78.23% ORAL JELLY 78.23% W/W PARKE DAVIS FRANCE

LANTANON TABLETS TABLET 30MG ORGANON PAKISTAN

LANTIGEN B ORAL DROPS, N/A BRUSCHETTINI SRL ITALY SUSPENSION

LANVIS TABLETS 40MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

LANVIS TABLETS 40MG TABLETS 40MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

LARGACTIL SOLUTION FOR 2.5% W/V HAWGREEN LTD. IRELAND INJECTION

LARGACTIL INJECTION 2.5% W/V SOLUTION FOR 2.5% W/V HAWGREEN LIMITED IRELAND INJECTION

LARGACTIL SYRUP 25MG/5ML ORAL SOLUTION 25MG/5ML HAWGREEN LIMITED IRELAND 606 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LARGACTIL TABLETS 100MG COATED TABLET 100MG HAWGREEN LIMITED IRELAND

LARGACTIL TABLETS 25MG COATED TABLET 25MG HAWGREEN LIMITED IRELAND

LARGACTIL TABLETS 50MG COATED TABLET 50MG HAWGREEN LIMITED IRELAND

LARGOPEN CAPSULE 250MG BILIM ILAC SANAYII VE TURKEY TICARET AS

LARGOPEN 125MG/5ML POWDER FOR ORAL 125MG/5ML BILIM ILAC SANAYII VE TURKEY SUSPEN. TICARET AS

LARIAM TABLETS 250MG ROCHE PHARMA SWITZERLAND (SCHWEIZ)AG

LARMABAK EYE DROPS N/A LABORATOIRESTHEA FRANCE

LASILIX 20MG/2ML SOLUTION FOR 20MG/2ML LABORATOIRES FRANCE INJECTION HOECHST

LASILIX 40MG TABLET 40MG LABORATOIRES FRANCE HOECHST

LASILIX RETARD 60MG SUSTAINED RELEASE 60MG LABORATOIRES FRANCE CAPSULE HOECHST

LASILIX SPECIAL 500MG TABLET 500MG LABORATOIRES FRANCE HOECHST

LASIX TABLETS 40MG HOECHST MARION PAKISTAN ROUSSEL

LASIX 40MG TABLET 40MG HOECHST MARION PAKISTAN ROUSSEL

LASONIL OINTMENT N/A BAYER PLC UNITED KINGDOM

LASONIL OINTMENT 0.8% W/W BAYER PLC UNITED KINGDOM

LASONIL N OINTMENT 5000 HDB-E/100G BAYER VITAL GMBH & GERMANY CO. KG

LASOPROL 15 CAPSULES 15MG AEGIS LTD. CYPRUS

LASOPROL 30 CAPSULES 30MG AEGIS LTD. CYPRUS

LATAN-N TABLET N/A WYETH-AYERST CANADA CANADA INC

LAXADIN (BISACODYL) TABLETS TABLET 5MG TEVA ISRAEL 5MG PHARMACEUTICALS INDUSTRIES LTD

LEDERFOLIN 15MG TABLETS TABLET 15 MG CYANAMID IBERICA S.A. SPAIN

LEFUMIDE-10 FILM COATED TABLETS 10MG CIPLA LIMITED INDIA

LEMLAX ORAL LIQUID 3.26G/5ML CO-PHARMA LIMITED UNITED KINGDOM

LEMON ENO POWDER FOR ORAL N/A BEECHAM GROUP PLC UNITED KINGDOM SOLUTION T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

LEMSIP CHESTY COUGH LIQUID LIQUID 50MG/5ML RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

LEMSIP CHILDREN'S SIX+ COLD POWDER FOR ORAL N/A RECKITT & COLMAN UNITED KINGDOM AND FLU RELIEF SOLUTION PRODUCTS LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 607

Trade Name Dosage Form Dose MA Holder Country

LEMSIP COLD + FLU POWDER FOR ORAL N/A RECKITT & COLMAN UNITED KINGDOM BLACKCURRANT SOLUTION PRODUCTS LIMITED

LEMSIP COLD + FLU BREATHE POWDER FOR ORAL N/A RECKITT & COLMAN UNITED KINGDOM EASY SOLUTION PRODUCTS LIMITED

LEMSIP COLD + FLU MAX POWDER FOR ORAL N/A RECKITT & COLMAN UNITED KINGDOM STRENGTH SOLUTION PRODUCTS LIMITED

LEMSIP COLD + FLU MAX CAPSULE N/A RECKITT & COLMAN UNITED KINGDOM STRENGTH CAPSULES PRODUCTS LIMITED

LEMSIP COLD + FLU ORIGINAL POWDER FOR ORAL N/A RECKITT & COLMAN UNITED KINGDOM LEMON SOLUTION PRODUCTS LIMITED

LEMSIP DRY TICKLY COUGH LIQUID N/A RECKITT & COLMAN UNITED KINGDOM LIQUID PRODUCTS LIMITED

LEMSIP FLU STRENGTH POWDER POWDER N/A RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

LEMSIP PHARMACY POWERCAPS MODIFIED RELEASE N/A RECKITT & COLMAN UNITED KINGDOM CAPSULE PRODUCTS LIMITED

LEMSIP POWDER POWDER N/A RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

LEMSIP POWER + POWDER POWDER N/A RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

LEMSIP SORE THROAT LOZENGE 2.4MG ERNEST JACKSON & CO UNITED KINGDOM ANTI-BACTERIAL LIMITED

LEMSIP SORE THROAT LOZENGE 2.4MG ERNEST JACKSON & CO UNITED KINGDOM ANTI-BACTERIAL CITRUS LIMITED

LEN VK 250MG TABLET 250MG PHARMACARE LIMITED SOUTH AFRICA — SOUTH AFRICA

LENNON — DAPSONE 100MG TABLET 100MG PHARMACARE LIMITED SOUTH AFRICA

LENOCEF -125 SUSPENSION SUSPENSION 125MG PHARMACARE LIMITED - SOUTH AFRICA SOUTH AFRICA

LENOCEF-250 CAPSULES 250MG PHARMACARE LIMITED- SOUTH AFRICA SOUTH AFRICA

LENOLAX LIQUID NA PHARMACARE LIMITED REPUBLIC OF SOUTH AFRICA

LEPONEX TABLETS 25MG NOVARTIS PHARMA AUSTRIA GMBH

LEPONEX TABLETS 100MG NOVARTIS PHARMA AUSTRIA GMBH

LEPONEX TABLETS 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LEPONEX TABLETS 100MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LEPONEX TABLETS 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ

LEPONEX TABLETS 100MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LEPONEX 100MG TABLETS 100MG NOVARTIS PHARM. UK. SWITZERLAND LTD. T/A SANDOZ PHARM. 608 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LEPONEX 25MG TABLETS 25MG NOVARTIS PHARM. UK SWITZERLAND LTD. T/A SANDOZ PHARM.

LEPUR FILM COATED TABLETS 5MG KLEVA LTD. GREECE

LEPUR FILM COATED TABLETS 10MG KLEVA LTD. GREECE

LEPUR FILM COATED TABLETS 20MG KLEVA LTD. GREECE

LESCOL CAPSULES 20MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LESCOL CAPSULES 40MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LESCOL CAPSULE 20MG NOVARTIS PAKISTAN

LESCOL CAPSULES 40MG NOVARTIS SPAIN FARMACEUTICA S.A

LESCOL CAPSULES 20MG NOVARTIS SPAIN FARMACEUTICA S.A

LESCOL FORTE PROLONGED RELEASE 80MG NOVARTIS PHARMA SWITZERLAND TABLETS SCHWEIZ AG

LESCOL XL SLOW RELEASE TABLETS 80MG NOVARTIS SPAIN FARMACEUTICA S.A

LESCOL XL 80MG PROLONGED FILM-COATED TABLETS 80 MG NOVARTIS UNITED KINGDOM RELEASE TABLETS PHARMACEUTICALS UK LIMITED

LEUCOVORIN CALCIUM FOLINIC SOLUTION FOR 50MG/ML F.H. FAULDING & CO. LTD AUSTRALIA ACID INJ. VIA INJECTION (T/A DAVID BULL LABS)

LEUKERAN COMPRESSION-COATED 2MG THE WELLCOME UNITED KINGDOM TABLET FOUNDATION LTD.

LEUKERAN COMPRESSION-COATED 5MG THE WELLCOME UNITED KINGDOM TABLET FOUNDATION LTD.

LEUKERAN TABLETS 2MG TABLET 2MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD T/A GLAXO WELLCOME

LEVOMED 100/10MG TABLET N/A MEDOCHEMIE LTD CYPRUS

LEVOMED 250/25MG TABLET N/A MEDOCHEMIE LTD CYPRUS

LEVOPHED SOLUTION FOR 1MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

LEVOPHED SOLUTION FOR 4MG/4ML(1MG/ML) ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

LEVOPRONT SYRUP 0.6G/ML DOMPE FARMACEUTICI ITALY SPA

LEVOVIST GRANULES FOR N/A SCHERING AG GERMANY INJECTION

LEVSIN/SL TABLETS N/A SCHWARZ PHARMA INC UNITED STATES OF AMERICA

LEXILIUM 6 TABLETS 6MG REMEDICA LTD CYPRUS

LEXOMIL (BROMAZEPAM) TABLETS (30) 6MG ROCHE S.A. MOROCCO

LEXOMIL 3MG TABLET 3MG PRODUIT ROCHE S.A. MOROCCO 23.9.2003 FR Journal officiel de l'Union européenne 609

Trade Name Dosage Form Dose MA Holder Country

LIBERTY ASPIRIN TABLETS 300MG OBG PHARMACEUTICALS UNITED KINGDOM LTD

LIBERTY PARACETAMOL TABLETS 500MG OBG PHARMACEUTICALS UNITED KINGDOM LTD

LIBERTY 'PARACIN' FILM COATED TABLETS 500MG OBG PHARMACEUTICALS UNITED KINGDOM LTD

LIBRIUM CAPSULES 10MG CAPSULES 10MG ICN PHARMACEUTICALS UNITED KINGDOM LTD

LIBRIUM CAPSULES 5MG CAPSULES 5MG ICN PHARMACEUTICALS UNITED KINGDOM LTD

LIBROFEM FILM COATED TABLET 200MG EASTERN UNITED KINGDOM PHARMACEUTICALS LIMITED

LIBROFEM TABLETS FILM COATED TABLET 200MG EASTERN UNITED KINGDOM PHARMACEUTICALS LIMITED

LIDOCAINE (LIGNOCAINE) SOLUTION FOR 4%W/V INTERNATIONAL UNITED KINGDOM LARYNGOJET INJECTION MEDICATION SYSTEMS (UK) LIMITED

LIDOCAINE (LIGNOCAINE) MINIJET SOLUTION FOR 2%W/V INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS (UK) LIMITED

LIDOCAINE (LIGNOCAINE) MINJET SOLUTION FOR 1%W/V INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS (UK) LIMITED

LIDOCAINE 5%W/V AND TOPICAL SOLUTION N/A AURUM UNITED KINGDOM PHENYLEPHRINE 0.5%W/V PHARMACEUTICALS LIMITED

LIDOCAINE HCL AND SOLUTION FOR NA ABBOTT LABORATORIES UNITED STATES OF EPINEPHRINE INJ USP INJECTION AMERICA

LIDOCAINE HYDROCHLORIDE SOLUTION FOR 1G/50ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

LIDOCAINE INJECTION MINIJET AQUEOUS SOLUTION 10MG/ML INTERNATIONAL UNITED KINGDOM 1%W/V MEDICATION SYSTEMS LTD

LIDOCAINE INJECTION MINIJET AQUEOUS SOLUTION 20MG/1ML INTERNATIONAL UNITED KINGDOM 2%W/V MEDICATION SYSTEMS LTD

LIDOCAINE LARYNGOJET 4%W/V SOLUTION FOR TOPICAL 4%W/V INTERNATIONAL UNITED KINGDOM USE MEDICATION SYSTEMS LTD

LIDOCATON 2% 1:80 000 SOLUTION FOR N/A WEIMER PHARMA GMBH GERMANY INJECTION

LIFESOL 0.9% (NACL) IV SOLUTION SOLUTION FOR IV 0.9% W/V GEOFMAN PAKISTAN INJECTION PHARMACEUTICALS

LIFESOL 5% I.V. SOLUTION SOLUTION FOR IV 5% W/V GEOFMAN PAKISTAN (DEXTROSE 5%) INJECTION PHARMACEUTICALS

LIFUROX POWDER FOR IV/IM 250MG ELI LILLY ITALIA S.P.A. ITALY INJECT.

LIFUROX POWDER FOR IV/IM 750MG ELI LILLY ITALIA S.P.A. ITALY INJECT. 610 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LIFUROX POWDER FOR IV/IM 1500MG ELI LILLY ITALIA S.P.A. ITALY INJECT.

LIGNOCAINE 0.5% WITH AQUEOUS SOLUTION INJ N/A INTERNATIONAL UNITED KINGDOM ADRENALINE MEDICATION SYSTEMS LTD

LIGNOCAINE HCL INJ. WITH SOLUTION FOR N/A INTERNATIONAL UNITED KINGDOM ADRENALINE INJECTION MEDICATION SYSTEMS (UK) LIMITED

LIGNOCAINE HYDROCHLORIDE SOLUTION FOR 2.% W/V ANTIGEN IRELAND INJECTION PHARMACEUTICALS LTD

LIGNOCAINE HYDROCHLORIDE SOLUTION FOR BP 1.0% W/V ANITGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

LIGNOCAINE HYDROCHLORIDE SOLUTION FOR 2%W/V ANTIGEN IRELAND INJECTION INJECTION PHARMACEUTICALS LIMITED

LIGNOCAINE HYDROCHLORIDE SOLUTION FOR 2%W/V ANTIGEN IRELAND INJECTION INJECTION PHARMACEUTICALS LIMITED

LIGNOCAINE HYDROCHLORIDE SOLUTION FOR 2%W/V ANTIGEN IRELAND INJECTION INJECTION PHARMACEUTICALS LIMITED

LIGNOCAINE HYDROCHLORIDE SOLUTION FOR 1%W/V ANTIGEN IRELAND INJECTION INJECTION PHARMACEUTICALS LIMITED

LIGNOCAINE HYDROCHLORIDE SOLUTION FOR 1%W/V ANTIGEN IRELAND INJECTION INJECTION PHARMACEUTICALS LIMITED

LIGNOCAINE HYDROCHLORIDE SOLUTION FOR 1%W/V ANTIGEN IRELAND INJECTION INJECTIONS PHARMACEUTICALS LIMITED

LIGNOCAINE HYDROCHLORIDE SOLUTION FOR 1%W/V ANTIGEN IRELAND INJECTION INJECTION PHARMACEUTICALS LIMITED

LIGNOSPAN FORTE SOLUTION FOR N/A DEPROCO INC. UNITED STATES OF INJECTION AMERICA

LIGNOSPAN SPECIAL SOLUTION FOR N/A LABORATOIRES FRANCE INJECTION SEPTODONT

LIGNOSPAN STANDARD SOLUTION FOR N/A DEPROCO INC. UNITED STATES OF INJECTION AMERICA

LIMITROL TABLETS 10MG PHARMA EVO PAKISTAN

LINCOCIN CAPSULES 500MG PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

LINCOCIN SOLUTION FOR 600MG/2ML PHARMACIA & UPJOHN BELGIUM INJECTION N.V. / S.A.

LINDASOL SOLUTION FOR 1% W/V KLEVA LTD GREECE EXTERNAL USE

LIORESAL TABLETS 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LIORESAL TABLETS 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG 23.9.2003 FR Journal officiel de l'Union européenne 611

Trade Name Dosage Form Dose MA Holder Country

LIORESAL TABLETS 25MG NOVARTIS SPAIN FARMACEUTICA S.A

LIOTON «1000» GEL 100000 IU/100G SANOFI WINTHROP S.P.A. ITALY

LIPANTHYL 100MG CAPSULE 100MG LABORATOIRES FRANCE FOURNIER SCA

LIPANTHYL 200MG CAPSULE 200MG LABORATOIRES FRANCE FOURNIER SA

LIPANTHYL 300MG CAPSULE 300MG LABORATOIRES FRANCE FOURNIER SCA

LIPITOR COATED TABLETS 10MG WARNER LAMBERT IRELAND EXPORT LIMITED

LIPITOR COATED TABLETS 20MG WARNER LAMBERT IRELAND EXPORT LTD

LIPITOR COATED TABLETS 40MG WARNER LAMBERT IRELAND EXPORT LIMITED

LIPITOR TABLETS 10MG COATED TABLET 10MG WARNER LAMBERT UNITED KINGDOM EXPORT LTD T/A PARKE DAVIS RESEARCH LABS

LIPITOR TABLETS 40MG COATED TABLET 40MG WARNER LAMBERT UNITED KINGDOM EXPORT LTD T/A PARKE DAVIS RESEARCH LABS

LIPOBAY 0,4 FILM-COATED TABLET 0.4MG BAYER VITAL GMBH GERMANY

LIPOBAY 0.1 FILM-COATED TABLET 0.1MG BAYER VITAL GMBH & GERMANY CO. KG

LIPOBAY 0.2 FILM-COATED TABLET 0.2MG BAYER VITAL GMBH GERMANY

LIPOBAY 0.3 FILM-COATED TABLET 0.3MG BAYER VITAL GMBH GERMANY

LIPOFUNDIN MCT/LCT 10% EMULSION N/A B.BRAUN MELSUNGEN GERMANY AG

LIPOFUNDIN MCT/LCT 20% EMULSION N/A B.BRAUN MELSUNGEN GERMANY AG

LIPOFUNDIN N 10% EMULSION FOR INFUSION 100G/1000ML B.BRAUN MELSUNGEN GERMANY AG

LIPOFUNDIN N 20% EMULSION FOR INFUSION 200G/1000ML B.BRAUN MELSUNGEN GERMANY

LIPOFUNDIN S 10% EMULSION N/A B.BRAUN MELSUNGEN GERMANY AG

LIPOFUNDIN S 20% EMULSION N/A B.BRAUN MELSUNGEN GERMANY AG

LIPOGRASIL COATED TABLET N/A J.URIACH & CIA. S.A. SPAIN

LIPO-MERZ RETARD CAPSULES 500MG MERZ+CO. GMBH & CO. GERMANY

LIPOSTAT TABLETS 10MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

LIPOSTAT TABLETS 20MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

LIPOSTAT TABLETS 20MG BRISTOL-MYERS SQUIBB UNITED STATES OF COMPANY AMERICA

LIPOSTAT (SELECTIN) TABLETS 10MG BRISTOL-MYERS SQUIBB ITALY S.P.A 612 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LIPOSTAT (SELECTIN) TABLETS 20MG BRISTOL-MYERS SQUIBB ITALY S.P.A

LIPOSYN II 20% IV FAT EMULSION IV FAT EMULSION 20% ABBOTT LABORATORIES UNITED STATES OF AMERICA

LIPOSYN II INTRAVENOUS FAT INTRAVENOUS FAT N/A ABBOTT LABORATORIES UNITED STATES OF EMULSION EMULSION AMERICA

LIPOSYN III 10% INTRAVENOUS EMULSION 100MG/ML ABBOTT LABORATORIES UNITED STATES OF AMERICA

LIQUID PARAFFIN B.P. ORAL SOLUTION 100% V/V WILLIAM RANSOM & UNITED KINGDOM SON PLC

LIQUID PARAFFIN BP ORAL LIQUID 100%V/V LCM LTD UNITED KINGDOM

LIQUID PARAFFIN BP LIQUID 100% V/V PINEWOOD IRELAND LABORATORIES LTD T/A PINEWOOD HEALTHCARE

LISKOMET TABLET TABLET 250MG LISKO PAKISTAN

LISOCARD TABLETS 5MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

LISOCARD TABLETS 10MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

LISOPRIL TABLET 2.5MG DELTA HF ICELAND

LISOPRIL TABLET 5MG DELTA HF ICELAND

LISOPRIL TABLET 10MG DELTA HF ICELAND

LISOPRIL TABLET 20MG DELTA HF ICELAND

LISORIL-10 (LISINOPRIL TABLETS TABLET 10MG IPCA LABORATORIES INDIA USP) LIMITED

LISORIL-5 (LISINOPRIL TABLETS TABLET 5MG IPCA LABORATORIES INDIA USP) LIMITED

LISTERINE ANTISEPTIC LIQUID N/A WARNER-LAMBERT S.A. SOUTH AFRICA (PTY) LTD

LITHIMOLE EYE DROPS SOLUTION 0.25% W/V COOPER S.A. GREECE

LITHIMOLE EYE DROPS SOLUTION 0.5% W/V COOPER S.A. GREECE

LITHONATE CR 400MG CONTROLLED RELEASE 400MG APPROVED PRESCRIPTION UNITED KINGDOM TABLET SERVICES LTD

LIVIAL TABLETS 2.5MG TABLET 2.5MG ORGANON UNITED KINGDOM LABORATORIES LIMITED

LIVOSTIN NASAL SPRAY 0.5MG/ML JANSSEN-CILAG N.V. BELGIUM

LIVOSTIN EYE DROPS 0.5MG/ML JANSSEN-CILAG N.V. BELGIUM

LOBELIA TABLETS COATED TABLET N/A CATHAY OF UNITED KINGDOM BOURNEMOUTH LTD

LOCABIOTAL 1% NASAL/BUCCAL INHAL. 1% W/V LABORATOIRES SERVIER FRANCE SOLN.

LOCACORTEN — VIOFORM EAR DROPS N/A NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG 23.9.2003 FR Journal officiel de l'Union européenne 613

Trade Name Dosage Form Dose MA Holder Country

LOCACORTEN-VIOFORM CREAM N/A NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LOCASALEN OINTMENT N/A NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LOCERYL CREAM CREAM 0.25%W/W GALDERMA (UK) UNITED KINGDOM LIMITED

LOCERYL NAIL LACQUER 5% TOPICAL SOLUTION 5%W/V GALDERMA (UK) UNITED KINGDOM LIMITED

LOCOID LIPOCREAM 1MG/G YAMANOUCHI PHARMA NETHERLANDS B.V.

LOCOID OINTMENT 1MG/G YAMANOUCHI PHARMA NETHERLANDS B.V.

LOCOID CREAM 1MG/G YAMANOUCHI PHARMA NETHERLANDS B.V.

LOCOID C CREAM CREAM N/A YAMANOUCHI PHARMA UNITED KINGDOM LIMITED

LOCOID CRELO 0.1% TOPICAL EMULSION 1MG/G YAMANOUCHI PHARMA NETHERLANDS B.V.

LOCOID SCALP LOTION 1MG/ML YAMANOUCHI PHARMA NETHERLANDS B.V.

LOGYNON COATED TABLET N/A SCHERING AG GERMANY

LOGYNON (SH B 264 AB) COATED TABLET N/A SCHERING HEALTH CARE UNITED KINGDOM LIMITED

LOMAC -20 CAPSULES 20MG CIPLA INDIA

LOMARIN TABLETS 50MG GEYMONAT SPA ITALY

LOMARIN TABLETS 50MG GETMONAT SPA ITALY

LOMEXIN VAGINAL CREAM 2G/100G RECORDATI INDUSTRIA ITALY CHIMICA FARMACEUTICA S.P.A.

LOMEXIN DERMATOLOGICAL 2G/100G RECORDATI INDUSTRIA ITALY POWDER CHIMICA FARMACEUTICA S.P.A.

LOMEXIN VAGINAL SOLUTION 0.2G/100ML RECORDATI INDUSTRIA ITALY CHIMICA FARMACEUTICA S.P.A.

LOMEXIN SOLUTION, SPRAY 2G/100G RECORDATI INDUSTRIA ITALY CHIMICA FARMACEUTICA S.P.A.

LOMEXIN CREAM 2G/100G RECORDATI INDUSTRIA ITALY CHIMICA FARMACEUTICA S.P.A.

LOMEXIN «T» VAGINAL 1000MG RECORDATI INDUSTRIA ITALY OVULE(CAPSULE) CHIMICA FARMACEUTICA S.P.A.

LOMEXIN SOLUTION 2G/100ML RECORDATI INDUSTRIA ITALY CHIMICA FARMACEUTICA S.P.A.

LOMEXIN VAGINAL 200MG RECORDATI INDUSTRIA ITALY OVULE(CAPSULE) CHIMICA FARMACEUTICA S.P.A. 614 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LOMEX-T GASTRO RESISTANT 20MG OMEGA FARMA ICELAND TABLETS

LOMIR TABLETS 2.5MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LOMIR SRO CAPSULES 5MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LOMOTIL TABLETS N/A MONSANTO PLC UNITED KINGDOM

LOMOTIL TABLETS 2.5MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

LOMOTIL TABLETS N/A SEARLE PAKISTAN

LOMOTIL TABLETS N/A GOLDSHIELD UNITED KINGDOM PHARMACEUTICALS LIMITED T/A GOLDSHIELD PHARMACEUT

LONITEN TABLETS 10MG PHARMACIA LIMITED UNITED KINGDOM

LONITEN 10MG TABLET 10MG PHARMACIA & UPJOHN CANADA INC.

LOPAMID CAPSULE 2MG THE ACME BANGLADESH LABORATORIES LTD.

LOPEDIUM CAPSULE 2MG HEXAL AG GERMANY

LOPERAMIDE CAPSULES 2MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

LOPERAMIDE 2MG CAPSULES 2MG APPROVED UNITED KINGDOM PRESCRIPTION SERVICES LTD

LOPERAMIDE COATED TABLETS COATED TABLET 2MG LABORATORIO CHILE 2MG BENGUEREL LTDA

LOPERAMIDE HYDROCHLORIDE TABLETS 2MG PHARMAMED LTD. GERMANY

LOPERAMIDE HYDROCHLORIDE CAPSULES 2MG GENERICS (UK) LIMITED UNITED KINGDOM

LOPERAN CAPSULES 2MG CHIESI ESPANA S.A. SPAIN

LOPERAN 2MG CAPSULE 2MG CHIESI WASSERMANN SPAIN S.A.

LOPID 600 FILMCOATED TABLET 600MG PARKE-DAVIS GMBH GERMANY

LOPRESOR FILM COATED TABLETS 100MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LOPRESS 12.5 MG, TABLETS TABLETS 12.5 MG OMEGA FARMA EHF. ICELAND

LOPRESS 50 MG, TABLETS TABLETS 50 MG OMEGA FARMA EHF. ICELAND

LORANS 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS

LORANS 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS

LORAZEPAM TABLETS 1MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

LORAZEPAM TABLETS 2.5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 615

Trade Name Dosage Form Dose MA Holder Country

LORELIN DEPOT POWDER FOR INJECTION N/A DONG KOOK PHARM. KOREA REPUBLIC CO. LTD

LORITIN TABLET 10MG DELTA HF ICELAND

LOSEC GASTRO-RESISTANT 10MG HASSLE LAKEMEDEL AB SWEDEN CAPSULES

LOSEC CAPSULES 20MG ASTRA UNITED KINGDOM PHARMACEUTICALS LIMITED

LOSEC MUPS GASTRO-RESISTANT 10MG HASSLE LAKEMEDEL AB SWEDEN TABLETS

LOSEC MUPS GASTREO-RESISTANT 20MG HASSLE LAKEMEDEL AB SWEDEN TABLETS

LOSEC MUPS GASTRO-RESISTANT 40MG HASSLE LAKEMEDEL AB SWEDEN TABLETS

LOTRIDERM CREAM N/A SCHERING-PLOUGH S.A. BELGIUM

LUBEX LIQUID SKIN CLEANSING 30MG/G PERMAMED AG SWITZERLAND EMULSION

LUBEXYL SUSPENSION 40MG/G PERMAMED AG SWITZERLAND

LUCRIN DEPOT POWDER FOR INJECTION 11.25MG/2ML ABBOTT AG SWITZERLAND

LUCRIN DEPOT 3.75MG SOLUTION FOR 3.75MG/VIAL ABBOTT LABORATORIES SPAIN INJECTION S.A

LUDIOMIL FILM COATED TABLETS 25MG NOVARTIS SPAIN FARMACEUTICA S.A.

LUDIOMIL FILM COATED TABLETS 10MG NOVARTIS SPAIN FARMACEUTICA S.A.

LUDIOMIL FILM COATED TABLETS 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LUDIOMIL FILM COATED TABLETS 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

LUDIOMIL TABLET 10MG CIBA PAKISTAN

LUDIOMIL TABLET 25MG CIBA PAKISTAN

LUDIOMIL SOLUTION FOR N/A NOVARTIS PHARMA AUSTRIA INJECTION GMBH

LUMAREN INJECTABLE SOLUTION 50MG/2ML ELPEN PHARM. CO. INC. GREECE

LUMAREN COATED TABLET 150MG ELPEN PHARM. CO., INC. GREECE

LUMIGAN OPHTALMIC SOLUTION 0.03% ALLERGAN INC UNITED STATES OF AMERICA

LUSTRAL TABLET 100MG PFIZER LIMITED UNITED KINGDOM

LUSTRAL TABLET 50MG PFIZER LIMITED UNITED KINGDOM

LUSTYS GARLIC PERLES CAPSULE 0.66MG G R LANE HEALTH PRO- UNITED KINGDOM DUCTS LTD

LUTENYL TABLET 5MG LABORATOIRES THERA- FRANCE MEX

LUTRAX SOLUTION 0.15MG/ML ALCON LABORATORIOS, MEXICO S.A. DE C.V. 616 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

LYCLEAR 1% W/W CREME RINSE CREAM 1% W/W GLAXO WELLCOME UK UNITED KINGDOM LIMITED

LYOVAC COSMEGEN INJECTION POWDER FOR INJECTION 0.5MG MERCK SHRP & DOHME NETHERLANDS 0.5MG B.V.

LYSPAFEN TABLET N/A JANSSEN-CILAG AG SWITZERLAND

MAALOX SUSPENSION NA RORER IRELAND PHARMACEUTICALS LIMITED

MAALOX «PLUS» TABLETS N/A RHONE POULENC RORER ITALY S.P.A.

MAALOX NO.2 TABLET N/A RORER UNITED KINGDOM PHARMACEUTICALS LTD. (T/A RHONE POULENC RORER)

MAALOX PLUS TABLET N/A RORER UNITED KINGDOM PHARMACEUTICALS LTD. (T/A RHONE POULENC RORER)

MAALOX PLUS SUSPENSION N/A RORER UNITED KINGDOM PHARMACEUTICALS LTD. (T/A RHONE POULENC RORER)

MAALOX PLUS TABLETS N/A RORER UNITED KINGDOM PHARMACEUTICALS

MAALOX PLUS SUSPENSION NA RORER IRELAND PHARMACEUTICALS LIMITED

MAALOX TC (THERAPEUTIC SUSPENSION N/A RORER UNITED KINGDOM CONCENTRATION) PHARMACEUTICALS LTD. (T/A RHONE POULENC RORER)

MAALOX TC (THERAPEUTIC TABLET N/A RORER UNITED KINGDOM CONCENTRATION) PHARMACEUTICALS LTD. (T/A RHONE POULENC RORER)

MABRON 50MG CAPSULE 50MG MEDOCHEMIE LTD CYPRUS

MABTHERA SOLUTION SOLUTION(VIALS) 100MG,500MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) LTD.

MACOREL CONTROLLED RELEASE 20MG/CAP ELPEN PHARM. CO. INC. GREECE CAPS

MACOX ZH JR TABLETS N/A MACLEODS INDIA PHARMACEUTICALS LTD

MACOX-150 TABLET 150MG MACLEODS INDIA

MACOX-150 CAPSULES 150MG MACLEODS INDIA PHARMACEUTICALS LTD

MACOX-300 TABLET 300MG MACLEODS INDIA PHARMACEUTICALS LTD

MACOX-300 CAPSULES 300MG MACLEODS INDIA PHARMACEUTICALS LTD

MACOX-450 CAPSULES 450MG MACLEODS INDIA PHARMACEUTICALS LTD 23.9.2003 FR Journal officiel de l'Union européenne 617

Trade Name Dosage Form Dose MA Holder Country

MACOX-ZH TABLETS N/A MACLEODS INDIA PHARMACEUTICALS LTD

MACRODANTIN CAPSULES 50MG PROCTOER & GAMBLE UNITED KINGDOM PHARMACEUTICALS UK LIMITED

MACRODANTIN CAPSULES 100MG PROCTER & GAMBLE UNITED KINGDOM PHARMACEUTICALS UK LIMITED

MACROZIDE-500 TABLET 500MG MACLEODS INDIA

MACROZIDE-750 TABLET 750MG MACLEODS INDIA PHARMACEUTICALS LTD

MADOPAR 250MG TABLET N/A ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

MAG. PHOS. 6X NEW ERA TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM BIOCHEMIC NO.8 NO.8 LABORATORIES LIMITED

MAGNESIA SAN PELLEGRINO ORAL POWDER 900MG/G SAPROCHI SA SWITZERLAND (ANISE FLAVOUR)

MAGNESIA SAN PELLEGRINO ORAL POWDER 4.5G/10G SAPROCHI SA SWITZERLAND (LEMON FLAVOUR)

MAGNESIUM COMPLEXE CAPSULE N/A LABORATOIRE GOLAZ SWITZERLAND SA

MAGNESIUM COMPLEXE CAPSULES CAPSULES NA LABORATOIRES GOLAZ SWITZERLAND SA

MAGNESIUM SULPHATE BP SOLUTION FOR N/A EVANS MEDICAL LIMITED UNITED KINGDOM INJECTION

MAGNESIUM SULPHATE BP ORAL POWDER 100%W/W LCM LTD UNITED KINGDOM

MAGNESIUM SULPHATE PASTE BP PASTE N/A LCM LTD UNITED KINGDOM

MAGNESIUM SULPHATE PASTE BP PASTE N/A LCM LTD UNITED KINGDOM

MAGNESIUM SULPHATE PASTE BP PASTE N/A LCM LTD UNITED KINGDOM

MAGNESIUM TRISILICATE BP ORAL SUSPENSION N/A LCM LTD UNITED KINGDOM

MAGNESIUM TRISILICATE CO. BP TABLETS N/A SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

MAGNEVIST SOLUTION FOR IV 469MG/ML SCHERING AG GERMANY INJECTION

MAGNEVIST SOLN. FOR IV INJECTION 469MG/ML SCHERING AG GERMANY

MAGRILAN 20MG CAPSULE 20MG MEDOCHEMIE LTD CYPRUS

MAGUROL 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS

MANNITOL SOLUTION FOR 10% W/V BP GALEN RESEARCH UNITED KINGDOM INJECTION LABORATORIES LIMITED

MANNITOL 20% IV INFUSION SOLUTION FOR 200G/1L BAXTER HEALTHCARE UNITED KINGDOM INJECTION LIMITED

MANNITOL INTRAVENOUS SOLUTION FOR 150G/1000ML BAXTER HEALTHCARE UNITED KINGDOM INFUSION 15%W/V INJECTION LIMITED

MANNITOL INTRAVENOUS SOLUTION FOR 10%W/V BAXTER HEALTHCARE UNITED KINGDOM INFUSON 10%W/V INJECTION LIMITED 618 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MANNITOL IV INFUSION SOLUTION FOR 20%BP FRESENIUS LIMITED UNITED KINGDOM POLYFUSOR M 20%BP INJECTION

MANNITOL/DEMO SOLUTION FOR IV INFU- 200MG (20% W/V) DEMO SA GREECE SION

MANNS KNOBLAUCH PILLEN PLUS COATED TABLET N/A DR. GERHARD MANN, GERMANY CHEM.-PHARM. FABRIK GMBH

MANUSEPT ANTIBACTERIAL HAND TOPICAL SOLUTION N/A SETON PRODUCTS LTD UNITED KINGDOM RUB

MARCAIN SOLUTION FOR 2.5MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION

MARCAIN SOLUTION FOR 5MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION

MARCAIN ADRENALIN SOLUTION FOR N/A ASTRA LAKEMEDEL AB SWEDEN INJECTION

MARCAIN ADRENALIN SOLUTION FOR N/A ASTRA LAKEMEDEL AB SWEDEN INJECTION

MARCAIN HEAVY SOLUTION FOR 5MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION

MARCAIN HEAVY SOLUTION FOR 5MG/ML ASTRAZENECA SVERIGE SWEDEN INJECTION AB

MARCAIN SPINAL SOLUTION FOR 5MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION

MAREVAN TABLET 3 MG GOLDSHIELD GROUP PLC UNITED KINGDOM T/A GOLDSHIELD PHAR- MACEUTICALS

MAREVAN TABLETS 1 MG GOLDSHIELD GROUP PLC UNITED KINGDOM T/A GOLDSHIELD PHAR- MACEUTICALS

MAREVAN TABLETS 5 MG GOLDSHIELD GROUP PLC UNITED KINGDOM T/A GOLDSHIELD PHAR- MACEUTICALS

MARVELON TABLETS 0.15MG AND ORGANON UNITED KINGDOM 0.03MG LABORATORIES

MARVELON 150/30 TABLETS TABLET N/A ORGANON UNITED KINGDOM LABORATORIES LIMITED

MASTER-AID DISINFETTANTE CUTANEOUS SOLUTION 1G/100ML PIETRASANTA PHARMA ITALY S.R.L.

MATERNA TAB TABLETS N/A WYETH-AYERST CANADA CANADA INC.

MAXEPA CAPSULE N/A SEVEN SEAS LIMITED UNITED KINGDOM

MAXIDEX OPHTHALMIC SUSPEN- 1MG/ML S.A. ALCON-COUVREUR BELGIUM SION N.V.

MAXIDEX OPHTHALMIC OINTMENT 1MG/G S.A. ALCON-COUVREUR BELGIUM N.V.

MAXIMUM STRENGTH ANADIN TABLETS N/A WHITEHALL UNITED KINGDOM LABORATORIES LTD

MAXIMUM STRENGTH ASPRO EFFERVESCENT TABLET 500MG ROCHE PRODUCTS UNITED KINGDOM CLEAR LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 619

Trade Name Dosage Form Dose MA Holder Country

MAXIPIME POWDER FOR INJECTION 1000MG/3ML BRISTOL MYERS SQUIBB ITALY S.P.A

MAXIPIME POWDER FOR INJECTION 500MG/1.5ML BRISTOL MYERS SQUIBB ITALY S.P.A

MAXIPIME INJECTION 2G POWDER FOR INJECTION 2G BRISTOL-MYERS SQUIBB ITALY PHARMACEUTICALS LTD

MAXITROL OPHTHALMIC SUSPEN- N/A S.A. ALCON-COUVREUR BELGIUM SION N.V.

MAXITROL OPHTHALMIC OINTMENT N/A S.A. ALCON-COUVREUR BELGIUM N.V.

MAXIVALET SUGAR COATED TABLETS 10MG DEMO ABEE GREECE

MAXOLON TABLET 10MG SMITH KLINE BEECHAM PAKISTAN

MAXOLON TABLET 10MG SMITH KLINE & PAKISTAN BEECHAM

MAXOLON INJECTION 5MG/ML SOLUTION FOR 0.5% W/V MONMOUTH UNITED KINGDOM INJECTION PHARMACEUTICALS LTD

MAXOLON PAEDIATRIC LIQUID ORAL SOLUTION 1MG/ML MONMOUTH UNITED KINGDOM PHARMACEUTICALS LTD

MAXOLON TABLETS 10MG TABLET 10MG MONMOUTH UNITED KINGDOM PHARMACEUTICALS LTD

MCP HEXAL 10 TABLET 10MG HEXAL AG GERMANY

MCP-RATIOPHARM SOLUTION 5.2MG/ML RATIOPHARM GMBH GERMANY

MCP-RATIOPHARM 10 SUPPOSITORY 10MG RATIOPHARM GMBH GERMANY

MCP-RATIOPHARM 10 TABLETTEN TABLET 10MG RATIOPHARM GMBH GERMANY

MDS NORDION S.A. TECHNETIUM INTRAVENOUS INJECTION NA BRISTOL=MYERS SQUIBB BELGIUM (TC-99M) GEN PHARMA BELGIUM S.A.

MEASLES AND RUBELLA VIRUS POWDER FOR INJECTION N/A SERUM INSTITUTE OF INDIA VACCINE LIVE INDIA LTD

MEASLES MUMPS AND RUBELLA FREEZE DRIED CAKE F/INJ N/A M/S SERUM INSTITUTE OF INDIA LIVE ATTENUATED INDIA LIMITED

MEASLES VACCINE LIVE ATTENUA- POWDER FOR INJECTION 1000 CCID50 SERUM INSTITUTE OF INDIA TED INDIA LTD

MEASLES, MUMPS AND RUBELLA POWDER FOR INJECTION N/A SERUM INSTITUTE OF INDIA VACCINE INDIA LTD.

MEBEVERINE TABLETS BP 135MG FILM COATED TABLETS 135MG GENERICS (UK) LIMITED UNITED KINGDOM

MECLON CREAM N/A FARMIGEA SPA ITALY

MECLON VAGINAL PESSARY N/A FARMIGEA SPA ITALY

MECLON «1000» VAGINAL DOUCHE, N/A FARMIGEA SPA ITALY SOLUTION

MECLON «1000» VAGINAL CREAM N/A FARMIGEA SPA ITALY

MEDAXONE 1G POWDER FOR INJECTION 1G MEDOCHEMIE LTD CYPRUS

MEDAXONUM PWDR FOR INJ WITH 1G MEDOCHEMIE LTD. CYPRUS SOLVENT 620 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MEDAXONUM 500MG POWDER FOR INJ 500MG/VIAL MEDOCHEMIE LTD CYPRUS +SOLVENT

MEDIANOX CAPSULE 500MG DR.GROSSMANN AG SWITZERLAND PHARMACA

MEDIATOR 150MG COATED TABLET 150MG LABORATOIRES SERVIER FRANCE

MEDICAID ANTISEPTIC CREAM CREAM 0.5%W/W EASTERN UNITED KINGDOM PHARMACEUTICALS LIMITED

MEDIJEL GEL DENTAL GEL N/A D D D LIMITED UNITED KINGDOM

MEDIJEL PASTILLES LOZENGE N/A D D D LIMITED UNITED KINGDOM

MEDI-KEEL A THROAT LOZENGES LOZENGES N/A ADCOCK INGRAM LTD SOUTH AFRICA

MEDI-KEEL A THROAT SPRAY THROAT SPRAY 0.5G/100ML THE PREMIER SOUTH AFRICA PHARMACEUTICAL COMPANY LTD.

MEDINOL OVER 6 PARACETAMOL ORAL SUSPENSION 250 MG CUPAL LIMITED UNITED KINGDOM

MEDINOL OVER 6 PARACETAMOL ORAL SUSPENSION 250MG/5ML CUPAL LTD UNITED KINGDOM ORAL SUSPEN.

MEDINOL UNDER 6 ORAL SUSPENSION 120 MG CUPAL LIMITED UNITED KINGDOM PARACETAMOL

MEDINOL UNDER 6 SUSPENSION 120MG/5ML CUPAL LTD. UNITED KINGDOM PARACETAMOL ORAL SUSP BP

MEDOBETA OINTMENT 0.1%W/W MEDOCHEMIE LTD CYPRUS

MEDOBETA CREAM 0.1G/100G MEDOCHEMIE LTD CYPRUS

MEDOCIPRIN TABLETS 500MG MEDOCHEMIE LTD. CYPRUS

MEDOCIPRIN TABLET 250MG MEDOCHEMIE LTD CYPRUS

MEDOCLAZIDE 80MG TABLET 80MG MEDOCHEMIE LTD CYPRUS

MEDOCLOR 500MG CAPSULE 500MG MEDOCHEMIE LTD CYPRUS

MEDOCRIPTINE 10MG CAPSULE 10MG MEDOCHEMIE LTD CYPRUS

MEDOCRIPTINE 2.5MG TABLET 2.5MG MEDOCHEMIE LTD CYPRUS

MEDOCYCLINE 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

MEDODERMONE CREAM 0.05% W/W MEDOCHEMIE LTD CYPRUS

MEDODERMONE OINTMENT 0.05% W/W MEDOCHEMIE LTD CYPRUS

MEDOFED SYRUP N/A MEDOCHEMIE LTD CYPRUS

MEDOFLUCON 150MG CAPSULE 150MG MEDOCHEMIE LTD CYPRUS

MEDOFLUCON 50MG CAPSULE 50MG MEDOCHEMIE LTD CYPRUS

MEDOFULVIN 125MG TABLET 125MG MEDOCHEMIE LTD CYPRUS

MEDOFULVIN 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS

MEDOLAX TABLET 12MG MEDOCHEMIE LTD CYPRUS

MEDOLEXIN POWDER FOR 125MG/5ML MEDOCHEMIE LTD CYPRUS OR.SUSPENSION

MEDOLEXIN 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS 23.9.2003 FR Journal officiel de l'Union européenne 621

Trade Name Dosage Form Dose MA Holder Country

MEDOLEXIN 500MG CAPSULE 500MG MEDOCHEMIE LTD CYPRUS

MEDOLEXIN FORTE 250MG/5ML POWDER FOR OR. SUS- 250MG/5ML MEDOCHEMIE LTD CYPRUS PENSION

MEDOLIN 2MG/5ML SYRUP 2MG/5ML MEDOCHEMIE LTD CYPRUS

MEDOLIN 4MG TABLET 4MG MEDOCHEMIE LTD CYPRUS

MEDOMYCIN CAPSULE 100MG MEDOCHEMIE LTD CYPRUS

MEDONOL TABLET N/A MEDOCHEMIE LTD CYPRUS

MEDOPEN 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

MEDOPHENICOL 1G POWDER FOR INJECTION 1G MEDOCHEMIE LTD CYPRUS

MEDOPRAZOLE 20MG CAPSULE 20MG MEDOCHEMIE LTD CYPRUS

MEDOPRED 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

MEDOSTATIN TABLETS 20MG MEDOCHEMIE LTD. CYPRUS

MEDOVERINE 135MG FILM FILM COATED TABLETS 135MG MEDOCHEMIE LTD. — CYPRUS COATED TABLETS CYPRUS

MEDOVIR 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

MEDOVIR 250MG POWDER FOR INJECTION 250MG MEDOCHEMIE LTD CYPRUS

MEDOVIR 5% W/W CREAM 5% W/W MEDOCHEMIE LTD CYPRUS

MEDOVIR 800MG TABLET 800MG MEDOCHEMIE LTD CYPRUS

MEDOZINE 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

MEFEMIC CAPSULE CAPSULE 250MG CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD

MEFENAMIC ACID CAPSULES 250MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

MEFENAMIC ACID 500MG TABLETS COATED TABLET 500MG SANOFI WINTHROP UNITED KINGDOM LIMITED T/A STERWIN MEDICINES

MEFENAMIC ACID BP CAPSULES CAPSULES 250MG SANOFI WINTHROP T/A UNITED KINGDOM 250MG STERWIN MEDICINES

MEFINTER FILM COATED CAPLET 500MG PT INTERBAT INDONESIA

MEFLIAM TABLET 250MG CIPLA LTD INDIA

MEGAPRESS TABLET 5MG GENEPHARM S.A. GREECE

MEGGEZONES LOZENGE N/A SCHERING-PLOUGH UNITED KINGDOM LIMITED

MELIANE COATED TABLET N/A LABORATOIRES FRANCE SCHERING

MELLERIL FILM COATED TABLETS 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

MELLERIL FILM COATED TABLETS 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

MELLERIL TABLET 10MG SANDOZ PAKISTAN

MELLERIL TABLET 25MG SANDOZ PAKISTAN 622 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MELLERIL FILM-COATED TABLETS 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

MELLERIL FILM COATED TABLETS 100MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

MELLERIL COATED TABLETS 25MG NOVARTIS FARMA — PORTUGAL PRODUTOS FARMACEUTICOS S.A

MELLERIL COATED TABLETS 10MG NOVARTIS FARMA — PORTUGAL PRODUTOS FARMACEUTICOS S.A

MELLERIL 100MG TABLETS 100MG NOVARTIS PAKISTAN

MELLERIL 10MG TABLET 10MG NOVARTIS PAKISTAN

MELLERIL 25MG TABLET 25MG NOVARTIS PAKISTAN

MELOX TABLETS 7.5MG MEDOCHEMIE LTD. CYPRUS

MELOX TABLETS 15MG MEDOCHEMIE LTD. CYPRUS

MELOX SUPPOSITORIES 15MG MEDOCHEMIE LTD. CYPRUS

MELOX 15MG SUPPOSITORIES 15MG MEDOCHEMIE LTD CYPRUS

MENCEVAX (ACWY) POWDER FOR INJECTION N/A SMITHKLINE BEECHAM BELGIUM BIOLOGICALS

MENCEVAX AC POWDER FOR INJECTION N/A SMITHKLINE BEECHAM BELGIUM BIOLOGICALS

MENINGITEC SUSPENSION FOR 25MCG/0.5ML JOHN WYETH & UNITED KINGDOM INJECTION BROTHER LTD

MENINGITEC SUSPENSION FOR 25MCG JOHN WYETH & UNITED KINGDOM INJECTION BROTHER LIMITED T/A WYETH VACCINES

MENJUGATE POWDER FOR INJECTION N/A CHIRON S.P.A ITALY

MENOMUNE — A/C/Y/W-135 FREEZE-DRIED N/A AVENTIS PASTEUR, INC. UNITED STATES OF PREPARATION AMERICA

MENOMUNE-A/C/Y/W-135 COMBINED VACCINE N/A AVENTIS PASTEUR UNITED STATES OF AMERICA

MENOPHASE TABLET N/A MONSANTO PLC T/A UNITED KINGDOM SEARLE

MENTHODEX COUGH MIXTURE ORAL SOLUTION N/A BELL SONS & CO UNITED KINGDOM (DRUGGISTS) LIMITED

MENTHOLATUM ANTISEPTIC LOZENGE N/A THE MENTHOLATUM UNITED KINGDOM LOZENGE COMPANY LIMITED

MENTHOLATUM OINTMENT N/A THE MENTHOLATUM UNITED KINGDOM BALM/MENTHOLATUM VAPOUR COMPANY LIMITED RUB

MENTHOLATUM DEEP HEAT RUB CREAM N/A THE MENTHOLATUM UNITED KINGDOM COMPANY LIMITED

MENTHOLATUM NASAL INHALER INHALATION SOLUTION N/A THE MENTHOLATUM UNITED KINGDOM COMPANY LIMITED

MENTHOLATUM/SUPERDRUG TOPICAL SPRAY N/A THE MENTHOLATUM UNITED KINGDOM HEAT SPRAY COMPANY LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 623

Trade Name Dosage Form Dose MA Holder Country

MENZZA CREAM N/A HOE PHARMACEUTICALS MALAYSIA SDN BHD

MEPHAMYCIN LACTAB 250MG MEPHA PHARMA AG SWITZERLAND

MEPHAMYCIN LACTAB 500MG MEPHA PHARMA AG SWITZERLAND

MEPHAMYCIN SUSPENSION 200MG/5ML MEPHA PHARMA AG SWITZERLAND

MEPHAQUIN LACTAB 250MG MEPHA PHARMA AG SWITZERLAND

MEPIVASTESIN INJECTION SOLUTION 30MG/ML ESPE DENTAL AG GERMANY

MERCILON TABLETS 150UG AND 20UG ORGANON UNITED KINGDOM LABORATORIES

MERCILON TABLETS TABLET N/A ORGANON UNITED KINGDOM LABORATORIES LIMITED

MERESA 200 TABLET 200MG DOLORGIET GMBH & CO. GERMANY KG

MERESA 50 CAPSULE 50MG DOLORGIET GMBH & CO. GERMANY KG

MEROCAINE LOZENGES N/A MARION MERRELL LTD UNITED KINGDOM

MEROCETS LOZENGES LOZENGE 1.4MG SETON PRODUCTS UNITED KINGDOM LIMITED

MERONEM POWDER FOR INJECTION 500MG ZENECA LIMITED UNITED KINGDOM

MERONEM POWDER FOR INJECTION 1G ZENECA LIMITED UNITED KINGDOM

MERONEM POWDER FOR INJECTION 250MG/VIAL ZENECA LIMITED UNITED KINGDOM

MERONEM POWDER FOR IM 500MG ZENECA LIMITED UNITED KINGDOM INJECTION

MERONEM POWDER FOR INJECTION 1G ZENECA LIMITED UNITED KINGDOM

MERONEM POWDER FOR IV 500MG ZENECA LIMITED UNITED KINGDOM INJECTION

MESAGIN ENTERIC COATED 400MG KLEVA LTD GREECE TABLETS

MESONEX TABLET 50MG ADELCO SA GREECE

MESONEX TABLETS 100MG ADELCO GREECE CHROMATOURGIA ATHINON E. COLOCOTRONIS BROS S.A.

MESTINON TABLET 60MG ROCHE PAKISTAN

MESTINON TABLETS 60MG TABLET 60MG ICN PHARMACEUTICALS UNITED KINGDOM LIMITED

MESTINON TABLETS 60MG TABLET 60MG ICN PHARMACEUTICALS UNITED KINGDOM LIMITED

METADOXIL TABLET 500MG LFD MANUFACTURING THAILAND LIMITED

META-IODOBENZYLGUANIDINE SOLUTION FOR N/A NYCOMED AMERSHAM UNITED KINGDOM (131-I) INJECTIONS PLC

META-IODOBENZYLGUANIDINE SOLUTION FOR 18.5MB/ML AMERSHAM PLC UNITED KINGDOM (131-I) FOR DIAGNOSTIC USE INJECTIONS 624 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

METALYSE POW AND SOLVENT F/ S. 8,000 U BOEHRINGER INGELHEIM GERMANY F/INJ INTERNATIONAL GMBH

METALYSE POW AND SOLV F/SOL F/ 10,000 U BOEHRINGER INGELHEIM GERMANY INJ INTERNATIONAL GMBH

METFORMIN — BMS TABLETS 500MG GEA LTD DENMARK

METFORMIN DENK 850 FILM COATED TABLETS 850MG E.DENK OHG GERMANY

METFORMIN TABLET TABLET 500MG CAMDEN INDUSTRIES (M) MALAYSIA SDN BHD

METFORMIN TABLETS BP TABLETS 500MG INTAS INDIA PHARMACEUTICALS LTD.

METHADONE MIXTURE ORAL SOLUTION 1MG/1ML MACARTHYS UNITED KINGDOM 1MG/1ML DTF LABORATORIES LIMITED

METHADONE MIXTURE DTF ORAL SOLUTION 0.1%W/V MARTINDALE UNITED KINGDOM 1MG IN 1ML PHARMACEUTICALS LTD

METHADONE ORAL SOLN. ORAL SOLUTION 1MG/ML ROSEMONT UNITED KINGDOM 1MG/1ML SUGAR FREE PHARMACEUTICALS LTD

METHOTREXATE INJECTION SOLUTION FOR 25MG/ML FAULDING UNITED KINGDOM 25MG/ML INJECTION PHARMACEUTICALS PLC

METHOTREXATE INJECTION SOLUTION FOR 5MG/2ML FAULDING UNITED KINGDOM 5MG/2ML INJECTION PHARMACEUTICALS PLC

METHOTREXATE INJECTION BP SOLUTION FOR 50MG/2ML PHARMACIA (PERTH) PTY. AUSTRALIA VIAL INJECTION LTD.

METHOTREXATE INJECTION VIAL SOLUTION FOR 5MG/2ML F.H. FAULDING & CO. LTD AUSTRALIA INJECTION (T/A DAVID BULL LABS)

METHOTREXATE SODIUM TABLETS TABLETS 2.5MG WYETH-AYERST UNITED STATES OF LABORATORIES AMERICA

METHOTREXATUM PHARMACIA SOLUTION FOR 25MG/1ML PHARMACIA NV/SA BELGIUM INJECTION

METHYL SALICYLATE OINTMENT OINTMENT 50%W/W THORNTON & ROSS LTD UNITED KINGDOM BP

METHYLDOPA BP 125MG TABLET 125MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

METHYLDOPA BP 250MG TABLET 250MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

METHYLDOPA BP 500MG TABLET 500MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

METHYLDOPA TABLETS FILM COATED TABLET 250MG CP PHARMACEUTICALS UNITED KINGDOM LIMITED

METHYLDOPA TABLETS BP 125MG TABLETS 125MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

METHYLDOPA TABLETS BP 125MG FILM COATED TABLET 125MG CP PHARMACEUTICALS UNITED KINGDOM LTD

METHYLDOPA TABLETS BP 250MG TABLETS 250MG CP PHARMACEUTICALS UNITED KINGDOM LTD. 23.9.2003 FR Journal officiel de l'Union européenne 625

Trade Name Dosage Form Dose MA Holder Country

METHYLDOPA TABLETS BP 500MG TABLETS 500MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

METHYLDOPA TABLETS BP 500MG FILM COATED TABLET 500MG CP PHARMACEUTICALS UNITED KINGDOM LTD

METHYLENE BLUE INJECTION USP SOLUTION FOR 1%W/V MARTINDALE UNITED KINGDOM 1% INJECTION PHARMACEUTICALS LTD

METHYLENE BLUE INJECTION USP SOLUTION FOR 1% W/V FAULDING UNITED KINGDOM 1% 5ML INJECTION PHARMACEUTICALS PLC

METHYLPREDNISOLONE INJ. VIAL POWDER FOR INJECTION 1G/VIAL F.H. FAULDING & CO. AUSTRALIA LTD. (T/A DAVID BULL LABS)

METHYLPREDNISOLONE MERCK POWDER FOR INJECTION 40MG MERCK GENERICS FRANCE

METHYLPREDNISOLONE SODIUM POWDER FOR INJECTION 500MG FAULDING UNITED KINGDOM SUCCINATE PHARMACEUTICALS PLC

METOCLOPRAMIDE INJECTION SOLUTION FOR 10MG/2ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

METOCLOPRAMIDE INJECTION BP SOLUTION FOR 10MG/2ML ANTIGEN IRELAND 10MG/2ML INJECTION PHARMACEUTICALS LIMITED

METOCLOPRAMIDE INJECTION USP SOLUTION FOR 10MG/2ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

METOLAR TABLETS 50MG CIPLA LIMITED INDIA

METOLAR 100 TABLETS 100MG CIPLA LIMITED INDIA

METOMIDE TABLET 10MG CAMDEN INDUSTRIES (M) MALAYSIA SDN BHD

METOPROLOL TARTARATE TABLET 100MG GENERICS (UK) LIMITED UNITED KINGDOM TABLETS 100MG

METOSYN CREAM 0.05% W/V ZENECA LIMITED UNITED KINGDOM

METOSYN FAPG CREAM CREAM 0.05% W / W BIOGLAN UNITED KINGDOM LABORATORIES LTD

METOSYN OINTMENT OINTMENT 0.05% W / W BIOGLAN UNITED KINGDOM LABORARORIES LTD

METRODIN HP 150IU POWDER FOR INJECTION 150IU HFSH/ML LABORATOIRES SERONO ITALY SA

METRODIN HP 75IU INJECTABLE 75IU HFSH/ML LABORATOIRES SERONO ITALY PREPARATION SA

METROGYL INJECTABLE SOLUTION 500MG/100ML COOPER S.A. GREECE

METROGYL 200 TABLET 200MG ALPHAPHARM PTY AUSTRALIA LIMITED

METROGYL 400 TABLET 400MG ALPHAPHARM PTY AUSTRALIA LIMITED

METROGYL INJECTION SOLUTION FOR 5MG/ML UNIQUE INDIA INJECTION PHARMACEUTICAL LABORATORIES

METROLYL SUPPOSITORIES 500MG LAGAP UNITED KINGDOM PHARMACEUTICALS LIMITED 626 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

METROLYL SUPPOSITORY 1G LAGAP UNITED KINGDOM PHARMACEUTICALS LIMITED

METRONIDAZOLE TABLETS 200MG NORTON UNITED KINGDOM HEALTHCARE LIMITED

METRONIDAZOLE TABLETS 400MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

METRONIDAZOLE TABLET 200MG CAMDEN INDUSTRIES(M) MALAYSIA SDN.BHD

METRONIDAZOLE TABLETS 200MG PHARMAMED LTD. MALTA

METRONIDAZOLE SOLUTION FOR 500MG/100ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

METRONIDAZOLE TABLET 200MG CIPLA LTD INDIA

METRONIDAZOLE INJECTION IV INFUSION SOLUTION 500MG/100ML B.BRAUN MELSUNGEN GERMANY 500MG/100ML AG

METRONIDAZOLE INJECTION, USP SOLUTION FOR 5MG/ML ABBOTT LABORATORIES UNITED STATES OF 500MG INJECTION AMERICA

METRONIDAZOLE INTRAVENOUS INTRAVENOUS INFUSION 5MG/ML VYSALI INDIA INFUSION BP PHARMACEUTICALS LIMI- TED

METRONIDAZOLE MERCK SOLUTION F/INF. IN A 0.5G/100ML MERCK GENERIQUES FRANCE VIAL

METRONIDAZOLE TABLETS BP TABLET 200MG TABLETS (INDIA) LIMITED INDIA TRICHOGYL-200

METROTOP GEL 0.8% W/V SETON PRODUCTS LTD UNITED KINGDOM

METVIX CREAM 160MG/G GALDERMA (UK) UNITED KINGDOM LIMITED

MEXETIL CAPSULES 200MG BOEHRINGER INGELHEIM GERMANY PHARMA KG

MIACALCIC NASAL SPRAY 200IU NOVARTIS SPAIN FARMACEUTICA S.A

MIACALCIC NASAL SPRAY 200IU NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

MIACALCIC SOLUTION FOR 100IU/ML NOVARTIS PHARMA SWITZERLAND INJECTION SCHWEIZ AG

MIANSERIN TABLETS 10MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

MIANSERIN 20MG TABLETS NORTON HEALTHCARE UNITED KINGDOM LIMITED

MIANSERIN TABLETS 30MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

MIANSERIN TABLETS 10MG REMEDICA LTD. CYPRUS

MIANSERIN TABLETS BP 10MG TABLET 10MG GENERICS (UK) LIMITED UNITED KINGDOM

MIANSERIN TABLETS BP 30MG COATED TABLETS 30MG GENERICS (UK) LTD. UNITED KINGDOM

MIBG-131-D SOLUTION FOR N/A CIS BIO INTERNATIONAL FRANCE INJECTION

MIBG-131-T SOLUTION FOR N/A CIS BIO INTERNATIONAL FRANCE INJECTION 23.9.2003 FR Journal officiel de l'Union européenne 627

Trade Name Dosage Form Dose MA Holder Country

MICANOL CREAM 1% CREAM 1% W / W BIOGLAN UNITED KINGDOM LABORATORIES

MICANOL CREAM 3% CREAM 3% W / W BIOGLAN UNITED KINGDOM LABORATORIES LTD

MICARDIS TABLET 40MG BOEHRINGER INGELHEIM GERMANY INTERNATIONAL GMBH

MICARDIS TABLETS 80MG BOEHRINGER INGELHEIN GERMANY INTERNATIONAL GMBH

MICARDIS PLUS TABLETS NA BOEHRINGER INGELHEIM EUROPEAN COMMUNITY

MICOGEL CREAM 2%W/W CIPLA LIMITED INDIA

MICONAL ECOBI CREAM 2% W/W FARMACEUTICI ECOBI ITALY S.A.S

MICONAL ECOBI POWDER (TOPICAL) 2% W/W FARMACEUTICI ECOBI ITALY SAS

MICONAL ECOBI VAGINAL CREAM 2% W/W FARMACEUTICI ECOBI ITALY S.A.S

MICONAL ECOBI VAGINAL OVULES 50MG FARMACEUTICI ECOBI ITALY S.A.S

MICONAL ECOBI VAGINAL SOLUTION N/A FARMACEUTICI ECOBI ITALY S.A.S

MICONAL ECOBI VAGINAL CAPSULES 1200MG FARMACEUTICI ECOBI ITALY S.A.S

MICROCIDAL — 125 TABLET 125MG PHARMACARE LIMITED SOUTH AFRICA

MICROENEMA RECTAL ENEMA NA ATCO LABORATORIES PAKISTAN (PVT) LTD

MICROGYNON COATED TABLET N/A SCHERING AG GERMANY

MICROGYNON COATED TABLET N/A SCHERING HEALTH CARE UNITED KINGDOM LIMITED

MICROLAX ENEMA, RECTAL N/A PHARMACIA SVERIGE AB SWEDEN SOLUTION

MICTRAL SACHETS GRANULES FOR ORAL N/A SANOFI WINTHROP UNITED KINGDOM SOLN. LIMITED

MIDAZOLAM 2MG/ML INJECTION SOLUTION FOR 2MG/ML PHOENIX PHARMA LTD UNITED KINGDOM INJECTION

MIDAZOLAM INJECTION BP SOLUTION FOR 5MG/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LIMITED

MIDAZOLAM INJECTION BP SOLUTION FOR 1MG/ML RANBAXY INDIA 1MG/ML INJECTION LABORATORIES LTD

MIDAZOLAM INJECTION BP SOLUTION FOR 5MG/ML RANBAXY INDIA 5MG/ML INJECTION LABORATORIES LTD.

MIDAZOLAM INJECTION BP SOLUTION FOR 5MG/ML CP PHARMACEUTICALS UNITED KINGDOM 5MG/ML INJECTION LTD

MIFLONIDE POWDER IN CAPSULES 200MCG NOVARTIS SPAIN FOR INHALATION FARMACEUTICA S.A

MIFLONIDE POWDER IN CAPSULES 400MCG NOVARTIS SPAIN FOR INHALATION FARMACEUTICA S.A 628 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MIFLONIDE 200 POWDER FOR 200MG NOVARTIS PHARMA SWITZERLAND INHALATION SCHWEIZ AG — SWITZERLAND

MIFLONIDE 400 POWDER FOR INHALTION 400MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG- SWITZERLAND

MIGRALEVE COATED TABLET N/A UNICLIFFE LIMITED T/A UNITED KINGDOM PFIZER CONSUMER HEALTHCARE

MIGRALEVE YELLOW COATED TABLET N/A UNICLIFFE LIMITED T/A UNITED KINGDOM PFIZER CONSUMER HEALTHCARE

MIGRALGINE ORAL SOLUTION N/A LABORATOIRES MARTIN- FRANCE JOHNSON & JOHNSON-MSD

MIGRALGINE CAPSULES N/A LABORATOIRES FRANCE JEAN-PAUL MARTIN

MIGRANERTON CAPSULE N/A DOLORGIET GMBH & CO. GERMANY KG

MIGRIL TABLETS N/A THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

MIGRIL TABLETS N/A GLAXO WELLCOME PAKISTAN

MILITHIN HARD CAPSULES 300MG MINERVA GREECE PHARMACEUTICAL S.A.

MILTEX SOLUTION FOR TOPICAL 600MG/10ML ASTA MEDICA AG GERMANY USE

MINADEX TONIC ORAL EMULSION N/A SEVEN SEAS LIMITED UNITED KINGDOM

MINESSE TABLETS NA JOHN WYETH & IRELAND BROTHER LIMITED T/A WYETH LABORATORIES

MINIDIAB TABLETS 5MG PHARMACIA & UPJOHN ITALY S.P.A.

MINIHEP SYRINGE N/A LEO LABORATORIES UNITED KINGDOM LIMITED

MINIHEP SOLUTION FOR 25,000IU/ML LEO PHARMACETICAL DENMARK INJECTION PRODUCTS

MINIMS ATROPINE SULPHATE 1% EYE DROPS 1%W/V CHAUVIN UNITED KINGDOM PHARMACEUTICALS LIMI- TED

MINIMS BENOXINATE EYE DROPS 0.4% W/V CHAUVIN UNITED KINGDOM HYDROCHLORIDE 0.4% W/V PHARMACEUTICALS LTD.

MINIMS CYCLOPENTOLATE EYE DROPS 1% W/V CHAUVIN UNITED KINGDOM HYDROCHLORIDE PHARMACEUTICALS LTD.

MINIMS FLUORESCEI SODIUM EYE DROPS 1% CHAUVIN UNITED KINGDOM PHARMACEUTICALS LIMITED

MINIMS METIPRANOLOL 0.3% W/V EYE DROPS 0.3% W/V CHAUVIN UNITED KINGDOM PHARMACEUTICALS LIMITED

MINIMS PHENYLEPHRINE EYE DROPS 10% W/V CHAUVIN UNITED KINGDOM HYDROCHLORIDE PHARMACEUTICALS LTD. 23.9.2003 FR Journal officiel de l'Union européenne 629

Trade Name Dosage Form Dose MA Holder Country

MINIMS PHENYLEPHRINE EYE DROPS 2.5% W/V CHAUVIN UNITED KINGDOM HYDROCHLORIDE SOL. PHARMACEUTICALS LTD.

MINIMS PILOCARPINE NITRATE EYE DROPS 2% W/V CHAUVIN UNITED KINGDOM 2.0% W/V PHARMACEUTICALS LIMITED

MINIMS TROPICAMIDE 0.5% W/V EYE DROPS 0.5% W/V CHAUVIN UNITED KINGDOM PHARMACEUTICALS LTD.

MINIMS TROPICAMIDE 1% W/V EYE DROPS 1% W/V CHAUVIN UNITED KINGDOM PHARMACEUTICALS LTD.

MINIRIN NASAL SPRAY 10MCG/DOSE FERRING AB SWEDEN

MINIRIN NASAL DROPS 0.1MG/ML FERRING AB SWEDEN

MINIRIN TABLETS 0.2MG FERRING AB SWEDEN

MINIRIN TABLETS 0.1MG FERRING AB SWEDEN

MINIRIN NASAL DROPS 0.1MG/ML FERRING AB SWEDEN

MINIRIN NASAL SPRAY 10MICROGRAMS/ FERRING AB SWEDEN DO

MINITRAN 10 TRANSDERMAL PATCH 10MG/24HOUR 3M HEALTH CARE UNITED KINGDOM LIMITED

MINITRAN 5, TRANSDERMAL PATCH 5MG/24HRS 3M HEALTH CARE UNITED KINGDOM LIMITED

MINOCIN CAPSULES 100MG LEDERLE LABORATORIES UNITED STATES OF AMERICA

MINOCIN CAPSULES 50MG LEDERLE LABORATORIES UNITED STATES OF AMERICA

MINOCYCLINE 100MG CAPSULES 100MG AEGIS LTD. CYPRUS

MINOCYCLINE 50MG CAPSULES 50MG AEGIS LTD. CYPRUS

MINOXIDIL TABLETS 10MG DANBURY PHARMACAL UNITED STATES OF INC. AMERICA

MINSK TABLET 10MG ANFARM HELLAS S.A. GREECE

MINULET COATED TABLETS N/A WYETH-PHARMA GMBH GERMANY

MINULET TABLETS NA JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES

MINULET TABLETS COATED TABLET N/A JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES —UK

MIOCAMEN GRANULES FOR SUSPEN- 20% W/W A.MENARINI INDUSTRIE ITALY SION FARMACEUTICHE RIU- NITE S.R.L.

MIOCAMEN 600MG TABLET 600MG A.MENARINI INDUSTRIE ITALY FARMACEUTICHE RIUNITE S.R.L.

MIOCHOL-E INTRAOCULAR SOLUTION 10MG/ML NOVARTIS SWITZERLAND OPHTHALMICS AG

MIOCHOL-E 1:100 WITH INTRAOCULAR SOLUTION N/A CIBA VISION UNITED STATES OF ELECTROLYTE DILUENT CORPORATION AMERICA 630 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MIOREL TABLETS 10MG KLEVA LIMITED GREECE

MIOSTAT INTRAOCULAR SOLUTION 0.01% W/V ALCON LABORATORIES UNITED STATES OF INC. AMERICA

MIOSTAT INTRAOCULAR SOLUTION 0.10 MG S.A ALCON COUVREUR BELGIUM N.V

MIOVISIN POWDER AND SOLUTION 20MG FARMIGEA SPA ITALY FOR INJ

MIRENA 20 MICROG/24H INTRAUTERINE SYSTEM 52MG LEIRAS OY FINLAND

MISODOMIN TABLETS 40MG KLEVA LIMITED GREECE

MITOCIN POWDER FOR INJECTION 2MG KOREA UNITED PHARM. KOREA REPUBLIC INC.

MITOCIN POWDER FOR INJECTION 10MG KOREA UNITED PHARM. KOREA REPUBLIC INC.

MITOMYCIN POWDER FOR INJECTION 10MG/VIAL FAULDING UNITED KINGDOM PHARMACEUTICALS PLC., T/A DAVID BULL LABO- RATORIES

MIVACRON INJECTION SOLUTION FOR 2MG/ML THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION LIMITED

MIVACRON INJECTION 2MG/ML SOLUTION FOR 2MG/ML THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION LIMITED

MIXTARD 30 HM 100IU/ML SUPENSION FOR NA NOVO NORDISK DENMARK 10 ML VIAL INJECTION

MIXTARD 30 HM PENFILL SOLUTION FOR NA NOVO NORDISK A/S DENMARK 100IU/ML 1.5ML INJECTION

MIZOLLEN S.R. 10MG SR COATED TABLET 10MG LABORATOIRES FRANCE SYNTHELABO

MMR-II-VAX VACCINE N/A MERCK SHARP & DOHME NETHERLANDS

MOBIC SUPPOSITORIES 7.5MG BOEHRINGER INGELHEIM GERMANY PHARMA KG

MOBIC SOLUTION FOR 15MG/1.5ML BOEHRINGER INGELHEIM GERMANY INJECTION INTERNATIONAL GMBH

MOBIC 15MG TABLETS 15MG BOEHRINGER INGELHEIM GERMANY PHARMA KG

MOBILAT CREAM N/A SANKYO PHARMA GMBH GERMANY

MOBILAT GEL N/A SANKYO PHARMA GMBH GERMANY

MOBILIS 20 CAPSULE 20MG ALPHAPHARM PTY AUSTRALIA LIMITED

MOBILIS D-20 DISPERSIBLE TABLET 20MG ALPHAPHARM PTY AUSTRALIA LIMITED

MOBILISIN CREAM N/A SANKYO PHARMA GMBH GERMANY

MODECATE SOLUTION FOR IM 25MG/ML BRISTOL MYERS SQUIBB ITALY INJECTION S.P.A.

MODITEN TABLETS 1MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

MODOPAR 125 CAPSULE N/A F. HOFFMANN- FRANCE LA ROCHE LTD. 23.9.2003 FR Journal officiel de l'Union européenne 631

Trade Name Dosage Form Dose MA Holder Country

MODOPAR 250 CAPSULE N/A F. HOFFMANN-LA ROCHE FRANCE LTD.

MODOPAR 62.5 CAPSULE N/A F. HOFFMANN-LA ROCHE FRANCE LTD.

MODOPAR LP 125 PROLONGED RELEASE N/A F. HOFFMANN-LA ROCHE FRANCE CAPSULE LTD.

MODURETIC TABLET N/A MERCK SHARP & DOHME PAKISTAN

MODURETIC TABLET N/A M.S.D. PAKISTAN

MODURETIC 5/50MG TABLET N/A MERCK SHARP & DOHME NETHERLANDS B.V.

MOGADON TABLETS 5MG TABLETS 5MG ICN PHARMACEUTICALS UNITED KINGDOM LTD

MOISTUR-EYES «DRY EYE» DROPS EYE DROPS 0.3% W/V CO-PHARMA LIMITED UNITED KINGDOM

MOLCER EAR DROPS 5%W/V WALLACE UNITED KINGDOM MANUFACTURING CHEMISTS LIMITED

MOMENDOL COMPRESSA RIVESTITA 220MG AZ.CHIM. RIUN ITALY ANGELINI FRANCESCO ACRAF S.P.A

MOMENDOL, GEL GEL NA AZ. CHIM. RIUN. ITALY ANGELINI FRANCESCO ACRAF SPA — ITALY

MOMENT 200, BLISTER 12 COMPRESSA RIVESTITA 200MG AZ. CHIM. RIUN. ITALY ANGELINI FRANCESCO ACRAF SPA — ITALY

MOMENT 200, BLISTER 24 COMPRESSA RIVESTITA 200MG AZ. CHIM. RIUN. ITALY ANGELINI FRANCESCO ACRAF SPA — ITALY

MOMENT 200, GOCCE ORALI GOCCE ORALI NA AZ. CHIM. RIUN. ITALY ANGELINI FRANCESCO ACRAF SPA-ITALY

MONO MACK 20MG TABLETS 20MG HEINRICH MACK NACHF GERMANY

MONO MACK 40MG TABLETS 40MG HEINRICH MACK NACHF GERMANY

MONO MACK DEPOT TABLETS W/SUST. ACTION 100MG HEINRICH MACK NACHF GERMANY

MONOCLOX 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

MONOLONG CAPSULES 60MG CTS CHEMICAL ISRAEL INDUSTRIES LTD.

MONOLONG 60MG CAPSULES CAPSULES 60MG CTS CHEMICAL ISRAEL INDUSTRIES LTD

MONOPARIN SOLUTION FOR 1000IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

MONOPARIN SOLUTION FOR 5000IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

MONOPARIN SOLUTION FOR 25000IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

MONOPARIN 1000IU/ML SOLUTION FOR 1000IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD 632 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MONOPARIN 25,000IU/ML SOLUTION FOR 25000 IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD

MONOPARIN 5000IU/ML SOLUTION FOR 5000 IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD

MONOPARIN CALCIUM SOLUTION FOR 25000IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

MONOPARIN-CA 25000 IU/ML SOLUTION FOR 25000 IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD

MONOPAS TABLET 1G MACLEODS INDIA PHARMACEUTICALS LTD

MONOPRIL (ELITEN) TABLETS 10MG BRISTOL MYERS SQUIBB ITALY S.P.A

MONOPRIL (ELITEN) TABLETS 20MG BRISTOL MYERS SQUIBB ITALY S.P.A

MONOSORDIL CONTROLLED RELEASE 60MG ELPEN PHARM. CO. INC. GREECE CAPS

MONOSORDIL TABLET 20MG ELPEN S.A GREECE

MONOTARD HM 100 IU/ML 10ML SUSPENSION FOR NA NOVO NORDISK A/S DENMARK VIAL INJECTION

MONO-TILDIEM SR 200MG SUSTAINED RELEASE 200MG LABORATOIRES FRANCE CAPSULE SYNTHELABO

MONO-TILDIEM SR 300MG SUSTAINED RELEASE 300MG LABORATOIRES FRANCE CAPSULE SYNTHELABO

MONOVAS 10MG TABLET TABLET 10MG MUSTAFA NEVZAT ILAC TURKEY SANAYII A.S.

MONOVENT ORAL SOLUTION 1.5MG/5ML LAGAP UNITED KINGDOM PHARMACEUTICALS LIMITED

MORPHINE SULPHATE INJECTION SOLUTION FOR 15MG/ML ANTIGEN IRELAND BP INJECTION PHARMACEUTICALS LIMITED

MORPHINE SULPHATE BP SOLUTION FOR 10 MG/ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

MORPHINE SULPHATE INJ. BP SOLUTION FOR 1%W/V MACARTHYS UNITED KINGDOM 10MG IN 1ML INJECTION LABORATORIES LIMITED

MORPHINE SULPHATE INJ. BP SOLUTION FOR 2%W/V PL 01883/6177R UNITED KINGDOM 20MG IN 1ML INJECTIONS

MORPHINE SULPHATE INJ.BP 15MG SOLUTION FOR 1.5%W/V MACARTHYS UNITED KINGDOM IN 1ML INJECTIONS LABORATORIES LIMITED

MORPHINE SULPHATE INJECTION SOLUTION FOR 10MG/1ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

MORPHINE SULPHATE INJECTION SOLUTION FOR 15MG/1ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

MORPHINE SULPHATE INJECTION SOLUTION FOR 60MG/2ML EVANS MEDICAL UNITED KINGDOM BP INJECTION LIMITED

MORPHINE SULPHATE INJECTION SOLUTION FOR 30MG/ML EVANS MEDICAL LIMITED UNITED KINGDOM BP INJECTION 23.9.2003 FR Journal officiel de l'Union européenne 633

Trade Name Dosage Form Dose MA Holder Country

MORPHINE SULPHATE INJECTION SOLUTION FOR 15MG/ML EVANS MEDICAL UNITED KINGDOM BP INJECTION LIMITED

MORPHINE SULPHATE INJECTION, SOLUTION FOR 15.45G/L ABBOTT LABORATORIES UNITED STATES OF USP INJECTION AMERICA

MORPHINE SUPHATE INJECTION BP SOLUTION FOR 10MG/ML EVANS MEDICAL UNITED KINGDOM INJECTION LIMITED

MOTHERWORT COMPOUND COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM TABLETS

MOTILIUM TABLET 10MG JANSSEN PAKISTAN

MOTILIUM TABLET 10MG JANSSEN PAKISTAN

MOTILIUM SUSPENSION 1MG/ML JANSSEN PAKISTAN

MOTILIUM 10MG TABLET 10MG JANSSEN-CILAG N.V. BELGIUM

MOTILIUM 1MG/ML SUSPENSION 1MG/ML JANSSEN-CILAG N.V. BELGIUM

MOTILIUM BABY SUPPOSITORY 10MG JANSSEN-CILAG N.V. BELGIUM

MOTILIUM CHILDREN SUPPOSITORY 60MG JANSSEN-CILAG N.V. BELGIUM

MOTILIUM CHILDREN SUPPOSITORY 30MG JANSSEN-CILAG N.V. BELGIUM

MOTILIUM SYRUP SYRUP 1MG/ML JANSSEN PAKISTAN

MOTIPRESS TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM

MOTIVAL TABLETS N/A E.R. SQUIBB & SONS LTD UNITED KINGDOM

MOTIVAL TABLETS N/A BRISTOL MYERS SQUIBB EGYPT

MOVICOL POWDER FOR ORAL N/A LABORATOIRES FRANCE SOLUTION NORGINE PHARMA

MOVICOL POWDER FOR ORAL N/A NORGINE LIMITED UNITED KINGDOM SOLUTION

MOXEN 250 CAPSULES 250MG AEGIS LTD. CYPRUS

MOXEN 500 CAPSULES 500MG AEGIS LTD. CYPRUS

MOXICLAV POWDER FOR 156.25MG/5ML MEDOCHEMIE LTD CYPRUS OR.SUSPENSION

MOXICLAV 375MG TABLET N/A MEDOCHEMIE LTD CYPRUS

MOXICLAV 625MG TABLET N/A MEDOCHEMIE LTD CYPRUS

MOXICLAV FORTE DRY POWDER FOR 312MG/5ML MEDOCHEMIE LTD. CYPRUS SUSPENSION

MOXILEN POWDER FOR 125MG/5ML MEDOCHEMIE LTD CYPRUS OR.SUSPENSION

MOXILEN 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

MOXILEN 500MG POWDER FOR INJECTION 500MG MEDOCHEMIE LTD CYPRUS

MOXILEN 500MG CAPSULE 500MG MEDOCHEMIE LTD CYPRUS

MSI 10 MUNDIPHARMA SOLUTION FOR 10MGµL MUNDIPHARMA GMBH GERMANY INJECTION

MSI 20 MUNDIPHARMA SOLUTION FOR 20MG/ML MUNDIPHARMA GMBH GERMANY INJECTION 634 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MST CONTINUS SUSPENSION GRANULES FOR ORAL N/A NAPP LABORATORIES UNITED KINGDOM 30MG SOLUT. LIMITED

MST CONTINUS SUSPENSION ORAL SUSPENSION N/A NAPP LABORATORIES UNITED KINGDOM 100MG LIMITED

MST CONTINUS SUSPENSION ORAL SUSPENSION N/A NAPP LABORATORIES UNITED KINGDOM 60MG LIMITED

MST CONTINUS TABLETS 100MG MODIFIED RELEASE 100MG NPP LABORATORIES UNITED KINGDOM TABLET LIMITED

MST CONTINUS TABLETS 10MG MODIFIED RELEASE 10MG NAPP LABORATORIES UNITED KINGDOM TABLET LIMITED

MST CONTINUS TABLETS 200MG MODIFIED RELEASE 200MG NAPP LABORATORIES UNITED KINGDOM TABLETS LIMITED

MST CONTINUS TABLETS 30MG TABLETS 30MG NAPP LABORATORIES UNITED KINGDOM LIMITED

MST CONTINUS TABLETS 60MG MODIFIED RELEASE 60MG NAPP LABORATORIES UNITED KINGDOM TABLETS LIMITED

MUCAINE SUSPENSION N/A JOHN WYETH & UNITED KINGDOM BROTHER LTD

MUCAINE SUSPENSION ORAL SUSPENSION N/A JOHN WYETH & UNITED KINGDOM BROTHER LTD

MUCICLAR SYRUP 0.3% W/V VECCHI & C PIAM S.A.P.A. ITALY

MUCICLAR RETARD CAPSULE 75MG VECCHI & C PIAM S.A.P.A. ITALY

MUCICLAR SIROP ADULTES SYRUP 5G/100ML PARKE-DAVIS AFRIQUE SENEGAL DE L'OUEST

MUCICLAR SIROP ENFANTS ET SYRUP 2G/100ML PARKE-DAVIS AFRIQUE SENEGAL NOURRISSONS DE L'OUEST

MUCOBROXOL RETARD TABLETS 75MG MUNDIPHARMA GMBH GERMANY

MUCOBROXOL 60 EFFERVESCENT TABLETS 60MG MUNDIPHARMA GMBH GERMANY

MUCOBROXOL SYRUP SYRUP N/A MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

MUCOCIS SYRUP 5% W/V FONTEN FARMACEUTICI ITALY S.R.L.

MUCODYNE PAEDIATRIC SYRUP ORAL SOLUTION 125MG/5ML MAY & BAKER LIMITED UNITED KINGDOM 125MG

MUCODYNE SYRUP 250MG/5ML ORAL SOLUTION 250MG/5ML MAY & BAKER LIMITED UNITED KINGDOM

MUCOFALK ORANGE GRANULES 3.25G DR. FALK PHARMA GMBH GERMANY

MUCOFALK APPLE GRANULES 3.25G DR. FALK PHARMA GMBH GERMANY

MUCOGEL SUSPENSION N/A PHARMAX LIMITED UNITED KINGDOM

MUCOPRONT CAPSULES 375MG HEINRICH MACK NACHF GERMANY

MUCOPRONT SYRUP SOLUTION 5G/100G HEINRICH MACK NACHF GERMANY

MUCOSOLVAN AMP 15MG/2ML BOEHRINGER INGELHEIM GERMANY PHARMA KG 23.9.2003 FR Journal officiel de l'Union européenne 635

Trade Name Dosage Form Dose MA Holder Country

MUCOSOLVAN LIQUID 15MG/5ML BOEHRINGER INGELHEIM GERMANY PHARMA KG

MUCOSOLVAN LIQUID 30MG/5ML BOEHRINGER INGELHEIM GERMANY KG

MUCOSOLVAN SOLUTION 15MG/2ML BOEHRINGER INGELHEIM GERMANY PHARMA KG

MUCOSOLVAN SOLUTION 30MG/2ML BOEHRINGER INGELHEIM GERMANY PHARMA KG

MUCOSOLVAN TABLETS 30MG BOEHRINGER INGELHEIM GERMANY PHARMA KG

MUCOSOLVAN TABLETS 60MG BOEHRINGER INGELHEIM GERMANY KG

MUCOSOLVAN L.A. CAPSULES 75MG BOEHRINGER INGELHEIM GERMANY PHARMA KG

MUCOTREIS SYRUP 5G/100ML ECOBI FARMACEUTICI ITALY S.A.S.

MUCOTREIS POWDER 0.3G/BAG ECOBI FARMACEUTICI ITALY S.A.S

MUCOTREIS SYRUP 2G/100ML ECOBI FARMACEUTICI ITALY S.A.S

MULTIPARIN SOLUTION FOR 1000IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

MULTIPARIN SOLUTION FOR 5000IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

MULTIPARIN SOLUTION FOR 25000IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

MULTIPARIN 1000IU/ML(5ML SOLUTION FOR 1000 IU/ML CP PHARMACEUTICALS UNITED KINGDOM VIALS) INJECTION LTD

MULTIPARIN 25,000IU/ML SOLUTION FOR 25000 IU / ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD

MULTIPARIN 5000IU/ML(IN 5ML SOLUTION FOR 5000 IU/ML CP PHARMACEUTICALS UNITED KINGDOM VIALS) INJECTION LTD

MULTIVITAMIN COATED TABLETS NA PHARMAMED LTD. MALTA

MULTIVITAMIN DROPS ORAL DROPS N/A WARNER-LAMBERT UNITED KINGDOM CONSUMER HEALTHCARE

MULTIVITAMINS CAPSULE N/A SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

MUMPSVAX VACCINE 5000 TCID50 MERCK SHARP & DOHME NETHERLANDS

MUPHORAN POWDER AND SOL FOR 200MG/4ML LES LABORATOIRES FRANCE IV INF SERVIER

MURINE PLUS EYE DROPS N/A ABBOTT PAKISTAN

MURINE TEARS LUBRICANT EYE DROPS N/A ABBOTT LABORATORIES UNITED STATES OF AMERICA

MURINE TEARS PLUS LUB. EYE DROPS N/A ABBOTT LABORATORIES UNITED STATES OF REDNESS RELIEVER AMERICA

MUSE 1000 MICROGRAMS URETHRAL STICK 1000MCG VIVUS UK UNITED KINGDOM 636 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

MUSE 125 MICROGRAMS URETHRAL STICK 125 MCG VIVUS UK UNITED KINGDOM

MUSE 250 MICROGRAMS URETHRAL STICK 250 MCG VIVUS UK UNITED KINGDOM

MUSE 500 MICROGRAMS URETHRAL STICK 500MCG VIVUS UK UNITED KINGDOM

MXL CAPSULES 120MG MODIFIED RELEASE 120MG NAPP LABORATORIES UNITED KINGDOM CAPSULE LIMITED

MXL CAPSULES 150MG MODIFIED RELEASE 150MG NAPP LABORATORIES UNITED KINGDOM CAPSULES LIMITED

MXL CAPSULES 200MG MODIFIED RELEASE 200MG NAPP LABORATORIES UNITED KINGDOM CAPSULE LIMITED

MXL CAPSULES 60MG MODIFIED RELEASE 60MG NAPP UNITED KINGDOM CAPSULE PHARMACEUTICALS LIMITED

MYCETIN LYOPHILISED EYE DROPS 25MG/VIAL FARMIGEA SPA ITALY

MYCIL ATHLETE'S FOOT SPRAY TOPICAL SPRAY 0.12%W/W CROOKES HEALTHCARE UNITED KINGDOM LIMITED

MYCIL OINTMENT OINTMENT N/A CROOKES HEALTHCARE UNITED KINGDOM LIMITED

MYCIL POWDER TOPICAL POWDER N/A CROOKES HEALTHCARE UNITED KINGDOM LIMITED

MYCOHEAL VAGINAL SUPPOSITORIES 200MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LIMITED

MYCOHEAL CREAM NA DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO. LTD

MYCOHEAL HC CREAM N/A DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LIMITED

MYCOHEAL HC CREAM CREAM NA DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT

MYCOSPOR GEL 1% W/W BAYER VITAL GMBH & GERMANY CO. KG

MYCOSPOR CREAM 0.01G/G BAYER VITAL GMBH & GERMANY CO. KG

MYCOSPOR SOLUTION 0.01G/ML BAYER VITAL GMBH & GERMANY CO. KG

MYCOSPOR CREAM N/A BAYER PAKISTAN

MYCOSPOR CREAM 0.01G/G BAYER PAKISTAN

MYCOSTATIN CREAM 100,000 UI / 1G E R SQUIBB & SONS LTD UNITED KINGDOM

MYCOSTATIN ORAL SUSPENSION 100,000 UI / ML SQUIBB INDUSTRIA SPAIN FARMACEUTICA, S.A.

MYCOSTATIN OINTMENT 100,000 UI / G SQUIBB INDUSTRIA SPAIN FARMACEUTICA, S.A.

MYCOSTATIN BABY OINTMENT OINTMENT 100,000UI / G SQUIBB INDUSTRIA SPAIN FARMACEUTICA, S.A.

MYDRIATICUM EYE DROPS 5MG/ML CIBA VISION AG SWITZERLAND 23.9.2003 FR Journal officiel de l'Union européenne 637

Trade Name Dosage Form Dose MA Holder Country

MYDRIATICUM 0.5% EYE DROPS 5.00MG/ML NOVARTIS SWITZERLAND OPHTHALMICS AG

MYDRILATE EYE DROPS 1% INTRAPHARM UNITED KINGDOM LABORATORIES LIMITED

MYDRILATE EYE DROPS 0,50% INTRAPHARM UNITED KINGDOM LABORATORIES LIMITED

MYLERAN TABLETS 2MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

MYLERAN FILM COATED TABLET 2MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD T/A GLAXO WELLCOME

MYLERAN FILM COATED TABLETS 2MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

MYLERAN TABLETS 2MG COATED TABLETS 2MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

MYOCRISIN INJECTION SOLUTION FOR 10% W/V JHC HEALTHCARE LTD UNITED KINGDOM INJECTION

MYOCRISIN INJECTION 10% SOLUTION FOR 10% W/V JHC HEALTHCARE IRELAND INJECTION LIMITED

MYOCRISIN INJECTION 4% SOLUTION FOR 4% W/V JHC HEALTHCARE IRELAND INJECTION LIMITED

MYOCRISTIN INJECTION SOLUTION FOR 4% JHC HEALTHCARE LTD UNITED KINGDOM INJECTION

MYOFLEX TABLET SEE REMARKS PRIME MALAYSIA PHARMACEUTICAL

MYOGESIC TABLETS N/A DAR AL DAWA JORDAN DEVELOPMENT ND INVESTMENT CO IMITED

MYOVIEW POWDER FOR INJECTION 0.23MG/VIAL NYCOMED AMERSHAM UNITED KINGDOM PLC

MYPRODOL CAPSULES NA ADCOCK INGRAM SOUTH AFRICA LIMITED

MYSOLINE TABLETS 250MG ZENECA LIMITED UNITED KINGDOM

NAAXIA EYE DROPS 38MG/ML CIBA VISION AG SWITZERLAND

NAAXIA EYE DROPS 38MG/ML NOVARTIS SWITZERLAND OPHTHALMICS AG

NABUGESIC TABLETS 500MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO. LTD

NACL 5% EYE DROPS 50MG/ML NOVARTIS SWITZERLAND OPHTHALMICS AG

NACL 5% DISPERSA EYE DROPS 5% W/V CIBA VISION AG SWITZERLAND

NADITONE TABLETS 500MG KLEVA LTD. GREECE

NADRIFOR TABLETS 10MG KLEVA LTD GREECE

NAFORDYL TABLETS 20MG KLEVA LIMITED GREECE

NAFTAZOLINA NASAL DROPS, SPRAY 0.2% W/V BRUSCHETTINI SRL ITALY SOLN. 638 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NAFTAZOLINA NASAL DROPS, SOLUTION 2G/100ML BRUSCHETTINI SRL ITALY

NALCROM CAPSULES 100MG CAPSULES 100MG FISONS LIMITED T/A UNITED KINGDOM RHONE-POULENC RORER

NALCROM CAPSULES 100MG CAPSULE 100MG FISONS LTD T/A UNITED KINGDOM RHONE-POULENC RORER

NALIDIX 500 TABLET 0.5G DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO. LTD

NALIDIXIC ACID TABLETS 500MG PHARMAMED LTD. MALTA

NALIDIXIC ACID SUSPENSION ORAL SUSPENSION 300MG/5ML ROSEMONT UNITED KINGDOM PHARMACEUTICALS LIMITED

NALION 0.5MG TABLET 0.5MG MEDOCHEMIE LTD CYPRUS

NALOXONE HYDROCHLORIDE SOLUTION FOR 0.4MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

NALOXONE HYDROCHLORIDE SOLUTION FOR 0.02MG/ML ANTIGEN IRELAND INJECTION INJECTION PHARMACEUTICALS LIMITED

NALOXONE HYDROCHLORIDE SOLUTION FOR 0.04MG/1ML ANTIGEN IRELAND INJECTION INJECTION PHARMACEUTICALS LIMITED

NALOXONE HYDROCHLORIDE SOLUTION FOR 40MCG/2ML F.H. FAULDING & CO LTD AUSTRALIA INJECTION INJECTION (T/A DAVID BULL LABS)

NALOXONE HYDROCHLORIDE SOLUTION FOR 400MICROGRAMS ANTIGEN IRELAND INJECTION USP INJECTION PHARMACEUTICALS LIMITED

NALOXONE HYDROCHLORIDE SOLUTION FOR 0.4MG/1ML INTERNATIONAL UNITED KINGDOM MINIJET INJECTION MEDICATION SYSTEMS (UK) LIMITED

NALOXONE HYDROCHLORIDE SOLUTION FOR 0.8MG/2ML INTERNATIONAL UNITED KINGDOM MINJET INJECTION MEDICATION SYSTEMS (UK) LIMITED

NALOXONE HYDROCHLORIDE USP SOLUTION FOR 20 MICROGRAM ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

NALOXONE HYDROCHLORIDRE SOLUTION FOR 0.02MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

NALOXONE INJ MINIJET SOLUTION FOR 0.8MG/2ML INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS LTD

NALOXONE INJECTION MINIJET SOLUTION FOR 0.4MG/1ML INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS LTD

NALOXONE MERCK 0.4MG/ML SOLUTION FOR INJ. 0.4MG/ML MERCK GENERIQUES FRANCE

NANOTIV POWDER FOR INJECTION 500IU (I+II) PHARMACIA & UPJOHN SWEDEN AB

NANOTIV POWDER FOR INJECTION 1000IU(I+II) PHARMACIA & UPJOHN SWEDEN AB

NANOTIV 1000IU POWDER AND POWDER AND SOLVENT N/A BIOVITRUM AB SWEDEN SOLVENT 23.9.2003 FR Journal officiel de l'Union européenne 639

Trade Name Dosage Form Dose MA Holder Country

NANOTIV POWDER AND SOLVENT POWDER AND SOLVENT N/A BIOVITRUM AB SWEDEN

NAPHCON-A OPHTHALMIC SOLUTION N/A S.A. ALCON-COUVREUR BELGIUM N.V.

NAPROREX 250 TABLETS 250MG AEGIS LTD. CYPRUS

NAPROREX 375 TABLETS 375MG AEGIS LTD. CYPRUS

NAPROREX 500 TABLETS 500MG AEGIS LTD. CYPRUS

NAPROREX EC 250 TABLETS 250MG AEGIS LTD. CYPRUS

NAPROREX EC 375 TABLETS 375MG AEGIS LTD. CYPRUS

NAPROREX EC 500 TABLETS 500MG AEGIS LTD. CYPRUS

NAPROSYN 250 TABLET 250MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

NAPROSYN 500 TABLET 500MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

NAPROSYN EC 250MG TABLET 250MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

NAPROSYN EC 500MG TABLET 500MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

NAPROVAL CAPSULES 250MG LABORATORIO REIG SPAIN JOFRE S.A

NAPROXEN TABLETS 250MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

NAPROXEN TABLETS 500MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

NAPROXEN BP 250MG TABLET 250MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

NAPROXEN BP 500MG TABLET 500MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

NAPROXEN TABLETS BP TABLETS 250MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

NAPROXEN TABLETS BP TABLETS 500MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

NAPROXEN-MEPHA 500 LACTAB 500MG MEPHA PHARMA AG SWITZERLAND

NARAMIG TABLETS 2.5MG COATED TABLET 2.5MG GLAXO WELLCOME UK UNITED KINGDOM LTD

NARCAN SOLUTION FOR 0.4MG/ML ENDO UNITED STATES OF INJECTION PHARMACEUTICALS INC. AMERICA

NARIXAN HARD GELATIN CAPSULE 120MG ALFA WASSERMANN ITALY SR. S.P.A.

NARIXAN CAPSULE 120MG ALFA WASSERMANN ITALY S.P.A.

NAROP SOL. FOR INJ. AND IV INF. 2MG/ML ASTRA LAKEMEDEL AB SWEDEN

NAROP SOLUTION FOR 7.5MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION 640 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NAROP SOLUTION FOR 10MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION

NAROPIN SOL. FOR INJ. AND IV INF. 2MG/ML ASTRA LAKEMEDEL AB SWEDEN

NAROPIN SOLUTION FOR 7.5MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION

NAROPIN SOLUTION FOR 10MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION

NASACORT NASAL SPRAY 0.055% W/W MAY & BAKER LIMITED UNITED KINGDOM T/A RHONE POULENC RORER

NASACORT NASAL SPRAY 0.055% W/W MAY & BAKER LIMITED UNITED KINGDOM T/A RHONE POULENC RORER

NASACORT AQ NASAL SPRAY 55MCG/ACTUA- RHONE-POULENC RORER UNITED STATES OF TION PHARMACEUTICALS INC. AMERICA

NASELIN NASAL SPRAY SOLUTION 0.05%W/V CIPLA LIMITED INDIA

NASENSPRAY E RATIOPHARM NASAL SPRAY SOLUTION 0.09MG/0.09ML RATIOPHARM GMBH GERMANY

NASENSPRAY K RATIOPHARM NASAL SPRAY SOLUTION 0.045MG/0.09ML RATIOPHARM GMBH GERMANY

NASONEX NASAL SPRAY 50MG/G SCHERING — PLOUGH BELGIUM S.A.

NAT PHOS. NEW ERA NO.10 NAT TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM PHOS NO.10 LABORATORIES LIMITED

NAT. MUR. NEW ERA BIOCHEMIC TISSUE SALT TABLET NO.9 NA NEW ERA UNITED KINGDOM NO.9 LABORATORIES LIMITED

NAT. SULPH. — NEW ERA NO.11 TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM NAT SULPH NO.11 LABORATORIES LIMITED

NATRASLEEP FILM COATED TABLETS N/A PETER BLACK UNITED KINGDOM HEALTHCARE LIMITED

NATRILIX FILM-COATED TABLET 2.5MG LES LABORATOIRES FRANCE SERVIER

NATRILIX TABLETS 2.5MG SERVIER PAKISTAN

NATRILIX COATED TABLETS 2.5MG. SERVIER EGYPT EGYPT INDUSTRIES LTD

NATRILIX 2.5MG TABLET 2.5MG SERVIER PAKISTAN

NATRILIX SR SUST. REL. COATED 1.5MG LES LABORATOIRES FRANCE TABLET SERVIER

NATRILIX SR TABLETS 1.5MG SERVIER PAKISTAN

NATRILIX SR TABLETS 1.5MG SERVIER PAKISTAN

NATRILIX SR COATED TABLET 1.5 MG SERVIER EGYPT EGYPT INDUSTRIES LTD.

NATRILIX SR 1.5MG SUST. REL. COATED 1.5MG LABORATOIRES SERVIER FRANCE TABLET

NAUTISOL 12.5MG LIQUID FOR INJECTION 12.5MG/2ML MEDOCHEMIE LTD CYPRUS

NAUTISOL 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS 23.9.2003 FR Journal officiel de l'Union européenne 641

Trade Name Dosage Form Dose MA Holder Country

NAVELBINE 10MG/1ML INJECTABLE SOLUTION 10MG/1ML PIERRE FABRE FRANCE MEDICAMENT

NAVELBINE 50MG/5ML INJECTABLE SOLUTION 50MG/5ML PIERRE FABRE FRANCE MEDICAMENT

NAVIDOXINE TABLET N/A U.C.B. S.A. BELGIUM

NAVOBAN CAPSULES 5MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

NAVOBAN SOLUTION FOR 5MG/5ML NOVARTIS PHARMA SWITZERLAND INJECTION SCHWEIZ AG

NEBILET 5MG TABLET 5MG MENARINI GERMANY INTERNATIONAL OPERATIONS LUXEMBOURG S.A.

NEGRAM 500MG TABLETS TABLET 500MG SANOFI WINTHROP UNITED KINGDOM LIMITED

NEGRAM SUSPENSION 6% W/V ORAL SUSPENSION 6% W/V SANOFI WINTHROP FRANCE LIMITED

NELSONS CHILBLAIN CREAM CREAM 9%V/W A NELSONS AND UNITED KINGDOM COMPANY LTD

NEO BOROCILLINA MOUTH WASH 24MG/100ML ALFA WASSERMANN ITALY S.P.A.

NEO BOROCILLINA TABLETS N/A ALFA WASSERMANN ITALY S.P.A.

NEO BOROCILLINA ORAL SPRAY 600MG/100ML ALFA WASSERMANN ITALY S.P.A.

NEO BOROCILLINA TABLETS N/A ALFA WASSERMANN ITALY S.P.A.

NEO BOROCILLINA «C» TABLET N/A ALFA WASSERMANN ITALY S.P.A.

NEO BOROCILLINA «C» SENZ/ZUC TABLET N/A ALFA WASSERMANN ITALY

NEO BOROCILLINA C TABLET N/A ALFA WASSERMANN ITALY S.P.A.

NEO BOROCILLINA SENZA ZUC- TABLET N/A ALFA WASSERMANN ITALY CHERO S.P.A.

NEO BOROCILLINA TOSSE SOLUTION FOR ORAL USE N/A ALFA WASSERMANN ITALY

NEO BOROCILLINA TOSSE MOUTH SOLUBLE TABLET N/A ALFA WASSERMANN ITALY S.P.A.

NEO-BUCOSIN LOZENGE N/A SYNPHARMA AG SWITZERLAND

NEODIPAR TABLETS TABLETS 500MG HOECHST PAKISTAN

NEO-MEDROL ACNE LOTION LOTION N/A PHARMACIA & UPJOHN CANADA INC.

NEO-MERCAZOLE TABLET 20MG ROCHE PRODUCTS UNITED KINGDOM LIMITED

NEO-MERCAZOLE TABLETS 5MG TABLET 5MG ROCHE PRODUCTE UNITED KINGDOM LIMITED

NEOMIGRAN NASAL SPRAY 4MG/ML NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG 642 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NEO-NACLEX TABLET 5MG GOLDSHIELD GROUP PLC UNITED KINGDOM T/A GOLDSHIELD PHARMACEUTICALS

NEORAL 25MG CAPSULE 25MG NOVARTIS PAKISTAN

NEORAL ORAL SOLUTION ORAL SOLUTION 100 MG/ML NOVARTIS IRELAND PHARMACEUTICALS UK LIMITED

NEORAL SOFT GELATIN CAPSULE SOFT GELATIN CAPSULES 25 MG NOVARTIS IRELAND PHARMACEUTICALS UK LIMITED

NEORECORMON 10000IU POWDER AND SOLVENT 10000IU/ML ROCHE REGISTRATION UNITED KINGDOM F. INJ. LIMITED

NEORECORMON 1000IU POWDER AND SOLVENT 1000IU/ML ROCHE REGISTRATION UNITED KINGDOM F. INJ. LIMITED

NEORECORMON 2000IU POWDER AND SOLVENT 2000IU/ML ROCHE REGISTRATION UNITED KINGDOM F. INJ. LIMITED

NEORECORMON 5000IU POWDER AND SOLVENT 5000IU/ML ROCHE REGISTRATION UNITED KINGDOM F. INJ. LIMITED

NEOSPECT KIT FOR RADIOPHARM POWDER FOR INJECTION 47MCG/KIT NYCOMED IMAGING AS EUROPEAN COMMUNITY PREP.

NEOSTIGMINE SOLUTION FOR 0.5MG/1ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

NEOSTIGMINE INJECTION SOLUTION FOR 2.5MG/ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

NEOSTIGMINE INJECTION BP SOLUTION FOR 2.5.MG/ML ANTIGEN IRELAND 2.5.MG/ML INJECTION PHARMACEUTICALS LIMITED

NEOSTIGMINE METHYLSULFATE SOLUTION FOR 1MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

NEOSTIGMINE METHYLSULPHATE SOLUTION FOR 2.5MG/ML PHOENIX UNITED KINGDOM INJECTION PHARMACEUTICALS LTD.

NEOSTIGMINE METHYLSULPHATE SOLUTION FOR 2.5MG/ML BODENE (PROPRIETARY) SOUTH AFRICA INJ INTRAMED INJECTION LIMITED T/A INTRAMED

NEOSTIGMINE METHYLSULPHATE- SOLUTION FOR 2.5MG/ML BODENE (PROPRIETARY) REPUBLIC OF SOUTH FRESENIUS INJECTION LIMITED T/A INTRAMED AFRICA

NEOTIGASON CAPSULE 25MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) LITD

NEOTIGASON CAPSULE 10MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) LTD

NEOXENE VAGINAL OVULES 10MG FARMACEUTICI ECOBI ITALY S.A.S

NEPHRIL TABLETS 1MG PFIZER LIMITED UNITED KINGDOM

NERISONE CREAM 1MG/G SCHERING AG GERMANY

NERISONE OINTMENT 1MG/G SCHERING AG GERMANY

NERISONE CREAM 0.1G/100G SCHERING SPA ITALY

NERISONE OINTMENT 0.1G/100G SCHERING SPA ITALY

NERISONE FATTY OINTMENT 0.1G/100G SCHERING SPA ITALY 23.9.2003 FR Journal officiel de l'Union européenne 643

Trade Name Dosage Form Dose MA Holder Country

NERISONE C CREAM N/A SCHERING SPA ITALY

NERISONE C CREAM N/A SCHERING PAKISTAN

NERISONE CREAM CREAM 1MG/G SCHERING PAKISTAN

NETROMICIN SOLUTION FOR 150MG/1.5ML SCHERING-PLOUGH BELGIUM INJECTIONS NV/SA

NETROMICIN/NETROMYCIN SOLUTION FOR 50MG/2ML SCHERING-PLOUGH S.A. BELGIUM INJECTION

NETROMYCIN SOLUTION FOR 50MG/2ML SCHERING-PLOUGH BELGIUM INJECTION NV/SA

NETROMYCIN SOLUTION FOR 50MG/ML SCHERING-PLOUGH UNITED KINGDOM INJECTION LIMITED

NETROMYCINE/NETROMYCIN SOLUTION FOR 150MG/1.5ML SCHERING-PLOUGH S.A. BELGIUM INJECTION

NEUMEGA SUBCUTANEOUS 5MG/ML GENERICS INSTITUTE, UNITED STATES OF INJECTION INC. AMERICA

NEUPOGEN VIAL 30MU AND 48MU ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

NEUROBAT SUGAR COATED TABLET N/A PT INTERBAT INDONESIA

NEUROLITE DRY SUBSTANCE AND N/A DUPONT PHARMA GMBH GERMANY SOLVENT

NEUROMULTIVIT FILM COATED TABLETS N/A LANNACHER HEILMITTEL AUSTRIA GES.M.B.H.

NEURONTIN 100MG CAPSULE 100MG PARKE-DAVIS GMBH GERMANY

NEURONTIN 300MG CAPSULE 300MG PARKE-DAVIS GMBH GERMANY

NEURONTIN 400MG CAPSULE 400MG PARKE-DAVIS GMBH GERMANY

NEURONTIN CAPSULES 100MG CAPSULE 100MG WARNER LAMBERT (UK) UNITED KINGDOM LIMITED T/A PARKE DAVIS

NEURONTIN CAPSULES 100MG CAPSULE 100MG WARNER LAMBERT (UK) UNITED KINGDOM LTD. T/A PARKE DAVIS

NEURONTIN CAPSULES 300MG CAPSULE 300MG WARNER LAMBERT (UK) UNITED KINGDOM LTD. T/A PARKE DAVIS

NEURONTIN TABLETS 600MG FILM COATED TABLET 600MG WARNER LAMBERT (UK) UNITED KINGDOM LTD. T/A PARKE DAVIS

NEURONTIN TABLETS 800MG FILM COATED TABLET 800MG WARNER LAMBERT (UK) UNITED KINGDOM LTD. T/A PARKE DAVIS

NEURO-RATIOPHARM N FILM COATED TABLET N/A RATIOPHARM GMBH GERMANY FILMTABLETTEN

NEURORUBIN LACTABS N/A MEPHA PHARMA AG SWITZERLAND

NEURORUBINE SOLUTION FOR N/A MEPHA PHARMA AG SWITZERLAND INJECTION

NEURORUBINE FORTE LACTAB N/A MEPHA PHARMA AG SWITZERLAND

NEUTROMAX 300MCG (30 M.U.I) SOLUTION FOR 300MCG INSTITUTO SIDUS S.A. ARGENTINA INJECTION 644 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NEUTROMAX 480MCG (48 M.U.I) SOLUTION FOR 480MCG INSTITUTO SIDUS S.A. ARGENTINA INJECTION

NEVIRAN TABLET 400MG FONTEN FARMACEUTICI ITALY S.R.L.

NEVIRAN CREAM 5% W/W FONTEN FARMACEUTICI ITALY S.R.L.

NEVPARIN SOLUTION FOR 25000IU/5ML MUSTAFA NEVZAT ILAC TURKEY INJECTION SANAYII AS

NEW ERA COMBINATION A — TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM SCIATICA LABORATORIES LIMITED

NEW ERA COMBINATION B (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATION C (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATION E SALT TABLETS N/A NEW ERA — UNITED KINGDOM LABORATORIES LTD — UK

NEW ERA COMBINATION F (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATION G (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATION H (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATION I (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATION J (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATION K TISSUE SALT TABLETS 6X NEW ERA UNITED KINGDOM LABORATORIES LIMITED

NEW ERA COMBINATION L (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATION M (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATION N (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATION P (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATION R (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATION S (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA COMBINATRION D (SEE TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM REMARKS) LABORATORIES LIMITED

NEW ERA NO.12 SILICA TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM LABORATORIES LIMITED

NEW ERA NO.6 KALI. PHOS. TISSUE SALT TABLETS NA NEW ERA UNITED KINGDOM LABORATORIES LIMITED

NEXIUM GASTRO-RESISTANT 40MG HASSLE LAKEMEDEL AB SWEDEN TABLET 23.9.2003 FR Journal officiel de l'Union européenne 645

Trade Name Dosage Form Dose MA Holder Country

NEXIUM GASTRO-RESISTANT 20MG HASSLE LAKEMEDEL AB SWEDEN TABLET

NICARDIA CAPSULES 10MG CAPSULES 10MG J.B. CHEMICALS & INDIA PHARMACEUTICALS LTD

NICARDIA RETARD-10 FILM COATED TABLET 10MG J.B.CHEMICALS & INDIA PHARMACEUTICALS LTD

NICARDIA RETARD-20 FILM COATED TABLET 20MG J.B.CHEMICALS & INDIA PHARMACEUTICALS LTD

NICEF CAPSULES 250MG GALEN LIMITED UNITED KINGDOM

NICEF CAPSULES 500MG GALEN LIMITED UNITED KINGDOM

NICOBREVIN CAPSULE N/A NICOBREVIN UNITED KINGDOM

NICO-HEPATOCYN COATED TABLET N/A J.URIACH & CIA. S.A. SPAIN

NICORETTE MEDICATED CHEWING 2MG PHARMACIA & UPJOHN SWEDEN GUM SVERIGE AB

NICORETTE MEDICATED CHEWING 4MG PHARMACIA & UPJOHN SWEDEN GUM SVERIGE AB

NICORETTE TRANSDERMAL PATCHES 5MG/16 HOURS PHARMACIA & UPJOHN SWEDEN SVERIGE AB

NICORETTE TRANSDERMAL PATCHES 10MG/16HOURS PHARMACIA & UPJOHN SWEDEN SVERIGE AB

NICORETTE TRANSDERMAL PATCHES 15MG/16HOURS PHARMACIA & UPJOHN SWEDEN SVERIGE AB

NICORETTE MEDICATED CHEWING 2MG PHARMACIA SVERIGE AB SWEDEN GUM

NICORETTE MEDICATED CHEWING 4MG PHARMACIA SVERIGE AB SWEDEN GUM

NICORETTE TRANSDERMAL PATCH 5MG/16HOURS PHARMACIA SVERIGE AB SWEDEN

NICORETTE TRANSDERMAL PATCH 10MG/16HOURS PHARMACIA SVERIGE AB SWEDEN

NICORETTE TRANSDERMAL PATCH 15MG/16HOURS PHARMACIA SVERIGE AB SWEDEN

NICORETTE INHALATOR INHALATION VAPOUR 10MG/CARTRIDGE PHARMACIA LIMITED UNITED KINGDOM

NICORETTE INHALOR LIQUID FOR INHALATION 10MG/CARTRIDGE PHARMACIA & UPJOHN UNITED KINGDOM LIMITED

NICORETTE MINT MEDICATED CHEWING 2MG PHARMACIA & UPJOHN SWEDEN GUM SVERIGE AB

NICORETTE MINT MEDICATED CHEWING 4MG PHARMACIA & UPJOHN SWEDEN GUM SVERIGE AB

NICORETTE MINT MEDICATED CHEWING 2MG PHARMACIA SVERIGE AB SWEDEN GUM

NICORETTE MINT MEDICATED CHEWING 4MG PHARMACIA SVERIGE AB SWEDEN GUM

NICOTINAMIDE TABLET TABLET 50MG CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD.

NICOTINELL TTS 10 TRANSDERMAL PATCH 17.5MG/PATCH NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG 646 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NICOTINELL TTS 20 TRANSDERMAL PATCH 35MG/ PATCH NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

NICOTINELL TTS 30 TRANSDERMAL PATCH 52.5MG/PATCH NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

NIDAGYL 200 TABLETS 200MG AEGIS LTD. CYPRUS

NIDAGYL 400 TABLETS 400MG AEGIS LTD. CYPRUS

NIDAGYL 500 CAPSULES 500MG AEGIS LTD. CYPRUS

NIDAGYL 500 TABLETS 500MG AEGIS LTD. CYPRUS

NIDOL TABLETS 100MG POLIPHARM CO. LTD. THAILAND

NIDOL SUSPENSION 1G/100ML POLIPHARM CO. LTD. THAILAND

NIFECARD CAPSULES 10MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LIMITED

NIFECARD-10 CAPSULES 10MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

NIFEDI-DENK 10 RETARD RETARD TABLETS 10MG E.DENK OHG GERMANY

NIFEDI-DENK 20 RETARD RETARD TABLETS 20MG E.DENK OHG GERMANY

NIFEDIPINE CAPSULES 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

NIFEDIPINE CAPSULES 10MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

NIFEDIPINE CAPSULES 10MG GENERICS (UK) LIMITED UNITED KINGDOM

NIFEDIPINE SLOW RELEASE SLOW RELEASE TABS 20MG CIPLA LIMITED INDIA (NIFELAT RETARD)

NIFELAT TABLETS 10MG REMEDICA LTD CYPRUS

NIFELAT-10 CAPSULES 10MG CIPLA LIMITED INDIA

NIFELAT-10 CAPSULE 10MG CIPLA LIMITED INDIA

NIFLUGEL 2.5 % PERCUTANEOUS GEL 2.5G/100G LABORATOIRES UPSA FRANCE

NIFLURIL 250MG CAPSULE 250MG LABORATOIRES UPSA FRANCE

NIFLURIL FOR CHILDREN 400MG SCORED SUPPOSITORY 0.4G LABORATOIRES UPSA FRANCE

NIFOPRESS RETARD TABLETS COATED TABLET 20MG GOLDSHIELD GROUP PLC UNITED KINGDOM 20MG

NIFTEN MODIFIED RELEASE N/A ZENECA LIMITED UNITED KINGDOM CAPSULES

NIGHT NURSE ORAL SOLUTION N/A BEECHAM GROUP PLC UNITED KINGDOM T/A SMITHKLINE BEECHAM COMSUMER HEALTHCARE

NIGHT NURSE CAPSULES CAPSULE N/A BEECHAM GROUP PLC UNITED KINGDOM T/A SMITHKLINE BEECHAM CONSUMER HEALTHCARE

NIGHTTIME COLD AND FLU CAPSULE N/A STANLEY CANADA LIQUID CAPSULES PHARMACEUTICALS LTD 23.9.2003 FR Journal officiel de l'Union européenne 647

Trade Name Dosage Form Dose MA Holder Country

NIMBEX SOLUTION FOR 2MG/ML THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION

NIMBEX SOLUTION FOR 5MG/ML THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION

NIMELID TABLETS 100MG GENEPHARM S.A. GREECE

NIMOTOP FILM-COATED TABLET 30MG BAYER VITAL GMBH & GERMANY CO. KG

NIMOTOP INFUSION SOLUTION 0.01G/50ML BAYER VITAL GMBH & GERMANY CO. KG

NIMTECH TABLETS 100MG MACLEODS INDIA PHARMACEUTICALS LTD

NIPENT PWD. FOR SOL. FOR 10MG WARNER LAMBERT (UK) UNITED KINGDOM INJ/INF LIMITED

NIPENT POWDER FOR IV INJ. 10MG PARKE DAVIS SPA ITALY SOLN.

NIPENT POWDER FOR SOLUTION 10MG CYANAMID OF GREAT UNITED KINGDOM FOR BRITAIN LTD INJECTION/INFUSION

NIPIDOL 5MG TABLET TABLET 5MG BIOFARMA ILAC SAN.VE TURKEY TIC.A.S

NIPIDOL 5MG TABLET TABLET 5MG BIOFARMA ILLAC SAN.VE TURKEY TIC.A.S.

NIPODUR TABLET 150MG ANFARM HELLAS S.A. GREECE

NIPOGALIN POWDER FOR INJECTION 750MG ANFARM HELLAS S.A. GREECE

NISITA SALINE NASAL OINTMENT OINTMENT N/A KARL ENGELHARD GERMANY

NITRAZEPAM TABLETS 5MG GLAXO WELLCOME POLAND POZNAN S.A.

NITRAZEPAM BP 5MG TABLET 500MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

NITRAZEPAM TABLETS BP 5MG TABLETS 5MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

NITRAZEPAM TABLETS BP 5MG TABLET 5MG CP PHARMACEUTICALS UNITED KINGDOM LTD

NITREDON TABLETS 5MG REMEDICA LTD. CYPRUS

NITRODERM TTS TRANSDERMAL PATCHES 5MG NOVARTIS PHARMA ITALY

NITRODERM TTS TRANSDERMAL PATCHES 10MG NOVARTIS FARMA SPA ITALY

NITRODERM TTS 10 TRANSDERMAL PATCHES 50MG/20CM(2) NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

NITRODERM TTS 5 TRANSDERMAL PATCH 25MG/10CM(2) NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

NITROGLYCERIN INJECTION USP SOLUTION FOR 5MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

NITROLINGUAL SPRAY SOLUTION 0.4MG/SPRAY DOS G. POHL-BOSKAMP GMBH GERMANY &CO 648 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NIVAQUINE TABLETS 200MG TABLET 200MG MAY & BAKER LIMITED UNITED KINGDOM (T/A RHONE-POULENC RORER)

NIZORAL SHAMPOO 2% W/W JANSSEN-CILAG N.V. BELGIUM

NIZORAL CREAM 20MG/G JANSSEN-CILAG N.V. BELGIUM

NIZORAL 200MG TABLET 200MG JANSSEN-CILAG N.V. BELGIUM

NIZORAL 200MG TABLET 200MG JANSSEN-CILAG N.V. BELGIUM

NOCTAMID-1 TABLET 1MG SCHERING AG GERMANY

NOCTAMIDE 1MG TABLET 1MG LABORATOIRES FRANCE SCHERING

NOCTYL FILM-COATED TABLETS 15MG LABORATOIRES MONOT FRANCE

NOLVADEX COATED TABLETS 10MG ZENECA LIMITED UNITED KINGDOM

NOLVADEX — D COATED TABLETS 20MG ZENECA LIMITED UNITED KINGDOM

NOLVADEX D (20MG TABLETS) COATED TABLET 20MG ZENECA LIMITED UNITED KINGDOM

NOLVADEX TABLETS 10MG COATED TABLET 10MG ZENECA LIMITED UNITED KINGDOM

NOOTROPIL FILM-COATED TABLET 800MG U.C.B. S.A. BELGIUM

NOOTROPIL INTRAVENOUS INFUSION 12G/60ML U.C.B. S.A. BELGIUM

NOOTROPIL INJECTABLE AMPOULE 1G/5ML U.C.B. S.A. BELGIUM

NOOTROPIL 20% DRINKABLE SOLUTION 20G/100ML U.C.B. S.A. BELGIUM

NOPIL SYRUP N/A MEPHA PHARMA AG SWITZERLAND

NOPIL TABLETS N/A MEPHA PHARMA AG SWITZERLAND

NOPIL FORTE TABLETS N/A MEPHA PHARMA AG SWITZERLAND

NOPRILAM PILL N/A LABORATORIOS BIAL — PORTUGAL PORTELA & CA, S.A.

NOPRILAM COATED TABLET NA LABORATORIOS BIAL PORTUGAL

NOPRILAM COATED TABLETS NA LABORATOIRES BIAL PORTUGAL

NOPRILAM DT COVERED PILLS N/A LABORATORIOS BIAL — PORTUGAL PORTELA & CA, S.A.

NOPRILAM DT COATED TABLET NA LABORATORIOS BIAL PORTUGAL

NOPRILAM DT COATED TABLETS NA LABORATOIRES BIAL PORTUGAL

NOPRILAM DT 400 POWDER FOR ORAL SUSP. N/A LABORATORIOS PORTUGAL BIAL-PORTELA & CA S.A.

NOPRON TABLET 250MG VIANEX S.A GREECE

NORADRENALINE SOLUTION FOR 0.2% W/V ABBOTT LABORATORIES UNITED KINGDOM (NOREPINEPHRINE) 1:1000 INJECTION LIMITED

NORADRENALINE AGUETTANT SOLUTION FOR INFUSION 8MG/4ML LABORATOIRE FRANCE AGUETTANT

NORCURON 10MG POWDER FOR INJECTION 10MG/5ML ORGANON TEKNIKA B.V. UNITED KINGDOM (PART OF AKZO NOBEL)

NORDETTE COATED TABLETS N/A WYETH-PHARMA GMBH GERMANY 23.9.2003 FR Journal officiel de l'Union européenne 649

Trade Name Dosage Form Dose MA Holder Country

NORDITRON SIMPLE XX SOLUTION FOR 5MG/1.5ML NOVO NORDISK A/S DENMARK INJECTION

NORDITROPIN POWDER FOR INJECTION 4IU(1.3MG)/ML NOVO NORDISK A/S DENMARK

NORDITROPIN POWDER FOR INJECTION 12IU(4MG)/ML NOVO NORDISK A/S. DENMARK

NORDITROPIN PENSET POWDER FOR INJECTION 12 IU (4MG)/ML NOVO NORDISK A/S DENMARK

NORDITROPIN SIMPLEXX SOLUTION FOR 10MG/1.5ML NOVO NORDISK A/S DENMARK INJECTION

NORDITROPIN SIMPLEXX SOLUTION FOR 10MG/1.5ML NOVO NORDISK A/S DENMARK 10MG/1.5ML INJECTION

NORDITROPIN SIMPLEXX SOLUTION FOR 5MG/1.5ML NOVO NORDISK A/S DENMARK 5MG/1.5ML INJECTION

NORFLEX ORPHENADRINE TABLET 100MG 3M PHARMACEUTICALS AUSTRALIA CITRATE 100MG PTY LTD

NORGAGIL GRANULES N/A LABORATORIES FRANCE NORGAN

NORGALAX UNIDOSE RECTAL GEL 0.12G NORGINE PHARMA FRANCE

NORGALAX ENEMA N/A NORGINE LIMITED UNITED KINGDOM

NORGESIC TABLET N/A 3M HEALTH CARE UNITED KINGDOM LIMITED,

NORMACOL GRANULES FOR ORAL N/A LABORATOIRES FRANCE SOL. NORGINE PHARMA

NORMACOL GRANULES 62%W/W NORGINE LIMITED UNITED KINGDOM

NORMACOL INFANTS ENEMA UNIDOSE RECTAL N/A LABORATOIRES FRANCE SOLUTION NORGINE PHARMA

NORMACOL LAVEMENT ADULTES UNIDOSE RECTAL N/A NORGINE PHARMA FRANCE SOLUTION

NORMACOL LAVEMENT ENFANTS UNIDOSE RECTAL N/A NORGINE PHARMA FRANCE SOLUTION

NORMACOL PLUS GRANULES N/A NORGINE LIMITED UNITED KINGDOM

NORMACOL PLUS ORAL GRANULES N/A NORGINE LIMITED UNITED KINGDOM

NORMAGLAUCON SOLUTION NA DR.GERHARD MANN, GERMANY CHEM-PHARM. FABRIK GMBH

NORMIX COATED TABLETS 200MG ALFA WASSERMANN ITALY S.P.A.

NORMIX GRANULES FOR ORAL 2G/100ML ALFA WASSERMANN ITALY SUSP. S.P.A.

NORMOLOSE TABLET 100MG ADELCO SA GREECE

NORMOLOSE TABLET 50MG ADELCO SA GREECE

NORMOLOSE TABLET 25MG ADELCO SA GREECE

NOROXIN TABLET 400MG MERCK SHARP & DOHME PAKISTAN

NOROXIN TABLET 400MG MERCK SHARP & DOHME PAKISTAN

NOROXIN 400MG TABLET 400MG MERCK SHARP & DOHME NETHERLANDS B.V. 650 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NORTRILEN TABLET 10MG H. LUNDBECK A/S DENMARK

NORTRILEN TABLET 25MG H. LUNDBECK A/S DENMARK

NORTUSSINE ADULTES SYRUP N/A NORGINE PHARMA FRANCE

NORTUSSINE INFANTS SYRUP N/A NORGINE PHARMA FRANCE

NORVIR ORAL SOLUTION 80MG/ML ABBOTT LABORATORIES UNITED KINGDOM LTD.

NORVIR SOFT-GELATIN CAPSULES 100MG ABBOTT AG SWITZERLAND

NORVIR CAPSULES 100MG ABBOTT LABORATORIES UNITED STATES OF AMERICA

NORVIR SOFT CAPSULES 100MG ABBOTT LABORATORIES UNITED KINGDOM LTD.

NOSKITO GEL N/A TRIMA ISRAEL ISRAEL PHARMACEUTICAL PRODUCTS LIMITED

NO-SPA TABLET 40MG CHINOIN HUNGARY PHARMACEUTICAL AND CHEMICAL WORKS CO. LTD.

NO-SPA SOLUTION FOR 40MG/2ML CHINOIN HUNGARY INJECTION PHARMACEUTICAL AND CHEMICAL WORKS CO LTD.

NOTEN TABLET 50MG ALPHAPHARM PTY LIMI- AUSTRALIA TED

NOTORIUM TABLET 1.5MG ADELCO- GREECE CHROMATOURGIA ATHINON E. COLOCOTRONIS BROS SA

NOTORIUM TABLET 3MG ADELCO SA GREECE

NOTORIUM TABLET 6MG ADELCO SA GREECE

NOVACLAV 375 TABLETS TABLETS NA CIPLA LTD. INDIA

NOVAGESIC-FLU 20 CAPSULE N/A SCANPHARM A.S. JAMAICA

NOVAL EYE DROPS SOLUTION 0.5% W/V DEMO ABEE GREECE

NOVAL EYE DROPS SOLUTION 0.25% W/V DEMO ABEE GREECE

NOVALGINE 500MG COATED TABLET 500MG LABORATOIRE HOECHST FRANCE

NOVAMILOR TAB TABLETS N/A NOVOPHARM LTD CANADA

NOVAMOXIN CAP 250MG CAPSULES 250MG NOVOPHARM LTD CANADA

NOVAMOXIN SUS 125MG/5ML POWDER FOR SOLUTION 125MG/5ML NOVOPHARM LIMITED CANADA

NOVAMOXIN SUS 250MG/5ML POWDER FOR SOLUTION 250MG/5ML NOVOPHARM LIMITED CANADA

NOVANTRONE SOLUTION FOR 20MG/10ML JOHN WYETH & UNITED KINGDOM INJECTION BROTHER LTD.

NOVANTRONE SOLUTION FOR IV INFU- 20MG/10ML CYANAMID OF GREAT UNITED KINGDOM SION BRITAIN LTD 23.9.2003 FR Journal officiel de l'Union européenne 651

Trade Name Dosage Form Dose MA Holder Country

NOVANTRONE INJECTION SOLUTION FOR 2MG/2ML CYANAMID OF GREAT UNITED KINGDOM INJECTION/INFUSION BRITAIN LTD

NOVATAX-1000 POWDER FOR INJECTION 1G CIPLA LTD INDIA

NOVESIN 0.4% EYE DROPS 0.4% W/V CIBA VISION AG SWITZERLAND

NOVESIN 0.4% EYE DROPS 4.00MG/ML NOVARTIS SWITZERLAND OPHTHALMICS AG

NOVOAMOXIN CAP 500MG CAPSULES 500MG NOVOPHARM LTD CANADA

NOVO-AMPICILLIN CAPSULE 500MG NOVOPHARM LIMITED CANADA

NOVO-ATENOL TAB 100MG TABLET 100MG NOVOPHARM LIMITED CANADA

NOVO-ATENOL TAB 50MG TABLET 50MG NOVOPHARM LIMITED CANADA

NOVO-AZT CAP 100MG CAPSULE 100MG NOVOPHARM LIMITED CANADA

NOVOBAN CAPSULE 5MG NOVARTIS SVERIGE AB SWEDEN

NOVOBAN SOLUTION FOR 1MG/1ML NOVARTIS SVERIGE AB SWEDEN INJECTION

NOVO-BROMAZEPAM TABLET 6MG NOVOPHARM LIMITED CANADA

NOVO-BROMAZEPAM TAB 3MG TABLET 3MG NOVOPHARM LIMITED CANADA

NOVO-BUSPIRONE TAB 10MG TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-CAPTORIL TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-CAPTORIL TABLET 50MG NOVOPHARM LIMITED CANADA

NOVO-CEFACLOR CAPSULE 500MG NOVOPHARM LIMITED CANADA

NOVO-CEFACLOR CAP 250MG CAPSULE 250MG NOVOPHARM LIMITED CANADA

NOVO-CHLOROCAP CAP 250MG CAPSULES 250MG NOVOPHARM LTD CANADA

NOVO-CHOLAMINE — PWR POWDER FOR ORAL SUSP. 4G NOVOPHARM LTD CANADA

NOVO-CLOPAMINE TABLETS — TABLETS 10MG NOVOPHARM LTD CANADA 10MG

NOVO-CLOPAMINE TABLETS — TABLETS 25MG NOVOPHARM LIMITED CANADA 25MG

NOVO-DIFENAC SUPPOSITORY 100MG NOVOPHARM LIMITED CANADA

NOVO-DIFENAC ENTERIC COATED TABLET 50MG NOVOPHARM LIMITED CANADA

NOVO-DILTAZEM TAB 60MG TABLETS 60MG NOVOPHARM LTD CANADA

NOVO-DIPAM TABLET 5MG NOVOPHARM LIMITED CANADA

NOVO-DIPAM TABLET 2MG NOVOPHARM LIMITED CANADA

NOVO-DIPIRADOL TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-DOMPERIDONE TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-DOXEPIN CAP 25MG CAPSULES 25MG NOVOPHARM LTD CANADA

NOVO-DOXYLIN CAPSULE 100MG NOVOPHARM LIMITED CANADA

NOVO-FAMOTIDINE TABLET 20MG NOVOPHARM LIMITED CANADA 652 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NOVOFEM TABLETS NA NOVO NORDISK A/S DENMARK

NOVO-FLUPAM CAP 15MG CAPSULES 15MG NOVOPHARM LIMITED CANADA

NOVO-FLUPAM CAP 30MG CAPSULE 30MG NOVOPHARM LTD CANADA

NOVO-FLUVOXAMINE TABLET 50MG NOVOPHARM LIMITED CANADA

NOVO-FLUXOETINE CAPSULE 20MG NOVOPHARM LIMITED CANADA

NOVO-FOLIACID 5MG TABLETS 5MG NOVOPHARM LTD CANADA

NOVO-GLICLAZIDE TABLET 80MG NOVOPHARM LIMITED CANADA

NOVO-GLYBURIDE TABLETS 5MG NOVOPHARM LIMITED CANADA

NOVO-HEXIDYL 2MG TABLET 2MG NOVOPHARM LIMITED CANADA

NOVO-HYDROCORT CRM 1% CREAM 1% W / W NOVOPHARM LTD CANADA

NOVO-HYDROXYZIN CAPSULE 25MG NOVOPHARM LIMITED CANADA

NOVO-HYLAZIN TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-HYLAZIN 10MG USP TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-INDAPAMIDE TABLET 2.5MG NOVOPHARM LIMITED CANADA

NOVO-KETOTIFEN SYRUP 1MG/5ML NOVOPHARM LIMITED CANADA

NOVO-LEXIN CAP 250MG CAPSULES 250MG NOVOPHARM LTD CANADA

NOVO-LORAZEM TABLET 1MG NOVOPHARM LIMITED CANADA

NOVO-LORAZEM TABLET 2MG NOVOPHARM LIMITED CANADA

NOVO-MAPROTILINE TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-MAPROTILINE TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-MAPROTILINE — TAB 50MG TABLETS 50MG NOVOPHARM LTD CANADA

NOVO-METFORMIN TABLET 850MG NOVOPHARM LIMITED CANADA

NOVO-MEXILETINE CAPSULES 200MG NOVOPHARM LTD CANADA

NOVOMIX 30 FLEXPEN SUSPENSION FOR 100U/ML NOVO NORDISK A/S EUROPEAN COMMUNITY INJECTION IN A PRE-FILLED PEN

NOVOMIX 30 PENFILL SUSPENSION FOR 100U/ML NOVO NORDISK A/S EUROPEAN COMMUNITY INJECTION IN CARTRIDGES

NOVO-MOCLOBEMIDE TABLET 150MG NOVOPHARM LIMITED CANADA

NOVO-NADOLOL TABLET 40MG NOVOPHARM LIMITED CANADA

NOVO-NAPROX TAB 250MG TABLETS 250MG NOVOPHARM LTD CANADA

NOVO-NIFEDIN CAP 10MG CAPSULES 10MG NOVOPHARM LTD CANADA

NOVO-NORFLOXACIN TABLET 400MG NOVOPHARM LIMITED CANADA

NOVONORM TABLET 0.5MG NOVO NORDISK A/S UNITED KINGDOM

NOVONORM TABLET 1MG NOVO NORDISK A/S UNITED KINGDOM

NOVONORM TABLET 2MG NOVO NORDISK A/S UNITED KINGDOM 23.9.2003 FR Journal officiel de l'Union européenne 653

Trade Name Dosage Form Dose MA Holder Country

NOVO-PERIDOL TABLET 5MG NOVOPHARM LIMITED CANADA

NOVO-PHENYTOIN CAPSULE 100MG NOVOPHARM LIMITED CANADA

NOVO-PRAMINE TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-PRAMINE TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-PRANOL TABLET 40MG NOVOPHARM LIMITED CANADA

NOVO-PRANOL TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-PRAZIN TABLET 1MG NOVOPHARM LIMITED CANADA

NOVO-PREDNISONE 5MG TABLETS 5MG NOVOPHARM LTD CANADA

NOVO-QUINIDIN 200MG TABLETS 200MG NOVOPHARM LTD CANADA

NOVO-RANIDINE TAB 150MG TABLETS 150MG NOVOPHARM LTD CANADA

NOVORAPID 100UNITS/ML SOLUTION FOR 100UNITS/ML NOVO NORDISK A/S UNITED KINGDOM INJECTION

NOVORAPID NOVOLET SOLUTION FOR 100UNITS/ML NOVO NORDISK A/S UNITED KINGDOM 100UNITS/ML INJECTION

NOVORAPID PENFILL 100UNITS/ML SOLUTION FOR 100UNITS/ML NOVO NORDISK A/S UNITED KINGDOM INJECTION

NOVO-RIDAZINE 25MG TABLETS 25MG NOVOPHARM LTD CANADA

NOVOSEVEN POWDER FOR INJECTION 60KIU (1.2MG) NOVO NORDISK A/S UNITED KINGDOM

NOVOSEVEN POWDER FOR INJECTION 120KIU (2.4MG) EU/1/96/006/002 DENMARK

NOVOSEVEN POWDER FOR INJECTION 240KIU (4.8MG) NOVO NORDISK A/S DENMARK

NOVO-SOTALOL TABLET 80MG NOVOPHARM LIMITED CANADA

NOVO-SPIROTON TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-SUNDAC TAB 200MG TABLETS 200MG NOVOPHARM LTD CANADA

NOVO-TETRA 250MG CAPSULES 250MG NOVOPHARM LTD CANADA

NOVO-TRIFLUZINE TABLET 5MG NOVOPHARM LIMITED CANADA

NOVO-TRIPRAMINE TAB 25MG BP TABLET 25MG NOVOPHARM LIMITED CANADA

NOVO-TRIPRAMINE TAB 50MG TABLETS 50MG NOVOPHARM LTD CANADA

NOVO-TRIPTYN TABLET 10MG NOVOPHARM LIMITED CANADA

NOVO-TRIPTYN TAB 25MG TABLETS 25MG NOVOPHARM LTD CANADA

NUBAIN SOLUTION FOR 10MG/ML ENDO UNITED STATES OF INJECTION PHARMACEUTICALS INC. AMERICA

NUBAIN SOLUTION FOR 20MG/ML ENDO UNITED STATES OF INJECTION PHARMACEUTICALS INC AMERICA

NUELIN SA 175MG TABLETS MODIFIED RELEASE 175MG 3M HEALTH CARE UNITED KINGDOM TABLET LIMITED

NUELIN SA 250MG TABLETS MODIFIED RELEASE 250MG 3M HEALTH CARE UNITED KINGDOM TABLET LIMITED

NUELIN TABLETS TABLET 125MG 3M HEALTH CARE UNITED KINGDOM LIMITED 654 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

NU-LAX FRUIT LAXATIVE SENNA BLOCK 80MG/G ORCHARD AUSTRALIA LEAF MANUFACTURING CO. PTY LTD

NUMARK ANTI-DIARRHOEA CAPSULES 2MG GALPHARM UNITED KINGDOM CAPSULES HEALTHCARE LIMITED — UK

NUMARK CHESTY COUGH ORAL LIQUID 100MG/5ML BELL SONS & CO UNITED KINGDOM (DRUGGISTS) LIMITED

NUMARK CHESTY COUGH SYRUP N/A BELL SONS & CO UNITED KINGDOM EXPECTORANT (DRUGGISTS) LIMITED

NUMARK CHILDREN CHESTY ORAL SOLUTION N/A ROSEMONT UNITED KINGDOM COUGH LINCTUS PHARMACEUTICALS LIMITED

NUMARK DECONGESTANT FILM COATED TABLETS NA DEXCEL-PHARMA UNITED KINGDOM TABLETS WITH PARACETAMOL LIMITED

NUMARK NIGHT TIME SLEEP AID COATED TABLET 25MG NORMA CHEMICALS UNITED KINGDOM

NUPERCAINAL OINTMENT 1.1%W/W EASTERN UNITED KINGDOM PHARMACEUTICALS LIMITED

NUROFEN COATED TABLET 200MG CROOKES HEALTHCARE UNITED KINGDOM LIMITED

NUROFEN 400 COATED TABLET 400MG CROOKES HEALTHCARE UNITED KINGDOM LIMITED

NUROFEN COLD AND FLU COATED TABLET N/A CROOKES HEALTHCARE UNITED KINGDOM LIMITED

NUROFEN FOR CHILDREN SUGAR ORAL SUSPENSION 100MG/5ML CROOKES HEALTHCARE UNITED KINGDOM FREE LIMITED

NUROFEN PLUS COATED TABLET N/A CROOKES HEALTHCARE UNITED KINGDOM LIMITED

NURSE HARVEY'S GRIPE MIXTURE ORAL SOLUTION N/A HARVEY SCRUTON LTD UNITED KINGDOM

NURSE SYKES POWDERS ORAL POWDER N/A ANGLIAN PHARMA PLC UNITED KINGDOM

NUSEALS TABLET 75MG LILLY PAKISTAN

NU-SEALS 300 GASTRO-RESISTANT 300MG ELI LILLY & COMPANY UNITED KINGDOM TABLET LIMITED

NU-SEALS 75 COATED TABLET 75MG ELI LILLY & COMPANY UNITED KINGDOM LIMITED

NUTRAMID TABLETS 10MG THE ACME BANGLADESH LABORATORIES LTD — BANGLADESH

NUTRINEAL PD4 PERIT. DIALYSIS SOL F/INTRAPERITONEAL N/A BAXTER HEALTHCARE UNITED KINGDOM SOL. ADM LIMITED

NUVELLE CONTINUOUS COATED TABLET N/A SCHERING HEALTH CARE UNITED KINGDOM LTD

NUVELLE TABLETS COATED TABLET N/A SCHERING HEALTH CARE UNITED KINGDOM LTD

NUVELLE TS TRANSDERMAL PATCH N/A ETHICAL UNITED KINGDOM PHARMACEUTICALS (UK) LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 655

Trade Name Dosage Form Dose MA Holder Country

NUVELLE TS TRANSDERMAL PATCH N/A SCHERING HEALTH CARE UNITED KINGDOM LTD

NYADERM CRM 100000 UNIT/GM CREAM 100000 UNIT TARO CANADA PHARMACEUTICALS INC.

NYLAX WITH SENNA TABLET 7.5MG CROOKES HEALTHCARE UNITED KINGDOM LIMITED

NYLOL OPHTHALMIC GEL 1.00MG/ML NOVARTIS SWITZERLAND OPHTHALMICS AG

NYOLOL 0.25% EYE DROPS 0.0125G/5ML CIBA VISION FRANCE OPHTHALMICS

NYOLOL 0.5% EYE DROPS 0.5% W/V CIBA VISION FRANCE OPHTHALMICS

NYOLOL 0.5% EYE DROPS 0.5MG/ML NOVARTIS FRANCE OPHTHALMICS SA

NYOLOL GEL OPHTHALMIC GEL 1MG/G CIBA VISION AG SWITZERLAND

NYSTATIN TABLETS 500,000UNITS TARO ISRAEL PHARMACEUTICAL INDUSTRIES LTD.

NYSTATIN READY MIX SUSPENSION 100,000U/ML TARO ISRAEL SUSPENSION PHARMACEUTICAL INDUSTRIES LTD.

NYSTATIN TABLETS TABLET 500,000 UNITS TARO ISRAEL PHARMACEUTICAL INDUSTRIES LTD

NYSTATIN, READY MIX SUSPENSION 100,000 U/ML TARO ISRAEL SUSPENSION PHARMACEUTICAL INDUSTRIES LTD

NYTOL TABLET 25MG STAFFORD-MILLER UNITED KINGDOM LIMITED

NYTOL ONE-A-NIGHT TABLET 50 MG STAFFORD-MILLER UNITED KINGDOM LIMITED

NYTOL ONE-A-NIGHT TABLET 50MG STAFFORD MILLER UNITED KINGDOM LIMITED

NYTOL TABLETS TABLET 25MG STAFFORD MILLER UNITED KINGDOM LIMITED

OCATANATE 500 POWDER AND SOLVENT 500 I.U./VIAL OCTAPHARMA VERTRIEB GERMANY FOR SOL. VON PLASMADERIVATEN GMBH

OCTAGRAM SOLUTION FOR INFUSION 50MG/ML OCTAPHARMA AUSTRIA PHARMAZEUTIKA PRODUKTIONSGES.M.B.H.

OCTANATE 1000 POWDER AND SOLVENT 1000 I.U./VIAL OCTAPHARMA VERTRIEB GERMANY FOR SOL. VON PLASMADERIVATEN GMBH

OCTANATE 250 POWDER AND SOLVENT 250 I.U./VIAL OCTAPHARMA VERTRIEB GERMANY FOR SOL. VON PLASMADERIVATEN GMBH

OCTOFENE 100MG SUPPOSITORY 100MG LABORATOIRES DEBAT FRANCE

OCTOFENE 200MG SUPPOSITORY 200MG LABORATOIRES DEBAT FRANCE

OCTOFENE 750MG SUPPOSITORY 750MG LABORATOIRES DEBAT FRANCE 656 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

OCTONATIV-M POWDER FOR INJECTION 1000IU(I+II) PHARMACIA & UPJOHN SWEDEN AB

OCTONATIV-M POWDER FOR INJECTION 250IU(I+II) PHARMACIA & UPJOHN SWEDEN AB

OCTONATIV-M POWDER FOR INJECTION 500IU PHARMACIA & UPJOHN SWEDEN AB

OCTONATIV-M POWDER AND SOLVENT 500 IU BIOVITRUM AB SWEDEN

OCTONATIV-M 1000IU POWDER AND SOLVENT (I+11) 1000IU BIOVITRUM AB SWEDEN

OCTORAX TABLETS 20MG DEM ABEE GREECE

OCTOSTIM SOLUTION FOR 15MCG/ML FERRING AB SWEDEN INJECTION

OCUBRAX EYE DROPS N/A ALCON CUSI S.A. SPAIN

OCULOSAN EYE DROPS N/A CIBA VISION AG SWITZERLAND

OCULOSAN EYE DROPS NA NOVARTIS SWITZERLAND OPHTHALMICS AG

OCULOTECT EYE GEL 1000IU/G CIBA VISION AG SWITZERLAND

OCULOTECT EYE GEL 1000 UI /1G NOVARTIS SWITZERLAND OPHTHALMICS AG

OCULOTECT FLUID EYE DROPS 0.5G/10ML CIBA VISION FRANCE OPHTHALMICS

OCUTIM EYE DROPS SOLUTION 0.25% W/W CIPLA LIMITED INDIA

OCUTIM 0.5% EYE DROPS 0.5% W/V CIPLA LIMITED INDIA

ODASOL/GENEPHARM E.C. CAPSULES 20MG GENEPHARM S.A. GREECE

OESTRADIOL IMPLANT IMPLANT (SUB-CUTAN. 25MG ORGANON UNITED KINGDOM USE) LABORATORIES LIMITED

OESTRADIOL IMPLANT IMPLANT (SUB-CUTAN. 50MG ORGANON UNITED KINGDOM USE) LABORATORIES LIMITED

OESTRING VAGINAL DEVICE 7.5MCG/24HOURS PHARMACIA & UPJOHN SWEDEN SVERIGE AB

OESTRODOSE 0.06% GEL FOR PERCUTANEOUS 0.06% W/W LABORATOIRES FRANCE APPL BESINS-ISCOVESCO

OESTROFEMINAL 0.3MG CAPSULES 0.3MG HEINRICH MACK NACHF GERMANY

OESTROFEMINAL 0.6MG CAPSULES 0.6MG HEINRICH MACK NACHF GERMANY

OESTROFEMINAL 1.25MG CAPSULES 1.25MG HEINRICH MACK NACHF GERMANY

OFLOCET EAR DROPS 1.5MG/0.5ML LABORATOIRES AVENTIS FRANCE

OFLOCET 200MG TABLET 200MG LABORATOIRES AVENTIS FRANCE

OFLOCET 200MG/40ML SOLUTION FOR INFUSION 200MG/40ML LABORATOIRES FRANCE DIAMANT

OFLOMAC-100 TABLETS 100MG MACLEODS INDIA PHARMACEUTICALS LTD

OFLOMAC-200 TABLET 200MG MACLEODS INDIA PHARMACEUTICALS LTD 23.9.2003 FR Journal officiel de l'Union européenne 657

Trade Name Dosage Form Dose MA Holder Country

OFLOMAC-300 TABLETS 300MG MACLEODS INDIA PHARMACEUTICALS LTD

OFLOMAC-400 TABLET 400MG MACLEODS INDIA PHARMACEUTICALS LTD

OFLOX 0.3% OPHTHALMIC SOLUTION 0.3% W/V ALLERGAN IRELAND PHARMACEUTICALS (IRELAND) LTD., INC.

OFTALMIL EYE WASH N/A BRUSCHETTINI SRL ITALY

OFTALMIL EYE DROPS, SOLUTION N/A BRUSCHETTINI SRL ITALY

OILATUM SOAP 7.5% W/W STIEFEL LABORATORIES IRELAND (UK) LTD

OILATUM CREAM CREAM NA STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

OILATUM EMOLLIENT TOPICAL SOLUTION 63.4% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LTD

OILATUM GEL TOPICAL SOLUTION 70% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

OILATUM JUNIOR TOPICAL SOLUTION 63.4% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

OILATUM JUNIOR FLARE-UP TOPICAL SOLUTION N/A STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

OILATUM PLUS TOPICAL SOLUTION N/A STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

OILY CREAM BP CREAM NO ACTIVE ING. ADAMS HEALTHCARE UNITED KINGDOM LIMITED

OILY PHENOL INJECTION 5% W/V SOLUTION FOR 5%W/V MACARTHYS UNITED KINGDOM INJECTION LABORATORIES LTD

OKA-AZITHROMYCIN TABLETS 250MG OKASA PHARMA PTV INDIA LTD.

OKACIN EYE DROPS 3MG/ML CIBA VISION AG SWITZERLAND

OKACIN EYE DROPS NA NOVARTIS SWITZERLAND OPHTHALMICS AG

OKA-OMEPRAZOLE CAPSULES CAPSULE 20MG OKASA PHARMA PVT. INDIA LTD -INDIA

OKAVIR TABLETS 150MG OKASA PHARMA INDIA LTD- INDIA

OKI SOLUTION FOR ORAL N/A DOMPE' SPA ITALY MUCOSA

OLBAS BLACKCURRANT PASTILLES LOZENGE NA GR LANE HEALTH UNITED KINGDOM PRODUCTS LIMITED

OLBAS INHALER INHALATION LIQUID NA GR LANE HEALTH UNITED KINGDOM PRODUCTS

OLBAS OIL TOPICAL SOLUTION N/A G R LANE HEALTH UNITED KINGDOM PRODUCTS

OLBAS PASTILLES LOZENGE N/A G R LANE HEALTH UNITED KINGDOM PRODUCTS LTD

OLBETAM CAPSULES 250MG PHARMACIA & UPJOHN ITALY S.P.A. 658 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

OLFEN GEL 10MG/G MEPHA PHARMA AG SWITZERLAND

OLFEN ROLL-ON GEL 10MG/1G MEPHA PHARMA AG SWITZERLAND

OLFEN-100 RECTOCAPS 100MG MEPHA PHARMA AG SWITZERLAND

OLFEN-100 SR DEPOCAPS 100MG MEPHA PHARMA AG SWITZERLAND

OLFEN-25 LACTABS 25MG MEPHA PHARMA AG SWITZERLAND

OLFEN-50 LACTABS 50MG MEPHA PHARMA AG SWITZERLAND

OLFEN-75 SOLUTION FOR N/A MEPHA PHARMA AG SWITZERLAND INJECTION

OLFEN-75 RETARD DEPOTABS 75MG MEPHA PHARMA AG SWITZERLAND

OMEDAR TABLETS TABLETS 21 MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO. LTD.

OMEDOR ENTERIC COATED 20MG DAR AL DAWA JORDAN TABLETS DEVELOPMENT AND INVESTMENT CO LIMITED

OMNIC 0.4 MODIFIED RELEASE 0.4MG YAMANOUCHI PHARMA NETHERLANDS CAPSULES B.V.

OMNIPAQUE SOLUTION FOR 180MG I/ML NYCOMED UK LIMITED UNITED KINGDOM INJECTION

OMNIPAQUE SOLUTION FOR 240MG I/ML NYCOMED U.K. LIMITED NORWAY INJECTION

OMNIPAQUE SOLUTION FOR 300MG I/ML NYCOMED U.K. LIMITED NORWAY INJECTIONS

OMNIPAQUE SOLUTION FOR 350MG I/ML NYCOMED U.K. LIMITED NORWAY INJECTION

OMNIPAQUE SOLUTION FOR 140MG I/ML NYCOMED IMAGING AS NORWAY INJECTION

OMNIPAQUE SOLUTION FOR 180MG I/ML NYCOMED IMAGING AS NORWAY INJECTIONS

OMNIPAQUE SOLUTION FOR 240MG I/ML NYCOMED IMAGING AS NORWAY INJECTION

OMNIPAQUE SOLUTION FOR 300MG I/ML NYCOMED IMAGING AS NORWAY INJECTIONS

OMNIPAQUE SOLUTION FOR 350MG I/ML NYCOMED IMAGING AS NORWAY INJECTIONS

OMNIPAQUE SOLUTION FOR SEE REMARKS AMERSHAM HEALTH AS NORWAY INJECTION

OMNIPAQUE SOLUTION FOR SEE REMARKS AMERSHAM HEALTH AS NORWAY INJECTION

OMNISCAN SOLUTION FOR N/A NYCOMED IMAGING AS NORWAY INJECTION

OMNISCAN SOLUTION FOR 287MG/1ML NYCOMED IMAGING AS NORWAY INJECTION

OMNISCAN SOLUTION FOR 0.5 MMOL/ML AMERSHAM HEALTH AS NORWAY INJECTION

OMNISCAN SOLUTION FOR 0.5MMOL/ML AMERSHAM HEALTH AS NORWAY INJECTION 23.9.2003 FR Journal officiel de l'Union européenne 659

Trade Name Dosage Form Dose MA Holder Country

OMP TABLET (OMEPRAZOLE) TABLET 20MG CHONG KUN DANG KOREA (DEM PEOPLE'S PHARMACEUTICAL CORP. REP)

ONCASPAR SOLUTION FOR 750 IU/ML MEDAC GESELLSCHAFT GERMANY INJECTION FUR KLINISCHE SPEZIALPRAPARATE MBH

ONCOVIN SOLUTION FOR 1MG/ML LABORATOIRES LILLY FRANCE INJECTION FRANCE

ONCTOSE HYDROCORTISONE CREAM N/A LABORATOIRES MONOT FRANCE

ONE ALPHA CAPSULE CAPSULE 0.25MCG LEO PAKISTAN

ONE-ALPHA CAPSULES 0.5MCG LEO PHARMACEUTICAL DENMARK PRODUCTS

ONE-ALPHA CAPSULES 0.25MCG LEO PHARMACEUTICAL DENMARK PRODUCTS

ONE-ALPHA CAPSULES 1MCG LEO PHARMACEUTICAL DENMARK PRODUCTS

ONE-ALPHA DROPS 2MCG/ML LEO PHARMACEUTICAL DENMARK PRODUCTS

ONE-ALPHA SOLUTION FOR 2MCG/ML LEO PHARMACEUTICAL DENMARK INJECTION PRODUCTS

ONE-ALPHA CAPSULES CAPSULES 1MCG LEO PAKISTAN

ONKOVERTIN 40 IN 0.9%W/V INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY SODIUM CHLORIDE AG

ONKOVERTIN 40 IN 5% W/V INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY GLUCOSE AG

ONKOVERTIN 70 IN 0.9%W/V INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY SODIUM CHLORIDE AG

OPHTAMOLOL EYE DROPS 0.25% W/V DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

OPHTAMOLOL EYE DROPS 0.5% DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

OPRAZOLE TABLETS (14) 20MG HIKMA JORDAN PHARMACEUTICALS

OPTAMID OPHTHALMIC DROPS NA PROGE FARMA SRL ITALY

OPTICROM AQUEOUS EYE DROPS EYE DROPS 2% W/V FISONS LIMITED UNITED KINGDOM

OPTICROM AQUEOUS EYE DROPS EYE DROPS 2%W/V FISONS LTD UNITED KINGDOM

OPTICROM EYE OINT. OR EYE OINTMENT 4% W/V FISONS LIMITED UNITED KINGDOM VISICROM EYE OINT.

OPTICROM EYE EYE OINTMENT 4%W/W FISONS LTD T/A UNITED KINGDOM OINTMENT/VISICROM RHONE-POULENC RORER

OPTICROM-UD EYE DROPS IN AMPOULES 20MG/ML RHONE-POULENC RORER SWITZERLAND AG

OPTICROM-UD EYE DROPS IN AMPOULES N/A H. LUNBECK A/S DENMARK

OPTILAST EYE DROPS 0.05% W/V ASTA MEDICA LTD UNITED KINGDOM 660 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

OPTIPAX EAR DROPS SOLUTION N/A BIOCODEX FRANCE LABORATORIES

OPTREX EYE DROPS EYE DROPS 13%V/V OPTREX LIMITED UNITED KINGDOM

OPTREX EYE LOTION EYE LOTION 13%V/V OPTREX LIMITED UNITED KINGDOM

OPTREX MEDICATED EYE DROPS EYE DROPS N/A OPTREX LIMITED UNITED KINGDOM

ORACORT PASTE PASTE 0.10% W/W TARO ISRAEL PHARMACEUTICAL INDUSTRIES LTD

ORAL POLIO VACCINE — SOLUTION FOR ORAL N/A EVANS MEDICAL UNITED KINGDOM TRIVALENT ADMI. LIMITED

ORAL POLIOMYELITIS VACCINE DRINKABLE SOLUTION NA AVENTIS PASTEUR S.A. FRANCE

ORAL POLIOMYELITIS VACCINE SUSP. FOR ORAL N/A SMITHKLINE BEECHAM BELGIUM POLIO SABIN ADMINIST. BIOLOGICALS

ORALDENE SOLUTION 5MG/5ML WARNER LAMBERT UNITED KINGDOM CONSUMER HEALTHCARE

ORAMORPH ORAL SOLUTION 10MG/5ML BOEHRINGER UNITED KINGDOM INGELHEIM LTD

ORAP 1MG TABLET 1MG JANSSEN-CILAG N.V. BELGIUM

ORAP FORTE TABLET 4MG JANSSEN-CILAG N.V. BELGIUM

ORAP FORTE TABLETS 4MG JANSSEN CILAG NV BELGIUM

ORELOX 100MG TABLET 100MG LABORATOIRES AVENTIS FRANCE

ORELOX 40MG/5ML ENFANT ET GRANULES FOR ORAL 40MG/5ML LABORATOIRES AVENTIS FRANCE NOURRISSON SUSPEN.

ORFENAL 50 TABLETS 50MG REMEDICA LTD CYPRUS

ORIGINAL ANDREWS SALT EFFERVESCENT POWDER N/A SMITHKLINE BEECHAM UNITED KINGDOM (SWG) LIMITED

ORIGINAL PHENSIC ASPIRIN TABLET N/A SEVEN SEAS LIMITED T/A UNITED KINGDOM MERCK CONSUMER HEALTH

ORIMETEN TABLETS 250MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

ORIMETEN TABLETS 250MG NOVARTIS FARMA SPA ITALY

ORLEPT TABLETS 200MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

OROCHOL BERNA DOUBLE LYOPHILISED VACC. FOR N/A SWISS SERUM AND SWITZERLAND SACHET REC VACCINE INSTITUTE

OROFAR WITH LIDOCAIN LOZENGES N/A NOVARTIS CONSUMER SWITZERLAND HEALTH SA

OROFAR WITH LIDOCAIN SOLUTION N/A NOVARTIS CONSUMER SWITZERLAND HEALTH SA

OROPRAM 10 MG, TABLETS TABLETS 10 MG OMEGA FARMA EHF. ICELAND

OROPRAM 20 MG, TABLETS TABLETS 20 MG OMEGA FARMA EHF. ICELAND

OROPRAM 40 MG, TABLETS TABLETS 40 MG OMEGA FARMA EHF. ICELAND 23.9.2003 FR Journal officiel de l'Union européenne 661

Trade Name Dosage Form Dose MA Holder Country

OROVITE 7 GRANULES FOR ORAL N/A SETON HEALTHCARE UNITED KINGDOM SUSP. GROUP PLC

OROVITE 7 GRANULES FOR ORAL N/A SETON PRODUCTS UNITED KINGDOM SUSP. LIMITED

OROVITE TABLETS TABLET N/A SETON HEALTHCARE UNITED KINGDOM GROUP PLC

OROVITE TABLETS TABLETS N/A SETON PRODUCTS UNITED KINGDOM LIMITED

ORREPASTE PASTE N/A HOE PHARMACEUTICALS MALAYSIA SDN.BHD.

ORREPASTE, CREAM CREAM 0.1% W/W HOE PHARMACEUTICALS MALAYSIA SDN. BHD

ORSINON TABLET 500MG REKAH ISRAEL PHARMACEUTICAL INDUSTRY LTD

ORTHOCLONE OKT 3 SOLUTION FOR 5MG/5ML JANSSEN-CILAG AG SWITZERLAND INJECTION

ORTHO-GYNEST VAGINAL CREAM 0.1MG/G JANSSEN-CILAG AG SWITZERLAND

ORTHO-GYNEST VAGINAL OVULE 0.5MG JANSSEN-CILAG AG SWITZERLAND

ORUVAIL 100 MODIFIED RELEASE 100MG HAWGREEN LIMITED IRELAND CAPSULE

ORUVAIL 200 MODIFIED RELEASE 200MG HAWGREEN LIMITED IRELAND CAPSULE

OSANGIN TABLETS N/A MARCO ANTONETTO SPA ITALY

OSMOFUNDIN 10% INFUSION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY AG

OSMOFUNDIN 15% N INFUSION SOLUTION 15% W/V B.BRAUN MELSUNGEN GERMANY AG

OSMOFUNDIN 15% N INFUSION SOLUTION 15% W/V B.BRAUN MELSNGEN AG GERMANY

OSMOGEL GEL F/LOCAL N/A LABORATOIRES MONOT FRANCE APPLICATION

OSPAMOX TABLET 500MG BIOCHEMIE GMBH AUSTRIA

OSPEXIN TABLET 500MG BIOCHEMIE GMBH AUSTRIA

OSSIN RETARDDRAGEES TABLET 40MG GRUNENTHAL GMBH GERMANY

OSTEDRON CAPSULES 400MG KLEVA LIMITED GREECE

OSTEOCALCIN SOLUTION FOR 100 IU DOTT. A. TOSI ITALY INJECTION FARMACEUTICI S.A.S.

OTOMIZE EAR SPRAY METERED AEROSOL N/A STAFFORD-MILLER UNITED KINGDOM LIMITED

OTOPAIN EAR DROPS N/A PT INTERBAT INDONESIA

OTORALGYL WITH EAR SPRAY N/A LABORATOIRES FRANCE PHENYLEPHRINE MARTIN-JOHNSON & JOHNSON-MSD

OTOSPORIN EAR DROPS N/A THE WELLCOME UNITED KINGDOM FOUNDATION LTD. 662 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

OTOSPORIN EAR DROPS NA THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

OTOSPORIN DROPS EAR DROPS NA GLAXOWELLCOME PAKISTAN

OTRINOL PROLONGED RELEASE 120MG NOVARTIS CONSUMER SWITZERLAND CAPSULE HEALTH SA

OTRISAL BABY NASAL SPRAY N/A NOVARTIS CONSUMER AUSTRIA HEALTH — GEBRO GMBH

OTRIVIN NASAL SPRAY 0.1% W/V NOVARTIS CONSUMER SWITZERLAND HEALTH SA

OTRIVIN SOLUTION 0.05% W/V NOVARTIS CONSUMER SWITZERLAND HEALTH SA

OTRIVIN SOLUTION 0.1% W/V NOVARTIS CONSUMER SWITZERLAND HEALTH SA

OTRIVIN GEL 0.1% W/W NOVARTIS CONSUMER SWITZERLAND HEALTH SA

OTRIVIN NEBULISING SOLUTION N/A CIBA PAKISTAN

OTRIVIN NASAL DROPS 1MG/ML NOVARTIS CONSUMER SWITZERLAND HEALTH SCHWEIZ AG

OTRIVIN 0.05% NASAL DROPS 0.5MG/ML NOVARTIS CONSUMER SWITZERLAND HEALTH SCHWEIZ AG

OTRIVIN 0.1% NASAL DROPS IN 1MG/ML NOVARTIS CONSUMER SWITZERLAND NEBULISER HEALTH SCHWEIZ AG

OTRIVIN 0.1% NASAL GEL 0.1%W/W NOVARTIS CONSUMER SWITZERLAND HEALTH SCHWEIZ AG

OTRIVIN 0.1% METERED DOSE SPRAY 1MG/1ML NOVARTIS CONSUMER SWITZERLAND HEALTH SCHWEIZ AG

OVRAL COATED TABLETS N/A WYETH-PHARMA GMBH GERMANY

OWS (DICLOFENAC SODIUM) SOLUTION FOR 75MG/2ML UNIMED KOREA REPUBLIC INJECTION PHARMACEUTICALS INC.

OXACID 200 CAPSULES 200MG AEGIS LTD. CYPRUS

OXACTIN CAPSULES 20MG SCHEIN UNITED KINGDOM PHARMACEUTICAL UK LIMITED

OXILAN — 300 SOLUTION FOR 300MG IODINE/ML COOK IMAGING UNITED STATES OF INJECTION CORPORATION AMERICA

OXILAN — 350 SOLUTION FOR 350MG IODINE/ML COOK IMAGING UNITED STATES OF INJECTION CORPORATION AMERICA

OXIS TURBUHALER INHALATION POWDER 6MCG/AC ASTRA UNITED KINGDOM PHARMACEUTICALS LIMITED

OXIS TURBUHALER INHALATION POWDER 12MCG/AC ASTRA UNITED KINGDOM PHARMACEUTICALS LIMITED

OXISEPT SOL.EXT.U.S. 7.5% 75MG DEMO S.A. GREECE

OXISEPT 10% EXTERNAL SOLUTION 10% DEMO SA GREECE

OXSORALEN LOTION 1% W/V ICN PHARMACEUTICALS UNITED STATES OF INC. AMERICA 23.9.2003 FR Journal officiel de l'Union européenne 663

Trade Name Dosage Form Dose MA Holder Country

OXSORALEN CAPSULE 10MG ICN PHARMACEUTICALS, UNITED STATES OF INC. AMERICA

OXSORALEN CAPSULES 10MG ICN PHARMACEUTICALS UNITED STATES OF AMERICA

OXSORALEN LOTION 1% V/V ICN PHARMACEUTICALS UNITED STATES OF INC. AMERICA

OXSORALEN CAPSULES 10MG ICN PHARMACEUTICALS UNITED STATES OF INC. AMERICA

OXYBUTYNIN HYDROCHLORIDE TABLET 5MG GENERICS (UK) LIMITED UNITED KINGDOM

OXYBUTYNIN HYDROCHLORIDE TABLETS 5MG GENERICS (UK) LIMITED UNITED KINGDOM

OXYBUTYNIN HYDROCHLORIDE TABLET 5MG SANOFI WINTHROP LTD UNITED KINGDOM TABLETS 5MG

OXYTETRACYCLINE TABLETS 250MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

OXYTETRACYCLINE TABLETS 250MG PHARMAMED LTD. MALTA

OXYTETRACYCLINE 100MG TABLET 100MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

OXYTETRACYCLINE BP 250MG TABLET 250MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

OXYTETRACYCLINE BP 50MG TABLET 50MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMETED

OZEPAL TABLETS 5MG DEMO ABEE GREECE

OZOPULMIN SUPPOSITORIES 40MG GEYMONAT SPA ITALY

OZOPULMIN SUPPOSITORIES 80MG GEYMONAT SPA ITALY

OZOPULMIN SUPPOSITORIES 160MG GEYMONAT SPA ITALY

OZOPULMIN GEL N/A GEYMONAT SPA ITALY

OZOPULMIN SYRUP N/A GEYMONAT SPA ITALY

OZOTHINE SYRUP 0.24G/100ML SOCIETE PHOCEAL FRANCE

PABRINEX INTRAMUSCULAR HIGH SOLUTION FOR N/A LINK UNITED KINGDOM POTENCY INJECTION PHARMACEUTICALS LIMITED

PABRINEX INTRAVENOUS HIGH SOLUTION FOR N/A LINK UNITED KINGDOM POTENCY INJECTION PHARMACEUTICALS LIMITED

PACIFENE TABLETS 200MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

PACIFENE MAXIMUM STRENGTH TABLETS 400MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

PACIMOL(PARACETAMOL TABLETS TABLET 500MG IPCA LABORATORIES INDIA BP) LIMITED

PAEDIATRIC PARACETAMOL ORAL ORAL SOLUTION 120MG WILLIAM RANSOM & UNITED KINGDOM SOLUTION BP SON PLC 664 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PALDESIC (PARACETAMOL ORAL SUSPENSION 120MG/5ML ROSEMONT UNITED KINGDOM SUSPEN. 120MG/5ML) PHARMACEUTICALS LIMITED

PALUDRINE TABLETS 100MG ZENECA LIMITED UNITED KINGDOM

PALUDRINE 100MG TABLET 100MG ASTRAZENECA UK UNITED KINGDOM LIMITED

PAMECIL POWDER FOR OR. 125MG/5ML MEDOCHEMIE LTD CYPRUS SUSPENSION

PAMECIL 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

PAMECIL 250MG POWDER FOR INJECTION 250MG MEDOCHEMIE LTD CYPRUS

PAMOCIL CAPSULES 1G FARMA UNO SRL ITALY

PAMOL SUSPENSION 120MG/5ML DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LIMITED

PANADOL SUPPOSITORY 500MG SANOFI WINTHROP — PORTUGAL PRODUCTOS FARMACEUTICOS, LDA.

PANADOL SUPPOSITORY 250MG SANOFI WINTHROP — FRANCE PRODUCTOS FARMACEUTICOS, LDA.

PANADOL SUPPOSITORY 125MG SANOFI WINTHROP — PORTUGAL PRODUCTOS FARMACEUTICOS, LDA.

PANADOL TABLET 500MG PHARMATEC PAKISTAN

PANADOL TABLET 500MG WINTHROP PAKISTAN

PANADOL COATED EMBOSSED 500MG SMITHKLINE BEECHAM IRELAND TABLETS (IRELAND)

PANADOL 250MG SUPPOSITORIES 250MG GLAXOSMITHKLINE FRANCE SANTE GRAND PUBLIC

PANADOL ACTIFAST TABLETS 500MG SMITHKLINE BEECHAM IRELAND (IRELAND) LIMITED

PANADOL ACTIFAST TABLET 500MG SMITHKLINE BEECHAM UNITED KINGDOM (SWG) LIMITED T/A GSK CONSUMER HEALTHCARE

PANADOL BABY AND INFANT ORAL SUSPENSION 120MG/5ML SMITHKLINE BEECHAM UNITED KINGDOM SUSPENSION (SWG) LTD T/A SMITHK. BEEC. CONSUM. HLTHC

PANADOL COLD AND FLU CAPLETS NA SMITHKLINE BEECHAM AUSTRALIA CONSUMER HEALTHCARE

PANADOL EXTRA TABLET N/A PHARMATEC PAKISTAN

PANADOL EXTRA TABLET N/A WINTHROP PAKISTAN

PANADOL EXTRA COATED EMBOSSED NA SMITHKLINE BEECHAM IRELAND TABLETS (IRELAND) LTD

PANADOL EXTRA TABLETS TABLET N/A SMITHKLINE BEECHAM UNITED KINGDOM (SWG) LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 665

Trade Name Dosage Form Dose MA Holder Country

PANADOL SINUS CAPLETS NA SMITHKLINE BEECHAM AUSTRALIA CONSUMER HEALTHCARE

PANADOL SOLUBLE TABLETS EFFERVESCENT TABLET 500MG SMITHKLINE BEECHAM UNITED KINGDOM 500MG (SWG) LTD T/A STERLING HEALTH

PANADOL SUPPOSITORIES SUPPOSITORY 125MG SMITHKLINE BEECHAM FRANCE SANTE AND HYGIENE

PANADOL TABLETS (500MG) TABLET 500MG SMITHKLINE BEECHAM UNITED KINGDOM (SWG) LIMITED T/A SMITHKL. BEEC. CONS. HC

PANADOL ULTRA TABLETS N/A SMITHKLINE BEECHAM UNITED KINGDOM LTD T/A GLAXOSMITHKLINE CONS HEALTHCARE

PANAGESIC TABLET 30MG MEDOCHEMIE LTD CYPRUS

PANCURONIUM BROMIDE SOLUTION FOR 4MG/2ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

PANCURONIUM BROMIDE SOLUTION FOR 4MG/2ML FAULDING UNITED KINGDOM INJECTION BP 4MG/2ML INJECTION PHARMACEUTICALS PLC

PANETS CAPLETS TABLET 500MG THE BOOTS COMPANY UNITED KINGDOM PLC

PANETS TABLETS TABLET 500MG THE BOOTS COMPANY UNITED KINGDOM PLC

PANOXYL ACNEGEL 10 GEL 10% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

PANOXYL ACNEGEL 5 GEL 5% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

PANOXYL AQUAGEL 10 GEL 10% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

PANOXYL AQUAGEL 2.5 GEL 2.5% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LTD

PANOXYL AQUAGEL 5 GEL 5% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

PANOXYL WASH 10% W/W TOPICAL SUSPENSION 10% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

PANTINE TABLET SUGAR-COATED TABLET 15MG CAMDEN INDUSTRIES (M) MALAYSIA SDN BHD

PANTOGAR CAPSULES N/A ADROKA AG SWITZERLAND

PARA PLUS LOTION IN PRESSURISED N/A LABORATORE S.C.A.T FRANCE BOT

PARA SPECIAL POUX (LICE) SHAMPOO N/A LABORATOIRES S.C.A.T FRANCE

PARA SPECIAL POUX (LICE) SOL FOR LOCAL N/A LABORATOIRES S.C.A.T FRANCE APPLICATION

PARACEN 500 TABLETS 500MG AEGIS LTD. CYPRUS

PARACETAMOL TABLETS 500MG PHARMAMED LTD. MALTA

PARACETAMOL TABLETS 500MG CIPLA LIMITED INDIA 666 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PARACETAMOL 500MG SOLUBLE TABLET FOR ORAL 500MG SANOFI WINTHROP LTD UNITED KINGDOM TABLETS SOLUTION

PARACETAMOL BP 500MG TABLET 500MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

PARACETAMOL DENK 125 SUPPOSOTORY 125MG E.DENK OHG GERMANY

PARACETAMOL DENK 250 SUPPOSITORY 250MG E.DENK OHG GERMANY

PARACETAMOL DENK 500' SUPPOSITORY 500MG E.DENK OHG GERMANY

PARACETAMOL INFANT DROPS ORAL SOLUTION 100MG/ML OLINKA UK LIMITED UNITED KINGDOM 100MG/ML

PARACETAMOL TABLET B.P. TABLET 500MG ASPAR UNITED KINGDOM 500MG PHARMACEUTICALS LTD

PARACETAMOL TABLET BP 500MG TABLET 500MG ASPAR UNITED KINGDOM PHARMACEUTICALS LTD

PARACETAMOL TABLETS 500MG TABLET 500MG SANOFI WINTHROP UNITED KINGDOM LIMITED

PARACETAMOL TABLETS 500MG TABLET 500MG SANOFI WINTHROP LTD UNITED KINGDOM

PARACETAMOL TABLETS 500MG TABLET 500MG SANOFI WINTHROP UNITED KINGDOM LIMITED

PARACETAMOL TABLETS 500MG TABLET 500MG GEOFMAN PAKISTAN PHARMACEUTICALS

PARACETAMOL TABLETS BP TABLETS 500MG M & A PHARMACHEM UNITED KINGDOM 500MG LIMITED — UK

PARACETAMOL TABLETS BP TABLET 500MG OBG PHARMACEUTICALS UNITED KINGDOM 500MG LIMITED

PARACETAMOL TABLETS BP TABLETS 500MG OBG PHARMACEUTICALS UNITED KINGDOM 500MG LIMITED

PARACETAMOL TABLETS BP UNCOATED TABLET 500MG TABLET (INDIA) LIMITED INDIA 500MG FEVASTIN

PARACETAMOL+CAFFEINE TABLET N/A SANOFI WINTHROP UNITED KINGDOM TABLETS LIMITED T/A STERWIN MEDICINES

PARACETAMOL-RATIOPHARM SUPPOSITORY 125MG RATIOPHARM GMBH GERMANY 125 SUPPOSITORIEN

PARACETAMOL-RATIOPHARM SUPPOSITORY 250MG RATIOPHARM GMBH GERMANY 250 SUPPOSITORIEN

PARACETS TABLET 500MG SUSEEX UNITED KINGDOM PHARMACEUTICAL LIMITED

PARACETS (PARACETS G) CAPSULE 500MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

PARACETS PLUS COLD RELIEF CAPSULE N/A SUSSEX UNITED KINGDOM CAPS PHARMACEUTICAL LIMITED

PARACIL TABLET 500 MG TABLET 500MG SM PHARMACEUTICALS MALAYSIA SDN BHD

PARAFFIN WHITE SOFT BP OINTMENT 100%W/W LCM LTD UNITED KINGDOM 23.9.2003 FR Journal officiel de l'Union européenne 667

Trade Name Dosage Form Dose MA Holder Country

PARALDEHYDE INJECTION SOLUTION FOR 5ML/VIAL F.H. FAULDING & CO LTD UNITED KINGDOM INJECTION (T/A DAVID BULL LABS)

PARALIEF TABLETS 500MG CLONMEL HEALTHCARE IRELAND LIMITED

PARAMETTES CHEWABLE TABLETS N/A WYETH-AYERST CANADA CANADA MULTIVIT. PLUS IRON INC.

PARAMOL 500 TABLET TABLET 500MG CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD

PARAPLATIN SOLN. FOR I.V INFUSION 450MG/45ML BRISTOL-MYERS SQUIBB ITALY S.P.A.

PARAPLATIN SOLN. FOR I.V INFUSION 50MG/5ML BRISTOL MYERS SQUIBB ITALY S.P.A.

PARAPLATIN POWDER FOR INJECTION 450MG BRISTOL-MYERS UNITED STATES OF COMPANY AMERICA

PARASUPP 125 MG SUPPOSITORIES 125 MG DELTA HF ICELAND SUPPOSITORIES

PARASUPP 250 MG SUPPOSITORIES 125MG DELTA HF ICELAND SUPPOSITOPRIES

PARASUPP 60 MG SUPPOSITORIES SUPPOSITORIES 60 MG DELTA HF ICELAND

PARATABS 160 MG TABLET 160MG DELTA HF ICELAND ORODISPERSIBLE

PARATABS 500 MG TABLETS TABLETS 500MG DELTA HF ICELAND

PARATABS 80 MG TABLET 80 MG DELTA HF ICELAND ORODISPERSIBLE

PARATABS RETARD 500MG TABLET 500 MG DELTA HF ICELAND PROLONGED-RELEASE

PARCOTEN 500/10 TABLETS N/A AEGIS LTD. CYPRUS

PARIET TABLETS 10MG JANSSEN-CILAG N.V. BELGIUM

PARIET TABLETS 20MG JANSSEN-CILAG N.V. BELGIUM

PARIET 10MG ORAL TABLET 10MG EISAI LTD UNITED KINGDOM

PARIET 20MG ORAL TABLET 20MG EISAI LTD UNITED KINGDOM

PARITREL TABLETS 100MG TRIMA ISRAEL ISRAEL PHARMACEUTICAL PRODUCTS LIIMITED

PARKODIN TABLET N/A DELTA HF ICELAND

PARKODIN SUPPOSITORIES N/A DELTA HF ICELAND

PARKODIN FORTE 30/500 TABLETS TABLETS N/A DELTA HF ICELAND

PARKODIN FORTE 30/500MG SUPPOSITORIES N/A DELTA HF ICELAND SUPPOSITORIES

PARLODEL TABLETS 2.5MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

PARLODEL TABLET 2.5MG SANDOZ PAKISTAN

PARLODEL TABLETS 2.5MG NOVARTIS PHARMA N.V BELGIUM 668 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PARLODEL TABLETS 2.5MG NOVARTIS FARMA SPA ITALY

PARLODEL 2.5MG TABLET 2.5MG NOVARTIS PAKISTAN

PARMOL 120 SYRUP SYRUP 120MG/5ML HOVID SDN. BHD. MALAYSIA

PAROXAT TABLETS 20MG OMEGA FARMA ICELAND

PARPLATIN SOLN. FOR I.V INFUSION 150MG/15ML BRISTOL MYERS SQUIBB ITALY S.P.A

PARRASUPP 500 MG SUPPOSITORIES 500 MG DELTA HF ICELAND SUPPOSITORIES

PASSIFLORA TABLETS, COATED TABLET 71.4MG PETER BLACK UNITED KINGDOM NATRACALM HEALTHCARE LTD.

PATANOL 0.1% OPHTHALMIC SOLUTION 0.1% W/V ALCON LABORATORIES UNITED STATES OF INC. AMERICA

PAVULON 4MG=2ML SOLUTION FOR 2MG/ML N.V. ORGANON (PART OF NETHERLANDS INJECTION AKZO NOBEL)

PAVULON 4MG=2ML SOLUTION FOR 2MG/ML N.V.ORGANON NETHERLANDS INJECTION

PAX INJECTION 10MG/2ML SOLUTION FOR 10MG/2ML PHARMACARE LIMITED SOUTH AFRICA INJECTION

PAXIDORM TABLETS TABLETS 25MG NORMA CHEMICALS UNITED KINGDOM LIMITED

PECTYLIN-C EXPECTORANT ORAL LIQUID NA IPCA LABORATORIES INDIA LIMITED

PEDITRACE CONC. F/SOLUTION F/INF. N/A PHARMACIA & UPJOHN SWEDEN SVERIGE AB

PEDITRACE SOLUTION FOR INFUSION N/A FRESENIUS KABI LIMITED UNITED KINGDOM

PEDITRACE SOLUTION FOR INFUSION NA FRESENIUS KABI LIMITED UNITED KINGDOM

PEDVAX HIB VACCINE N/A MERCK SHARP & DOHME NETHERLANDS

PEGASYS SOLUTION FOR 135MCG/VIAL ROCHE REGISTRATION EUROPEAN COMMUNITY INJECTION LIMITED

PEGASYS SOLUTION FOR 180MCG/VIAL ROCHE REGISTRATION EUROPEAN COMMUNITY INJECTION LIMITED

PEGINTRON POW.AND SOL.F/SOL.F/INJ. SEE REMARKS SP EUROPE EUROPEAN COMMUNITY

PELLIT INSECT GEL GEL 1G/100G KARL ENGELHARD GERMANY

PENBRITIN CAPSULE 250MG SMITH KLINE & PAKISTAN BEECHAM

PENBRITIN CAPSULE 500MG SMITH KLINE & PAKISTAN BEECHAM

PENBRITIN CAPSULES 250MG CAPSULE 250MG BEECHAM GROUP PLC UNITED KINGDOM

PENBRITIN CAPSULES 500MG CAPSULE 500MG BEECHAM GROUP PLC UNITED KINGDOM

PENBRITIN PAEDIATRIC SUSP. POWDER FOR ORAL 125MG/1.25ML BEECHAM GROUP PLC UNITED KINGDOM 125MG/1.25ML SOLUTION 23.9.2003 FR Journal officiel de l'Union européenne 669

Trade Name Dosage Form Dose MA Holder Country

PENBRITIN SYRUP 125MG/5ML POWDER FOR ORAL 125MG/5ML BEECHAM GROUP PLC UNITED KINGDOM SOLUTION

PENBRITIN SYRUP FORTE POWDER FOR ORAL 250MG/5ML BEECHAM GROUP PLC UNITED KINGDOM SOLUTION

PENBRITIN VIALS FOR INJECTION POWDER FOR INJECTION 250MG BEECHAM GROUP PLC UNITED KINGDOM

PENBRITIN VIALS FOR INJECTION POWDER FOR INJECTION 500MG BEECHAM GROUP PLC UNITED KINGDOM

PENFEN TABLETS 50MG ATCO LABORATORIES PAKISTAN (PVT) LTD

PENFEN SOLUTION FOR 75MG/3ML ATCO LABORATORIES PAKISTAN INJECTION (PVT) LTD

PENICILLAMINE COATED TABLETS 250MG GENERICS (UK) LIMITED UNITED KINGDOM

PENICILLIN VK TABLETS 250MG ATHLONE IRELAND LABORATORIES LIMITED

PENIILLAMINE TABLETS BP 250MG TABLET 250MG GENERICS (UK) LIMITED UNITED KINGDOM

PENODIL CAPSULES 250MG REMEDICA LTD CYPRUS

PENRAZOL E.C. CAPSULE 20MG ELPEN S.A. GREECE

PENSORDIL TABLET 10MG ELPEN S.A GREECE

PENTACOL TABLETS 400MG SOFAR SPA ITALY

PENTACOQ SUSPENSION FOR N/A PASTEUR MERIEUX FRANCE INJECTION

PENTAGLOBIN SOL FOR IV USE 50MG/ML BIOTEST PHARMA GMBH GERMANY

PENTAMIDINE ISETHIONATE SOLUTION FOR 300MG ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

PENTASA MESALAZINE ENEMA 1G RECTAL SUSPENSION 1G/100ML FERRING UNITED KINGDOM PHARMACEUTICALS LIMITED

PENTASA SUPPOSITORIES IGM SUPPOSITORY 1G FERRING UNITED KINGDOM PHARMACEUTICALS LIMITED

PENTASPAN INJECTABLE SOLUTION FOR N/A DUPONT PHARMA INC CANADA INJECTION

PENTAZOCINE CAPSULES 50MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

PENTOSTAM SOLUTION FOR 10G/100ML THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION LIMITED

PENTOTHAL SODIUM POWDER FOR INJECTION 0.5G ABBOTT S.P.A. ITALY

PENTOTHAL SODIUM POWDER FOR INJECTION 1G ABBOTT S.P.A. ITALY

PEP TABLETS N/A HEALTHY IDEAS LIMITED UNITED KINGDOM

PEPDINE 20MG TABLET 20MG MERCK SHARP & DOHME NETHERLANDS B.V.

PEPDINE 40MG TABLET 40MG MERCK SHARP & DOHME NETHERLANDS B.V.

PERAZODIN 100 TABLETS 100MG REMEDICA LTD CYPRUS 670 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PERFANE 100MG/20ML IV INJ. SOLN FOR DILU- 100MG/20ML LABORATOIRES MARION FRANCE TION MERRELL DOW S.A.

PERFORMER MODIFIED RELEASE 750MG VECCHI & PIAM S.A.P.A ITALY TABLET

PERFORMER GRANULES FOR ORAL 250MG/5ML VECCHI & C. PIAM S.A.P.A ITALY SUSP.

PERGONAL POWDER FOR INJECTABLE N/A SERONO PHARMA S.P.A. ITALY SOL

PERGONAL 150IU POWDER FOR INJECTION N/A LABORATOIRES SERONO SWITZERLAND SA

PERGONAL 75IU INJECTABLE 75IU HMG/ML LABORATOIRES SERONO SWITZERLAND PREPARATION SA

PERIACTIN 4MG TABLET 4MG MERCK SHARP & DOHME NETHERLANDS B.V.

PERIDON TABLET 10MG ITALCHIMICI SPA ITALY

PERIDON SUPPOSITORIES 30MG ITALCHIMICI SPA ITALY

PERIDON SUPPOSITORIES 60MG ITALCHIMICI SPA ITALY

PERIDON SYRUP 100MG/100ML ITALCHIMICI SPA ITALY

PERINORM (METOCLOPRAMIDE TABLET 10MG IPCA LABORATORIES INDIA TABLETS BP) LIMITED

PERISET-4 (ONDANSETRON TABLET 4MG IPCA LABORATORIES INDIA TABLETS) LIMITED

PERLUTEX TABLETS 5MG LEO PHARMACEUTICAL DENMARK PRODUCTS

PEROFEN 200 TABLETS 200MG REMEDICA LTD CYPRUS

PERPECTOR DROPS N/A DR.GROSSMANN AG SWITZERLAND PHARMACA

PERSANTIN S.C. TABLET 25MG BOEHRINGER INGELHEIM GERMANY PHARMA KG

PERSANTIN S.C. TABLET 75MG BOEHRIGER INGELHEIM GERMANY PHARMA KG

PERSANTIN SUGAR COATED TABLET 25MG BOEHRINGER-INGELHEIM PAKISTAN

PERSANTIN TABLETS 100MG BOEHRINGER INGELHEIM PAKISTAN

PERSANTIN 100MG SUGAR COATED TABLET 100MG BOEHRINGER-INGELHEIM PAKISTAN

PERSKINDOL CLASSIC GEL N/A PHARMA-SINGER AG SWITZERLAND

PERSKINDOL CLASSIC SPRAY N/A PHARMA-SINGER AG SWITZERLAND

PERSKINDOL CLASSIC LINIMENT N/A PHARMA-SINGER AG SWITZERLAND

PERSKINDOL CLASSIC BATH-OIL N/A PHARMA-SINGER AG SWITZERLAND

PETHIDINE SOLUTION FOR 100MG/2ML DUOPHARMA(M) MALAYSIA INJECTION SDN.BHD.

PETHIDINE INJECTION BP50MG/ML SOLUTION FOR 50MG/ML ANITGEN IRELAND INJECTION PHARMACEUTICALS LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 671

Trade Name Dosage Form Dose MA Holder Country

PETHIDINE INJ. BP SOLUTION FOR 5% W/V MACARTHYS UNITED KINGDOM INJECTION LABORATORIES LTD T/A MARTINDALE PHARMACEUTICALS

PETHIDINE INJECTION SOLUTION FOR 50MG/1ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

PETHIDINE INJECTION SOLUTION FOR 100MG/2ML ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

PEVARYL POWDER 10MG/G JANSSEN-CILAG AG SWITZERLAND

PEVARYL CREAM 10MG/G JANSSEN-CILAG N.V. SWITZERLAND

PEVARYL CREAM 1G/100G JANSSEN-CILAG N.V. BELGIUM

PEVARYL MILK 10MG/G JANSSEN-CILAG AG SWITZERLAND

PEVARYL 1% SOLUTION 1G/100G JANNSEN-CILAG AG SWITZERLAND

PEVARYL LIPOGEL GEL 10MG/G JANSSEN-CILAG AG SWITZERLAND

PEVARYL PV FOAMING SOLUTION 1G/100G JANSSEN-CILAG AG SWITZERLAND

PEVARYL SHAMPOO SOLUTION 10MG/G JANSSEN-CILAG AG SWITZERLAND

PEVISONE CREAM N/A JANSSEN-CILAG AG SWITZERLAND

PEVISONE CREAM N/A JANSSEN-CILAG N.V. BELGIUM

PHARMATOVIT CAPSULES N/A PHARMATON SA SWITZERLAND

PHENERGAN ELIXIR 5MG/5ML RHONE-POULENC-RORER PAKISTAN

PHENERGAN ELIXIR ORAL SOLUTION 5MG/5ML MAY & BAKER LIMITED UNITED KINGDOM

PHENERGAN INJECTION 2.5% W/V SOLUTION FOR 2.5% W/V MAY & BAKER LIMITED UNITED KINGDOM INJECTION (REFER TO CPP)

PHENERGAN TABLETS 10MG COATED TABLET 10MG MAY & BAKER LIMITED UNITED KINGDOM (T/A RHONE-POULENC RORER)

PHENERGAN TABLETS 25MG COATED TABLET 25MG MAY & BAKER LIMITED UNITED KINGDOM (T/A RHONE-POULENC RORER)

PHENINDIONE TABLETS TABLETS 50MG GOLDSHIELD GROUP PLC UNITED KINGDOM T/A GOLDSHIELD PHARMACEUTICALS

PHENOBARBITAL TABLETS 30MG PHARMAMED LTD. MALTA

PHENOBARBITONE BP 60MG TABLET 60MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

PHENOBARBITONE BP 15MG TABLETS 15MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

PHENOBARBITONE BP 30MG TABLET 30MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

PHENOBARBITONE TABLETS BP TABLETS 30MG APPROVED UNITED KINGDOM 30MG PRESCRIPTION SERVICES LIMITED 672 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PHENOL OILY BP OIL FOR INJECTION 5%W/V EVANS MEDICAL LIMITED UNITED KINGDOM

PHENOXYBENZAMINE INJECTION SOLUTION FOR 100MG/2ML FORLEY LIMITED IRELAND CONCENTRATE INJECTION

PHENOXYMETHYLPENICILLIN 250 TABLETS 250 MG REMEDICA LTD CYPRUS

PHENSEDYL WITH CODEINE ORAL SOLUTION N/A MAY & BAKER (T/A UNITED KINGDOM COUGH LINCTUS RHONE-POULENC RORER)'

PHENYLBUTAZONE BP 100MG TABLET 100MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMI- TED

PHENYLBUTAZONE BP 200MG TABLET 200MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMI- TED

PHILLIP'S MILK OF MAGNESIA ORAL SUSPENSION 415MG/5ML SMITHKLINE BEECHAM UNITED KINGDOM (SWG) LTD T/A STERLING HEALTH

PHILLIP'S MILK OF MAGNESIA TABLET 300MG SMITHKLINE BEECHAM UNITED KINGDOM TABLETS (SWG) LTD T/A STERLING HEALTH/SKB INTRNTL

PHLOGENZYM GASTRO-RESISTANT N/A MUCOS PHARMA GMBH GERMANY TABLET & CO.

PHOLCODINE LINCTUS B.P. ORAL SOLUTION 5MG/5ML WILLIAM RANSOM & UNITED KINGDOM SON PLC

PHOLCODINE LINCTUS BP ORAL SOLUTION 5MG LCM LTD UNITED KINGDOM

PHOSPHATE SODIQUE DE SOL FOR INJECTION IN 4MG MERCK GENERIQUES FRANCE DEXAMETHASONE MERCK AMP

PHYLLOCONTIN CONTINUS MODIFIED RELEASE 225MG NAPP LABORATORIES UNITED KINGDOM TABLETS 225MG TABLET LIMITED

PHYLLOCONTIN FORTE CONTINUS MODIFIED RELEASE 350MG NAPP LABORATORIES UNITED KINGDOM TABS. 350MG TABLETS LIMITED

PHYLLOCONTIN PAEDIATRIC MODIFIED RELEASE 100MG NAPP LABORATORIES UNITED KINGDOM CONTINUS TABLETS TABLET LIMITED

PHYSIONEAL GLUCOSE SOL.F PERITONEAL N/A BAXTER HEALTHCARE IRELAND DIALYSIS LIMITED UK

PHYSIONEAL GLUCOSE SOLUTION N/A BAXTER HEALTHCARE IRELAND LIMITED UK

PHYSIONEAL GLUCOSE 3.86%W/V SOL. F. PERITONEAL DIA- N/A BAXTER HEALTHCARE IRELAND LYS LIMITED UK

PHYSIOTENS 0.2 FILM COATED TABLET 0.2MG SOLVAY ARZNEIMITTEL GERMANY GMBH

PHYSIOTENS 0.3 FILM COATED TABLET 0.3MG SOLVAY ARZNEIMITTEL GERMANY GMBH

PHYSIOTENS 0.4 FILM COATED TABLET 0.4MG SOLVAY ARZNEIMITTEL GERMANY GMBH

PHYTEX PAINT PAINT N/A WYNLIT LABORATORIES UNITED KINGDOM LIMITED

PHYTOMENADIONE INJECTION BP SOLUTION FOR 10MG/1ML ROTEXMEDICA GMBH, GERMANY 10MG (VITAMIN K1 INJECTION INJECTION ARZNEIMITTELWERK 10MG) 23.9.2003 FR Journal officiel de l'Union européenne 673

Trade Name Dosage Form Dose MA Holder Country

PICKLES OINTMENT OINTMENT N/A J PICKLES (HARROGATE) UNITED KINGDOM LIMITED T/A J. PICKLES AND SON

PICOLAX POWDER POWDER FOR ORAL N/A FERRING UNITED KINGDOM SOLUTION PHARMACEUTICALS LIMITED

PICO-SALAX POWDER SINGLE DOSE N/A FERRING AB SWEDEN

PIL-FOOD CAPSULE N/A LABORATOIRE GOLAZ SWITZERLAND SA

PIL-FOOD CAPSULES CAPSULES NA LABORATOIRE GOLAZ SWITZERLAND SA

PILOCARPINA CLORIDRATO SOLUTION 4% COLLIRIO TUBILUX PHARMA S.P.A. ITALY

PILOCARPINE 1% EYE DROPS (OPTIFILM) 0.01G/ML AMOUN EGYPT PHARMACEUTICAL INDUSTRIES CO.

PILOCARPINE 2% EYE DROPS(OPTIFILM) 0.02G/ML AMOUN EGYPT PHARMACEUTICAL INDUSTRIES CO.

PILOCARPINE EYE DROPS 0.5% EYE DROPS 0.5% W/W SCHERING-PLOUGH UNITED KINGDOM LIMITED

PILOCARPINE EYE DROPS 1% BP EYE DROPS 1% W/V SCHERING-PLOUGH UNITED KINGDOM LIMITED

PILOCARPINE EYE DROPS 2% BP EYE DROPS 2% W/V SCHERING-PLOUGH UNITED KINGDOM LIMITED

PILOCARPINE EYE DROPS 3% EYE DROPS 3% W/V SCHERING-PLOUGH UNITED KINGDOM LIMITED

PILOCARPINE EYE DROPS 4% EYE DROPS 4% W/V SCHERING-PLOUGH UNITED KINGDOM LIMITED

PILOCARPINE EYE DROPS BP 1% EYE DROPS 1%W/V MARTINDALE UNITED KINGDOM PHARMACEUTICALS LTD

PILOCOLLYRE EYE DROPS SOLUTION 4% W/V COOPER S.A. GREECE

PILOCOLLYRE EYE DROPS SOLUTION 1% W/V COOPER S.A. GREECE

PILOCOLLYRE EYE DROPS SOLUTION 2% W/V COOPER S.A. GREECE

PILODREN EYE DROPS N/A FARMILA FARMACEUTICI ITALY MILANO S.P.A.

PILOPOS 2% EYE DROPS 2% W/V URSAPHARM GERMANY ARZNEIMITTEL GMBH

PILOTONINA EYE DROPS 2% W/V FARMILA FARMACEUTICI ITALY MILANO S.P.A.

PILOTONINA EYE DROPS 4% W/V FARMILA FARMACEUTICI ITALY MILANO S.P.A.

PIMAFUCIN CREAM 20MG/G YAMANOUCHI PHARMA NETHERLANDS B.V.

PIMAFUCORT CREAM N/A YAMANOUCHI PHARMA NETHERLANDS B.V.

PINADONE METHADONE MIXTURE ORAL SOLUTION 1MG/ML PINEWOOD IRELAND DTF LABORATORIES LIMITED 674 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PINADONE METHADONE ORAL SOLUTION, SUGAR 1MG/ML PINEWOOD IRELAND MIXTURE DTF FREE LABORATORIES LIMITED

PINORAX STRONG ORAL SUSPENSION 75/1000 PINEWOOD IRELAND CO-DANTHRAMER LABORATORIES LIMITED

PIPRIL 1G POWDER FOR INJECTION 1G/10ML LEDERLE GERMANY PHARMACEUTICALS

PIPRIL 2G POWDER FOR INJECTION 2G/20ML LEDERLE ARZNEIMITTEL GERMANY GMBH & CO

PIPRIL INJECTION POWDER FOR INJECTION 4G/VIAL CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD.

PIPRIL INJECTION POWDER FOR INJECTION 2G/VIAL CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD.

PIRACTAM CAPSULES 10MG KOREA UNITED PHARM. KOREA REPUBLIC INC.

PIRFALIN OPHTHALMIC DROPS 0.005% W/V FARMIGEA SPA ITALY

PIRITON TABLET 4MG STAFFORD-MILLER UNITED KINGDOM LIMITED

PIRITON SYRUP 2MG/5ML STAFFORD-MILLER UNITED KINGDOM LIMITED

PIRITON SYRUP SYRUP (ORAL SOLUTION) 2MG/5ML STAFFORD MILLER UNITED KINGDOM LIMITED

PIRITON TABLETS TABLET 4MG STAFFORD MILLER UNITED KINGDOM LIMITED

PIROXICAM CAPSULES 10MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

PIROXICAM CAPSULE 20MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

PITRESSIN SOLUTION FOR 0.4 MG/1 ML GOLDSHIELD GROUP PLC UNITED KINGDOM INJECTION T/A GOLDSHIELD PHARMACEUTICALS

PITRESSIN AMPOULES SOLUTION FOR 20PU GOLDSHIELD UNITED KINGDOM INJECTION PHARMACEUTICALS LIMITED

PK-MERZ INFUSION SOLUTION 200 MG MERZ+CO. GMBH & CO. GERMANY

PK-MERZ TABLETS 100 MG MERZ+CO. GMBH & CO. GERMANY

PLACIS INJECTABLE SOLUTION 10MG/10ML CHIESI ESPANA S.A. SPAIN

PLACIS INJECTABLE SOLUTION 50MG/50ML CHIESI ESPANA S.A. SPAIN

PLACIS 10MG SOLUTION INJECTABLE 10MG/20ML CHIESI WASSERMANN SPAIN S.A.

PLACIS 50MG SOLUTION INJECTABLE 50MG/50ML CHIESI WASSERMANN SPAIN S.A.

PLAQUENIL TABLET 200MG SANOFI WINTHROP LTD. UNITED KINGDOM

PLASMA-LYTE 148 ELECTROLYTE SOLUTION FOR N/A BAXTER HEALTHCARE UNITED KINGDOM SOL IN WATER INJECTION LIMITED

PLATINWAS INJECTABLE SOLUTION 150MG/15ML CHIESI ESPANA S.A. SPAIN 23.9.2003 FR Journal officiel de l'Union européenne 675

Trade Name Dosage Form Dose MA Holder Country

PLAVIX FILM COATED TABLETS 75MG SANOFI PHARMA FRANCE BRISTOL-MYERS SQUIBB SNC

PLEGISOL SOLUTION N/A ABBOTT LABORATORIES UNITED STATES OF AMERICA

PLEGISOL SOLN F/CARDIAC SOLN F/CARDIAC N/A ABBOTT LABORATORIES UNITED STATES OF PERFUSION PERFUSION AMERICA

PLEGIVEX CARDIOPLEGIA SOLUTION NA GALEN LIMITED UNITED KINGDOM

PLENDIL PROLONGED RELEASE 5MG HASSLE LAKEMEDEL AB SWEDEN TABLETS

PLENDIL PROLONGED RELEASE 10MG HASSLE LAKEMEDEL AB SWEDEN TABLETS

PMS- HALOPERIDOL SOLUTION ORAL SOLUTION 2MG/ML PHARMASCIENCE INC. CANADA

PMS-IPRATROPIUM LIQUID 250MCG/ML PHARMASCIENCE INC. CANADA

PMS-SELEGILENE TABLET 5MG PHARMASCIENCE INC. CANADA

PNEUMO 23 SOLUTION FOR N/A PASTEUR MERIEUX FRANCE INJECTION

PNEUMOREL 0.2% SYRUP 0.2% W/V LES LABORATOIRES FRANCE SERVIER

PNEUMOREL 80MG COATED TABLET 80MG LES LABORATOIRES FRANCE SERVIER

POFOL INJECTION SUSPENSION FOR 10MG/ML DONG KOOK PHARM. KOREA REPUBLIC INJECTION CO. LTD

POLARAMINE SYRUP 0.40MG/ML SCHERING-PLOUGH NV/ BELGIUM SA

POLARAMINE EXPECTORANT SYRUP N/A SCHERING-PLOUGH S.A. BELGIUM

POLARMINE REPETABS 6MG SCHERING-PLOUGH NV/ BELGIUM SA

POLARONIL TABLETS N/A SCHERING-PLOUGH S.A. BELGIUM

POLJODURATO OPHTHALMIC DROPS N/A FARMIGEA SPA ITALY

POLYDERM OINTMENT USP OINTMENT N/A TARO CANADA PHARMACEUTICALS INC.

POLYFAX OPHTHALMIC OINTMENT N/A THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

POLYFAX OINTMENT OINTMENT N/A THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

POLYGNAX VAGINAL CAPSULE N/A LABORATOIRE FRANCE INNOTECH INTERNATIONAL

POLYGYNAX VAGINAL CAPSULE N/A LABORATOIRE FRANCE INNOTECH INTERNATIONAL

POLYOSIDE MENINGOCOCCAL INJECTABLE N/A PASTEUR MERIEUX FRANCE A+C VACCINE

POLYSILANE DELALANDE CHEWABLE TABLET N/A LABORATOIRES FRANCE SYNTHELABO 676 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

POLYSILANE NOURRISSON GRANULATES N/A LABORATOIRES FRANCE JOULLIE SYNTHELABO

POLYTAR LIQUID 1% W/W STIEFEL LABORATORIES IRELAND (UK) LTD

POLYTAR ANTI-FUNGAL SHAMPOO N/A STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

POLYTAR EMOLLIENT TOPICAL SOLUTION 25% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

POLYTAR PLUS TOPICAL SOLUTION 1% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

POLYTONYL FOR ADULTS POWDER FOR ORAL N/A UPSA CONSEIL FRANCE SOLN

POLYTONYL FOR CHILDREN POWDER FOR ORAL N/A UPSA CONSEIL FRANCE SOLN

POLYTRIM OPHTHALMIC OINTMENT N/A THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

POLYTRIM EYE DROPS N/A THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

PONDOCILLIN TABLETS 500MG LEO PHARMACEUTICAL DENMARK PRODUCTS

PONSTAN SYRUP 50MG/5ML PARKE DAVIS & UNITED KINGDOM COMPANY

PONSTAN CAPSULE 250MG PARKE-DAVIS GMBH GERMANY

PONSTAN FORTE FILMCOATED TABLET 500MG GODECKE AG GERMANY

PONSTAN FORTE TABLET 500MG PARKE DAVIS PAKISTAN

PONSTAN FORTE TABLET 500MG PARKE-DAVIS PAKISTAN

PONSTYL CAPSULE 250MG PARKE-DAVIS AFRIQUE SENEGAL DE L'OUEST

PONSTYL FORT 500MG TABLET 500MG PARKE-DAVIS AFRIQUE SENEGAL DE L'OUEST

PONSTYL SIROP ENFANT SYRUP 50MG/5ML PARKE-DAVIS AFRIQUE SENEGAL DE L'OUEST

PORFYROCIN 125MG/5ML POWDER FOR OR. 125MG/5ML MEDOCHEMIE LTD CYPRUS SUSPENSION

PORFYROCIN 250MG/5ML POWDER FOR OR. 250MG/5ML MEDOCHEMIE LTD CYPRUS SUSPENSION

PORFYROCIN 500MG/5ML POWDER FOR OR. 500MG/5ML MEDOCHEMIE LTD CYPRUS SUSPENSION

PORPHYROCIN 250MG TABLET 250MG MEDOCHEMIE LTD CYPRUS

POSALFILIN OINTMENT N/A NORGINE LIMITED UNITED KINGDOM

POSALFILIN OINTMENT N/A NORGINE LIMITED UNITED KINGDOM

POSIFENICOL 1 % EYE DROPS 1 % W/V URSAPHARM GERMANY ARZNEIMITTEL GMBH

POSIFENICOL C 1 % EYE OINTMENT 1 % W/W URSAPHARM GERMANY ARZNEIMITTEL GMBH 23.9.2003 FR Journal officiel de l'Union européenne 677

Trade Name Dosage Form Dose MA Holder Country

POTABA ENVULES 3G ORAL POWDER 3G GLENWOOD UNITED KINGDOM

POTASSIUM CHLORIDE 20% SOLUTION FOR INFUSION 20G/100ML LABORATOIRE FRANCE AGUETTANT AGUETTANT

POTASSIUM CHLORIDE 20% INJECTABLE SOLUTION 20% W/V LABORATOIRE FRANCE AGUETTANT AGUETTANT

POTRELEASE TR TABLET 600MG TABLET 600MG SM PHARMACEUTICALS MALAYSIA SDN BHD

POVIDONE IODINE TOPICAL SOLUTION 10GM/100ML AMOUN EGYPT PHARMACEUTICAL CO S.A.E

PR HEAT SPRAY TOPICAL SPRAY N/A CROOKES HEALTHCARE UNITED KINGDOM LIMITED

PRAZIQUANTEL FILM COATED TABLETS 600MG PHARMAMED LTD. MALTA

PRAZOSIN TABLETS BP 0.5MG TABLETS 0.5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

PRAZOSIN TABLETS BP 1MG TABLETS 1MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

PRAZOSIN TABLETS BP 2MG TABLETS 2MG NORTON HEALTHCARE UNITED KINGDOM LIMTED

PRAZOSIN TABLETS BP 5MG TABLETS 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

PRECONCEIVE TABLETS 400MCG TABLET 400MCG G R LANE PRODUCTS UNITED KINGDOM LTD

PRED FORTE OPHTHALMIC SUSPEN- 1% W/V ALLERGAN IRELAND SION PHARMACEUTICALS (IRELAND) LTD., INC.

PREDFOAM FOAM RETENTION ENEMA 31.4MG/DOSE PHARMAX LIMITED UNITED KINGDOM

PREDNISOLON TABLETS 5MG NYCOMED AUSTRIA AUSTRIA GMBH

PREDNISOLONE ENTERIC COATED 5MG BIOREX LABORATORIES UNITED KINGDOM TABLETS LTD.

PREDNISOLONE TABLET 5MG CAMDEN INDUSTRIES (M) MALAYSIA SDN.BHD

PREDNISOLONE TABLETS 20MG CLONMEL HEALTHCARE IRELAND LIMITED

PREDNISOLONE BP 1MG TABLET 1MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

PREDNISOLONE BP 5MG TABLETS 5MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

PREDNISOLONE TABLETS BP 1MG TABLETS 1MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

PREDNISOLONE TABLETS BP 1MG TABLET 1MG CP PHARMACEUTICALS UNITED KINGDOM LTD

PREDNISOLONE TABLETS BP 5MG TABLETS 5MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

PREDNISOLON-RATIOPHARM 5 TABLET 5MG RATIOPHARM GMBH GERMANY 678 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PREFRIN PHENYLEPHRINE HCL EYE DROPS 1.2MG/ML ALLERGAN IRELAND LIQUIFILM PHARMACEUTICALS (IRELAND) LTD., INC.

PREMAK-C TABLET N/A JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES —UK

PREMAK-C COATED TABLET 1.25MG JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES —UK

PREMARIN TABLET 0.625MG WYETH LEDERLE PAKISTAN

PREMARIN 0.625MG TABLET 0.625MG WYETH-LEDERLE PAKISTAN

PREMARIN 0.625MG TABLETS 0.625MG JOHN WYETH & UNITED KINGDOM BROTHER LTD.

PREMARIN 0.625MG COATED TABLET 0.625MG JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES - UK

PREMARIN 1.25MG TABLET 1.25MG WYETH-LEDERLE PAKISTAN

PREMARIN 1.25MG TABLETS 1.25MG JOHN WYETH & UNITED KINGDOM BROTHER LTD.

PREMARIN COATED TABLET COATED TABLET 0.625MG JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES

PREMARIN TABLETS 1.25MG. TABLET 1.25MG JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES —UK

PREMARIN VAGINAL CREAM CREAM 0.625MG / G WYETH-AYERST CANADA CANADA INC.

PREMARIN VAGINAL CREAM CREAM 34.72MG JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES - UK

PREMELLE 2.5 TABLETS NA JOHN WYETH AND IRELAND BROTHER LIMITED

PREMELLE 5 TABLET N/A JOHN WYETH & UNITED KINGDOM BROTHER LTD

PREMELLE CYCLE 10 TABLETS TABLETS NA JOHN WYETH & UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES

PREMELLE CYCLE 5 TABLETS NA JOHN WYETH AND IRELAND BROTHER LIMITED

PREMIQUE COATED TABLETS NA JOHN WYETH & UNITED KINGDOM BROTHER LIMITED

PREMIQUE CYCLE TABLETS NA JOHN WYETH & UNITED KINGDOM BROTHER

PREMPACK-C 0.625MG TABLETS 0.625MG JOHN WYETH & UNITED KINGDOM BROTHER LTD

PREMPACK-C 0.625MG TABLETS 0.625MG JOHN WYETH & UNITED KINGDOM BROTHER LTD 23.9.2003 FR Journal officiel de l'Union européenne 679

Trade Name Dosage Form Dose MA Holder Country

PREMPACK-C 1.25MG TABLET 1.25MG JOHN WYETH & UNITED KINGDOM BROTHER LTD.

PREMPAK-C 1.25MG TABLETS 1.25MG JOHN WYETH & UNITED KINGDOM BROTHER LTD

PRENOL TABLETS 5MG AEGIS LTD CYPRUS

PREPERATION H OINTMENT N/A WHITEHALL UNITED KINGDOM LABORATORIES LTD

PREPERATION H SUPPOSITORIES N/A WHITEHALL UNITED KINGDOM LABORATORIES LTD

PREPULSID (CYPRID) 5MG TABLET 5MG JANSSEN-CILAG N.V. BELGIUM

PREPULSID 10MG TABLET 10MG JANSSEN-CILAG N.V. BELGIUM

PREPULSID 1MG/ML ORAL SUSPENSION 1MG/ML JANSSEN-CILAG N.V. BELGIUM

PRESSICAINE A SANS SOLN FOR DENTAL 3% W/V LABORATOIRES SPAD FRANCE VASOCONSTRICTEUR 3% INJECTION

PRESSICAINE N SOLUTION FOR DENTAL N/A LABORATOIRES SPAD FRANCE INJ

PRETERAX SCORED TABLET N/A LES LABORATOIRES FRANCE SERVIER

PREVENAR SUSPENSION FOR NA WYETH LEDERLE EUROPEAN COMMUNITY INJECTION VACCINES SA

PRIMALAN SYRUP 0.03G/60ML LABORATOIRES PIERRE FRANCE FABRE MEDICAMENT

PRIMALAN 5MG SCORED TABLET 5MG LABORATOIRES PIERRE FRANCE FABRE MEDICAMENT

PRIMOLUT N TABLET 5MG SCHERING AG GERMANY

PRIMOLUT N TABLET 5MG SCHERING PAKISTAN

PRIMOLUT N TABLETS 5MG SCHERING PAKISTAN

PRIMOLUT N TABLET 5MG SCHERING HEALTH CARE UNITED KINGDOM LIMITED

PRIMPERAN ORAL SOLUTION DROPS 260MG/100ML LABORATOIRES FRANCE SYNTHELABO

PRIMPERAN 0.1% ORAL SOLUTION 0.1% W/V LABORATOIRES FRANCE SYNTHELABO

PRIMPERAN 10MG SCORED TABLET 10MG LABORATOIRES FRANCE SYNTHELABO

PRIMPERAN 10MG/2ML SOLUTION FOR 10MG/2ML LABORATOIRES FRANCE INJECTION SYNTHELABO

PRIODERM LOTION 0.5% LOTION 0.5%W/V MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

PRIODERM SHAMPOO SHAMPOO 1%W/W MUNDIPHARMA PHAR- CYPRUS MACEUTICALS LTD

PRIORIX POWDER FOR INJECTION N/A SMITHKLINE BEECHAM BELGIUM BIOLOGICALS

PRITOR TABLETS 80MG GLAXO GROUP LTD. UNITED KINGDOM

PRITOR TABLETS 40MG GLAXO GROUP LTD. UNITED KINGDOM 680 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PROCARDIN 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

PROCARDIN 75MG TABLET 75MG MEDOCHEMIE LTD CYPRUS

PROCHLORPERAZINE TABLETS 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

PROCHLORPERAZINE INJECTION SOLUTION FOR 1.25%W/V ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

PROCHLORPERAZINE INJECTION SOLUTION FOR 12.5MG/ML ANTIGEN IRELAND BP INJECTION PHARMACEUTICALS LIMITED

PROCHLORPERAZINE MALEATE TABLETS 5MG PHARMAMED LTD. MALTA

PROCTOFOAM HEMORRHOIDAL FOAM N/A SCHWARZ PHARMA UNITED STATES OF AMERICA

PROCTOFOAM-HC TOPICAL AEROSOL N/A SCHWARZ PHARMA INC. UNITED STATES OF AMERICA

PROCTO-GLYVENOL CREAM N/A NOVARTIS CONSUMER SWITZERLAND HEALTH SA

PROCTO-GLYVENOL SUPPOSITORIES N/A NOVARTIS CONSUMER SWITZERLAND HEALTH SA

PROCTOSEDYL OINTMENT OINTMENT N/A HOECHST MARION UNITED KINGDOM ROUSSEL LIMITED

PROCTOSEDYL SUPPOSITORIES SUPPOSITORY N/A HOECHST MARION UNITED KINGDOM ROUSSEL LIMITED

PROCTOSOLL CREAM N/A ALFA WASSERMANN ITALY S.P.A.

PROCYCLIDINE TABLETS 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

PROCYCLIDINE SYR. SUG. FREE ORAL SOLUTION 5MG/5ML ROSEMONT UNITED KINGDOM ARPICOLIN SF PHARMACEUTICALS LIMITED

PROFASI 10000 IU INJECTABLE 10000 IU HCG/ML LABORATOIRES SERONO SWITZERLAND PREPARATION SA

PROFASI 5000IU INJECTABLE 5000IU HCG/ML LABORATOIRES SERONO ITALY PREPARATION SA

PROFASI HP POWDER AND SOLVENT N/A SERONO PHARMA S.P.A. ITALY FOR INJ.

PROFENID GEL 2.5% LABORATOIRES AVENTIS FRANCE

PROFENID 100MG SUPPOSITORIES 100MG LABORATOIRES SPECIA FRANCE

PROFENID 100MG FILM-COATED TABLET 100MG LABORATOIRES SPECIA FRANCE

PROFENID 100MG (IV USE) POWDER 100MG/VIAL RHONE-POULENC RORER FRANCE F.SOLN.F.INJECTION

PROFENID 100MG, POWDER AND SOLVENT N/A SPECIA LABORATORIES FRANCE INTRAMUSCULAR FOR INJ

PROFENID 2.5 PER CENT GEL N/A RPR SPECIA FRANCE LABORATORIES

PROFENID 50MG CAPSULE 50MG LABORATOIRES SPECIA FRANCE

PROFENID LP 200MG SR FILM COATED TABLET 200MG RHONE-POULENC RORER FRANCE 23.9.2003 FR Journal officiel de l'Union européenne 681

Trade Name Dosage Form Dose MA Holder Country

PROFLAVINE CREAM B.P.C.1973 CREAM N/A THORNTON & ROSS LTD UNITED KINGDOM

PROGEMOX TABLET 1G PROGE FARM S.R.L. ITALY

PROGEMOX COMPRESSE 1G PROGE FARM S.R.L ITALY

PROGERON TABLETS 100MG REMEDICA LTD. CYPRUS

PROGESTOGEL 1 POUR CENT GEL N/A BESINS INTERNATIONAL FRANCE

PROGRAF CAPSULES 1MG HIKMA JORDAN PHARMACEUTICALS

PROGRAF CAPSULES 5MG HIKMA JORDAN PHARMACEUTICALS

PROGYLUTON COATED TABLET N/A SCHERING AG GERMANY

PROGYNOVA 2MG TABLET COATED TABLET 2MG SCHERING HEALTH CARE UNITED KINGDOM LTD

PROGYNOVA TS TRANSDERMAL PATCH 3.8MG SCHERING HEALTH CARE UNITED KINGDOM LTD

PROGYNOVA TS FORTE TRANSDERMAL PATCH 7.6MG SCHERING HEALTH CARE UNITED KINGDOM LTD

PROHANCE SOLN FOR I.V INJECTION 2.79.3MG/ML BRACCO S.P.A ITALY

PROHANCE SOLN FOR IV INJECTION 279.3MG/ML BRACCO S.P.A ITALY

PROMENSIL TABLET 200MG NOVOGEN AUSTRALIA LABORATORIES PTY LTD

PROMETHAZINE TABLETS 25MG REMEDICA LTD. CYPRUS

PROMETHAZINE HCL SYRUP PLAIN SYRUP 6.25MG/5ML WYETH-AYERST UNITED STATES OF LABORATORIES AMERICA

PROMETHAZINE HCL12.5MG TABLETS 12.5MG WYETH-AYERST UNITED STATES OF LABORATORIES AMERICA

PROMETHAZINE HYDROCHLORIDE TABLETS 25MG PHARMAMED LTD. MALTA

PRONESTYL TABLETS 250MG E.R. SQUIBB & SONS LTD UNITED KINGDOM

PRONTOPYRIN PLUS TABLETS N/A HEINRICH MACK NACHF GERMANY

PROPA PH FOAMING FACE WASH FACE WASH N/A DEL LABORATORIES INC. UNITED STATES OF AMERICA

PROPAFENON «GENERICON» FILM COATED TABLETS 150MG GENERICON PHARMA AUSTRIA GES.M.B.H

PROPANTHELINE TABLETS 15MG REMEDICA LTD. CYPRUS

PROPECIA 1MG TABLETS FILM COATED TABLET 1MG MERCK SHARP & DOHME UNITED KINGDOM LIMITED

PROPECIA TABLETS TABLET 1MG MERCK & CO. INC UNITED STATES OF AMERICA

PROPESS PESSARY 10MG CONTROLLED UNITED KINGDOM THERAPEUTICS (SCOTLAND) LIMITED

PROPESS 10MG VAGINAL PESSARY 10MG CONTROLLED UNITED KINGDOM THERAPEUTICS (SCOTLAND) LIMITED 682 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PROPESS 10MG PESSARY 10MG CONTROLLED UNITED KINGDOM THERAPEUTICS (SCOTLAND) LTD.

PROPESS 10MG PESSARY 10MG CONTROLLED UNITED KINGDOM THERAPEUTICS (SCOTLAND) LIMITED

PROPOFOL EMULSION FOR IV INJ / 10MG/ML ABBOTT LABORATORIES UNITED KINGDOM INF

PROPOFOL ABBOTT EMULSION FOR IV INJ./ 10MG/ML ABBOTT AG SWITZERLAND INF.

PROPOFOL-LIPURO 1% (10MG/ML) EMULSION FOR INJ. OR 10MG/ML B.BRAUN MELSUNGEN GERMANY INFU AG

PROPRANOLO BP 80MG TABLET 80MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

PROPRANOLOL TABLETS 40MG PHARMAMED LTD. MALTA

PROPRANOLOL BP 10MG TABLET 10MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMI- TED

PROPRANOLOL BP 40MG TABLET 40MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMI- TED

PROPRANOLOL TABLET 40MG TABLET 40MG RAZA MANUFACTURING MALAYSIA BERHAD

PROPYLTHIOURACIL BP TABLET 50MG CP PHARMACEUTICALS UNITED KINGDOM LIMITED

PROPYLTHIOURACIL TABLETS BP TABLETS 50MG CP PHARMACEUTICALS UNITED KINGDOM 50MG LTD.

PROPYLTHIOURACIL TABLETS BP TABLET 50 MG CP PHARMACEUTICALS UNITED KINGDOM 50MG LTD

PROSCAR 5MG TABLET 5MG MERCK SHARP & DOHME NETHERLANDS B.V.

PROSPAN COUGH SYRUP SYRUP 0.7G/100ML KARL ENGELHARD GERMANY

PROSPAN HERBAL DROPS DROPS 20MG/ML KARL ENGELHARD GERMANY

PROSTAP SR LEUPROPELIN POWDER FOR INJECTION 3.75MG/VIAL CYANAMID OF GREAT UNITED KINGDOM ACETATE DEPOT INJ BRITAIN LTD.

PROSTATONIN CAPSULE N/A PHARMATON SA SWITZERLAND

PROSTIN 15M INJECTABLE SOLUTION 0.25MG/ML PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

PROSTIN E2 CONC. FOR SOL. FOR INJ. 10MG/ML PHARMACIA & UPJOHN BELGIUM N.V./ S.A.

PROSTIN E2 CONC. FOR SOL. FOR INF. 1MG/ML PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

PROSTIN E2 VAGINAL GEL 1MG/3G PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

PROSTIN E2 VAGINAL GEL 2MG/3G PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

PROSTIN E2 VAGINAL TABLETS 3MG PHARMACIA & UPJOHN BELGIUM N.V. / S.A. 23.9.2003 FR Journal officiel de l'Union européenne 683

Trade Name Dosage Form Dose MA Holder Country

PROSTIN VR 0.5MG CONC. FOR SOL. FOR INF. 0.5MG/ML PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

PROSULF SOLUTION FOR 10MG/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD.

PROSULF INJECTION SOLUTION FOR 10MG/ML CP PHARMACEUTICALS UNITED KINGDOM 1%,PROTAMINE SULPHATE INJECTION LTD

PROTAMINE SULPHATE INJECTION SOLUTION FOR 50MG/5ML EVANS MEDICAL UNITED KINGDOM BP INJECTION LIMITED

PROTAMINE SULPHATE INJECTION SOLUTION FOR 10MG/ML CP PHARMACEUTICALS UNITED KINGDOM BP,50MG/5ML INJECTION LTD

PROTAMINE SULPHATE LEO SOLUTION FOR 10MG/ML LEO PHARMACEUTICAL DENMARK INJECTION PRODUCTS

PROTHIAZINE TABLETS 25MG CTS CHEMICAL ISRAEL INDUSTRIES

PROTHIAZINE SYRUP 5MG/5ML CTS CHEMICAL ISRAEL INDUSTRIES

PROTHIAZINE SYRUP SYRUP 5MG/5ML CTS CHEMICAL ISRAEL INDUSTRIES LTD

PROTOMID TABLET 250MG MACLEODS INDIA

PROTOP CAPSULE 20MG PT INTERBAT INDONESIA

PROTOP CAPSULES BOX, BOTTLE 20 MG/CAP PT INTERBAT INDONESIA 14

PROVERA TABLETS 5MG PHARMACIA N.V. / S.A. BELGIUM

PROVERA TABLETS 100MG PHARMACIA & UPJOHN ITALY S.P.A.

PROVERA TABLETS 100MG PHARMACIA ITALIA SPA ITALY

PROVIRON TABLET 25MG SCHERING AG GERMANY

PROVIRON TABLET 25MG SCHERING PAKISTAN

PROVIRON TABLETS TABLET 25MG SCHERING PAKISTAN

PRO-VIRON TABLETS TABLETS 25MG SCHERING HEALTH CARE UNITED KINGDOM LIMITED

PROVISC OCULAR VISCOELASTIC 10MG/ML S.A. ALCON-COUVREUR BELGIUM SOLN. N.V.

PROXEN 500MG TABLET 500MG MEDOCHEMIE LTD CYPRUS

PROXIL 250MG TABLET 250MG CODAL SYNTO LTD CYPRUS

PROZAC CAPSULE 20MG ELI LILLY & COMPANY UNITED KINGDOM LIMITED

PROZAC WKLY DELAYED RELEASE 90MG ELI LILLY AND COMPANY UNITED STATES OF CAPS AMERICA

PRURI-MED SKIN CLEANSING N/A PERMAMED AG SWITZERLAND EMULSION

PSILO-BALSAM N GEL N/A STADA OTC GERMANY ARZNEIMITTEL GMBH

PTU TABLETS 50MG MACLEODS INDIA PHARMACEUTICALS LTD 684 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

PULANIL TABLETS 200MG HANBUL PHARMA KOREA

PULMEX OINTMENT N/A NOVARTIS CONSUMER SWITZERLAND HEALTH SA

PULMEX BABY OINTMENT N/A NOVARTIS CONSUMER SWITZERLAND HEALTH SA

PULMICORT INHALATION SUSPENSION 0.25MG/ML DRACO LAKEMEDEL AB SWEDEN

PULMICORT INHALATION SUSPENSION 0.5MG/ML DRACO LAKEMEDEL AB SWEDEN

PULMICORT AEROSOL FOR 50MCG/DOSE DRACO LAKEMEDEL AB SWEDEN INHALATION

PULMICORT AEROSOL FOR 200MCG/DOSE DRACO LAKEMEDEL AB SWEDEN INHALATION

PULMICORT INHALER 50MCG BARRETT HODGSON PAKISTAN

PULMICORT TURBUHALER INHALATION POWDER 100MCG/DOSE DRACO LAKEMEDEL AB SWEDEN

PULMICORT TURBUHALER INHALATION POWDER 200MCG/DOSE DRACO LAKEMEDEL AB SWEDEN

PULMO BAILLY ORAL LIQUID NA DDD LIMITED UNITED KINGDOM

PULMOCIS POWDER FOR INJECTION N/A LABORATOIRES CIS BIO FRANCE INTERNATIONAL

PULMOZYME AMPOULE 2.5MG/2.5ML ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

PULMOZYME INHALATION INHALATION SOLUTION 1MG/ML ROCHE PRODUCTS UNITED KINGDOM SOLUTION 1MG/ML LIMITED

PULSATE TABLETS 150MG SAMI PAKISTAN

PULVO 47 POWDER FOR TOPICAL 2.10(7) CU/100G LABORATOIRES FRANCE APPL. FOURNIER SCA

PULVO 47 NEOMYCIN POWDER FOR TOPICAL N/A LABORATOIRES FRANCE APPL. FOURNIER SCA

PUMP-HEP SOLUTION FOR 1000IU/ML LEO LABORATORIES UNITED KINGDOM INJECTIONS LIMITED

PURFALOX CAPSULE 200MG KLEVA LTD GREECE

PURI-NETHOL TABLETS 50MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

PURI-NETHOL TABLETS 50MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

PUVADIN 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

PYLORID TABETS 400MG COATED TABLET 400MG GLAXO GROUP LTD UNITED KINGDOM

PYOPEN INJECTION 1G POWDER FOR INJECTION 1G BEECHAM GROUP PLC UNITED KINGDOM

PYOPEN INJECTION 5G POWDER FOR INJECTION 5G BEECHAM GROUP PLC UNITED KINGDOM

PYRALVEX BUCCAL & GINGIVAL GEL N/A NORGINE PHARMA FRANCE

PYRALVEX GEL FOR ORAL MUCOSA N/A NORGINE PHARMA FRANCE

PYRALVEX SOLUTION N/A NORGINE LIMITED UNITED KINGDOM 23.9.2003 FR Journal officiel de l'Union européenne 685

Trade Name Dosage Form Dose MA Holder Country

PYRALVEX GEL N/A NORGINE PHARMA FRANCE

PYRAZINAMIDE TABLETS 500MG PHARMAMED LTD. MALTA

PYRCOST CAPSULE 20MG KLEVA LTD GREECE

PYRCOST SUPPOSITORY 20MG KLEVA LTD GREECE

PYRCOST GEL 0.5% W/W KLEVA LTD. GREECE

PYRIDOXINE HYDROCHLORIDE TABLET 50 MG CP PHARMACEUTICALS UNITED KINGDOM 50MG TABLETS BP LTD

PYRIDOXINE TABLETS BP 50MG TABLETS 50MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

PYRIDOXINE TABLETS BP 50MG TABLETS 50MG NORTON UNITED KINGDOM PHARMACEUTICALS LIMITED

PYRIDOXINE-10 TABLET TABLET 10MG CAMDEN INDUSTRIES (M) MALAYSIA SDN. BHD.

QUADRASA POWDER FOR RECTAL 2G NORGINE PHARMA FRANCE SOL.

QUIET LIFE TABLETS COATED TABLET N/A G R LANE HEALTH UNITED KINGDOM PRODUCTS LTD

QUINIMAX 125MG SCORED FILM-COATED N/A SANOFI WINTHROP FRANCE TABLET

QUINIMAX 125MG/ML SOLUTION FOR N/A SANOFI WINTHROP FRANCE INJECTION

QUINIMAX 250MG/2ML SOLUTION FOR N/A SANOFI WINTHROP FRANCE INJECTION

QUINIMAX 500MG FILM-COATED TABLET N/A SANOFI WINTHROP FRANCE

QUINIMAX 500MG/4ML SOLUTION FOR N/A LABORATOIRES SANOFI FRANCE INJECTION WINTHROP

QUININE TABLET 300MG CAMDEN INDUSTRIES(M) MALAYSIA SDN.BHD.

QUININE DIHYDROCHLORIDE SOLUTION FOR 600MG/2ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

QUININE SULPHATE TABLETS 200MG PHARMAMED LTD. MALTA

QUININE SULPHATE TABLETS 300MG PHARMAMED LTD. MALTA

QUININE SULPHATE 300 TABLETS 300MG REMEDICA LTD CYPRUS

QUININE SULPHATE BP 300MG TABLET 300MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

QUININE SULPHATE TABLETS BP TABLETS 300MG CP PHARMACEUTICALS UNITED KINGDOM 300MG LTD.

QUININE SULPHATE TABLETS BP COATED TABLET 300MG CP PHARMACEUTICALS UNITED KINGDOM 300MG LTD

QUINOCORT CREAM CREAM N/A QUINODERM LIMITED UNITED KINGDOM

QVAR 100 AEROSOL AEROSOL 100MCG 3M HEALTHCARE UNITED KINGDOM LIMITED 686 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

QVAR 100 AUTOHALER AEROSOL 100MCG 3M HEALTHCARE UNITED KINGDOM LIMITED

QVAR 50 AEROSOL AEROSOL 50MCG 3M HEALTHCARE UNITED KINGDOM LIMITED

QVAR 50 AUTOHALER AEROSOL 50MCG 3M HEALTHCARE UNITED KINGDOM LIMITED

RABIVAC POWDER FOR SOL. FOR N/A CHIRON BEHRING GMBH GERMANY INJE &CO

RADIAN B MUSCLE LOTION TOPICAL SOLUTION N/A ROCHE PRODUCTS UNITED KINGDOM LIMITED

RADIAN MASS.CR./ASKIT MUS. CREAM N/A ROCHE PRODUCTS UNITED KINGDOM RUB/RADIAN B LIMITED

RALGEX CREAM N/A SETON PRODUCTS UNITED KINGDOM LIMITED

RALGEX FREEZE SPRAY TOPICAL SPRAY N/A SETON PRODUCTS UNITED KINGDOM LIMITED

RALGEX FREEZE SPRAY TOPICAL SPRAY N/A SETON PRODUCTS UNITED KINGDOM LIMITED

RALGEX HEAT RUB CREAM CREAM N/A SETON PRODUCTS UNITED KINGDOM LIMITED

RALGEX HEAT SPRAY TOPICAL SPRAY N/A SETON PRODUCTS UNITED KINGDOM LIMITED

RALGEX LOW ODOUR HEAT TOPICAL SPRAY N/A SETON PRODUCTS UNITED KINGDOM SPRAY LIMITED

RAMAXIR CAPSULES 250MG REMEDICA LTD. CYPRUS

RANIGYL TABLET 200MG RAZA MANUFACTURING MALAYSIA BERHAD

RANITIDINE COATED TABLET 75MG EASTERN UNITED KINGDOM PHARMACEUTICALS LIMITED

RANITIDINE TABLETS BP FILM COATED TABLETS 75MG RANBAXY (UK) LIMITED UNITED KINGDOM

RANITINE FILMCOATED TABLETS 150MG BIOFARMA ILAC SAN.VE TURKEY TIC. A.S.

RANIVIT 150 TABLETS 150MG M/S VITAPURE INDIA CORPORATION

RANSOM GLYCERIN, LEMON AND ORAL SOLUTION N/A WILLIAM RANSOM & UNITED KINGDOM HONEY LINCTUS SON PLC

RANTAC-150 TABLET 150MG UNIQUE INDIA PHARMACEUTICAL LABORATORIES

RANTIN TABLETS 150MG MACTER PAKISTAN INTERNATIONAL (PVT) LTD.

RANTUDIL FORTE CAPSULE 60MG BAYER VITAL GMBH & GERMANY CO. KG

RANTUDIL FORTE CAPSULES 60MG TROPON GMBH GERMANY

RANTUDIL RETARD CAPSULE 90MG BAYER VITAL GMBH & GERMANY CO. KG 23.9.2003 FR Journal officiel de l'Union européenne 687

Trade Name Dosage Form Dose MA Holder Country

RANTUDIL RETARD CAPSULES 90MG TROPON GMBH GERMANY

RAPAMUNE ORAL SOLUTION 1MG/1ML WYETH-AYERST UNITED KINGDOM LABORATORIES

RAPAMUNE ORAL SOLUTION 1MG/ML WYETH EUROPA LTD. UNITED KINGDOM

RAPIFEN 0.5MG/ML SOLUTION FOR 0.5MG/ML JANSSEN-CILAG N.V. BELGIUM INJECTION

RAPOLYTE POWDER N/A HELSINN BIREX IRELAND PHARMACEUTICALS LTD.

RAXAR TABLETS 400MG TABLET 400MG GLAXO WELLCOME UK UNITED KINGDOM LTD

RAXAR TABLETS 600MG TABLET 600MG GLAXO WELLCOME UK UNITED KINGDOM LTD

RBC CREAM CREAM N/A RYBAR LABS. LIMITED UNITED KINGDOM

REBETOL HARD CAPSULES 200MG SP EUROPE UNITED KINGDOM

REBIF 22MCG SOLUTION FOR 22MCG/0.5ML ARES SERONO (EUROPE) ITALY INJECTION LTD.

RECOFOL EMULSION FOR INFUSION 20MG/ML LEIRAS OY FINLAND

RECOFOL 10MG/ML EMULSION FOR INJEC./ 10MG/ML LEIRAS OY FINLAND INFUS

RECOMBINANT HUMAN INJECTION 6000IU/VIAL NANJING HUAXIN BIO- REPUBLIC OF CHINA ERYTHROPOIETIN PHARMACEUTICALS LTD

RECOMBINANT HUMAN INJECTION 3000IU/VIAL NANJING HUAXIN BIO- REPUBLIC OF CHINA ERYTHROPOIETIN PHARMACEUTICALS LTD

RECOMBINANT HUMAN INJECTION 4000IU/VIAL NANJING HUAXIN BIO- REPUBLIC OF CHINA ERYTHROPOIETIN PHARMACEUTICALS LTD

RECOMBINANT HUMAN INJECTION 2000IU/VIAL NANJING HUAXIN BIO- REPUBLIC OF CHINA ERYTHROPOIETIN PHARMACEUTICALS LTD

RECOMBINATE ANTIHAEMOPHILIC POWDER FOR INJECTION 250IU/VIAL BAXTER HEALTHCARE UNITED KINGDOM FACTOR LIMITED

RECOMBINATE RAHF NOMINAL POWDER OR INJECTION 500IU/VIAL BAXTER HEALTHCARE UNITED KINGDOM LIMITED

RECOMBINATE RAHF NOMINAL POWDER FOR INJECTION 1000IU/VIAL BAXTER HEALTHCARE UNITED KINGDOM 1000IU/VIAL LIMITED

RECORMON PREFILLED SYRINGES PREFILLED SYRINGES 1000 IU/0.6ML ROCHE PHARMA SWITZERLAND (SCHWEIZ) LTD.

RECORMON PREFILLED SYRINGES PREFILLED SYRINGES 4000/6000 IU ROCHE PHARMA SWITZERLAND (SCHWEIZ) LTD.

RECORMON PREFILLED SYRINGES PREFILLED SYRINGES 2000/3000/5000 ROCHE PHARMA SWITZERLAND (SCHWEIZ) LTD.

RECTODELT 10MG SUPPOSITORY 10MG TROMMSDORFF GMBH & GERMANY CO. AG

RECTODELT 30MG SUPPOSITORY 30MG TROMMSDORFF GMBH & GERMANY CO. AG

RECTODELT 5MG SUPPOSITORY 5MG TROMMSDORFF GMBH & GERMANY CO. KG 688 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

RECTOPLEXIL 3.3MG CHILDREN SUPPOSITORY 3.3MG LABORATOIRES FRANCE THERAPLIX

RECTOPLEXIL CHILDREN SUPPOSITORY 3.3MG LABORATOIRES FRANCE THERAPLIX

REDUCTIL HARD CAPSULE 10MG ABBOTT LABORATORIES UNITED KINGDOM

REDUCTIL HARD CAPSULE 15MG ABBOTT LABORATORIES UNITED KINGDOM

REFACTO POWDER AND SOLVENT 250IU GENETICS INSTITUTE OF EUROPEAN COMMUNITY FOR SOLUTION FOR EUROPE B.V. INJECTION

REFACTO POWDER AND SOLVENT 500IU GENETICS INSTITUTE OF EUROPEAN COMMUNITY FOR SOLUTION FOR EUROPE B.V. INJECTION

REFACTO POWDER AND SOLVENT 1000IU GENETICS INSTITUTE OF EUROPEAN COMMUNITY FOR SOLUTION FOR EUROPE B.V. INJECTION

REFRESH PLUS LUBRICANT EYE DROPS 0.5% W/V ALLERGAN UNITED STATES OF AMERICA

REGAINE 2% CUTANEOUS SOLUTION 20MG/ML PHARMACIA N.V./S.A. BELGIUM

REGAINE 2% GEL 20MG/G PHARMACIA & UPJOHN BELGIUM N.V / S.A

REGAINE 5% CUTANEOUS SOLUTION 5% W/V PHARMACIA N.V. / S.A. BELGIUM

REGAINE EXTRA STRENGTH 5% TOPICAL SOLUTION 5% PHARMACIA LIMITED UNITED KINGDOM

REHIDRAT POWDER FOR ORAL N/A MONSANTO PLC T/A UNITED KINGDOM SOLUTION SEARLE

REHIDRAT POWDER FOR ORAL NA PHARMACIA LIMITED UNITED KINGDOM SOLUTION

RELAXIN TABLETS 3MG MACTER PAKISTAN INTERNATIONAL (PVT) LTD.

RELENZA 5MG/DOSE POWDER FOR 5MG/DOSE LABORATOIRE GLAXO FRANCE INHALATION WELLCOME

RELENZA ROTADISK INSUFFLATION BLISTER 5MG GLAXO WELLCOME AUSTRALIA PACK AUSTRALIA LTD.

RELIFEX TABLETS 500MG COATED TABLET 500MG BEECHAM GROUP PLC UNITED KINGDOM

REMEDEINE EFFERVESCENT EFFERVESCENT TABLET N/A NAPP LABORATORIES UNITED KINGDOM TABLETS LIMITED

REMEDEINE FORTE EFFERVESCENT EFFERVESCENT TABLET N/A NAPP LABORATORIES UNITED KINGDOM TABLETS LIMITED

REMEDEINE FORTE TABLETS TABLET N/A NAPP LABORATORIES UNITED KINGDOM LIMITED

REMEDEINE TABLETS TABLET N/A NAPP LABORATORIES UNITED KINGDOM LIMITED

REMEGEL CHEWABLE TABLET CHEWABLE TABLET 800 MG SETON PRODUCTS UNITED KINGDOM LIMITED

REMEGEL FRESHMINT CHEWABLE TABLET 800 MG SETON PRODUCTS UNITED KINGDOM LIMITED

REMETHAN 25 TABLETS 25MG REMEDICA LTD CYPRUS 23.9.2003 FR Journal officiel de l'Union européenne 689

Trade Name Dosage Form Dose MA Holder Country

REMETHAN 50 TABLETS 50MG REMEDICA LTD CYPRUS

REMICADE POW.ANDCONC.F/SOL/F/ SEE REMARKS CENTOCOR B.V. UNITED KINGDOM INF.

REMINYL ORAL SOLUTION 4MG/1ML JANSSEN BELGIUM PHARMACEUTICA N.V.

REMINYL FILM-COATED TABLETS 8MG JANSSEN CILAG SPA ITALY

REMINYL FILM COATED TABLETS 4MG JANSSEN CILAG SPA ITALY

REMINYL FILM COATED TABLETS 12MG JANSSEN CILAG SPA ITALY

REMOV GRANULE 100MG/SACHET VECCHI & C PIAM S.A.P.A. ITALY

REMOV TABLET 100MG VECCHI & C PIAM S.A.P.A. ITALY

REMYCIN 100 TABLETS 100MG REMEDICA LTD CYPRUS

RENITEC TABLET 10MG MERCK SHARP & DOHME PAKISTAN

RENITEC TABLET 5MG MSD PAKISTAN

RENITEC TABLET 5MG M.S.D. PAKISTAN

RENITEC 20MG TABLET 20MG MERCK SHARP & DOHME NETHERLANDS B.V.

RENITEC 20MG TABLETS 20MG MSD PAKISTAN

RENITEC 5MG TABLET 5MG MERCK SHARP & DOHME NETHERLANDS B.V.

RENNIE CHEWABLE TABLET N/A LABORATOIRES ROCHE FRANCE NICHOLAS S.A.

RENNIE DEFLATINE TABLET NS ROCHE PRODUCTS UNITED KINGDOM LIMITED

RENNIE DUO ORAL SUSPENSION NS ROCHE PRODUCTS UNITED KINGDOM LIMITED

RENNIE PEPPERMINT TABLET N/A ROCHE PRODUCTS UNITED KINGDOM LIMITED

RENNIE RAP-EZE CHEWABLE TABLET 500MG ROCHE PRODUCTS UNITED KINGDOM LIMITED

RENNIE SPEARMINT TABLET NS ROCHE PRODUCTS UNITED KINGDOM LIMITED

REOPRO SOLUTION FOR 2MG/ML CENTOCOR B.V. NETHERLANDS INJECTION

REPARIL GEL N GEL NA MADAUS AG GERMANY

REPLAVITE REHYDRATION GRANULES N/A SUSSEX UNITED KINGDOM TREATMENT GRANULES PHARMACEUTICAL LIMITED

REPLENINE, (REPLENIN-VF) POWDER FOR INJECTION N/A BPL, BIO PRODUCTS UNITED KINGDOM LABORATORY

RESCUE REMEDY (BACH) ORAL LIQUID N/A NELSON A. & CO LTD UNITED KINGDOM

RESCULA EYE DROPS 1.2MG/ML NOVARTIS ARGENTINA ARGENTINA SAICYF 690 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

RESCULA EYE DROPS EYE DROPS 1.5MG/ML NOVARTIS SWITZERLAND OPHTHALMICS AG

RESFOLIN TABLET 15MG VECCHI & C PIAM S.A.P.A. ITALY

RESOVIST O.5 MMOL FE/ML SOLUTION FOR 1MG SCHERING AG GERMANY INJECTION

RETACNYL 0.025% CREAM 0.025% LABORATOIRES FRANCE GALDERMA

RETACNYL 0.05% CREAM 0.05% LABORATOIRE FRANCE GALDERMA

RETENS CAPSULE 100MG CHIESI WASSERMANN SPAIN S.A.

RETENS CAPSULES 116MG CHIESI ESPANA S.A. SPAIN

RETIN A SOLUTION 1.183MG/G JANSSEN-CILAG AG SWITZERLAND

RETIN A 0.025% GEL 0.025% JANSSEN-CILAG AG SWITZERLAND

RETIN A 0.05% CREAM 0.05% JANSSEN-CILAG AG SWITZERLAND

RETITOP 0.05% CREAM 0.05% W/W LABORATOIRES FRANCE ROCHE-POSAY

RETROVIR CAPSULES 100MG CAPSULES 100MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

RETROVIR CAPSULES 250MG CAPSULES 250MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

RETROVIR IV FOR INFUSION SOLUTION FOR 10MG/ML THE WELLCOME UNITED KINGDOM INJECTIONS FOUNDATION LIMITED

RETROVIR SYRUP 50MG/5ML ORAL SOLUTION 50MG/5ML THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

REVIA TABLETS 50MG DUPONT UNITED STATES OF PHARMACEUTICALS AMERICA COMPANY

REVIDOX TABLET 100MG MACLEODS INDIA PHARMACEUTICALS LTD

RHE FD TABLETS N/A MACLEODS INDIA PHARMACEUTICALS LTD

RHESONATIV POWDER FOR INJECTION (I+II) 1250IU PHARMACIA & UPJOHN SWEDEN AB

RHESSONATIV 1250 IU POWDER AND SOLVENT 200 MG BIOVITRUM AB

RHEUMASOL TABLETS COATED TABLET N/A PETER BLACK UNITED KINGDOM HEALTHCARE LTD

RHINATHIOL 2% FOR CHILDREN SYRUP 2% W/V LABORATOIRES FRANCE AND INFANTS SYNTHELABO

RHINATHIOL 375MG CAPSULE 375MG LABORATOIRES FRANCE EXPECTORANT SYNTHELABO

RHINATHIOL 5% ADULTS SYRUP 5% W/V LABORATOIRES FRANCE EXPECTORANT SYNTHELABO

RHINATHIOL ADULTS SUGER-FREE SYRUP 5% W/V LABORATOIRES FRANCE EXPECTORANT SYNTHELABO 23.9.2003 FR Journal officiel de l'Union européenne 691

Trade Name Dosage Form Dose MA Holder Country

RHINATHIOL PROMETHAZINE SYRUP N/A LABORATOIRES FRANCE SYNTHELABO

RHINATHIOL SUGAR-FREE SYRUP 2% W/V LABORATOIRES FRANCE CHILDREN AND INFANTS SYNTHELABO

RHINOCAP CAPSULE N/A DR.GROSSMANN AG SWITZERLAND PHARMACA

RHINOCORT AQUA NASAL SPRAY 50MCG/DOSE TIKA LAKEMEDEL AB SWEDEN

RHINOCORT AQUA NASAL SPRAY 32MCG/DOSE TIKA LAKEMEDEL AB SWEDEN

RHINOCORT AQUA NASAL SPRAY 64MCG/DOSE TIKA LAKEMEDEL AB SWEDEN

RHINOLAST NASAL SPRAY NASAL SPRAY 0.1% W/V ASTA MEDICA LTD UNITED KINGDOM

RHINOPRONT CAPSULES N/A HEINRICH MACK NACHF GERMANY

RHINOPRONT SPRAY SOLUTION N/A HEINRICH MACK GERMANY

RHINOPRONT SYRUP SUSPENSION N/A HEINRICH MACK NACHF GERMANY

RHINOTUSSAL CAPSULES NA HEINRICH MACK NACHF GERMANY

RHINOTUSSAL SYRUP NA HEINRICH MACK NACHF GERMANY

RHUMAGEL GEL N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

RHUMAGEL GEL N/A HOE PHARMACEUTICALS MALAYSIA SDN BHD

RHUMAGEL GEL 0.5% W/W HOE PHARMACEUTICALS MALAYSIA SDN. BHD

RIAMET TABLETS N/A NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

RIBOMICIN OPHTHALMIC OINTMENT 0.3% W/W FARMIGEA SPA ITALY

RIBOMICIN OPHTHALMIC DROPS 0.3% W/V FARMIGEA SPA ITALY

RIFADINE 150MG CAPSULE 150MG LABORATOIRES MARION FRANCE MERRELL DOW

RIFADINE 300MG CAPSULE 300MG LABORATOIRES MARION FRANCE MERRELL DOW

RIFADINE LYOPHILISEE 600MG PREPARATION FOR 600MG LABORATOIRES MARION FRANCE INFUSION MERRELL DOW

RIFAMPICIN FILM COATED TABLETS 300MG PHARMAMED LTD. MALTA

RIFAMPICIN AND ISONIAZID AND TABLET 150/75/400MG MACLEODS INDIA PYRAZINAMIDE PHARMACEUTICALS LTD

RIFAMPICIN AND ISONIAZID TABLET N/A MACLEODS INDIA 150/100MG PHARMACEUTICALS LTD

RIFAMPICIN AND ISONIAZID TABLET N/A MACLEODS INDIA 150/75MG PHARMACEUTICALS LTD

RIFAMPICIN AND ISONIAZID TABLETS N/A MACLEODS INDIA 300/150MG PHARMACEUTICALS LTD

RIFAMPICIN AND ISONOIAZID TABLET 120/50/300MG MACLEODS INDIA AND PYRAZINAMIDE PHARMACEUTICALS LTD

RIFAMPICIN + ISONIAZID TABLETS 300MG +150MG PHARMAMED LTD. MALTA 692 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

RIFAREN CAPSULES 300MG REMEDICA LTD. CYPRUS

RIFAREN 150 CAPSULES 150MG REMEDICA LTD CYPRUS

RIFASYNT 150MG CAPSULE 150MG MEDOCHEMIE LTD CYPRUS

RIFASYNT 300MG CAPSULE 300MG MEDOCHEMIE LTD CYPRUS

RIFATER COATED TABLET N/A LABORATOIRES MARION FRANCE MERRELL DOW

RIFINAH TABLETS 150MG/100MG GRUPPO LEPETIT SPA ITALY

RIFINAH 300MG/150MG COATED TABLET N/A LABORATOIRES MARION FRANCE MERRELL FRANCE

RIKODEINE 9.5MG/5ML ORAL LIQUID 9.5MG/5ML 3M PHARMACEUTICALS AUSTRALIA PTY LTD.

RILCAPTON 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

RILCAPTON 50MG TABLET 50MG MEDOCHEMIE LTD CYPRUS

RILUTEK FILM COATED TABLET 50MG RHONE-POULENC RORER FRANCE S.A.

RINGER LACTATED AGUETTANT SOLUTION FOR INFUSION N/A LABORATOIRE AGUET- FRANCE TANT

RINGERS INJECTION USP SOLUTION FOR NA ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

RINGER'S INJECTION USP SOLUTION FOR IV N/A ABBOTT LABORATORIES UNITED STATES OF INFUSION AMERICA

RINGER'S IRRIGATION SOLUTION IRRIGATION SOLUTION N/A B.BRAUN MELSUNGEN GERMANY AG

RINGERS IV INFUSION SOLUTION FOR N/A BAXTER HEALTHCARE UNITED KINGDOM INJECTION LIMITED

RINGER'S LACTATE (HARTMANN SOL. FOR INJ./INF. N/A PARACELCIA INDUSTRIA PORTUGAL SOLUTION) FARMACEUTICA

RINSTEAD ADULT GEL OROMUCOSAL GEL N/A SCHERING-PLOUGH UNITED KINGDOM LIMITED

RINSTEAD CONTACT PASTILLE LOZENGE 2MG SCHERING-PLOUGH UNITED KINGDOM LIMITED

RINSTEAD SUGAR FREE PASTILLES LOZENGE N/A SCHERING-PLOUGH UNITED KINGDOM LIMITED

RINSTEAD TEETHING GEL ORAL GEL N/A SCHERING-PLOUGH UNITED KINGDOM LIMITED

RIOPAN PLUS SUS SUSPENSION N/A WYETH-AYERST CANADA CANADA INC.

RISDONE-1 TABLET 1MG INTAS INDIA PHARMACEUTICALS LTD

RISDONE-1 (RISPERIDONE TABLETS TABLET 1MG INTAS INDIA 1MG) PHARMACEUTICALS LTD

RISDONE-2 TABLETS 2MG INTAS INDIA PHARMACEUTICALS LTD

RISDONE-2 (RISPERIDONE TABLETS TABLET 2MG INTAS MALAYSIA 2MG) PHARMACEUTICALS LTD 23.9.2003 FR Journal officiel de l'Union européenne 693

Trade Name Dosage Form Dose MA Holder Country

RISDONE-3 TABLET 3MG INTAS INDIA PHARMACEUTICALS LTD

RISDONE-3 (RISPERIDONE TABLET 3MG INTAS MALAYSIA TABLETS 3MG) PHARMACEUTICALS LTD

RISDONE-4 4MG TABLET INTAS INDIA PHARMACEUTICALS LTD

RISDONE-4 (RISPERIDONE TABLET 4MG INTAS INDIA TABLETS 4MG) PHARMACEUTICALS LTD

RISPERDAL 1MG TABLET 1MG JANSSEN-CILAG N.V. BELGIUM

RISPERDAL 1MG/ML ORAL SOLUTION 1MG/ML JANSSEN-CILAG AG BELGIUM

RISPERDAL 2MG TABLET 2MG JANSSEN-CILAG N.V. BELGIUM

RISPERDAL 3MG TABLET 3MG JANSSEN-CILAG N.V. BELGIUM

RITALIN TABLETS 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

RITALIN TABLETS 10MG NOVARTIS PHARMA GERMANY GMBH

RITOSIN FILM TABLET 150MG BIOFARMA ILAC SAN VE TURKEY TIC A.S.

RIVOTRIL TABLETS 0.5MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

RIVOTRIL TABLET 2MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

ROACCUTANE CAPSULES 2.5MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

ROACCUTANE CAPSULES 10MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

ROACCUTANE CAPSULE 20MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

ROACCUTANE 10MG CAPSULE 10MG PRODUITS ROCHE FRANCE

ROACCUTANE 20MG CAPSULE 20MG PRODUITS ROCHE FRANCE

ROACCUTANE 5MG CAPSULES 5MG PRODUITS ROCHE FRANCE

ROBITUSSIN SYRUP 100MG/5ML WHITEHALL UNITED STATES OF INTERNATIONAL INC AMERICA

ROBITUSSIN DM SYRUP N/A WHITEHALL UNITED STATES OF INTERNATIONAL INC. AMERICA

ROBITUSSIN DM SYRUP SYRUP NS WYETH CONSUMER UNITED STATES OF HEALTHCARE AMERICA

ROBITUSSIN PAEDIATRIC COUGH SYRUP 7.5MG/5 ML WYETH CONSUMER UNITED STATES OF HEALTHCARE AMERICA

ROBITUSSIN PE SYRUP N/A WHITEHALL UNITED STATES OF INTERNATIONAL INC. AMERICA

ROBITUSSIN PE SYRUP SYRUP NA WYETH CONSUMER UNITED STATES OF HEALTHCARE AMERICA

ROCEPHIN ROCHE VIAL 2G ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG 694 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ROCEPHIN VIALS 250MG (I.M.) STERILE POWDER FOR 250MG ROCHE PHARMA SWITZERLAND RECONS (SCHWEIZ) AG

ROCEPHIN VIALS 500MG (I.V.) STERILE POWDER FOR 500MG ROCHE PHARMA SWITZERLAND RECON. (SCHWEIZ) AG

ROCEPHINE 1G/10ML (IV USE) POWDER AND SOLVENT 1G/10ML PRODUITS ROCHE FRANCE F. INJ.

ROCEPHINE 1G/3.5ML (IM USE) POWDER AND SOLVENT 1G/3.5ML PRODUITS ROCHE FRANCE F. INJ

ROCEPHINE 250MG/5ML (IV USE) POWDER AND SOLVENT 250MG/5ML PRODUITS ROCHE FRANCE F. INJ.

ROCEPHINE 2G POWDER F SOLN F 2G PRODUITS ROCHE FRANCE INFUSION

ROCEPHINE 500MG/5ML (IV USE) POWDER AND SOLVENT 500MG/5ML PRODUITS ROCHE FRANCE F. INJ.

ROCEPHINE VIALS 1G I.M. / I.V. STERILE POWDER FOR 1G ROCHE PHARMA SWITZERLAND RECONS (SCHWEIZ) AG

RODOGYL FILM COATED TABLET N/A RHONE-POULENC RORER FRANCE

ROFERON-A VIAL SEE CPP ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

ROKAMOL 500MG CAPLETS CAPLET 500MG TARO ISRAEL PHARMACEUTICAL INDUSTRIES LTD

ROPRIL AEGIS LTD. 12.5MG AEGIS LTD CYPRUS

ROPRIL 25 TABLETS 25MG AEGIS LTD. CYPRUS

ROPRIL 50 TABLETS 50MG AEGIS LTD. CYPRUS

ROR, TRIMOVAX, TRIMOVAX SOLUTION FOR N/A PASTEUR MERIEUX FRANCE MERIEUX INJECTION SERUMS & VACCINS LABORATORIES

ROVAMYCIN 1.5M IU FILM-COATED TABLETS 1.50 MILLION IU SPECIA LABORATORIES FRANCE

ROVAMYCINE FILM-COATED TABLETS 3 MILLION IU RHONE-POULENC RORER FRANCE

ROVAMYCINE FILM-COATED TABLETS 1.5 MILLION IU RHONE-POULENC RORER FRANCE

ROVAMYCINE 3 MILLION IU FILM-COATED TABLETS N/A SPECIA LABORATORIES FRANCE

ROVAMYCINE CHILDREN 0.75MIU GRANULES FOR ORAL 0.75MIU RHONE-POULENC RORER FRANCE SUSPENS PHARMASPECIALITES

ROWATANAL CREAM N/A ROWA IRELAND PHARMACEUTICALS LTD

ROXAID TABLET 150MG UNIMED KOREA REPUBLIC PHARMACEUTICALS INC.

ROXAMED TABLETS 150MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

ROXITAN 10 CAPSULES 10MG REMEDICA LTD CYPRUS

ROXY — 150 TABLET 150MG CIPLA LTD INDIA

ROZEX GEL FOR CUTANEOUS USE 0.75% W/W LABORATOIRES FRANCE GALDERMA 23.9.2003 FR Journal officiel de l'Union européenne 695

Trade Name Dosage Form Dose MA Holder Country

ROZEX CREAM 0.75% W/W GALDERMA(UK) LIMITED UNITED KINGDOM

ROZEX CREAM CREAM 0.75%W/W GALDERMA (UK) LIMITED UNITED KINGDOM

ROZEX GEL GEL 0.75% W/W GALDERMA (UK) LIMITED UNITED KINGDOM

RPR SULPHADIAZINE SOLUTION FOR 27.2% W/V CONCORD UNITED KINGDOM INJECTION PHARMACEUTICALS LIMITED

RREDENEMA RECTAL SOLUTION 0.2MG/ML PHARMAX LIMITED UNITED KINGDOM

RUBELLA VACCINE LIVE B.P. FREEZE-DRIED CAKE F/INJ 1000 CCID50 M/S SERUM INSTITUTE OF INDIA LYOPHILISED INDIA

RUBILIN RUBELLA VACCINE FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL UNITED KINGDOM LIMITED

RUBIMYCIN TABLET 250MG PHARMACARE LIMITED SOUTH AFRICA

RUDIVAX SOLUTION FOR N/A PASTEUR MERIEUX FRANCE INJECTION

RUDOLAC SYRUP 7G/10ML G.STREULI & CO. AG SWITZERLAND

RULID TABLET 150MG HOECHST MARION PAKISTAN ROUSSEL

RULID 100MG COATED TABLET 100MG LABORATOIRES AVENTIS FRANCE

RULID 100MG TABLET 100MG HOECHST MARION PAKISTAN ROUSSEL

RULID 150MG TABLET 150MG LABORATOIRES AVENTIS FRANCE

RULID 150MG TABLET 150MG HOECHST MARION PAKISTAN ROUSSEL

RULID 50MG TABLET FOR ORAL 50MG LABORATOIRES AVENTIS FRANCE SUSPEN.

RUMAFEN-400 TABLETS 400MG ATCO LABORATORIES PAKISTAN (PVT) LTD

RUMAFEN-600 TABLETS 600MG ATCO LABORATORIES PAKISTAN (PVT) LTD

RUMAFEN-600 SUSPENSION 100MG/5ML ATCO LABORATORIES PAKISTAN (PVT) LTD

RUMAFEN-600 GEL 10G/100G ATCO LABORATORIES PAKISTAN (PVT) LTD

RUPAN 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

RUSYDE TABLETS 20MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

RUSYDE TABLETS 40MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

RUVOMINOX INJECTABLE SOLUTION 75MG/3ML RAFARM GREECE

RYNACROM 2% NASAL SPRAY OR NASAL SPRAY 2%W/V FISONS LTD T/A RHONE UNITED KINGDOM RESISTON TWO POULENC RORER

RYNACROM 2% NASAL SPRAY OR NASAL SPRAY 2% W/V FISONS LTD. T/A RHONE UNITED KINGDOM RESTINON TWO POULENC RORER

RYNACROM 4% NASAL SPRAY NASAL SPRAY 4% W/V FISONS LIMITED UNITED KINGDOM

RYNACROM 4% NASAL SPRAY NASAL SPRAY 4%W/V FISONS LTD UNITED KINGDOM 696 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

RYNACROM COMPOUND NASAL SPRAY N/A FISONS LIMITED T/A UNITED KINGDOM RHONE-POULENC RORER

RYNACROM COMPOUND NASAL SPRAY(AEROSOL) N/A FISONS LTD T/A RHONE- UNITED KINGDOM POULENC RORER

RYNACROM NASAL DROPS NASAL DROPS 2%W/V FISONS LTD T/A RHONE- UNITED KINGDOM POULENC RORER

RYNACROM NASAL DROPS/NASAL NASAL DROPS 2% W/V FISONS LIMITED T/A UNITED KINGDOM SPRAY RHONE POULENC RORER

RYTHMODAN CAPSULES 100MG CAPSULE 100MG HOECHST MARION UNITED KINGDOM ROUSSEL LIMITED

RYTHMODAN INJECTION 50MG/ SOLUTION FOR 50MG/5ML ROUSSEL UNITED KINGDOM 5ML INJECTION LABORATORIES LTD

S.C.R. CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM

SABRIL 500MG TABLET 500MG LABORATOIRES MARION FRANCE MERRELL S.A.

SACCA CLEAR-FLEX 2000ML SOLUTION FOR DIALYSIS NA BIEFFE MEDITAL S.P.A. ITALY

SACCA CLEAR-FLEX 2000ML SOLUTION FOR DIALISYS N/A BIEFFE MEDITAL SPA ITALY

SALAMOL EASI-BREATHE INHALER 0.1MG/DOSE NORTON HEALTHCARE UNITED KINGDOM LIMITED

SALAMOL EASI-BREATHE CFC-FREE INHALER, AERSOSOL 100MCG/DOSE NORTON HEALTHCARE UNITED KINGDOM LIMITED

SALAMOL STERI-NEB 2.5MG SOLUTION FOR 2.5MG/2.5ML STERIPAK LIMITED UNITED KINGDOM NEBULISER

SALAMOL STERI-NEB 5MG SOLUTION FOR 5MG/2.5ML STERIPAK LIMITED UNITED KINGDOM NEBULISATION

SALAZOPYRIN TABLETS 500MG PHARMACIA & UPJOHN SWEDEN SVERIGE AB

SALAZOPYRIN SUPPOSITORIES 500MG PHARMACIA & UPJOHN SWEDEN SVERIGE AB

SALAZOPYRIN EN GASTRO-RESIS. TABLETS 500MG PHARMACIA & UPJOHN SWEDEN

SALAZOPYRIN ENEMA RECTAL SOLUTION 3%W/V PHARMACIA UNITED KINGDOM LABORATORIES LIMITED

SALBUTAMOL AEROSOL INHALATION 0.1MG/DOSE NORTON HEALTHCARE UNITED KINGDOM LIMITED

SALBUTAMOL TABLETS 4MG PHARMAMED LTD. MALTA

SALBUTAMOL TABLETS 4MG REMEDICA LTD. CYPRUS

SALBUTAMOL 2 TABLETS 2MG REMEDICA LTD CYPRUS

SALBUTAMOL SYRUP ORAL SYRUP 2MG/5ML EGYPTIAN EGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO (EIPICO)

SALINE STERI-NEB 0.9%W/V SOLUTION (SEE 22.5MCG/2.5ML STERIPAK LIMITED UNITED KINGDOM REMARKS)

SALIPAX CAPSULES 20MG MEPHA PHARMA AG SWITZERLAND

SALMOL CFC-FREE INHALER INHALER 29.64MG NOTRON HEALTHCARE UNITED KINGDOM LTD 23.9.2003 FR Journal officiel de l'Union européenne 697

Trade Name Dosage Form Dose MA Holder Country

SALOFALK SUPPOSITORIES 250MG DR. FALK PHARMA GMBH GERMANY

SALOFALK ENTERIC COATED 500MG DR. FALK PHARMA GMBH GERMANY TABLETS

SALOFALK ENTERIC-COATED 250MG DR. FALK PHARM GMBH GERMANY TABLETS

SALOFALK ENEMAS 4G/60ML DR. FALK PHARMA GMBH GERMANY

SAMIXON 500 IV POWDER FOR INJECTION 500MG/VIAL HIKMA JORDAN PHARMACEUTICALS

SANDA-100 CAPSULE 100MG OKASA PHARMA PVT INDIA LTD INDIA

SANDA-25 CAPSULE 25MG OKASA PHARMA PVT. INDIA LTD — INDIA

SANDIMMUM CAPSULES 100MG NOVARTIS PAKISTAN

SANDIMMUN NEORAL SOFT GELATIN CAPSULES 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

SANDIMMUN NEORAL ORAL SOLUTION 100MG/ML NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

SANDIMMUN NEORAL SOFT GELATIN CAPSULES 100MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

SANDIMMUN NEORAL SOFT GELATIN CAPSULES 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

SANDIMMUN NEORAL SOFT GELATIN CAPSULES 50MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

SANDIMMUN NEORAL ORAL SOLUTION 100MG/ML NOVARTIS SPAIN FARMACEUTICA S.A

SANDIMMUN NEORAL CAPSULES 100MG NOVARTIS SPAIN FARMACEUTICA S.A

SANDIMMUN NEORAL CAPSULES 25MG NOVARTIS SPAIN FARMACEUTICA S.A

SANDOMIGRAN TABLETS 0.5MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ

SANDOSTATIN SOLUTION FOR 0.1MG/ML NOVARTIS SPAIN INJECTION FARMACEUTICA S.A

SANDOSTATIN SOLUTION FOR 1MG/5ML NOVARTIS SPAIN INJECTION FARMACEUTICA S.A

SANDOSTATIN SOLUTION FOR 1MG/5ML NOVARTIS PHARMA SWITZERLAND INJECTION SCHWEIZ AG

SANDOSTATIN SOLUTION FOR 0.05MG/ML NOVARTIS PHARMA SWITZERLAND INJECTION SCHWEIZ AG

SANDOSTATIN SOLUTION FOR 0.5MG/ML NOVARTIS PHARMA SWITZERLAND INJECTION SCHWEIZ AG

SANDOSTATIN SOLUTION FOR 100MCG/ML NOVARTIS PHARMA SWITZERLAND INJECTION SCHWEIZ AG

SANDOSTATIN SOLUTION FOR 0.05MG/ML NOVARTIS SPAIN INJECTION FARMACEUTICA S.A

SANDOSTATIN LAR MICROSPHERES FOR INJ. 10MG NOVARTIS PHARMA AG SWITZERLAND 698 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SANDOSTATIN LAR MICROSPHERES FOR INJ. 20MG NOVARTIS PHARMA AG SWITZERLAND

SANDOSTATIN LAR MICROSPHERES FOR INJ. 30MG NOVARTIS PHARMA AG SWITZERLAND

SANDOSTATIN LAR POWDER FOR INJECTION 20MG NOVARTIS SPAIN FARMACEUTICA S.A.

SANDOSTATIN LAR POWDER FOR INJECTION 10MG NOVARTIS SPAIN FARMACEUTICA S.A

SANDOSTATIN LAR POWDER FOR INJECTION 30MG NOVARTIS SPAIN FARMACEUTICA S.A

SANDOSTATINA SOLUTION FOR 0.5MG/ML NOVARTIS FARMA — PORTUGAL INJECTION PRODUTOS FARMACEUTICOS S.A.

SANTE CAPSULES CAPSULES 20 MG MACTER PAKISTAN INTERNATIONAL (PVT)

SAROTEN TABLET 10MG H. LUNDBECK A/S DENMARK

SAROTEN TABLET 25MG H.LUNDBECK A/S DENMARK

SASTID SOAP SOAP N/A STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

SAUBASIN TABLETS 60MG KLEVA LTD GREECE

SAVENTRINE IV SOLUTION FOR 2MG/2ML PHARMAX LIMITED UNITED KINGDOM INJECTION

SAVOY COLD AND FLU RELIEF COATED TABLETS N/A NORMA CHEMICALS UNITED KINGDOM TABLETS LIMITED

SCHERIPROCT-SALBE OINTMENT N/A SCHERING WIEN AUSTRIA GESELLSCHAFT M.B.H.

SCHOLL ANTISEPTIC FOOT BALM CREAM N/A SCHOLL CONSUMER UNITED KINGDOM PRODUCTS

SCHOLL ATHLETES FOOT TOPICAL POWDER 1% W/W SCHOLL CONSUMER UNITED KINGDOM PRODUCTS

SCHOLL ATHLETE'S FOOT CREAM CREAM 1%W/W SCHOLL CONSUMER UNITED KINGDOM PRODUCTS

SCHOLL ATHLETES FOOT SPRAY TOPICAL SPRAY 1%W/W SCHOLL CONSUMER UNITED KINGDOM LIQUID PRODUCTS

SCHOLL CALLOUS REMOVERS PLASTER 40%W/W SCHOLL CONSUMER UNITED KINGDOM PRODUCTS

SCHOLL CORN AND CALLOUS TOPICAL SOLUTION N/A SCHOLL CONSUMER UNITED KINGDOM REM. LIQ. PRODUCTS

SCHOLL VERRUCA REMOVAL PLASTER 40%W/W SCHOLL CONSUMER UNITED KINGDOM SYSTEM PRODUCTS

SCOT-TUSSIN ALLERGY LIQUID 12.5MG/5ML SCOT-TUSSIN UNITED STATES OF SUGAR-FREE PHARMACAL CO., INC. AMERICA

SCOT-TUSSIN DM COUGH LOZENGE 5MG SCOT-TUSSIN UNITED STATES OF CHASERS PHARMACAL CO INC AMERICA

SCOT-TUSSIN DM SUGAR-FREE LIQUID N/A SCOT-TUSSIN UNITED STATES OF PHARMACAL CO., INC. AMERICA

SCOT-TUSSIN EXPECTORANT LIQUID 200MG/10ML SCOT-TUSSIN UNITED STATES OF SUGAR-FREE PHARMACAL CO., INC. AMERICA 23.9.2003 FR Journal officiel de l'Union européenne 699

Trade Name Dosage Form Dose MA Holder Country

SCOT-TUSSIN ORIGINAL S-F COLD LIQUID N/A SCOT-TUSSIN UNITED STATES OF AND ALLERGY PHARMACAL CO., INC. AMERICA

SCOT-TUSSIN SENIOR SUGAR-FREE LIQUID N/A SCOT-TUSSIN UNITED STATES OF PHARMACAL CO., INC. AMERICA

SEAL AND HEAL VERRUCA GEL N/A SCHOLL CONSUMER UNITED KINGDOM REMOVAL GEL PRODUCTS LIMITED

SEDOXIL PILLS 1MG MEDIBIAL — PRODUTOS PORTUGAL MEDICOS E FARMACEUTICOS, S.A.

SEDOXIL TABLET NA LABORATORIOS BIAL — PORTUGAL PORTELA & CA, S.A.

SEDOXIL TABLET 1MG MEDIBIAL — PRODUTOS PORTUGAL MEDICOS E FARMACEUTICOS S.A.

SEFAGEN SOLUTION FOR 1G BILIM ILAC SANAYII VE TURKEY INJECTION TICARET AS

SEKROL SYRUP NA BILIM ILAC SANAYII VE TURKEY TICARET AS

SELECIM TABLETS 5MG CIMEX AG SWITZERLAND

SELECTOL 200MG TABLET 200MG RORER UNITED KINGDOM PHARMACEUTICALS LTD. (T/A RHONE POULENC RORER)

SELEGELINE HYDOCHLORIDE TABLETS 10MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

SELEGELINE HYDROCHLORIDE TABLETS 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

SELEGILENE HCL TABLETS 5MG TEVA PHARMACEUTICAL ISRAEL INDUSTRIES LTD.

SELEGOS 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

SELEMYCIN 100MG/2ML LIQUID FOR INJECTION 100MG/2ML MEDOCHEMIE LTD CYPRUS

SELEMYCIN 250MG/2ML LIQUID FOR INJECTION 250MG/2ML MEDOCHEMIE LTD CYPRUS

SELEMYCIN 500MG/2ML LIQUID FOR INJECTION 500MG/2ML MEDOCHEMIE LTD CYPRUS

SELERIN TABLETS 5MG CIPLA LTD INDIA

SELEXID TABLETS 200MG LEO PHARMACEUTICAL DENMARK PRODUCTS

SELEXID POWDER FOR INJECTION 400G/VIAL LEO PHARMACEUTICAL DENMARK PRODUCTS

SELGIN TABLETS 5MG INTAS PHARMACEUTI- INDIA CALS LTD.

SELSUN SHAMPOO 2.5%W/V ABBOTT LABORATORIES UNITED KINGDOM LIMITED

SEMPREX CAPSULES 8MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

SENNA 7.5 TABLETS 7.5MG REMEDICA LTD CYPRUS

SENNA 7.5MG TABLET 7.5MG MEDOCHEMIE LTD CYPRUS 700 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SENOKOT SYRUP ORAL SOLUTION 0.18% W/W RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

SENOKOT TABLETS TABLET 7.5MG RECKITT & COLMAN UNITED KINGDOM PRODUCTS LIMITED

SEPCEN TABLETS 500MG LABORATOIRES SPAIN CENTRUM

SEPCEN TABLETS 250MG LABORATOIRES SPAIN CENTRUM

SEPCEN 250 TABLETS 250MG ESPECIALIDADES SPAIN FARMACEUTICAS CENTRUM SA

SEPCEN 500 TABLETS 500MG ESPECIALIDADES SPAIN FARMACEUTICAS CENTRUM SA

SEPTANEST WITH ADRENALINE SOLUTION FOR 1/200,000 LABORATOIRES FRANCE INJECTION SEPTODENT

SEPTANEST WITH ADRENALINE SOLUTION FOR 1/100,000 LABORATOIRES FRANCE INJECTION SEPTODONT

SEPTI-AID OINTMENT 10%W/W RAZA MANUFACTURING MALAYSIA BERHAD

SEPTOPAL CHAIN 30 BEADS ON CHAIN N/A MERCK BIOMATERIAL GERMANY GMBH

SEPTRA INJ. SOL. FOR INFUSION N/A GLAXO SMITHKLINE INC. CANADA

SEPTRA TABLETS NA GLAXOSMITHKLINE INC CANADA

SEPTRA DS TABLETS NA GLAXOSMITHKLINE INC CANADA

SEPTRIN TABLETS N/A THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

SEPTRIN DISPERSIBLE TABLETS N/A THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

SEPTRIN PAEDIATRIC SUSPENSION NA GLAXO WELLCOME GERMANY GMBH & CO.

SEPTRIN TABLETS NA THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

SEPTRIN ADULT SUSPENSION SUSPENSION N/A THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

SEPTRIN FOR INFUSION SOLUTION FOR N/A THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION LIMITED

SEPTRIN FORTE (DOUBLE TABLETS N/A THE WELLCOME UNITED KINGDOM STRENGTH) FOUNDATION LTD.

SEPTRIN FORTE TABLETS TABLETS NA THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

SEPTRIN PAEDIATRIC SUSPENSION N/A THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

SEPTRIN TABLETS ADULT TABLETS NA THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

SEPTRIN TABLETS FORTE TABLETS NA GLAXOSMITHKLINE GERMANY GMBH & Co 23.9.2003 FR Journal officiel de l'Union européenne 701

Trade Name Dosage Form Dose MA Holder Country

SERENACE TABLET 1.5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

SERENACE TABLETS 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

SERENACE TABLET 10MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

SERENACE CAPSULE 500MCG NORTON HEALTHCARE UNITED KINGDOM LIMITED

SERENACE CAPSULES 0.5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

SERENACE TABLETS 1.5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

SERENACE TABLETS 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

SERENITY TABLETS COATED TABLET N/A CATHAY OF UNITED KINGDOM BOURNEMOUTH LTD

SERETIDE 100 DISKUS INHALATION POWDER N/A GLAXO WELLCOME UK UNITED KINGDOM LTD T/A ALLEN & HANBURYS

SERETIDE 100 DISKUS INHALATION POWDER NA ALLEN & HANDBURY'S IRELAND PRE-DISPENSED LIMITED

SERETIDE 125 EVOHALER PRESS. INHAL., N/A GLAXO WELLCOME UK UNITED KINGDOM SUSPENSION LIMITED

SERETIDE 125 EVOHALER PRESSURISED NA GLAXO WELLCOME UK UNITED KINGDOM INHALATION LIMITED T/A ALLEN AND HANDBURYS

SERETIDE 250 DISKUS INHALATION POWDER N/A GLAXO WELLCOME UK UNITED KINGDOM LTD T/A ALLEN & HANBURYS

SERETIDE 250 DISKUS INHALATION POWDER NA ALLEN & HANDBURY'S IRELAND PRE-DISPENSED LIMITED

SERETIDE 250 EVOHALER PRESS. INHAL., N/A GLAXO WELLCOME UK UNITED KINGDOM SUSPENSION LIMITED

SERETIDE 250 EVOHALER PRESSURED INHALATION NA GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN AND HANDBURYS

SERETIDE 50 EVOHALER PRESS. INHAL., N/A GLAXO WELLCOME UK UNITED KINGDOM SUSPENSION LIMITED

SERETIDE 50 EVOHALER PRESSURISED NA GLAXO WELLCOME UK UNITED KINGDOM INHALATIONS LIMITED T/A ALLEN AND HANDBURYS

SERETIDE 500 DISKUS INHALATION POWDER NA ALLEN & HANDBURY'S IRELAND PRE-DISPENSED LIMITED

SERETIDE DISKUS INHALATION POWDER 100MCG GLAXO WELLCOME UK IRELAND LIMITED

SERETIDE DISKUS INHALATION POWDER 250MCG GLAXO WELLCOME UK IRELAND LIMITED

SERETIDE DISKUS INHALATION POWDER 500MCG GLAXO WELLCOME UK IRELAND LIMITED 702 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SEREVENT SEE REMARKS 25MCG/DOSE LABORATOIRE FRANCE GLAXOSMITHKLINE

SEREVENT INHALER AEROSOL 25MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LTD T/A ALLEN & HANBURYS

SEREVENT INHALER INHALER 25MCG GLAXOWELLCOME PAKISTAN

SEREVENT INHALER AEROSOL 25MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LIMITIED T/A ALLEN AND HANDBURYS

SEREVENT INHALER PRESSURISED I 25UG/AC GLAXO WELLCOME UK UNITED KINGDOM NHALATION SUSPENSION LIMITED

SEROBID INHALER 200MD INHALER 25MCG CIPLA INDIA

SEROQUEL COATED TABLET 25MG ZENECA LIMITED UNITED KINGDOM

SEROQUEL COATED TABLET 100MG ZENECA LIMITED UNITED KINGDOM

SEROQUEL COATED TABLET 200MG ZENECA LIMITED UNITED KINGDOM

SEROQUEL COATED TABLETS 25MG ZENECA LIMITED UNITED KINGDOM

SEROQUEL COATED TABLETS 100MG ZENECA LIMITED UNITED KINGDOM

SEROQUEL COATED TABLETS 200MG ZENECA LIMITED UNITED KINGDOM

SEROQUEL PATIENT STARTER TABLET N/A ZENECA LIMITED UNITED KINGDOM PACK

SEROXAT LIQUID 20MG/10ML ORAL SUSPENSION 2MG/ML SMITHKLINE BEECHAM UNITED KINGDOM PLC

SEROXAT TABLETS 20MG COATED TABLET 20MG SMITHKLINE BEECHAM UNITED KINGDOM PLC

SEROXAT TABLETS 30MG COATED TABLET 30MG SMITHKLINE BEECHAM UNITED KINGDOM PLC

SERVEDOL TABLETS 20MG COATED TABLETS 20MG NAPP LABORATORIES UNITED KINGDOM LIMITED

SERVEDOL TABLETS 50MG COATED TABLETS 50MG 50MG NAPP LABORATORIES UNITED KINGDOM LIMITED

SERZONE TABLETS 50MG BRISTOL-MYERS SQUIBB UNITED STATES OF COMPANY AMERICA

SERZONE TABLETS 100MG BRISTOL-MYERS SQUIBB UNITED STATES OF COMPANY AMERICA

SERZONE TABLETS 150MG BRISTOL-MYERS SQUIBB UNITED STATES OF COMPANY AMERICA

SERZONE TABLETS 200MG BRISTOL-MYERS SQUIBB UNITED STATES OF COMPANY AMERICA

SERZONE TABLETS 250MG BRISTOL-MYERS SQUIBB UNITED STATES OF COMPANY AMERICA

SERZONE (DUTONIN) TABLETS 100MG BRISTOL-MYERS SQUIBB ITALY S.P.A

SERZONE (DUTONIN) TABLETS 200MG BRISTOL MYERS SQUIBB ITALY S.P.A

SETLERS ANTACID PEPPERMINT TABLETS 500MG STAFFORD MILLER UNITED KINGDOM LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 703

Trade Name Dosage Form Dose MA Holder Country

SETLERS ANTACID SPEARMINT TABLETS 500MG STAFFORD MILLER UNITED KINGDOM LIMITED

SETLERS ANTACID-PEPPERMINT TABLET 500MG STAFFORD-MILLER UNITED KINGDOM LIMITED

SETLERS ANTACID-SPEARMINT TABLET 500MG STAFFORD-MILLER UNITED KINGDOM LIMITED

SETLERS WIND-EZE CHEWABLE TABLET 125MG STAFFORD-MILLER UNITED KINGDOM LIMITED

SETLERS WIND-EZE SOFT GEL CAPSULES 125MG STAFFORD MILLER UNITED KINGDOM LIMITED

SETLERS WIND-EZE CHEWABLE TABLETS 125MG STAFFORD MILLER UNITED KINGDOM LIMITED

SEVEN SEAS COD LIVER OIL ORAL SOLUTION N/A SEVEN SEAS LIMITED UNITED KINGDOM

SEVORANE INHALATION LIQUID 100% V/V ABBOTT LABORATORIES UNITED KINGDOM LIMITED

SEVORANE INHALATION LIQUID 100%V/V ABBOTT LABORATORIES UNITED KINGDOM LIMITED

SEVREDOL ORAL SOLUTION ORAL SOLUTION 10MG/5ML NAPP LABORATORIES UNITED KINGDOM 10MG/5ML LTD.

SEVREDOL TABLETS 10MG COATED TABLETS 10MG NAPP LABORATORIES UNITED KINGDOM LIMITED

SEVRIN OINTMENT 30% W / W BIOGLAN UNITED KINGDOM LABORATORIES LTD

SGUARDI OPHTHALMIC DROPS 0.01G FARMIGEA SPA ITALY

SI[PROX 250 MG TABLETS TABLETS 250 MG DELTA HF ICELAND

SIBELIUM CAPSULE 5MG JANSSEN-CILAG N.V. BELGIUM

SICCAPOS GEL GEL 2MG/ML URSAPHARM GERMANY ARZNEIMITTEL GMBH

SICCAPROTECT EYE DROPS N/A URSAPHARM GERMANY ARZNEIMITTEL GMBH

SICORTEN CREAM 0.05% W/W NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

SICORTEN PLUS CREAM N/A NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

SIFROL TABLETS 0.088MG BOEHRINGER INGELHEIM GERMANY INTERNATIONAL GMBH

SIFROL TABLETS 0.18MG BOEHRINGER INGELHEIM GERMANY INTERNATIONAL GMBH

SIFROL TABLETS 0.7MG BOEHRINGER INGELHEIM GERMANY INTERNATIONAL GMBH

SILOMAT TABLETS 40MG BOEHRINGER INGELHEIM GERMANY PHARMA KG

SILVER NITRATE PENCIL 95% PAD MOULDED TOUGHENED 95% SOLOPORT LIMITED T/A UNITED KINGDOM TIP BRAY HEALTH & LEISURE

SIMCARD-10 TABLET 10MG CIPLA LTD INDIA

SIMECO SUSPENSION N/A WYETH-LEDERLE PAKISTAN 704 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SIMLO-10 (SIMVASTATIN TABLETS TABLET 10MG IPCA LABORATORIES INDIA USP) LIMITED

SIMPLE EYE OINTMENT BP EYE OINTMENT NO ACTIVE INGR. MARTINDALE UNITED KINGDOM PHARMACEUTICALS LTD

SIMULECT POWDER FOR INJECTION 20MG/VIAL NOVARTIS PHARMA AG SWITZERLAND

SIMULECT (INJECTION) LYOPHILISATE 20MG/ VIAL NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

SIMULECT SEE REMARKS 4MG/ML NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

SIMVACOR TABLETS 10MG KLEVA LTD GREECE

SIMVAKOL FILM TABLET 10MG NOBEL ILAC SANAYII VE TURKEY TICARET A.S.

SIMVOR 10MG TABLETS 10MG RANBAXY LABS LTD INDIA

SINECOD DROPS FOR CHILDREN 5MG/ML NOVARTIS CONSUMER SWITZERLAND HEALTH SA

SINECOD SYRUP 15MG/10ML NOVARTIS CONSUMER SWITZERLAND HEALTH SA

SINEMET 110MG TABLET N/A MERCK SHARP & DOHME NETHERLANDS B.V.

SINEMET 25/250 TABLETS 25/250MG MERCK SHARP & DOHME NETHERLANDS B.V.

SINEMET CR 250MG TABLETS 250MG MERCK SHARP & DOHME NETHERLANDS B.V.

SINEQUAN CAPSULE 50MG PFIZER LIMITED UNITED KINGDOM

SINEQUAN CAPSULE 25MG PFIZER LIMITED UNITED KINGDOM

SINEQUAN CAPSULE 10MG PFIZER LIMITED UNITED KINGDOM

SINEQUAN CAPSULE 75MG PFIZER LIMITED UNITED KINGDOM

SINGULAIR CHEWABLE TABLETS 4MG MERCK SHARP & DOHME NETHERLANDS LTD.

SINGULAIR 10MG TABLETS COATED TABLET 10MG MERCK SHARP & DOHME UNITED KINGDOM

SINGULAIR PAEDIATRIC 5MG CHEWABLE TABLET 5MG MERCK SHARP & DOHME UNITED KINGDOM

SINUFED SYRUP 30MG/5ML TRIMA ISRAEL ISRAEL PHARMACEUTICAL PRODUCTS LTD

SINUTAB TABLET N/A PARKE-DAVIS PAKISTAN

SINUTAB TABLET N/A PARKE-DAVIS PAKISTAN

SIOPEL CREAM CREAM N/A BIOGLAN UNITED KINGDOM LABORATORIES LTD

SIPRAZON 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS

SIPROGUT GOZ DAMLASI 0.3 % OPHTHALMIC SOLUTION 0.3% BILIM ILAC SANAYII VE TURKEY TICARET A.S.

SIPROX 100 MG TABLETS TABLETS 100 MG DELTA HF ICELAND

SIPROX 500 MG TABLETS TABLET 500 MG DELTA HF ICELAND 23.9.2003 FR Journal officiel de l'Union européenne 705

Trade Name Dosage Form Dose MA Holder Country

SIPROX 750 MG TABLET 750MG DELTA HF ICELAND

SIX PLUS PARAPED SUSPENSION ORAL SUSPENSION 250MG/5ML PINEWOOD UNITED KINGDOM LABORATORIES LIMITED T/A PINEWOOD HEALTHCARE LIMITED

SKINOREN CREAM 0.2G/G SCHERING AG ITALY

SKINOREN CREAM 20G/100G SCHERING SPA ITALY

SLOW K TABLETS TABLETS 600 MG NOVARTIS IRELAND PHARMACEUTICALS UK LIMITED

SLOW-FE MODIFIED RELEASE 160MG NOVARTIS UNITED KINGDOM TABLETS PHARMACEUTICALS UK LIMITED

SLOW-FE FOLIC MODIFIED RELEASE N/A NOVARTIS UNITED KINGDOM TABLETS PHARMACEUTICALS UK LIMITED

SLOW-K TABLETS 600MG NOVARTIS PHARMA B.V. NETHERLANDS AMHEM

SLOW-K TABLETS 600MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

SMILITENE CAPSULE 100MG RAFARM GREECE

SMILITENE CAPSULE 100MG RAFARM GREECE

SMOODERM CREAM NA DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

SNIP TABLETS N/A MEDOCHEMIE LTD CYPRUS

SNO PHENICOL EYE DROPS EYE DROPS 0.5% W/V CHAUVIN UNITED KINGDOM 0.5% W/V PHARMACEUTICALS LIMITED

SNOWFIRE HEALING TABLET OINTMENT N/A J PICKLES & SONS UNITED KINGDOM OINTMENT

SNUFFLEBABE VAPOUR RUB NASAL INHALATION N/A J PICKLES & SONS UNITED KINGDOM OINTMENT

SODAMINT BP/ SODIUM TABLET N/A SUSSEX UNITED KINGDOM BICARBONATE COMP. BP PHARMACEUTICAL LIMITED

SODIO CLORURO SOLUTION FOR IV 0.9G/ML INDUSTRIA ITALY INFUSION FARMACEUTICA GALENICA SENESE S.R.L.

SODIO CLORURO SOLUTION FOR IV 0.9% W/V INDUSTRIA ITALY INFUSION FARMACEUTICA GALENICA SENESE S.R.L.

SODIUM BICARBONATE TABLETS 600MG NORTON UNITED KINGDOM PHARMACEUTICALS LIMITED

SODIUM BICARBONATE CAPSULES 500MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

SODIUM BICARBONATE BP ORAL MPOWDER N/A LCM LTD UNITED KINGDOM 706 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SODIUM BICARBONATE INJ AQUEOUS SOLUTION 4.2% W/V INTERNATIONAL UNITED KINGDOM MINIJET MEDICATION SYSTEMS LTD

SODIUM BICARBONATE INJ AQUEOUS SOLUTION 8.4%W/V INTERNATIONAL UNITED KINGDOM MINIJET MEDICATION SYSTEMS LTD

SODIUM BICARBONATE IV INF. SOLUTION FOR 1.4% W/V FRESENIUS LIMITED UNITED KINGDOM POLYFUSOR BD INJECTIONS

SODIUM BICARBONATE IV INF. SOLUTION FOR 8.4%W/V FRESENIUS LIMITED UNITED KINGDOM POLYFUSOR BD INJECTIONS

SODIUM BICARBONATE MINIJET SOLUTION FOR 4.2%W/V INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS (UK) LIMITED

SODIUM BICARBONATE MINJET SOLUTION FOR 8.4% W/V INTERNATIONAL UNITED KINGDOM INJECTION MEDICATION SYSTEMS (UK) LIMITED

SODIUM BICARBONATE TABLETS TABLETS 600MG NORTON UNITED KINGDOM 600MG PHARMACEUTICALS LIMITED

SODIUM CHLORIDE + DEXTROSE SOLUTION FOR IV NA DEMA SA GREECE (0.9+5)% INFUSION

SODIUM CHLORIDE + DEXTROSE SOLUTION F/IV INFUSION NA DEMA SA GREECE (O.18 +4)%

SODIUM CHLORIDE 0.225% + SOLUTION FOR N/A BAXTER HEALTHCARE UNITED KINGDOM GLUCOSE 5% INJECTION LIMITED

SODIUM CHLORIDE 0.45% AND SOLUTION FOR N/A BAXTER HEALTHCARE UNITED KINGDOM GLUCOSE 5% INJECTION LIMITED

SODIUM CHLORIDE 0.9% SOLUTION FOR 0.9% DEMO SA GREECE (5, 10 OR 20ML) AMP INJECTION

SODIUM CHLORIDE 0.9% INJECTABLE SOLUTION 0.9% W/V LABORATOIRE FRANCE AGUETTANT AGUETTANT

SODIUM CHLORIDE 0.9% DEMO SOLUTION FOR INFUSION 0.9% DEMO SA GREECE

SODIUM CHLORIDE 0.9% SCHIWA SOLUTION FOR INFUSION 9G/1000ML B.BRAUN MELSUNGEN GERMANY

SODIUM CHLORIDE 0.9% W/V SOL. FOR INJ./INF. 0.9%W/V PARACELCIA INDUSTRIA PORTUGAL FARMACEUTICA S.A.

SODIUM CHLORIDE AGUETTANT INJECTABLE SOLUTION 0.9% W/V LABORATOIRE FRANCE AGUETTANT

SODIUM CHLORIDE INJECTION SOLUTION FOR 0.9%W/V ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

SODIUM CHLORIDE INJECTION SOLUTION FOR 0.9%W/V ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

SODIUM CHLORIDE INJECTION B.P. SOLUTION FOR 0.9% W/V PHOENIX UNITED KINGDOM INJECTION PHARMACEUTICALS LIMITED

SODIUM CHLORIDE INJECTION BP SOLUTION FOR 0.9% W/V PHOENIX PHARMA LTD UNITED KINGDOM INJECTION 23.9.2003 FR Journal officiel de l'Union européenne 707

Trade Name Dosage Form Dose MA Holder Country

SODIUM CHLORIDE INJECTION BP SOLUTION FOR 0.9% ANTIGEN IRELAND INJECTION PHARMACEUTICALS LTD

SODIUM CHLORIDE INJECTION BP SOLUTION FOR 0.9% W/V MACARTHYS LABS LTD. UNITED KINGDOM 0.9% W/V INJECTION T/A MARTINDALE PHARMACEUTICALS

SODIUM CHLORIDE INJECTION SOLUTION FOR INFUSION 0.9% DEMO SA GREECE DEMO

SODIUM CHLORIDE SOLUTIO IV. INFUSION 0.9%W/V DEMO S.A. GREECE GREECE INJECTION/DEMO

SODIUM CHLORIDE IV INFUSION SOLUTION FOR 0.45%W/V BAXTER HEALTHCARE UNITED KINGDOM INJECTION LIMITED

SODIUM CHLORIDE IV INFUSION SOLUTION FOR 0.9%W/V BAXTER HEALTHCARE UNITED KINGDOM INJECTION LIMITED

SODIUM CLORIDE INJECTION SOLUTION FOR 0.9%W/V ANTIGEN IRELAND INJECTION PHARMACEUTICALS LIMITED

SODIUM CROMOGLYCATE 2% EYE DROPS 2%W/W DOMINION PHARMA UNITED KINGDOM LIMITED

SODIUM IODIDE (131.I) CAPSULE 333KBQ-3.7MBQ NYCOMED AMERSHAM UNITED KINGDOM DIAGNOSTIC CAPSULE PLC

SODIUM NITROPRUSSIDE FOR IV POWDER FOR INJECTION 50MG/VIAL FAULDING UNITED KINGDOM INF. PHARMACEUTICALS PLC

SODIUM VALPROATE ENTERIC COATED 200MG NORTON HEALTHCARE UNITED KINGDOM TABLETS LIMITED

SODIUM VALPROATE ENTERIC COATED 500MG NORTON HEALTHCARE UNITED KINGDOM TABLETS LIMITED

SODIUM VALPROATE SUGAR FREE SOLUTION 200MG/5ML NORTON HEALTHCARE UNITED KINGDOM LIMITED

SOFRADEX EAR EYE OINTMENT EAR/EYE OINTMENT N/A ROUSSEL UNITED KINGDOM LABORATORIES LIMITED

SOFRADEX EAR/EYE DROPS EAR/EYE DROPS N/A ROUSSEL UNITED KINGDOM LABORATORIES LIMITED

SOFRAMYCIN EYE DROPS EYE DROPS 0.5% W/V ROUSSEL UNITED KINGDOM LABORATORIES LIMITED

SOFRAMYCIN EYE OINTMENT OINTMENT 0.55% W/W ROUSSEL UNITED KINGDOM 0.55% W/W LABORATORIES LIMITED

SOFRAMYCIN SKIN OINTMENT OINTMENT N/A ROUSSEL UNITED KINGDOM LABORATORIES LIMITED

SOFRA-TULLE PAD (DRESSING) 1.05% W/W ROUSSEL UNITED KINGDOM LABORATORIES LIMITED

SOFT CORN REMOVAL PADS PLASTER 12%W/W SCHOLL CONSUMER PRO- UNITED KINGDOM DUCTS

SOLAQUIN CREAM 2% ICN PHARMACEUTICALS UNITED STATES OF INC. AMERICA

SOLAQUIN FORTE CREAM 4% ICN PHARMACEUTICALS UNITED STATES OF INC. AMERICA

SOLAQUIN FORTE GEL 4% ICN PHARMACEUTICALS UNITED STATES OF INC. AMERICA 708 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SOLAQUIN FORTE 4% GEL N/A ICN PHARMACEUTICALS, UNITED STATES OF INC. AMERICA

SOLAQUIN FORTE 4% CREAM N/A ICN PHARMACEUTICALS UNITED STATES OF INC. AMERICA

SOLARCAINE CREAM N/A SCHERING-PLOUGH UNITED KINGDOM LIMITED

SOLARCAINE GEL GEL 0.5% W/W SCHERING-PLOUGH UNITED KINGDOM LIMITED

SOLARCAINE LOTION TOPICAL EMULSION N/A SCHERING-PLOUGH UNITED KINGDOM LIMITED

SOLARCAINE TOPICAL AEROSOL TOPICAL SPRAY N/A SCHERING-PLOUGH UNITED KINGDOM LIQUID SPRAY LIMITED

SOLCODERM SOLUTION SOL. FOR EXTERNAL N/A SOLCO BASLE LTD. SWITZERLAND APPL.

SOLCOGYN SOLUTION SOLUTION FOR CERVIX N/A SOLCO BASLE LTD. SWITZERLAND UTERI

SOLCOSERYL SOLUTION FOR IV 42.5MG/ML SOLCO BASLE LTD. SWITZERLAND INJECTION

SOLCOSERYL OINTMENT 2.07MG/G SOLCO BASLE LTD. SWITZERLAND

SOLCOSERYL DENTAL ADHESIVE ORAL AND GINGIVAL 2.125MG/G SOLCO BASLE LTD. SWITZERLAND PASTE PASTE

SOLCOSERYL JELLY GEL 4.15MG/G SOLCO BASLE LTD. SWITZERLAND

SOLCOTRICHOVAC POWDER FOR INJECTION 7×10(9) SOLCO BASLE LTD. SWITZERLAND

SOLEZE ANTISEPTIC CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM

SOLIAN 100MG SCORED TABLET 100MG SANOFI SYNTHELABO FRANCE

SOLIAN 400MG SCORED FILM-COATED 400MG SANOFI SYNTHELABO FRANCE TABLET

SOLOFALK SUPPOSITORIES 500MG DR.FALK PHARMA GMBH GERMANY

SOLONEX T-150 TABLET N/A MACLEODS INDIA PHARMACEUTICALS LTD

SOLONEX T-75 TABLET N/A MACLEODS INDIA

SOLONEX-100 TABLETS 100MG MACLEODS INDIA PHARMACEUTICALS LTD

SOLONEX-300 TABLET 300MG MACLEODS INDIA PHARMACEUTICALS LTD

SOLPADEINE CAPSULES CAPSULE N/A SMITHKLINE BEECHAM UNITED KINGDOM (SWG) LTD T/A SMITHK. BEECH. CONS. HLTHC.

SOLPADEINE SOLUBLE TABLETS TABLET FOR ORAL N/A SMITHKLINE BEECHAM UNITED KINGDOM SOLUTION (SWG) LIMITED

SOLPADEINE TABLETS TABLET N/A SMITHKLINE BEECHAM UNITED KINGDOM (SWG) LTD T/A STERLING HEALTH/SKB INTRNTL

SOLPAFLEX TABLETS COATED TABLET N/A SMITHKLINE BEECHAM UNITED KINGDOM INTERNATIONAL

SOLPRENE OPHTHALMIC DROPS N/A FARMIGEA SPA ITALY 23.9.2003 FR Journal officiel de l'Union européenne 709

Trade Name Dosage Form Dose MA Holder Country

SOLU CORTEF POWDER FOR SOL FOR 100MG/VIAL PHARMACIA & UPJOHN BELGIUM INJ N.V. / S.A.

SOLUDAMIN SINGLE DOSE ORAL 1G/SINGLE DOSE KLEVA LIMITED GREECE SOLUTION

SOLU-MEDROL SOLUTION FOR 500MG/VIAL PHARMACIA & UPJOHN BELGIUM INJECTION N.V. / S.A.

SOLU-MEDROL SOLUTION FOR 40MG/ML PHARMACIA & UPJOHN BELGIUM INJECTION N.V. / S.A.

SOLU-MEDROL SOLUTION FOR 125MG/2ML PHARMACIA & UPJOHN BELGIUM INJECTION N.V. / S.A.

SOLUTION INJ. DE CITRATE DE SOLUTION FOR 74 MBQ/ML CIS BIO INTERNATIONAL FRANCE GALLIUM 67 INJECTION

SOLUWAX EAR DROPS 0.5% W/V HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

SOLUZIONI PER DIALISI SOLN FOR PERITON. DIA- N/A BIEFFE MEDITAL S.P.A. ITALY PERITONEALE (FUN) LYS.

SOLVIN(BROMHEXINE ELIXIR) ELIXIR 4MG/5ML IPCA LABORATORIES INDIA LIMITED

SOMATOSTATINE UCB POWDER FOR INJECTION 3MG/ML U.C.B. S.A. BELGIUM

SOMATOSTATINE UCB LYOPHILISED FOR 250MCG UCB SA — SECTEUR BELGIUM INJECTION PHARMA

SOMATOSTATIN-UCB POWDER FOR INJECTION 250MCG UCB SA BELGIUM

SOMAZINA DROPS 10G/100ML FERRER SPAIN INTERNACIONAL, S.A.

SOMNITE SUSPENSION 2.5MG/5ML NORGINE LIMITED UNITED KINGDOM

SOMNUS COATED TABLET N/A CATHAY OF UNITED KINGDOM BOURNEMOUTH LTD

SONA B COMPLEX TABLETS N/A SONA NUTRITION LTD. IRELAND

SONA MULTIPLUS TABLETS N/A SONA NUTRITION LTD. IRELAND

SONATA HARD CAPSULES 5MG WYETH EUROPA LTD. UNITED KINGDOM

SONATA HARD CAPSULE 10MG WYETH EUROPA LTD. UNITED KINGDOM

SOOTHAKE GEL DENTAL GEL N/A J PICKLES & SONS UNITED KINGDOM

SOOTHAKE TOOTHACHE DENTAL SOLUTION N/A J PICKLES & SONS UNITED KINGDOM TINCTURE

SOOV BITE GEL N/A EGO PHARMACEUTICALS AUSTRALIA

SOOV BURN SPRAY AEROSOL N/A EGO PHARMACEUTICALS AUSTRALIA

SOOV CREAM CREAM N/A EGO PHARMACEUTICALS AUSTRALIA

SOTALOL TABLETS 80MG TABLETS 80MG MCDERMOTT IRELAND LABORATORIES LTD T/A GERARD LABORATORIES

SOTILEN CAPSULES 20MG MEDOCHEMIE LTD CYPRUS

SOTILEN 10MG CAPSULE 10MG MEDOCHEMIE LTD CYPRUS 710 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SPASMOMEN COATED TABLET 40MG A.MENARINI INDUSTRIE ITALY FARMACEUTICHE RIUNITE S.R.L.

SPASMONAL CAPSULES 60MG NORGINE LIMITED UNITED KINGDOM

SPASMONAL CAPSULES CAPSULES 60 MG NORGINE LIMITED UNITED KINGDOM

SPASMOPRIV CAPSULE 100MG POLIPHARM CO. LTD. THAILAND

SPECTRABAN ULTRA 28 LOTION N/A STIEFEL LABORATORIES IRELAND (SOLABAN A + B) (UK) LTD

SPERSACARPINE 1% EYE DROPS 1% W/V CIBA VISION AG SWITZERLAND

SPERSACARPINE 2% EYE DROPS 2% W/V CIBA VISION AG SWITZERLAND

SPERSACARPINE 2% EYE DROPS NA NOVARTIS SWITZERLAND OPHTHALMICS AG

SPERSADEX 0.1% EYE DROPS 1MG/ML CIBA VISION AG SWITZERLAND

SPERSADEX 0.1% EYE DROPS 1.00MG/ML NOVARTIS SWITZERLAND OPHTHALMICS AG

SPERSADEX COMP EYE DROPS NA NOVARTIS SWITZERLAND OPHTHALMICS AG

SPERSADEX COMP. EYE DROPS N/A CIBA VISION AG SWITZERLAND

SPERSALLERG EYE DROPS N/A CIBA VISION AG SWITZERLAND

SPERSALLERG EYE DROPS NA NOVARTIS SWITZERLAND OPHTHALMICS AG

SPERSALLERG SDU EYE DROPS N/A CIBA VISION AG SWITZERLAND

SPERSALLERG SDU EYE DROPS NA NOVARTIS SWITZERLAND OPHTHALMICS AG

SPERSANICOL EYE DROPS 5MG/ML CIBA VISION AG SWITZERLAND

SPERSANICOL EYE OINTMENT 10MG/G CIBA VISION AG SWITZERLAND

SPERSANICOL EYE DROPS 5.00MG/ML NOVARTIS SWITZERLAND OPHTHALMICS AG

SPERSANICOL EYE OINTMENT 10.00MG/G NOVARTIS SWITZERLAND OPHTHALMICS AG

SPIRACTIN 25 TABLETS 25MG ALPHAPHARM PTY AUSTRALIA LIMITED

SPIRIVA INHALATION POWDER, 18MCG BOEHRINGER INGELHEIM GERMANY CAPS. PHARMA

SPORANOX 100MG CAPSULE 100MG JANSSEN-CILAG N.V. BELGIUM

SPORANOX ORAL SOLUTION ORAL SOLUTION 10MG/ML JANSSEN-CILAG N.V. BELGIUM

SQUA-MED SHAMPOO N/A PERMAMED AG SWITZERLAND

ST JAMES' BALM OINTMENT N/A MEDICO-BIOLOGICAL UNITED KINGDOM LABS LTD

STABILISED CERETEC POWDER FOR INJECTION 0.5MG/VIAL NYCOMED AMERSHAM UNITED KINGDOM PLC

STABLON 12.5MG COATED TABLET 12.5MG LES LABORATOIRES FRANCE SERVIER 23.9.2003 FR Journal officiel de l'Union européenne 711

Trade Name Dosage Form Dose MA Holder Country

STADELANT TABLETS 20MG CHRISPA ALFA GREECE FARMAKEYTICI S.A.

STAMARIL SOLUTION FOR SC OR IM 1000LD50/0.5ML PASTEUR MERIEUX FRANCE USE

STAPHYLEX CAPSULES 250MG ALPHAPHARM PTY AUSTRALIA LIMITED

STAPHYLEX CAPSULES 500MG ALPHAPHARM PTY LTD AUSTRALIA

STAPHYLEX 250 CAPSULE 250MG ALPHAPHARM PTY AUSTRALIA LIMITED

STAPHYLEX 500 CAPSULE 500MG ALPHAPHARM PTY AUSTRALIA LIMITED

STAPHYLEXIN 250MG CAPSULE 250MG MEDOCHEMIE LTD CYPRUS

STARIL TABLETS 10MG BRISTOL-MYERS SQUIBB ITALY S.P.A

STARIL TABLETS 20MG BRISTOL-MYERS SQUIBB ITALY S.P.A

STARLIX FILM-COATED TABLETS 60MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

STARLIX FILM-COATED TABLETS 120MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

STARLIX FILM COATED TABLETS 60MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

STARLIX FILM-COATED TABLETS 120MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

STARLIX FILM COATED TABLETS 180MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

STARLIX FILM COATED TABLETS 60MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

STARLIX FILM COATED TABLETS 120MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

STARLIX FILM COATED TABLETS 180MG NOVARTIS EUROPHARM EUROPEAN COMMUNITY LIMITED

STAS HUSTENLOSER SAFT SOLUTION 15MG/5ML STADA OTC GERMANY ARZNEIMITTEL GMBH

STATICUM TABLET 5MG J.URIACH & CIA. S.A. SPAIN

STAVIN-30 CAPSULE 30MG OKASA PHARMA INDIA PVT.LTD-INDIA

STAVIN-40 CAPSULE 40MG OKAS PHARMA PVT- LTD -INDIA

STAVIR-40 CAPSULES 40MG CIPLA LTD INDIA

STEDON INJECTABLE SOLUTION 10MG/2ML ADELCO S.A. GREECE

STEDON TABLET 2MG ADELCO SA GREECE

STEDON TABLET 5MG ADELCO SA GREECE 712 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

STEDON INJ. SOLUTION 10MG/2ML ADELCO — GREECE CHROMATOURGIA ATHINON E. COLOCOTRONIS BROS S.A.

STELABID TABLET N/A SMITH KLINE & PAKISTAN BEECHAM

STELABID TABLETS TABLETS NA SMITHKLINE BEECHAM PAKISTAN

STELAZINE TABLET 1MG SMITH KLINE & PAKISTAN BEECHAM

STELAZINE TABLETS 1MG SMITHKLINE & BEECHAM PAKISTAN

STELAZINE SPANSULE CAPSULE MODIFIED RELEASE 2MG GOLDSHIELD UNITED KINGDOM 2MG CAPSULE PHARMACEUTICALS LTD

STELAZINE SPANSULE CAPSULES MODIFIED RELEASE 10MG GOLDSHIELD UNITED KINGDOM 10MG CAPSULE PHARMACEUTICALS LIMITED T/A GOLDSHIELD

STELAZINE SPANSULE CAPSULES MODIFIED RELEASE 15MG GOLDSHIELD UNITED KINGDOM 15MG CAPSULE PHARMACEUTICALS LTD

STELAZINE SPANSULE CAPSULES MODIFIED RELEASE 15MG GOLDSHIELD UNITED KINGDOM 15MG CAPSULE PHARMACEUTICALS LIMITED T/A GOLDSHIELD

STELAZINE SPANSULE CAPSULES MODIFIED RELEASE 2MG GOLDSHIELD UNITED KINGDOM 2MG CAPSULE PHARMACEUTICALS LIMITED T/A GOLDSHIELD

STELAZINE SYRUP SYRUP 1MG/5ML GOLDSHIELD UNITED KINGDOM PHARMACEUTICALS LIMITED T/A GOLDSHIELD

STELAZINE TABLETS 1MG COATED TABLET 1MG GOLDSHIELD UNITED KINGDOM PHARMACEUTICALS LTD

STELAZINE TABLETS 1MG COATED TABLET 1MG GOLDSHIELD UNITED KINGDOM PHARMACEUTICALS LIMITED T/A GOLDSHIELD

STELAZINE TABLETS 5MG COATED TABLET 5MG GOLDSHIELD UNITED KINGDOM PHARMACEUTICALS LTD

STELAZINE TABLETS 5MG COATED TABLET 5MG GOLDSHIELD UNITED KINGDOM PHARMACEUTICALS LIMITED T/A GOLDSHIELD

STEMETIL TABLET 5MG RHONE POULENC PAKISTAN

STEMETIL TABLET 5MG RHONE-POULENC-RORER PAKISTAN

STEMETIL INJECTION 1.25% W/V SOLUTION FOR 1.25% W/V CASTLEMEAD UNITED KINGDOM INJECTION HEALTHCARE LIMITED

STEMETIL INJECTION 1.25%W/V SOLUTION FOR 1.25%W/V CASTLEMEAD IRELAND INJECTION HEALTHCARE LTD

STEMETIL TABLES 25MG TABLET 25MG CASTLEMEAD UNITED KINGDOM HEALTHCARE LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 713

Trade Name Dosage Form Dose MA Holder Country

STEMETIL TABLETS TABLETS 5MG CASTLEMEAD IRELAND HEALTHCARE LTD

STEMETIL TABLETS TABLET 25MG CASTLEMEAD IRELAND HEALTHCARE LTD

STEMETIL TABLETS 5MG TABLET 5MG CASTLEMEAD UNITED KINGDOM HEALTHCARE LIMITED

STERETS NORMASOL TOPICAL SOLUTION 0.9% W/V SETON PREBBLES UNITED KINGDOM LIMITED

STERETS UNISEPT TOPICAL SOLUTION 0.25% V/V SETON PREBBLES UNITED KINGDOM LIMITED

STERIFLEX N0.5 SODIUM SOLUTION FOR IV 0.18% W/V FRESENIUS LIMITED UNITED KINGDOM CHLORIDE 0.18% INFUSION

STERIFLEX NO 10 DARR0W'S SOUTION FOR INJECTION N/A FRESENIUS LIMITED UNITED KINGDOM SOLUTION

STERIFLEX NO 11 HARTMANNS SOLUTION FOR N/A FRESENIUS LIMITED UNITED KINGDOM SOLUTION INJECTION

STERIFLEX NO 31 DEXTROSE IV SOLUTION FOR IV 20% W/V FRESENIUS LIMITED UNITED KINGDOM INFUSION 20% INFUSION

STERIFLEX NO 34 DEXTROSE IV SOLUTION FOR IV 50% W/V FRESENIUS LIMITED UNITED KINGDOM INFUSION BP INFUSION

STERIFLEX NO 42 SOLUTION FOR N/A FRESENIUS LIMITED UNITED KINGDOM INJECTIONS

STERIFLEX NO 45 SODIUM SOLUTION FOR N/A FRESENIUS LIMITED UNITED KINGDOM CHLORIDE AND DEXT. INJECTION

STERIFLEX NO 6 DEXTROSE IV INF. SOLUTION FOR IV 5% W/V FRESENIUS LIMITED UNITED KINGDOM 5% INFUSION

STERIFLEX NO 7 DEXTROSE 10% SOLUTION FOR IV 10%W/V FRESENIUS LIMITED UNITED KINGDOM INFUSION

STERIFLEX NO 9 RINGERS SOLUTION FOR N/A FRESENIUS LIMITED UNITED KINGDOM SOLUTION INJECTIONS

STERIFLEX NO.2 SODIUM SOLUTION FOR IV 0.45% W/V FRESENIUS LIMITED UNITED KINGDOM CHLORIDE 0.45% INFUSION

STERIFLEX NO1 SODIUM SOLUTION FOR IV 0.9% W/V FRESENIUS LIMITED UNITED KINGDOM CHLORIDE 0.9% INFUSION

STERIFLEX NO3 SODIUM SOLUTION FOR IV N/A FRESENIUS LIMITED UNITED KINGDOM CHLORIDE AND DEXTROSE INFUSION

STERILE CARDIOPLEGIA SOLUTION FOR N/A F.H. FAULDING & CO. LTD AUSTRALIA CONCENTRATE INJECTION (T/A DAVID BULL LABS)

STERILE DOBUTAMINE HCL SOLUTION FOR 250MG/20ML ANTIGEN IRELAND CONCENTRATE INJECTION PHARMACEUTICALS LIMI- TED

STERILE DOBUTAMINE SOLUTION FOR 250MG/IN 20ML ANTIGEN IRELAND HYDROCHLORIDE INJECTION PHARMACEUTICALS LIMITED

STERILE DOBUTAMINE SOLUTION FOR 250MG/20ML ANTIGEN IRELAND HYDROCHLORIDE CONC. INJECTION PHARMACEUTICALS LIMITED 714 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

STERILE DOPAMINE CONC. SOLUTION FOR 40MG/ML INTERNATIONAL UNITED KINGDOM SELECTAJET INJECTION MEDICATION SYSTEMS (UK) LIMITED

STERILE DOPAMINE SOLUTION FOR 200MG/5ML FAULDING UNITED KINGDOM CONCENTRATE 200MG/5ML INJECTION PHARMACEUTICALS PLC

STERILE DOPAMINE HCL SOLUTION FOR 200MG/5ML F.H. FAULDING & CO LTD AUSTRALIA INJECTION AMPOULE INJECTION (T/A DAVID BULL LABS)

STERILE SODIUM CHLORIDE CONCENTRATE FOR 30%W/V MACARTHYS LABS. UNITED KINGDOM CONC. BP 30%W/V INJECTION LIMITED T/A MARTINDALE PHARMACEUTICALS

STERILE WATER FOR INJECTION SOLUTION FOR NO ACTIVE ING. ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

STERILE WATER FOR INJECTION SOLUTION FOR NA ABBOTT LABORATORIES UNITED STATES OF USP INJECTION AMERICA

STERILE WATER FOR IRRIGATION SOLUTION FOR NO ACTIVE ING. ABBOTT LABORATORIES UNITED STATES OF USP IRRIGATION AMERICA

STERWIN REAL LEMON COLD POWDER FOR ORAL N/A SANOFI WINTHROP UNITED KINGDOM POWDERS SOLUTION LIMITED

STIEMYCIN 2% W/W TOPICAL SOLUTION 2% W/W STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

STIEVA-A CREAM 0.05% CREAM 0.05% THERAPEX INC. CANADA

STIEVA-A FORTE CREAM 0.1% CREAM 0.1% THERAPEX INC CANADA

STIEVAMYCIN GEL JELLY N/A STIEFEL CANADA INC CANADA

STILNOX 10MG FILM-COATED TABLET 10MG LABORATOIRES FRANCE SYNTHELABO

STIMOL ORAL SOLUTION IN 2G LABORATOIRES FRANCE SACHETS BIOCODEX

STIMOL ORAL SOLUTION 1G/10ML LABORATOIRES FRANCE BIOCODEX

STINGOSE PUMP SPRAY DISPENSER TOPICAL SOLUTION 20% W/V WELLVALUE LTD UNITED KINGDOM

STOCRIN ORAL SOLUTION 30MG/ML MERCK SHARP & DOHME EUROPEAN COMMUNITY LIMITED

STOCRIN 100MG HARD CAPSULES 100MG MERCK SHARP & DOHME EUROPEAN COMMUNITY LTD.

STOCRIN 200MG HARD CAPSULES 200MG MERCK SHARP & DOHME EUROPEAN COMMUNITY LTD.(UK)

STOCRIN 50MG HARD CAPSULES 50MG MERCK SHARP & DOHME EUROPEAN COMMUNITY LTD. (UK)

STREFEN LOZENGE NA CROOKES HEALTHCARE UNITED KINGDOM LIMITED

STREPSILS LOZENGE N/A KNOLL PAKISTAN

STREPSILS COUGH LOZENGES LOZENGE 2.5MG CROOKES HEALTHCARE UNITED KINGDOM LIMITED

STREPSILS HONEY AND LEMON LOZENGE N/A CROOKES HEALTHCARE UNITED KINGDOM LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 715

Trade Name Dosage Form Dose MA Holder Country

STREPSILS MENTHOL AND LOZENGE N/A CROOKES HEALTHCARE UNITED KINGDOM EUCALYPTUS LIMITED

STREPSILS ORIGINAL LOZENGE N/A CROOKES HEALTHCARE UNITED KINGDOM LIMITED

STREPSILS PAIN RELIEF PLUS LOZENGE N/A CROOKES HEALTHCARE UNITED KINGDOM LIMITED

STREPSILS PAIN RELIEF SPRAY OROMUCOSAL SPRAY 2% W/V CROOKES HEALTHCARE UNITED KINGDOM LIMITED

STREPSILS SUGAR FREE LOZENGES LOZENGE N/A CROOKES HEALTHCARE UNITED KINGDOM LIMITED

STREPSILS WITH HONEY AND LOZENGE N/A KNOLL PAKISTAN LEMON

STREPSILS WITH VITAMIN C LOZENGE N/A KNOLL PAKISTAN

STREPSILS WITH VITAMIN C LOZENGE N/A CROOKES HEALTHCARE UNITED KINGDOM 100MG LIMITED

STREPTASE 1,500,000 DRY SUBSTANCE FOR 15 — 18MG HOECHST MARION GERMANY INJECT. ROUSSEL DEUTSCHLAND GMBH

STREPTASE 250 000 UI POWDER FOR 250 000IU LABORATOIRES FRANCE INCECTABLE SOL HOECHST-HOUDE

STREPTASE 250,000 DRY SUBSTANCE FOR 2.5 — 3MG HOECHST MARION GERMANY INJECT. ROUSSEL DEUTSCHLAND GMBH

STREPTASE 750,000 DRY SUBSTANCE FOR 7.5 — 9MG HOECHST MARION GERMANY INJECT. ROUSSEL DEUTSCHLAND GMBH

STREPTOMYCIN SULPHATE POWDER FOR RECONSTI- 1G/VIAL EVANS MEDICAL LIMITED UNITED KINGDOM INJECTION BP TUTION

STRESAM CAPSULES 0.05G BIOCODEX FRANCE LABORATORIES

STRONG 15%W/V POTASSIUM INFUSION SOLUTION 15% W/V B.BRAUN MELSUNGEN GERMANY CHLORIDE SOL.73 CONCENT AG

STRONG CO-DANTHRAMER SUSPENSION N/A NAPP LABORATORIES UNITED KINGDOM SUSPENSION LIMITED

STRPTASE 750 000 UI POWDER FOR INJECTABLE 750 000IU LABORATOIRES FRANCE SOL HOECHST-HOUDE

STUD 100 DESENSITIZING SPRAY CUTANEOUS SPRAY, 9.6% W/W POUND INTERNATIONAL UNITED KINGDOM FOR MEN SOLUTION LTD

STUGERON TABLET 25MG JANSSEN PAKISTAN

STUGERON 25MG TABLET 25MG JANSSEN-CILAG N.V. BELGIUM

STUGERON FORTE CAPSULE 75MG JANSSEN-CILAG N.V. BELGIUM

SUBCUTANEOUS CALCIPARINE SOLUTION FOR 5000IU/0.2ML SANOFI-SYNTHELABO FRANCE SUBCUTANEOUS INJECTION

SUBUTEX 2MG SUBLINGUAL SUBLINGUAL TABLET 2MG SCHERING-PLOUGH UNITED KINGDOM TABLETS LIMITED

SUBUTEX 8MG SUBLINGUAL SUBLINGUAL TABLET 8MG SCHERING-PLOUGH UNITED KINGDOM TABLETS LIMITED 716 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SUCRALAN TABLET 1G LANNACHER HEIMITTEL AUSTRIA GMBH

SUCRALFATE TABLETS 1G TABLETS 1G NORTON HEALTHCARE UNITED KINGDOM LIMITED

SUCRANASE TABLETS 255MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

SUDAFED ELIXIR SYRUP 30MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LIMITED

SUDAFED TABLETS 60MG FILM COATED TABLETS 60MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

SUDOCREM ANTISEPTIC HEALING CREAM N/A TOSARA PRODUCTS (UK) UNITED KINGDOM CREAM LTD

SUFENTA 2ML AMPOULES INJECTABLE SOLUTION 0.01MG/2ML JANSSEN-CILAG N.V. BELGIUM

SULFADIAZIN-HEYL TABLETS 500MG HEYL CHEMISCH- GERMANY PHARMAZEUTISCHE FABRIK GMBH & CO. KG

SULFADOXINE + PYRIMETHAMINE TABLETS 500MG + 25MG PHARMAMED LTD. MALTA

SULFASALAZINE-HEYL GASTRO-RESISTANT F/C 500MG HEYL CHEMISCH- GERMANY TAB PHARMAZEUTISCHE FABRIK GMBH & CO KG

SULPHADIAZINE TABLETS BP TABLET 500MG CP PHARMACEUTICALS UNITED KINGDOM LTD

SULPHADIAZINE TABLETS BP TABLETS 500MG CP PHARMACEUTICALS UNITED KINGDOM 500MG LTD.

SULPHADIMIDINE BP 500MG TABLET 500MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

SULPHAKREAM-N CREAM N/A NABIQASIM PAKISTAN

SULPIREN 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

SULPIRIDE TABLETS 200MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

SULTRIN VAGINAL CREAM N/A JANSSEN-CILAG N.V. BELGIUM

SUPER WATE ON EMULSION ORAL EMULSION N/A D D D LIMITED UNITED KINGDOM

SUPPOSTE GLICER.S.PELLEGRINO SUPPOSITORY 2.72G SYNTHELABO S.P.A. ITALY

SUPPOSTE GLICER.S.PELLEGRINO SUPPOSITORY 1.36G SYNTHELABO S.P.A. ITALY

SUPRA-VIR CREAM 5%W/W TRIMA ISRAEL ISRAEL PHARMACEUTICAL PRODUCTS LTD

SUPRAVIRAN 200 TABLET 206.185MG GRUNENTHAL GMBH GERMANY

SUPRAVIRAN 250 POWDER FOR I.V. N/A GRUNENTHAL GMBH GERMANY INFUSION

SUPRAVIRAN 400 TABLET 412.37MG GRUNENTHAL GMBH GERMANY

SUPRAVIRAN 800 TABLETS 824.74MG GRUNENTHAL GMBH GERMANY

SUPRAVIRAN CREAM CREAM N/A GRUNENTHAL GMBH GERMANY 23.9.2003 FR Journal officiel de l'Union européenne 717

Trade Name Dosage Form Dose MA Holder Country

SUPREFACT 100MCG (1MG/ML) NASAL SOLUTION 1MG/ML LABORATOIRES AVENTIS FRANCE

SURAFEM PULVULES 20MG ELI LILLY AND COMPANY UNITED STATES OF AMERICA

SURELAX HERBAL TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM T/A ENGLISH GRAINS HEALTHCARE

SURGAM 200MG TABLET 200MG LABORATOIRES AVENTIS FRANCE

SURGAM 300MG SUPPOSITORY 300MG LABORATOIRES FRANCE ROUSSEL

SURGAM SA CAPSULES 300MG MODIFIED RELEASE CAP- 300MG ROUSSEL UNITED KINGDOM SULE LABORATORIES LIMITED

SURGAM TABLETS 300MG TABLET 300MG ROUSSEL UNITED KINGDOM LABORATORIES LIMITED

SURGICAL SPIRIT BP TOPICAL SOLUTION 95% V/V WILLIAM RANSOM & UNITED KINGDOM SON PLC

SURGICAL SPIRIT BP TOPICAL SOLUTION N/A LCM LTD UNITED KINGDOM

SURGICAL SPIRIT BP TOPICAL SOLUTION NA LCM LIMITED UNITED KINGDOM

SURMONTIL COATED TABLET 10MG FUTUNA LIMITED UNITED KINGDOM

SURMONTIL COATED TABLETS 25MG FUTUNA LIMITED UNITED KINGDOM

SURMONTIL CAPSULES 50MG FUTUNA LIMITED UNITED KINGDOM

SURMONTIL 10MG TABLETS COATED TABLET 10MG FUTUNA LIMITED UNITED KINGDOM

SURMONTIL CAPSULES 50MG CAPSULE 50MG FUTUNA LIMITED UNITED KINGDOM

SURMONTIL TABLETS 25MG COATED TABLET 25MG FUTUNA LIMITED UNITED KINGDOM

SURVANTA SUSP.ENDOTRACHEOPLM. 25MG/ML ABBOTT LABORATORIES UNITED KINGDOM INSTI LIMITED

SURVANTA (BERACTANT) INTRATRACHEAL 25MG/ML ABBOTT LABORATORIES UNITED STATES OF SUSPENSION AMERICA

SURVIVE 10MG TABLETS 10MG WERRICK PAKISTAN

SUSSEX PHARMACEUTICAL COLD CAPSULE N/A SUSSEX UNITED KINGDOM RELIEF CAPS. PHARMACEUTICAL LIMITED

SUSSEX PHARMACEUTICAL HOT POWDER N/A SUSSEX UNITED KINGDOM LEMON PHARMACEUTICAL LIMITED

SUSTAC TABLETS 2.6MG PHARMAX LIMITED UNITED KINGDOM

SUSTAC MODIFIED RELEASE 6.4MG PHARMAX LIMITED UNITED KINGDOM TABLETS

SUSTAC SLOW RELEASE TABLETS 2.6MG PHARMAX LIMITED UNITED KINGDOM

SUSTANON SOLUTION FOR SEE INGREDIENTS ORGANON UNITED KINGDOM INJECTION LABORATORIES LTD.

SUSTANON 100 INJECTION SOLUTION FOR N/A ORGANON UNITED KINGDOM INJECTION LABORATORIES LIMITED 718 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

SUSTANON 250 INJECTION SOLUTION FOR N/A ORGANON UNITED KINGDOM INJECTION LABORATORIES LIMITED

SWARM CREAM CREAM N/A J PICKLES & SONS UNITED KINGDOM

SYMBICORT MITE TURBUHALER INHALATION POWDER N/A DRACO LAKEMEDEL AB SWEDEN

SYMBICORT TURBUHALER INHALATION POWDER N/A DRACO LAKEMEDEL AB SWEDEN

SYNACTHEN DEPOT AQUEOUS INJECTABLE 1MG/ML NOVARTIS PHARMA SWITZERLAND SUSP. SCHWEIZ AG

SYNAGIS POWDER AND SOLVENT 50MG ABBOTT LABORATORIES EUROPEAN COMMUNITY F/SOLUTION F/INJECTION LIMITED

SYNAGIS POWDER AND SOLVENT 100MG ABBOTT LABORATORIES EUROPEAN COMMUNITY F/SOLUTION F/INJECTION LIMITED

SYNALAR GEL 0.025% W/W ZENECA LIMITED UNITED KINGDOM

SYNALAR CREAM 0.025% W/W ZENECA LIMITED UNITED KINGDOM

SYNALAR OINTMENT 0.025% W/W ZENECA LIMITED UNITED KINGDOM

SYNALAR 1 IN 4 CREAM 0.00625%W/W ZENECA LIMITED UNITED KINGDOM

SYNALAR C CREAM CREAM N/A BIOGLAN UNITED KINGDOM LABORATORIES LTD

SYNALAR C OINTMENT OINTMENT N/A BIOGLAN UNITED KINGDOM LABORATORIES LTD

SYNALAR CREAM CREAM 0.025% W/W BIOGLAN UNITED KINGDOM LABORATORIES LTD

SYNALAR CREAM 1/10 DILUTION CREAM 0.0025% W / W BIOGLAN UNITED KINGDOM LABORATORIES LTD

SYNALAR CREAM 1/4 DILUTION CREAM 0.006% W / W BIOGLAN UNITED KINGDOM LABORATORIES LTD

SYNALAR GEL GEL 0.025% W / W BIOGLAN UNITED KINGDOM LABORATORIES LTD

SYNALAR N CREAM N/A ZENECA LIMITED UNITED KINGDOM

SYNALAR N OINTMENT N/A ZENECA LIMITED UNITED KINGDOM

SYNALAR N CREAM CREAM N/A BIOGLAN UNITED KINGDOM LABORATORIES LTD

SYNALAR N OINTMENT OINTMENT N/A BIOGLAN UNITED KINGDOM LABORATORIES LTD

SYNALAR OINTMENT 0.025% W/W OINTMENT 0.025% W / W BIOGLAN UNITED KINGDOM LABORATORIES LTD

SYNALAR OINTMENT OINTMENT 0.006% W/W BIOGLAN UNITED KINGDOM 1/4 DILUTION LABORATORIES LTD

SYNALGO TABLETS 680MG GEYMONAT SPA ITALY

SYNAREL NASAL SPRAY 2MG/ML MONSANTO PLC T/A UNITED KINGDOM SEARLE

SYNAREL NASAL SPRAY 0.2%W/V MONSANTO PLC T/A UNITED KINGDOM SEARLE

SYNCLAR-250 TABLET 250MG CIPLA LIMITED INDIA

SYNDOL TABLET N/A MARION MERRELL LTD UNITED KINGDOM 23.9.2003 FR Journal officiel de l'Union européenne 719

Trade Name Dosage Form Dose MA Holder Country

SYNDOL CAPLETS TABLET NA SETON PRODUCTS UNITED KINGDOM LIMITED

SYNPHASE TABLET N/A MONSANTO PLC T/A UNITED KINGDOM SEARLE

SYNTOCINON SOLUTION FOR 10IU/ML NOVARTIS PHARMA SWITZERLAND INJECTION SCHWEIZ AG

SYNTOCINON SOLUTION FOR 10IU NOVARTIS SPAIN INJECTION FARMACEUTICA S.A

SYNTOMETRINE SOLUTION FOR N/A NOVARTIS PHARMA SWITZERLAND INJECTION SCHWEIZ AG

SYNTOMETRINE SOLUTION FOR NA NOVARTIS IRELAND INJECTION PHARMACEUTICALS UK LIMITED

SYNTOMYCIN 250MG CAPSULE 250MG CODAL SYNTO LTD CYPRUS

SYNTONOL 40MG TABLET 40MG CODAL SYNTO LTD CYPRUS

SYREA CAPSULE 500MG MEDAC GMBH GERMANY

SYSCOR CC MODIFIED RELEASE 10MG BAYER PLC UNITED KINGDOM TABLETS

SYSTEN 50 (EVOREL) PATCH 3.2MG JANSSEN-CILAG AG SWITZERLAND

SYSTRAL CREAM N/A ASTA MEDICA GERMANY

SYTRON 27.5MG IRON PER 5ML ORAL SOLUTION 190MG/5ML LINK PHARMACEUTICALS UNITED KINGDOM LIMITED

T & C SHAMPOO LOTION N/A HOE PHARMACEUTICALS MALAYSIA SDN. BHD.

TAB. AMLODIPINE BESYLATE TABLETS 5MG MACLEODS INDIA

TABROGYL TABLET 200MG TABROS PAKISTAN

TADENAN 50MG CAPSULE 50MG LABORATOIRES DEBAT FRANCE

TAGAMET INJECTABLE SOLUTION 200MG/2ML VIANEX S.A GREECE

TAGAMET TABLET 200MG SMITH KLINE & PAKISTAN BEECHAM

TAGAMET 400 TABLET 400MG SMITH KLINE & PAKISTAN BEECHAM

TAGAMET 400MG TABLETS COATED TABLET 400MG SMITHKLINE & FRENCH UNITED KINGDOM LABORATORIES LIMITED

TAGAMET INJECTION 200MG/2ML SOLUTION FOR 200MG/2ML SMITHKLINE & FRENCH UNITED KINGDOM INJECTION LABORATORIES LIMITED

TAGAMET SYRUP 4% W/V ORAL SOLUTION 4% W/V SMITHKLINE & FRENCH UNITED KINGDOM LABORATORIES LIMITED

TAGAMET TABLETS 200MG COATED TABLET 200MG SMITHKLINE & FRENCH UNITED KINGDOM LABORATORIES LIMITED

TAGAMET TABLETS 800MG COATED TABLET 800MG SMITHKLINE & FRENCH UNITED KINGDOM LABORATORIES LIMITED

TALCO MENTOLATO CUTANEOUS POWDER 125G LABORATORIO CHIMICO ITALY FARMACEUTICO A. SELLA S.R.L 720 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TAMAGON FORTE TABLET 120MG MEDOCHEMIE LTD CYPRUS

TAMBOCOR TABLET 100MG 3M HEALTH CARE UNITED KINGDOM LIMITED

TAMBOCOR TABLETS 100 MG 3 M HEALTH CARE UNITED KINGDOM LIMITED

TAMIFEN 10MG TABLET 10MG MEDOCHEMIE LTD CYPRUS

TAMIFEN DS TABLET 20MG MEDOCHEMIE LTD CYPRUS

TAMIFLU CAPSULE 75MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

TAMOFEN TABLET 10MG LEIRAS PAKISTAN

TAMOFEN TABLET 25MG LEIRAS PAKISTAN

TAMOFEN 20MG TABLETS 20MG LEIRAS OY FINLAND

TAMOXIFEN TABLETS 10MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

TAMOXIFEN TABLETS 20MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

TAMOXIFEN TABLETS 40MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

TAMOXIFEN TABLETS 10MG,20MG DOUGLAS NEW ZEALAND PHARMACEUTICALS LTD

TAMOXIFEN 10MG TABLET 10MG CODAL SYNTO LTD CYPRUS

TAMOXIFEN CITRATE TABLETS BP TABLETS 20MG GENERICS (UK) LTD. UNITED KINGDOM

TAMOXIFEN TABLETS BP 10MG TABLETS 10MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

TAMOXIFEN TABLETS BP 10MG COATED TABLET 10 MG CP PHARMACEUTICALS UNITED KINGDOM LTD

TAMOXIFEN TABLETS BP 20MG TABLETS 20MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

TAMOXIFEN TABLETS BP 20MG TABLET 20MG CP PHARMACEUTICALS UNITED KINGDOM LTD

TAMOXIFEN TABLETS BP 40MG TABLETS 40MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

TAMPOVAGAN PESSARY N/A CO-PHARMA LIMITED UNITED KINGDOM

TANTUM ACTIV GOLA, COLLUTTORIO 0.25% AZ. CHIM. RIUN. ITALY COLLUTORIO ANGELINI FRANCESCO ACRAF SPA — ITALY

TANTUM VERDE DENTAL PASTA DENTIFRICIA NA AZ. CHIM. RIUN. ITALY ANGELINI FRANCESCO ACRAF SPA — ITALY

TANTUM VERDE P, PASTIGLIA PASTIGLIA 3MG AZ. CHIM. RIUN. ITALY ANGELINI FRANCESCO ACRAF SPA — ITALY

TANTUM VERDE, COLLUTTORIO COLLUTTORIO 120ML NA AZ. CHIM. RIUN. ITALY 120ML ANGELINI FRANCESCO ACRAF SPA — ITALY 23.9.2003 FR Journal officiel de l'Union européenne 721

Trade Name Dosage Form Dose MA Holder Country

TANTUM VERDE, COLLUTTORIO COLLUTTORIO 240ML NA AZ. CHIM. RIUN. ITALY 240ML ANGELINI FRANCESCO ACRAF SPA — ITALY

TARGET GEL GEL 3% W/W CYANAMID UNITED KINGDOM

TARGOCID 200MG POWDER FOR INJECTION 200MG LABORATOIRES MARION FRANCE MERRELL DOW S.A.

TARGOSID POWDER FOR IM 200MG GRUPPO LEPETIT SPA ITALY INJECTION

TAROCTYL TABLETS 25MG TARO ISRAEL PHARMACEUTICAL INDUSTRIES LTD.

TAROCTYL INJECTION SOLUTION FOR 50MG/2ML TARO ISRAEL INJECTION PHARMACEUTICAL INDUSTRIES LTD.

TAROCTYL INJECTION 50MG/2ML SOLUTION FOR 25MG/ML TARO ISRAEL INJECTION PHARMACEUTICAL INDUSTRIES LTD

TARODENT MOUTHWASH MOUTHWASH 0.2% W/V TARO ISRAEL PHARMACEUTICAL INDUSTRIES LTD.

TAVANIC 250MG COATED TABLET 250MG LABORATOIRES AVENTIS FRANCE

TAVANIC 500MG COATED TABLET 500MG LABORATOIRES AVENTIS FRANCE

TAVANIC 5MG/ML SOLUTION FOR INFUSION 5MG/ML LABORATOIRES FRANCE ROUSSEL DIAMANT

TAVER 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

TAXOL INJECTABLE SOLUTION 30MG/5ML BRISTOL-MYERS SQUIBB ESTONIA EESTI AS

TAXOL SOLN. FOR I.V INFUSION 30MG/5ML BRISTOL MYERS SQUIBB ITALY S.P.A

TAXOTERE CONCENTRATE FOR INFU- 20MG/0.5ML RHONE-POULENC EUROPEAN COMMUNITY SION RORER(FRANCE)

TAXOTERE CONCENTRATE FOR INFU- 80MG/2ML RHONE-POULENC EUROPEAN COMMUNITY SION RORER(FRANCE)

TAXOTERE (DOCETAXEL) 20MG CONCENTRATE FOR INFU- N/A RHONE-POULENC RORER FRANCE SION S.A.

TAXOTERE (DOCETAXEL) 80MG CONCENTRATE FOR INFU- N/A RHONE-POULENC RORER FRANCE SION S.A.

TAZOCIN POWDER FOR INJECTION 2.25G CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD

TAZOCIN POWDER FOR INJECTION 4.5G CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD

TAZOCIN INJ. 2.25G POWDER FOR INJECTION N/A CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD.

TAZOCIN INJ. 4.5G POWDER FOR INJECTION N/A CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD.

TCK 1 KIT SOLUTION FOR N/A CIS BIO INTERNATIONAL FRANCE INJECTION

TCK-7 KIT POWDER FOR INJECTION N/A CIS BIO INTERNATIONAL FRANCE 722 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TCP LIQUID ANTISEPTIC LIQUID ANTISEPTIC N/A UNICLIFFE LIMITED T/A UNITED KINGDOM PFIZER CONSUMER HEALTHCARE

TCP FIRST AID ANTISEPTIC CREAM CREAM N/A PFIZER LIMITED UNITED KINGDOM

TCP OINTMENT OINTMENT N/A UNICLIFFE LIMITED T/A UNITED KINGDOM PFIZER CONSUMER HEALTHCARE

TCP SORE THROAT LOZENGES LOZENGE N/A UNICLIFFE LIMITED T/A UNITED KINGDOM PFIZER CONSUMER HEALTHCARE

TD-PUR SUSPENSION FOR NA CHIRON BEHRING GMBH GERMANY INJECTION & CO.

TEARS NATURALE FORTE LUBRICANT EYE DROPS N/A ALCON LABORATORIES UNITED STATES OF INC AMERICA

TEARS NATURALE II/ADEQUAD EYE DROPS N/A S.A. ALCON-COUVREUR BELGIUM N.V.

TEE TREE AND WITCH HAZEL CREAM N/A GR LANE HEALTH UNITED KINGDOM CREAM PRODUCTS LIMITED

TEEJEL GEL GEL N/A MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

TEFAMIN SUPPOSITORY 360MG RECORDATI INDUSTRIA ITALY CHIMICA FARMACEUTICA S.P.A.

TEFAMIN COATED TABLET 200MG RECORDATI INDUSTRIA ITALY CHIMICA FARMACEUTICA S.P.A.

TEGRAL TABLET 200MG NOVARTIS PAKISTAN

TEGRETOL TABLETS 200MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

TEGRETOL TABLET 200MG GEIGY PAKISTAN

TEGRETOL SYRUP 100MG/5ML NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

TEGRETOL SYRUP 20MG/ML NOVARTIS FARMA — PORTUGAL PRODUTOS FARMACEUTICOS S.A.

TEGRETOL DRINKABLE SUSPENSION 100MG/5ML NOVARTIS PHARMA S.A. FRANCE

TEGRETOL TABLETS 200MG NOVARTIS FARMA — PORTUGAL PRODUTOS FARMACEUTICOS S.A.

TEGRETOL TABLETS 200MG NOVARTIS FARMA SPA ITALY

TEGRETOL CR S.R. FILM COATED 200MG NOVARTIS PHARMA SWITZERLAND TABLETS SCHWEIZ AG

TEGRETOL CR S.R. FILM COATED TABLET 400MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

TEGRETOL CR DIVISIBLE TABLETS 400MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

TEGRETOL CR PROLONGED RELEASE 200MG NOVARTIS FARMA — PORTUGAL TABLETS PRODUTOS FARMACEUTICOS S.A. 23.9.2003 FR Journal officiel de l'Union européenne 723

Trade Name Dosage Form Dose MA Holder Country

TEGRETOL CR PROLONGED RELEASE 200MG NOVARTIS FARMA SPA ITALY TABLETS

TEGRETOL CR PROLONGED RELEASE 400MG NOVARTIS FARMA SPA ITALY TABLETS

TEGRETOL SYRUP SYRUP 100MG/5ML NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

TELAMENT PAEDIATRIC DROPS LIQUID 50MG/100ML ADCOCK INGRAM LTD SOUTH AFRICA

TELFAST 120MG COATED TABLET 120MG LABORATOIRES MARION FRANCE MERRELL S.A

TELFAST 120MG TABLET 120MG HOECHST MARION PAKISTAN ROUSSEL

TELFAST 180MG COATED TABLET 180MG LABORATOIRES MARION FRANCE MERRELL S.A.

TELFAST 180MG TABLET 180MG HOECHST MARION PAKISTAN ROUSSEL

TEMAZEPAM TABLETS 10MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

TEMAZEPAM TABLETS 20MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

TEMAZEPAM TABLETS 10MG TABLETS 10MG GENERICS (UK) LIMITED UNITED KINGDOM

TEMODAL CAPSULE 5MG SCHERING UNITED STATES OF CORPORATION AMERICA

TEMODAL CAPSULE 20MG SCHERING UNITED STATES OF CORPORATION AMERICA

TEMODAL CAPSULE 100MG SCHERING UNITED STATES OF CORPORATION AMERICA

TEMODAL CAPSULE 250MG SCHERING UNITED STATES OF CORPORATION AMERICA

TENOLOL (ATENOLOL TABLETS BP) TABLET 100MG IPCA LABORATORIES INDIA LIMITED

TENOMET 200 TABLETS 200MG REMEDICA LTD CYPRUS

TENORET TABLETS N/A ZENECA LIMITED UNITED KINGDOM

TENORETIC TABLETS N/A ZENECA LIMITED UNITED KINGDOM

TENORMIN TABLET 25MG ZENECA LIMITED UNITED KINGDOM

TENORMIN COATED TABLET 50MG ZENECA LIMITED UNITED KINGDOM

TENORMIN COATED TABLETS 100MG ZENECA LIMITED UNITED KINGDOM

TENORMIN SOLUTION FOR 0.05%W/V ZENECA LIMITED UNITED KINGDOM INJECTIONS

TENORMIN 100MG TABLET 100MG ICI PAKISTAN

TENORMIN 25MG TABLETS 25MG ICI PAKISTAN

TENORMIN 25MG TABLETS FILM COATED TABLET 25MG ZENECA LIMITED UNITED KINGDOM

TENORMIN 50MG TABLET 50MG ICI PAKISTAN

TENORMIN TABLETS 100MG COATED TABLET 100MG ZENECA LIMITED UNITED KINGDOM 724 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TERACYCLINE BP 250MG TABLET 250MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

TERFENADINE TABLETS 60MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

TERIL 200MG TABLETS TABLET 200MG TARO ISRAEL PHARMACEUTICAL INDUSTRIES LTD

TERNOLOL FILM-COATED TABLET 100MG HOVID SDN BHD MALAYSIA

TERRA-CORTIL OINTMENT N/A PFIZER LIMITED UNITED KINGDOM

TERRA-CORTRIL NYSTATIN CREAM N/A PFIZER LIMITED UNITED KINGDOM

TERRAMYCIN CAPSULES 250MG PFIZER LIMITED UNITED KINGDOM

TERRAMYCIN TABLET 250MG PFIZER LIMITED UNITED KINGDOM

TERRAMYCIN + POLYMYXIN B OPHTALMIC OINTMENT N/A PFIZER SA BELGIUM

TERRAMYCIN+POLYMYXIN B TOPICAL OINTMENT N/A PFIZER SA BELGIUM

TESTOSTERONE IMPLANT 100MG IMPLANT (SUB-CUTAN. 100MG ORGANON UNITED KINGDOM USE) LABORATORIES LIMITED

TESTOVIRON DEPOT 250 SOLUTION FOR 250MG SCHERING HEALTH CARE UNITED KINGDOM INJECTION LIMITED

TESTOVIRON-DEPOT-250 OILY SOLN. FOR IM INJEC. 250MG/ML SCHERING AG GERMANY

TETANUS ANTITOXIN B.P. 1500IU SOLUTION FOR 1500IU M/S SERUM INSTITUTE OF INDIA INJECTION INDIA LIMITED

TETANUS TOXOID VACCINE SOLUTION FOR =>40IU M/S SERUM INSTITUTE OF INDIA ADSORBED INJECTION INDIA LIMITED

TETANUS VACCINE (ADSORBED) SOLUTION FOR N/A EVANS MEDICAL UNITED KINGDOM INJECTION LIMITED

TETAVAX SUSP F INJ PREFILLED SYR 40IU/0.5ML AVENTIS PASTEUR S.A FRANCE

TETAVAX SUSP F INJ IN VIAL 40IU/0.5ML AVENTIS PASTEUR S.A FRANCE

TETAVAX ADSORBED INJECTABLE SUSPENSION 40IU/VACCINE PASTEUR MERIEUX FRANCE ANTI-TETANUS VACCINE

TETMOSOL SOAP 5% W/W ZENECA LIMITED UNITED KINGDOM

TETRACOQ INJECTABLE SUSPENSION N/A PASTEUR MERIEUX FRANCE

TETRACT HIB SUSPENSION FOR N/A PASTEUR MERIEUX FRANCE INJECTION

TETRACYCLINE 250 CAPSULES 250MG AEGIS LTD. CYPRUS

TETRACYCLINE BP 250MG CAPSULE 250MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

TETRADAR HYDROCHLORIDE 250 CAPSULE 250MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO. LTD

TETRALYSAL 150 CAPSULES CAPSULES 150MG GALDERMA (UK) LIMITED UNITED KINGDOM

TETRALYSAL 300 CAPSULE 300MG GALDERMA (UK) LIMITED UNITED KINGDOM 23.9.2003 FR Journal officiel de l'Union européenne 725

Trade Name Dosage Form Dose MA Holder Country

TETRAMIL OPHTHALMIC DROPS N/A FARMIGEA SPA ITALY

TETSEPT THROAT PASTILLES PASTILLES N/A MERZ+CO. GMBH & CO. GERMANY FORTE

TEVETEN 400 FILM COATED TABLET 400MG SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

TEVETEN 600 FILM COATED TABLET 600MG SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

THALAMONAL 2ML AMPOULE N/A JANSSEN-CILAG N.V. BELGIUM

THALLOUS CHLORIDE (201TL) SOLUTION FOR N/A NYCOMED AMERSHAM UNITED KINGDOM 37MB/ML INJECTIONS PLC

THELMOX 100 TABLETS 100MG REMEDICA LTD CYPRUS

THELMOX 500 TABLETS 500MG REMEDICA LTD CYPRUS

THEO DUR TABLET 300MG RECORDATI INDUSTRIA ITALY CHIMICA FARMACEUTICA S.P.A.

THEO DUR TABLET 200MG RECORDATI INDUSTRIA ITALY CHIMICA FARMACEUTICA S.P.A.

THEO DUR MODIFIED RELEASE 200MG RECORDATI INDUSTRIA ITALY TABLET CHIMICA FARMACEUTICA S.P.A.

THEO DUR MODIFIED RELEASE 300MG RECORDATI INDUSTRIA ITALY TABLET CHIMICA FARMACEUTICA S.P.A.

THERACAP 131TM CAPSULE N/A NYCOMED AMERSHAM UNITED KINGDOM PLC

THIAMINE SOLUTION FOR 100MG/2ML PHARMAMED MALTA INJECTION PARENTERALS LTD.

THIAMINE HYDROCHLORIDE TABLET 50MG PHARMAMED LTD. MALTA

THIOBACTIN COATED TABLET 250MG SANOFI WINTHROP FRANCE

THIOBACTIN 750MG/5ML SOLUTION FOR 750MG/5ML SANOFI WINTHROP FRANCE INJECTION

THIORIDAZINE 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

THYMOGLOBULINE 5MG/ML INJECTABLE 5MG/ML IMTIX-SANGSTAT FRANCE PREPARATION

THYMOL GLYCERIN COMPOUND DENTAL SOLUTION N/A LCM LTD UNITED KINGDOM BP

THYROX TABLETS 0.1MG MACLEODS INDIA PHARMACEUTICALS LTD

THYROXIN 100MCG TABLETS TABLETS 100MCG FORLEY GENERICS LTD. UNITED KINGDOM

THYROXIN 50MCG TABLETS TABLETS 50MCG FORLEY GENERICS LTD UNITED KINGDOM

THYROXINE 100 MCG TABLETS 100 MCG GOLDSHIELD GROUP PLC UNITED KINGDOM T/A GOLDSHIELD PHAR- MACEUTICALS

THYROXINE 100MCG TABLET 100MCG GOLDSHIELD GROUP PLC UNITED KINGDOM

THYROXINE 50MCG TABLET 50MCG GOLDSHIELD GROUP PLC UNITED KINGDOM 726 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

THYROXINE TABLETS TABLET 25MCG CP PHARMACEUTICALS UNITED KINGDOM LTD

THYROXINE TABLETS 100MCG TABLETS 100MCG APPROVED UNITED KINGDOM PRESCRIPTION SERVICES LIMITED

THYROXINE TABLETS 50MCG BP TABLETS 50MCG APPROVED UNITED KINGDOM PRESCRIPTION SERVICES LIMITED

THYROXINE TABLETS BP 25 TABLETS 25MCG CP PHARMACEUTICALS UNITED KINGDOM MICROGRAMS LTD.

THYROXINE TABLETS BP 50MCG TABLETS 50MCG MEDEVA PHARMA UNITED KINGDOM LIMITED

TICEVIS TABLETS 10MG MEDOCHEMIE LTD. CYPRUS

TICLID 250MG FILM-COATED TABLET 250MG SANOFI WINTHROP FRANCE

TIENAM 500MG POWDER FOR INFUSION 500MG MERCK SHARP & DOHME FRANCE CHIBRET

TIENAM I.V. 250MG STERILE POWDER FOR 250MG MERCK SHARP & DOHME NETHERLANDS INJECT B.V.

TIGER BALM RED OINTMENT N/A HAW PAR HEALTHCARE SINGAPORE LTD

TIGER BALM WHITE OINTMENT N/A HAW PAR HEALTHCARE SINGAPORE LTD

TIGER LINIMENT TOPICAL SOLUTION N/A HAW PAR HEALTHCARE SINGAPORE LTD

TIGER MUSCLE RUB CREAM CREAM N/A HAW PAR HEALTHCARE SINGAPORE LTD

TILADE OR TILADE SYNCRONER MET. DOSE PRESS. AERO- 2MG/ACTUATION FISONS LIMITED T/A UNITED KINGDOM SOL RHONE-POULENC RORER

TILADE OR TILADE SYNCRONER AERSOL 2.0MG/ACTUATION FISONS LTDT/A RHONE- UNITED KINGDOM POULENC RORER

TILADE PLAIN MET. DOSE PRESS. AERO- 2MG/ACTUATION FISONS PLC — UNITED KINGDOM SOL PHARMACEUTICAL DIVI- SION

TILDIEM 100MG POWDER FOR INJECTABLE 100MG/VIAL LABORATOIRES FRANCE SOL SYNTHELABO

TILDIEM 25MG POWDER FOR INJECTABLE 25MG/VIAL LABORATOIRES FRANCE SOL SYNTHELABO

TILDIEM 60MG TABLET 60MG LABORATOIRES FRANCE SYNTHELABO

TILIDON FILM COATED TABLET 10MG PT INTERBAT INDONESIA

TILIDON SYRUP 5MG/5ML PT INTERBAT INDONESIA

TILIDON FILM-COATED TABLET 10MG PT INTERBAT INDONESIA

TILIDON SYRUP SYRUP 60MG PT INTERBAT INDONESIA

TIMABAK 0.25% COLLYRE (5ML) EYEDROPS 0.25% LABORATOIRES THEA FRANCE

TIMABAK 0.50% COLLYRE (5ML) EYE DROPS 0.50% LABORATOIRES THEA FRANCE

TIMENTIN 0.8G POWDER FOR INFUSION N/A BEECHAM GROUP PLC UNITED KINGDOM 23.9.2003 FR Journal officiel de l'Union européenne 727

Trade Name Dosage Form Dose MA Holder Country

TIMENTIN 1.6G POWDER FOR INFUSION N/A BEECHAM GROUP PLC UNITED KINGDOM

TIMENTIN INJECTION 3.2G POWDER FOR INFUSION N/A BEECHAM GROUP PLC UNITED KINGDOM

TIMET 200 TABLETS 200MG AEGIS LTD. CYPRUS

TIMET 400 TABLETS 400MG AEGIS LTD. CYPRUS

TIMO-COMOD 0.5% EYE DROPS 0.5% W/V URSAPHARM GERMANY ARZNEIMITTEL GMBH

TIMOLOL EYE DROPS 0.5% W/W PL 00156/0033 UNITED KINGDOM

TIMOLOL EYE DROPS EYE DROPS 0.25% W/W NORTON HEALTHCARE UNITED KINGDOM LIMITED

TIMOLOL EYE DROPS EYE DROPS 0.5%W/V NORTON HEALTHCARE UNITED KINGDOM LIMITED

TIMOLOL MALEATE 0.25% EYE DROPS SOLUTION 0,25% EGYPTIAN EGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO (EIPICO)

TIMOLOL MALEATE 0.5% EYE DROPS 0.5% EGYPTIAN EGYPT INTERNATIONAL PHARMACEUTICAL INDUSTRIES CO (EIPICO)

TIMOLOL-POS EYE DROPS 0.5% URSAPHARM GERMANY ARZNEIMITTEL GMBH

TIMOPTOL 0.25% DPS EYE DROPS 0.25% W/V MERCK SHARP & DOHME NETHERLANDS B.V.

TIMOPTOL 0.50% DPS EYE DROPS 0.50% W/V MERCK SHARP & DOHME NETHERLANDS B.V.

TIMOPTOL-XE 0.25% DPS EYE DROPS 0.25% W/V MERCK SHARP & DOHME NETHERLANDS B.V.

TIMOSOL EYE DROPS 0.5%W/W SEHAZOO PAKISTAN LABORATORIES (PVT) LTD

TIMOSOL 0.5% OPHTHALMIC SOLUTION 0.5% W/V BILIM ILAC SANAYII VE TURKEY TICARET AS

TIMOSOL GOZ DAMLASI STERILE OPHTHALMIC 0.5% BILIM ILAC SANAYII VE TURKEY SOL'N TICARET A.S.

TINADERM SOLUTION 10MG/ML S-P CANADA CANADA

TINADERM CREAM 1% CREAM 1% W/W SCHERING-PLOUGH UNITED KINGDOM LIMITED

TINADERM PLUS POWDER 1% TOPICAL POWDER 1% W/W SCHERING-PLOUGH UNITED KINGDOM LIMITED

TINADERM PLUS POWDER TOPICAL SPRAY 0.09% W/W SCHERING-PLOUGH UNITED KINGDOM AEROSOL LIMITED

TIRABICIN FILM-COATED TABLETS 150MG KLEVA LTD. GREECE

TIRABICIN FILM COATED TABLETS 150MG KLEVA LIMITED GREECE

TISSUCOL KIT — 2ML POWDER FOR INJECTION N/A SEE REMARKS BAXTER AG BELGIUM

TISSUCOL KIT — 0.5ML KIT (SEE REMARKS) N/A BAXTER AG BELGIUM

TISSUCOL KIT — 1ML KIT (SEE REMARKS) N/A BAXTER AG BELGIUM 728 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TISSUCOL KIT — 5ML POWDER FOR INJECTION N/A SEE REMARKS BAXTER EG BELGIUM

TITRALAC CHEWABLE TABLETS 420MG 3M HEALTH CARE UNITED KINGDOM LIMITED

TITRALAC CHEWABLE TABLETS 420MG 3M HEALTHCARE LTD. UNITED KINGDOM

TIXYLIX CHILDREN'S COUGH ORAL SOLUTION N/A MAY & BAKER LIMITED UNITED KINGDOM LINCTUS

TL-201-S-1 SOLUTION FOR 37MBQ/ML CIS BIO INTERNATIONAL FRANCE INJECTION

TOBRADEX OPHTHALMIC SUSPEN- N/A S.A. ALCON-COUVREUR BELGIUM SION N.V

TOBRADEX OPHTHALMIC OINTMENT N/A S.A ALCON-COUVREUR BELGIUM N.V.

TOBRAMYCIN SOLUTION FOR 40MG/ML BP F.H.FAULDING & CO. AUSTRALIA INJECTION LIMITED (T/A DAVID BULL LABORATORIES)

TOBRAMYCIN INJECTION BP SOLUTION FOR 40MG/ML FAULDING UNITED KINGDOM INJECTIONS PHARMACEUTICALS PLC

TOBRAMYCIN INJECTION VIAL SOLUTION FOR 40MG/1ML F.H. FAULDING & CO LTD AUSTRALIA INJECTION (T/A DAVID BULL LABS)

TOBRAMYCIN SULFATE INJECTION SOLUTION FOR 80MG/2ML ABBOTT LABORATORIES UNITED STATES OF USP INJECTION AMERICA

TOBREX OPHTHALMIC SOLUTION 3MG/ML S.A. ALCON-COUVREUR BELGIUM N.V.

TOBREX OPHTHALMIC OINTMENT 3MG/G S.A. ALCON-COUVREUR BELGIUM N.V.

TOCLASE SYRUP 15MG/10ML U.C.B. S.A. BELGIUM

TOCLASE SYRUP N/A UCB S.A. BELGIUM

TOFRANIL SUGAR COATED TABLETS 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

TOFRANIL SUGAR COATED TABLETS 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

TOFRANIL TABLET 25MG GEIGY PAKISTAN

TOFRANIL SUGAR-COATED TABLETS 25MG NOVARTIS PHARMA AUSTRIA GMBH

TOFRANIL 25MG TABLETS 25MG NOVARTIS PAKISTAN

TOMUDEX POWDER FOR INJECTION 2MG ZENECA LIMITED UNITED KINGDOM

TON WAS 10 DRINKABLE VIALS SOLUTION FOR ORAL USE NA CHIESI ESPANA S.A. SPAIN

TONILAX COATED TABLETS N/A LABORATOIRES MONOT FRANCE

TONOCALCIN SOLUTION FOR 100 IU ALFA WASSERMANN ITALY INJECTIONS S.P.A.

TONOCALCIN SOLUTION FOR 50 IU ALFA WASSERMANN ITALY INJECTIONS S.P.A.

TONOCEBRIN S/C TABLET N/A WALTER RITTER GMBH + GERMANY CO. 23.9.2003 FR Journal officiel de l'Union européenne 729

Trade Name Dosage Form Dose MA Holder Country

TOPAMAX 100MG TABLET 100MG JANSSEN-CILAG AG SWITZERLAND

TOPAMAX 200MG TABLET 200MG JANSSEN-CILAG AG SWITZERLAND

TOPAMAX 25MG TABLET 25MG JANSSEN-CILAG AG SWITZERLAND

TOPAMAX 300MG TABLET 300MG JANSSEN-CILAG AG SWITZERLAND

TOPAMAX 400MG TABLET 400MG JANSSEN-CILAG AG SWITZERLAND

TOPAMAX 50MG TABLET 50MG JANSSEN-CILAG AG SWITZERLAND

TOPEX-25 TABLET 25MG CIPLA LTD INDIA

TOPTABS TABLET N/A SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

TORBETOL ACNE LOTION TOPICAL SOLUTION N/A TORBET LABORATORIES UNITED KINGDOM LIMITED

TORENTAL 100MG/5ML SOLUTION FOR 100MG/5ML LABORATOIRES FRANCE INJECTION HOECHST

TORENTAL LP 400MG SUSTAINED RELEASE 400MG LABORATOIRES FRANCE TABLET HOECHST HOUDE

TOSCACALM TABLETS 20MG GENEPHARM S.A. GREECE

TOSCAMYCIN-R TABLETS 150MG GENEPHARM S.A. GREECE

TOTAFORTE CAPSULE N/A DAGRA PHARMA B.V NETHERLANDS

TOTAMOL FILM COATED TABLET 50MG CP PHARMACEUTICALS UNITED KINGDOM LIMITED

TOTAMOL TABLET 25MG CP PHARMACEUTICALS UNITED KINGDOM LIMITED

TOTAMOL COATED TABLETS 100MG CP PHARMACEUTICALS UNITED KINGDOM LIMITED

TOTAMOL TABLETS 100MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

TOTAMOL TABLETS 25MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

TOTAMOL TABLETS 50MG CP PHARMACEUTICALS UNITED KINGDOM LTD.

TOTAMOL 25MG TABLET 25MG CP PHARMA PAKISTAN

TOTAMOL TABLET TABLET 50MG CP PHARMA P PAKISTAN

TOTAMOL TABLET TABLET 100MG CPPHARMA PAKISTAN

TOTARETIC TABLETS N/A CP PHARMACEUTICALS UNITED KINGDOM LTD.

TOTARETIC TABLETS N/A CP PHARMACEUTICALS UNITED KINGDOM LTD.

TOT'HEMA ORAL SOLUTION N/A LABORATOIRES FRANCE INNOTHERA

TOT'HEMA DRINKABLE SOLUTION NA LABORATOIRE FRANCE INNOTECH INTERNATIONAL

TRACHISAN LOZENGES LOZENGE N/A KARL ENGELHARD GERMANY 730 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TRACHISAN SORE THROAT SOLUTION N/A KARL ENGELHARD GERMANY GARGLE

TRACHITOL LOZENGES LOZENGES N/A KARL ENGELHARD GERMANY

TRACRIUM SOLUTION FOR SOLUTION FOR 25MG/2.5ML THE WELLCOME UNITED KINGDOM INJECTION INJECTION FOUNDATION LIMITED

TRACRIUM SOLUTION FOR SOLUTION FOR 50MG/5ML THE WELLCOME UNITED KINGDOM INJECTION INJECTION FOUNDATION LIMITED

TRACRIUM SOLUTION FOR SOLUTION FOR 250MG/25ML THE WELLCOME UNITED KINGDOM INJECTION INJECTION FOUNDATION LIMITED

TRACRIUM SOLUTION FOR SOLUTION FOR 25MG/2.5M THE WELLCOME ITALY INJECTION INJECTION FOUNDATION LTD

TRACRIUM SOLUTION FOR SOLUTION FOR 50MG/5ML THE WELLCOME ITALY INJECTION INJECTION FOUNDATION LTD

TRACUTIL CONCENTRATE F. SOL F. N/A B.BRAUN MELSUNGEN GERMANY INF AG

TRAMADEX CAPSULES 50MG AEGIS LTD CYPRUS

TRAMADOL SR CAPSULES 50MG ASTA MEDICA LTD UNITED KINGDOM

TRAMADOL SR CAPSULES 100MG ASTA MEDICA LTD UNITED KINGDOM

TRAMADOL SR CAPSULE 150MG ASTA MEDICA LTD UNITED KINGDOM

TRAMADOL SR CAPSULES 200MG ASTA MEDICA LTD UNITED KINGDOM

TRAMADOL HCL CAPSULES 50MG CAPSULE 50MG SANOFI WINTHROP UNITED KINGDOM LIMITED T/A STERWIN MEDICINES

TRAMADOL HYDROCHLORIDE CAPSULES 50 MG BIOGLAN UNITED KINGDOM LABORATORIES LTD.

TRAMADOL HYDROCHLORIDE CAPSULE 50MG SANOFI WINTHROP LTD UNITED KINGDOM CAPSULES 50MG

TRAMAKE CAPSULE 50MG GALEN LIMITED UNITED KINGDOM

TRAMAL 100 SOLUTION FOR 100MG/2ML GRUNENTHAL GERMANY INJECTION

TRAMAL CAPSULE CAPSULE 50MG SEARLE PAKISTAN

TRAMAL CAPSULES CAPSULES 50MG GRUNENTHAL GMBH GERMANY

TRAMAL DROPS SOLUTION 100MG/ML GRUNENTHAL GMBH GERMANY

TRAMAL RETARD 100MG FILM-COATED TABLETS 100MG GRUNENTHAL GMBH GERMANY

TRAMAL SUPPOSITORIES SUPPOSITORY 100MG GRUNENTAL GMBH GERMANY

TRAMUDIN CAPSULES CAPSULES FOR ORAL USE 50MG MUNDIPHARMA GMBH GERMANY

TRAMUDIN RETARD TABLETS RETARD TABLETS / ORAL 100MG MUNDIPHARMA GMBH GERMANY 100MG USE

TRANSACALM TABLETS 100MG LABORATOIRES A.J.C. FRANCE PHARMA

TRANSVASIN HEAT RUB CREAM CREAM N/A SETON PRODUCTS UNITED KINGDOM LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 731

Trade Name Dosage Form Dose MA Holder Country

TRANSVASIN HEAT SPRAY TOPICAL SPRAY N/A SETON HEALTHCARE UNITED KINGDOM GROUP PLC

TRANXENE 10MG CAPSULE 10MG SANOFI WINTHROP FRANCE

TRANXENE 5MG CAPSULE 5MG SANOFI WINTHROP FRANCE

TRASYLOL 100,000KIU/5ML SOLUTION FOR 100,000KIU/5ML BAYER AG GERMANY INJECTION

TRASYLOL 500,000KIU/50ML INFUSION SOLUTION 500,000KIU/50ML BAYER VITAL GMBH & GERMANY CO. KG

TRAUMON GEL 100MG/G BAYER VITAL GMBH & GERMANY CO. KG

TRAUMON GEL 100MG/1G TROPON GMBH GERMANY

TRAVATAN EYE DROPS SOLUTION 40MCG/ML ALCON LABORATORIES EUROPEAN COMMUNITY UK LIMITED

TRAVATAN OPHTHALMIC OPHTHALMIC SOLUTION 0.004% ALCON UNIVERSAL LTD. UNITED STATES OF SOLUTION C/O ALCON RESEARCH AMERICA LTD

TRAVILAN POWDER FOR INJECTION 1000MG ANFARM HELLAS S.A. GREECE

TRAVOCORT CREAM N/A H.E. CLISSMAN IRELAND

TRAVOCORT CREAM N/A SCHERING AG GERMANY

TRAVOCORT CREAM N/A SCHERING SPA ITALY

TRAVOCORT CREAM N/A SCHERING PAKISTAN

TRAVOCORT CREAM CREAM N/A SCHERING PAKISTAN

TRAVOGEN CREAM 10MG/G SCHERING AG GERMANY

TRAVOGEN CREAM 1MG/100G SCHERING SPA ITALY

TRAVOGEN CREAM CREAM 10MG/G SCHERING PAKISTAN

TRAVOGEN CREAM CREAM 10MG/10G SCHERING PAKISTAN

TREDOL 100 TABLETS 100MG AEGIS LTD. CYPRUS

TREDOL 25 TABLETS 25MG AEGIS LTD. CYPRUS

TREDOL 50 TABLETS 50MG AEGIS LTD. CYPRUS

TRIACANA TABLET 0.35MG LABORATORIES LAPHAL FRANCE

TRIAMCO TABLETS N/A NORTON HEALTHCARE UNITED KINGDOM LIMITED

TRIATEC 2.5MG CAPSULE 2.5MG LABORATOIRES FRANCE HOECHST

TRIATEC 5MG CAPSULE 5MG LABORATOIRES FRANCE HOECHST

TRIATEC FAIBLE 1.25MG CAPSULE 1.25MG LABORATOIRES FRANCE HOECHST

TRIDIL SOLUTION FOR IV 5MG/ML FAULDING PUERTO RICO UNITED STATES OF INFUSION INC AMERICA

TRIENE CREAM 5G/100G ALFA WASSERMANN ITALY S.P.A. 732 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TRIFLUOPERAZINE TABLETS 1MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

TRIFLUOPERAZINE TABLETS 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

TRIFLUOPERAZINE 1MG TABLET 1MG MEDOCHEMIE LTD CYPRUS

TRIFLUOPERAZINE 5MG TABLET 5MG MEDOCHEMIE LTD CYPRUS

TRIHERPINE EYE DROPS 10MG/ML CIBA VISION AG SWITZERLAND

TRIHERPINE EYE OINTMENT 10MG/G CIBA VISION AG SWITZERLAND

TRIIODOTHYRONINE POWDER FOR INJECTION 20 MCG GOLDSHIELD GROUP PLC UNITED KINGDOM T/A GOLDSHIELD PHARMACEUTICALS

TRIIODOTHYRONINE INJECTION POWDER FOR INJECTION 2MCG GOLDSHIELD UNITED KINGDOM 20MCG PHARMACEUTICALS LIMITED

TRILEPTAL FILM COATED TABLETS 150MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

TRILEPTAL FILM COATED TABLETS 300MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

TRILEPTAL FILM COATED TABLETS 600MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

TRILEPTAL ORAL SUSPENSION N/A NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

TRIMETABOL SOLUTION ORAL SUSPENSION N/A J.URIACH & CIA. S.A. SPAIN

TRIMIDAR M ORAL SUSPENSION NA DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO LTD

TRINORDIOL TABLETS NA JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES

TRINORDIOL TABLETS N/A JOHN WYETH AND UNITED KINGDOM BROTHER LIMITED T/A WYETH LABORATORIES —UK

TRINORDIOL 21 COATED TABLETS N/A WYETH-PHARMA GMBH GERMANY

TRINOVIN TABLET 200MG NOVOGEN AUSTRALIA LABORATORIES PTY LTD

TRISEQUENS FORTE -28 TABLETS TABLET NA NOVO NORDISK A/S DENMARK

TRISEQUENS-28TABLETS TABLET NA NOVO NORDISK A/S DENMARK

TRITANRIX SUSPENSION FOR N/A SMITHKLINE BEECHAM BELGIUM INJECTION BIOLOGICALS

TRITANRIX HEPB SUSPENSION FOR NA SMITHKLINE BEECHAM EUROPEAN COMMUNITY INJECTION BIOLOGICALS S.A.

TRIVASTAL RETARD 50 SUST. REL. COATED 50MG LES LABORATOIRES FRANCE TABLET SERVIER

TRIVAX-AD SOLUTION FOR N/A EVANS MEDICAL UNITED KINGDOM INJECTION LIMITED

TRIVEDON-20 TABLET 20MG CIPLA LIMITED INDIA 23.9.2003 FR Journal officiel de l'Union européenne 733

Trade Name Dosage Form Dose MA Holder Country

TRIZOLIN 400 TABLETS 400MG REMEDICA LTD CYPRUS

TROBICIN SUSPENSION FOR 2G/3.2ML PHARMACIA & UPJOHN BELGIUM INJECTION N.V. / S.A.

TROFOGIN CREAM VAGINAL N/A FARMIGEA SPA -ITALY ITALY

TROPEX EAR DROPS 5% W/V ROWA IRELAND PHARMACEUTICALS LTD

TROPIMIL OPHTHALMIC DROPS 0.5G/100ML FARMIGEA SPA ITALY

TROPIXAL EYE DROPS SOLUTION 0.5% W/V DEMO ABEE GREECE

TRUSOPT 2% OPHTHALMIC SOLUTION 2% W/V MERCK SHARP & DOHME NETHERLANDS B.V.

TRYPTANOL TABLET 10MG M.S.D. PAKISTAN

TRYPTANOL TABLET 25MG M.S.D. PAKISTAN

TRYPTIZOL 10MG TABLET 10MG MERCK SHARP & DOHME NETHERLANDS B.V.

TRYPTIZOL 25MG TABLET 25MG MERCK SHARP & DOHME NETHERLANDS B.V.

TUBERCULIN PPD DILUTIONS SOLUTION FOR N/A EVANS MEDICAL UNITED KINGDOM MANTOUX INJECTIONS LIMITED

TUBERCULIN PPD DILUTIONS SOLUTION FOR N/A EVANS MEDICAL UNITED KINGDOM MANTOUX INJECTION LIMITED

TUBERCULIN PPD RT 23 SSI SOLUTION FOR 2T.U./0.1ML STATENS SERUM DENMARK INJECTION INSTITUT

TUBERCULIN PPD UNDILUTED SOLUTION FOR N/A EVANS MEDICAL UNITED KINGDOM HEAF INJECTION LIMITED

TUBERCULIN PPD UNDILUTED SOUTION FOR INJECTION N/A EVANS MEDICAL UNITED KINGDOM MANTOUX LIMITED

TUBERSOL TUBERCULIN LIQUID FOR INJECTION N/A AVENTIS PASTEUR CANADA PPD(MANTOUX) LIMITED

TULOTRACT LIQUID 66,7G/100ML ARDEYPHARM GMBH GERMANY

TUPAST FILM COATED TABLETS 150MG KLEVA LTD. GREECE

TUPAST FILM COATED TABLETS 150MG KLEVA LIMITED GREECE

TUPAST FILM COATED TABLETS 300MG KLEVA LIMITED GREECE

TUSCALMAN BERNA DROPS N/A SWISS SERUM AND SWITZERLAND VACCINE INSTITUTE BERNE

TUSCALMAN BERNA SYRUP N/A SWISS SERUM AND SWITZERLAND VACCINE INSTITUTE BERNE

TUSCALMAN BERNA A SUPPOSITORIES N/A SWISS SERUM AND SWITZERLAND VACCINE INSTITUTE BERNE

TUSCALMAN BERNA B SUPPOSITORIES N/A SWISS SERUM AND SWITZERLAND VACCINE INSTITUTE BERNE

TWINRIX PAEDIATRIC SUSPENSION FOR INJEC- N/A SMITHKLINE BEECHAM BELGIUM TION BIOLOGICALS S.A. 734 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

TWINRIX-ADULT SUSPENSION FOR N/A SMITHKLINE BEECHAM EUROPEAN COMMUNITY INJECTION BIOLOGICALS S.A.

TYLENOL DROPS 100MG/ML JANSSEN-CILAG AG SWITZERLAND

TYLENOL 100MG SUPPOSITORY 100MG JANSSEN-CILAG AG SWITZERLAND

TYLENOL 200MG SUPPOSITORY 200MG JANSSEN-CILAG AG SWITZERLAND

TYLENOL 350MG SUPPOSITORY 350MG JANSSEN-CILAG AG SWITZERLAND

TYLENOL FORTE CAPLET 500MG JANSSEN-CILAG AG SWITZERLAND

TYLENOL FORTE TABLET 500MG JANSSEN-CILAG AG SWITZERLAND

TYPHERIX SOLUTION FOR 50MCG/ML SMITHKLINE BEECHAM UNITED KINGDOM INJECTION PLC

TYPHERIX SOLUTION FOR 25MCG/0.5ML SMITHKLINE BEECHAM BELGIUM INJECTION BIOLOGICALS

TYPHIM VI SOLUTION FOR 0.025MG/0.5ML PASTEUR MERIEUX FRANCE INJECTION

TYPOFEN TABLETS N/A KLEVA LTD. GREECE

TYPOFEN TABLETS N/A KLEVA LTD GREECE

TYROCOMBIN OINTMENT N/A SYNPHARMA AG SWITZERLAND

TYROCOMBIN POWDER N/A SYNPHARMA AG SWITZERLAND

TYROSUR OINTMENT N/A KARL ENGELHARD GERMANY

TYROSUR POWDER POWDER 1MG/G KARL ENGELHARD GERMANY

UBRETID TABLETS 5MG NYCOMED AUSTRIA AUSTRIA GMBH

UFEXIL TABLETS 250MG DEMO ABEE GREECE

UFEXIL SOLUTION FOR 200MG/100ML DEMO ABEE GREECE INJECTION

UFEXIL SOLUTION FOR INFUSION 100MG/50ML DEMO ABEE GREECE

UKIDAN 100'000IU POWDER FOR INJECTION N/A LABORATOIRES SERONO SWITZERLAND SA

ULCERAN 20MG TABLET 20MG MEDOCHEMIE LTD CYPRUS

ULCESEP TABLETS 20MG ESPECIALIDADES SPAIN FARMACEUTICAS CENTRUM SA

ULCESEP TABLETS 20MG LABORATOIRES SPAIN CENTRUM

ULCOMET 200MG TABLET 200MG MEDOCHEMIE LTD CYPRUS

ULCOMET 300MG/2ML LIQUID FOR INJECTION 300MG/2ML MEDOCHEMIE LTD CYPRUS

ULTAC-150 TABLET 150MG CIPLA LIMITED INDIA

ULTICADEX TABLET 5MG RAFARM GREECE

ULTICADEX TABLET 20MG RAFARM GREECE

ULTIVA FOR INJECTION 1MG/VIAL POWDER FOR INJECTION 1MG/ML GLAXO GROUP LIMITED UNITED KINGDOM 23.9.2003 FR Journal officiel de l'Union européenne 735

Trade Name Dosage Form Dose MA Holder Country

ULTIVA FOR INJECTION 2MG/VIAL POWDER FOR INFUSION 2MG GLAXO GROUP LIMITED UNITED KINGDOM

ULTIVA FOR INJECTION 5MG/VIAL POWDER FOR INFUSION 5MG GLAXO GROUP LIMITED UNITED KINGDOM

ULTRACORTENOL EYE DROPS 5MG/ML CIBA VISION AG SWITZERLAND

ULTRACORTENOL EYE DROPS 5.00MG/ML NOVARTIS SWITZERLAND OPHTHALMICS AG

ULTRALAN TABLET 20MG SCHERING AG GERMANY

ULTRALAN TABLET 5MG SCHERING AG GERMANY

ULTRATARD HM SUSPENSION FOR INJEC- 100IU/ML NOVO NORDISK A/S DENMARK TION

ULTRAVIST-240 SOLN. FOR IV INJEC./ 498.72MG/ML SCHERING AG GERMANY INFUS

ULTRAVIST-300 SOLN. FOR IV INJEC./ 623.4MG/ML SCHERING AG GERMANY INFUS

ULTRAVIST-370 SOLN. FOR IV INJ./INFUS 768.86MG/ML SCHERING AG GERMANY

UMAN ALBUMIN SOLUTION FOR INFUSION 20% FARMA BIAGINI S.P.A ITALY

UMODER TABLETS 100MG RAFARM GREECE

UNIBUTOL TABLETS 400MG KOREA UNITED PHARM. KOREA REPUBLIC INC.

UNICAP M TABLET N/A UPJOHN PAKISTAN

UNICAP M TABLETS N/A PHARMACIA & UPJOHN UNITED KINGDOM LTD.

UNIDERM CREAM 2%W/W RAZA MANUFACTURING MALAYSIA BERHAD

UNIFLU TABLETS; GREGOVITE 'C' COATED TAB; CHEWABLE N/A UNIGREG LIMITED UNITED KINGDOM TABLETS TAB.

UNIMED CHLORAMPHENICOL EYE DROPS 5MG/ML UNIMED KOREA REPUBLIC SOLUTION PHARMACEUTICALS INC.

UNIMED CIPROFLOXACIN TAB. TABLET 250MG UNIMED KOREA REPUBLIC PHARMACEUTICALS INC.

UNIMED GENTAMICIN SULFATE EYEDROPS 3MG/ML UNIMED KOREA REPUBLIC EYEDROPS PHARMACEUTICALS INC.

UNIPARIN FORTE SOLUTION FOR 10000IU/0.4ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD

UNIPARIN-CA 5000IU/0.2ML SOLUTION FOR 25000IU/ML CP PHARMACEUTICALS UNITED KINGDOM INJECTION LTD

UNIPHYLLIN CONTINUS TABLETS MODIFIED RELEASE 200MG NAPP LABORATORIES UNITED KINGDOM 200MG TABLET LIMITED

UNIPHYLLIN CONTINUS TABLETS MODIFIED RELEASE 300MG NAPP LABORAOIES UNITED KINGDOM 300MG TABLET LIMITED

UNIPHYLLIN CONTINUS TABLETS MODIFIED RELEASE 400MG NAPP LABORATORIES UNITED KINGDOM 400MG TABLET LIMITED

UNIPLATIN (CARBOPLATIN) SOLUTION FOR 10MG/ML UNIMED KOREA REPUBLIC INJECTION PHARMACEUTICALS INC. 736 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

UNIROID-HC OINTMENT OINTMENT N/A UNIGREG LIMITED UNITED KINGDOM

UNIROID-HC SUPPOSITORIES SUPPOSITORY N/A UNIGREG LIMITED UNITED KINGDOM

UPRIMA SUBLINGUAL TABLETS NA ABBOTT LABORATORIES UNITED KINGDOM LIMITED

UPSA BUFFERED EFF. ASPIRIN SCORED EFF. TABLETS N/A LABORATOIRES UPSA FRANCE WITH VIT. C

UPSA C EFFERVESCENT TABLETS EFFERVESCENT TABLETS 1000MG LABORATOIRES UPSA FRANCE

URACTONUM 25MG TABLET 25MG MEDOCHEMIE LTD CYPRUS

URAMOX TABLETS 250MG TARO ISRAEL PHARMACEUTICAL INDUSTRIES LTD.

URAMOX 250MG TALETS TABLET 250MG TARO ISRAEL PHARMACEUTICAL INDUSTRIES LTD

URBANYL TABLET 10MG HOECHST MARION TUNISIA ROUSSEL S.A.

URDOX TABLETS 300MG COATED 300MG TABLETS CP PHARMACEUTICALS UNITED KINGDOM TABLETS LTD

URIGON E.C. TABLETS 25MG DEMO ABEE GREECE

URIGON SOLUTION FOR 75MG/3ML DEMO ABEE GREECE INJECTION

URISPAS 200 COATED TABLET 200MG SHIRE UNITED KINGDOM PHARMACEUTICALS LTD

URITAB TABLETS 100MG RAZA MANUFACTURING MALAYSIA BERHAS

UROKINASE 10 000 HS MEDAC POWDER F/SOLUTION 10 000 HS MEDAC GESELLSCHAFT GERMANY FOR INJ FUR KLINISCHE SPEZIALPRAPARATE MBH

UROKINASE 100 000 HS MEDAC POWDER F/SOLUTION 100 000 HS MEDAC GESELLSCHAFT GERMANY FOR INJ FUR KLINISCHE SPEZIALPRAPARATE MBH

UROMITEXAN SOLUTION FOR 400MG/4ML ASTA MEDICA GERMANY INJECTION

UROTRACTIN CAPSULE 400MG POLIPHARM CO. LTD. THAILAND

UROVIDEO SOLUTION FOR IV I 60% W/V BRACCO S.P.A. ITALY NFUSION

URSOFALK CAPSULES 250MG DR. FALK PHARMA GMBH GERMANY

URSOGAL CAPSULES 250MG GALEN LIMITED UNITED KINGDOM

URSOGAL TABLETS 150MG GALEN LIMITED UNITED KINGDOM

UTABON ADULTS NASAL SPRAY, SOLUTION 50MG/100ML J.URIACH & CIA. S.A. SPAIN

UTABON CHILDREN NASAL DROPS, SOLUTION 25MG/100ML J.URIACH & CIA. S.A. SPAIN

UTOVLAN TABLET 5MG MONSANTO PLC T/A UNITED KINGDOM SEARLE

UTOVLAN TABLETS 5MG MONSANTO PLC T/A UNITED KINGDOM SEARLE 23.9.2003 FR Journal officiel de l'Union européenne 737

Trade Name Dosage Form Dose MA Holder Country

UTROGESTAN 100MG SOFT CAPSULE 100MG BESINS INTERNATIONAL FRANCE

UZIX INJECTABLE SOLUTION 500MG/2ML RAFARM GREECE

VACCIN BCG INSTITUT MERIEUX SOLUTION FOR N/A PASTEUR MERIEUX FRANCE INJECTION

VACCIN POLIOMYELITIQUE ORAL ORAL SOLUTION N/A LABORATORIES FRANCE PASTEUR MERIEUX

VACONTIL 2MG CAPSULE 2MG MEDOCHEMIE LTD CYPRUS

VACONTIL 2MG TABLET 2MG MEDOCHEMIE LTD CYPRUS

VAFLUSON KETOCONAZOLE 200MG KLEVA LTD GREECE

VAGIFEM -15 APPLICATORS WITH TABLET 25UG NOVO NORDISK A/S DENMARK INSERTS

VAGILEN VAGINAL PESSARY 500MG FARMIGEA S.P.A. ITALY

VAGILEN CAPSULE 250MG FARMIGEA SPA ITALY

VAGISIL MEDICATED CREME CREAM 2%W/W COMBE INTERNATIONAL UNITED KINGDOM LIMITED

VAGOCLYSS SOLUTION (VAGINAL 10MG/ML DR.GROSSMANN AG SWITZERLAND DOUCHE) PHARMACA

VALERIAN COMPOUND TABLETS COATED TABLET N/A GERARD HOUSE LIMITED UNITED KINGDOM

VALERIANA SCHIAPPARELLI COATED TABLETS 100MG ALFA WASSERMANN ITALY S.P.A.

VALERIANA SCHIAPPARELLI COATED TABLETS 100MG ALFA WASSERMANN ITALY S.P.A.

VALIREM TABLET 50MG GENEPHARM S.A GREECE

VALIUM 2MG TABLET 2MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

VALIUM 5MG TABLET 5MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

VALIUM ROCHE 2MG TABLETS 2MG PRODUITS ROCHE FRANCE

VALIUM ROCHE 5MG TABLETS 5MG LABORATOIRE FRANCE PRODUITS ROCHE

VALLERGAN FORTE SYRUP SYRUP 0.6%W/V CASTLEMEAD UNITED KINGDOM HEALTHCARE LIMITED

VALLERGAN FORTE SYRUP SYRUP 0.6%W/V CASTLEMEAD IRELAND HEALTHCARE LTD

VALLERGAN SYRUP SYRUP 0.15% W/V CASTLEMEAD IRELAND HEALTHCARE

VALLERGAN SYRUP 0.15%W/V SYRUP 0.15%W/W CASTLEMEAD UNITED KINGDOM HEALTHCARE LIMITED

VALOID INJECTION (CYCLIZINE SOLUTION FOR 50MG/ML THE WELLCOME UNITED KINGDOM LACTATE INJ. INJECTION FOUDATION LIMITED

VALORAN 1G POWDER FOR INJECTION 1G MEDOCHEMIE LTD CYPRUS

VALPROL-EC-500 TABLETS 500MG INTAS INDIA PHARMACEUTICALS LTD. 738 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

VALTREX FILM-COATED TABLETS 500MG WELLCOME SPAIN FARMACEUTICA S.A.

VALTREX TABLETS 500MG COATED TABLETS 500MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

VAMIN 18 ELECTROLYTE FREE SOLUTION FOR INFUSION N/A FRESENIUS KABI LIMITED UNITED KINGDOM

VAMIN 9 GLUCOSE SOLUTION FOR INFUSION N/A FRESENIUS KABI LIMITED UNITED KINGDOM

VAMIN 9 GLUCOSE SOLUTION FOR INFUSION NA FRESENIUS KABI LIMITED UNITED KINGDOM

VAMIN-GLUKOS INTRAVENOUS INFUSION N/A PHARMACIA & UPJOHN SWEDEN SVERIGE AB

VANCOCIN CAPSULE 125MG ELI LILLY & COMPANY UNITED KINGDOM

VANCOMICINA COMBINO PHARM POWDER FOR IV 500MG COMBINO PHARM SL SPAIN

VANCOMYCIN CP LILLY 500 POWDER FOR INFUSION 500,000IU LILLY DEUTSCHLAND GERMANY GMBH

VANCOMYCIN INJECTION POWDER FOR INJECTION 500MG F.H. FAULDING & CO LTD UNITED KINGDOM (T/A DAVID BULL LABS)

VANCOMYCINE MERCK 500MG POWDER FOR IV 500MG / VIAL MERCK GENERIQUES FRANCE PERFUSION

VANCOX POWDER FOR INJ. 500MG/1000MG LEMERY S.A. DE C.V. MEXICO SOLUTION

VANCOZINE POWDER FOR INJECTION 500MG KOREA UNITED PHARM. KOREA REPUBLIC INC.

VARICOGEL GEL N/A ALFA WASSERMANN ITALY S.P.A.

VARILIX POWDER FOR INJECTION >=2000PFU/0.5ML SMITHKLINE BEECHAM BELGIUM BIOLOGICALS

VARITECT CP SOLUTION FOR N/A BIOTEST PHARMA GMBH GERMANY INTRAVENOUS ADMINISTRATION

VASCOTEN 100MG TABLET 100MG MEDOCHEMIE LTD CYPRUS

VASCULIN CAPSULE 10MG GEOFMAN PAKISTAN PHARMACEUTICALS

VASEXTEN 10 MODIFIED RELEASE 10MG YAMANOUCHI PHARMA NETHERLANDS CAPSULES B.V.

VASEXTEN 20 MODIFIED RELEASE 20MG YAMANOUCHI PHARMA NETHERLANDS CAPSULES B.V.

VASOGEN CREAM N/A PHARMAX LIMITED UNITED KINGDOM

VASOPOS N EYE DROPS 0.5MG/ML URSAPHARM GERMANY ARZNEIMITTEL GMBH

VASOPRIL-20 TABLETS 20MG CIPLA LTD INDIA

VASORINIL NASAL SPRAY, SOLUTION 0.1G/100ML FARMILA FARMACEUTICI ITALY MILANO S.P.A.

VASOTOP TABLET 30MG CIPLA LTD. INDIA

VASOXINE SOLUTION FOR 2MG/ML THE WELLCOME UNITED KINGDOM INJECTION FOUNDATION LTD. 23.9.2003 FR Journal officiel de l'Union européenne 739

Trade Name Dosage Form Dose MA Holder Country

VASTAREL 20MG COATED TABLET 20MG LES LABORATOIRES FRANCE SERVIER

VASTAREL 20MG/ML ORAL SOLUTION, DROPS 20MG/ML LES LABORATOIRES FRANCE SERVIER

VASTAREL MR MODIFIED RELEASE FC 35MG LES LABORATOIRES FRANCE TABS SERVIER

VAXEM HIB INJECTABLE SOLUTION N/A CHIRON S.P.A. ITALY

VAXIGRIP SUSPENSION FOR N/A AVENTIS PASTEUR S.A. FRANCE INJECTION

VAXIGRIP SUSPENSION FOR NA AVENTIS PASTEUR S.A. FRANCE INJECTION

VECTARION 50MG FILM-COATED TABLET 50MG LES LABORATOIRES FRANCE SCORED SERVIER

VECTAVIR CREAM N/A NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

VEINAMITOL POWDER FOR BOUVABLE 3500MG LABORATOIRES NEGMA FRANCE SOLN.

VEINAMITOL POWDER FOR ORAL SOL 3.5G/SACHET NEGMA-LERADS FRANCE

VELBE POWDER FOR IV 10MG LILLY FRANCE S.A. FRANCE INJECTION

VENLOR-37.5 TABLETS 37.5MG CIPLA INDIA

VENOGAMMA POWDER FOR SOL FOR 0.06G/ML FINNISH RED CROSS FINLAND INF.I BLOOD TRANSFUSION SERVICE

VENORUTON GEL 20MG/G NOVARTIS CONSUMER SWITZERLAND HEALTH SA

VENORUTON 300 CAPSULES 300MG NOVARTIS CONSUMER SWITZERLAND HEALTH SA

VENOSMINE POMATA 4%W/W GEYMONAT SPA ITALY

VENOSMINE TABLETS 450MG GEYMONAT SPA ITALY

VENTEZE SYRUP 2MG/5ML PHARMACARE LIMITED SOUTH AFRICA

VENTIDE INHALER AEROSOL N/A GLAXO WELLCOME UK UNITED KINGDOM LTD

VENTIDE INHALER AEROSOL NA GLAXO WELLCOME UK UNITED KINGDOM LIMITED

VENTOLIN AEROSOL N/A GLAXO WELLCOME PAKISTAN

VENTOLIN TABLETS 2MG ALLEN & HANDBURY'S IRELAND LIMITED

VENTOLIN EVOHALER AEROSOL 100 MCG/AC GLAXO WELLCOME UK UNITED KINGDOM LTD

VENTOLIN EVOHALER AEROSOL 100UG/AC GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN AND HANDBURYS

VENTOLIN INHALER AEROSOL 100MCG ALLEN AND HANBURY UNITED KINGDOM LTD

VENTOLIN INHALER AEROSOL INHALER 100MCG PER MDI GLAXO WELLCOME PAKISTAN 740 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

VENTOLIN INHALER AEROSOL 100MCG/AC ALLEN AND HANDBURY UNITED KINGDOM LIMITED

VENTOLIN INHALER SUSPENSION 100MCG GLAXO WELLCOME SA SPAIN

VENTOLIN INJECTION SOLUTION FOR 500MCG/1ML GLAXO WELLCOME UK UNITED KINGDOM INJECTION LIMITED T/A ALLEN AND HANDBURYS

VENTOLIN INJECTION SOLUTION FOR 250MCG/5ML GLAXO WELLCOME UK UNITED KINGDOM INJECTION LIMITED

VENTOLIN INJECTION 250MCG/ SOLUTION FOR 0.25MG GLAXO WELLCOME UK UNITED KINGDOM 5ML INJECTION LTD T/A ALLEN & HANBURYS

VENTOLIN RESPIRATOR SOLUTION INHALATION SOLUTION 0.5% W/V GLAXO WELLCOME UK UNITED KINGDOM LTD

VENTOLIN RESPIRATOR SOLUTION INHALATION SOLUTION 5MG/ML GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN AND HANDBURYS

VENTOLIN SOLN. FOR I.V. INFU- SOLUTION FOR 5MG GLAXO WELLCOME UK UNITED KINGDOM SION INJECTION LTD T/A ALLEN & HANBURYS

VENTOLIN SOLUTION FOR IV SOLUTION FOR 5MG/1ML GLAXO WELLCOME UK UNITED KINGDOM INFUSION INJECTION LIMITED T/A ALLEN HANDBURYS

VENTOLIN SYRUP ORAL SOLUTION 2MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LIMITED

VENTOLIN TABLETS TABLETS 2MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

VENTOLIN TABLETS TABLETS 4MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED T/A ALLEN AND HANDBURYS

VENTOLIN TABLETS 2MG TABLET 2MG GLAXO WELLCOME UK UNITED KINGDOM LTD

VENTOLIN TABLETS 2MG TABLET 2MG GLAXO WELLCOME PAKISTAN

VENTOLIN, 10 FIALE 500MCG FIALE N/A GLAXOSMITHKLINE S.P.A ITALY

VEPESID CAPSULES 100MG CAPSULES 100MG BRISTOL MYERS SQUIBB UNITED KINGDOM HOLDINGS LTD

VEPESID CAPSULES 50MG CAPSULES 50MG BRISTOL MYERS SQUIBB UNITED KINGDOM HOLDINGS LTD

VEPESID INJECTION 5.0ML SOLUTION FOR 100MG/5ML BRISTOL MYERS SQUIBB UNITED KINGDOM INJECTION HOLDINGS LTD

VERACOL SOLUTION FOR 500MG/VIAL DEMO ABEE GREECE INJECTION

VERACOL SOLUTION FOR 1G/VIAL DEMO ABEE GREECE INJECTION

VERACOL POWDER FOR INJECTION 1G/VIAL DEMO ABEE GREECE

VERAPAMIL TABLETS 40MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

VERAPAMIL TABLETS 80MG NORTON HEALTHCARE UNITED KINGDOM LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 741

Trade Name Dosage Form Dose MA Holder Country

VERAPAMIL TABLETS 120MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

VERAPAMIL HCL TABLETS 160MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

VERAPAMIL HYDROCHLORIDE SOLUTION FOR 2.5MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION USP INJECTION AMERICA

VERAPAMIL TABLETS BP 40MG COATED TABLET 40MG GENERICS (UK) LIMITED UNITED KINGDOM

VERLOST COATED TABLETS 150MG RAFARM GREECE

VERMOX TABLET 500MG JANSSEN PAKISTAN

VERMOX SUSPENSION N/A JANSSEN PAKISTAN

VERMOX TABLET 100MG JANSSEN PAKISTAN

VERMOX SUSPENSION 100MG/5ML JANSSEN PAKISTAN

VERMOX TABLET 500MG JANSSEN PAKISTAN

VERMOX 100MG TABLET 100MG JANSSEN-CILAG N.V. BELGIUM

VERMOX 2% SUSPENSION 20MG/ML JANSSEN-CILAG N.V. BELGIUM

VERMOX 500MG TABLET 500MG JANSSEN-CILAG N.V. BELGIUM

VERORAB VACCINE N/A PASTEUR MERIEUX FRANCE SERUMS & VACCINES LABORATORIES

VERPIR CREAM 5% W/W KLEVA LTD. GREECE

VERRA-MED SOLUTION N/A PERMAMED AG SWITZERLAND

VERRUGON OINTMENT N/A J PICKLES (HARROGATE) UNITED KINGDOM LIMITED T/A J PICKLES AND SONS

VESSEL SOLUTION FOR 600 UNITS ALFA WASSERMANN ITALY INJECTION S.P.A.

VESSEL SOFT — GELATIN 250 UNITS ALFA WASSERMANN ITALY CAPSULE S.P.A.

VESSIFLEX GEL N/A ALFA WASSERMANN ITALY S.P.A.

VEXOL 1% OPHTHALMIC SUSPEN- 1% W/V ALCON LABORATORIES UNITED STATES OF SION INC. AMERICA

VEXOL 1% EYE DROPS EYE DROPS 1% W/V S.A. ALCON COUVREUR BELGIUM N.V

VIAGRA FILM-COATED TABLETS 25MG PFIZER LIMITED UNITED KINGDOM

VIAGRA FILM-COATED TABLETS 50MG PFIZER LIMITED UNITED KINGDOM

VIAGRA FILM-COATED TABLETS 100MG PFIZER LIMITED UNITED KINGDOM

VIAREX INHALER 0.05MG/DOSE SCHERING-PLOUGH BELGIUM NV/SA

VIARTRIL-S CAPSULES 250MG ROTTAPHARM S.R.L. ITALY

VIBRAMYCIN CAPSULES 100MG PFIZER LIMITED UNITED KINGDOM

VIBRAMYCIN CAPSULE 50MG PFIZER LIMITED UNITED KINGDOM 742 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

VIBRAMYCIN SYRUP 10MG/G PFIZER SA BELGIUM

VIBROCIL DROPS N/A NOVARTIS CONSUMER SWITZERLAND HEALTH SA

VIBROCIL GEL N/A NOVARTIS CONSUMER SWITZERLAND HEALTH SA

VIBROCIL SPRAY N/A NOVARTIS CONSUMER SWITZERLAND HEALTH SA

VI-CAPS CAPSULE N/A DR.GROSSMANN AG SWITZERLAND PHARMACA

VICEMEX EFFERVESCENT TABLETS 1G CIMEX AG SWITZERLAND

VICKS INHALER INHALATION SOLUTION N/A PROCTER & GAMBLE UNITED KINGDOM (HEALTH & BEAUTY CARE) LIMITED

VICKS MEDINITE ORAL SOLUTION N/A PROCTER & GAMBLE UNITED KINGDOM (HEALTH & BEAUTY CARE) LIMITED

VICKS SINEX DECONGESTANT NASAL SPRAY N/A PROCTER & GAMBLE UNITED KINGDOM (HEALTH & BEAUTY CARE) LIMITED

VICKS VAPORUB NASAL INHALATION N/A PROCTER & GAMBLE UNITED KINGDOM OINTMENT (HEALTH & BEAUTY CARE) LIMITED

VICKS VAPOSYRUP FOR CHESTY ORAL SOLUTION 1.333%W/V PROCTER & GAMBLE UNITED KINGDOM COUGHS (HEALTH & BEAUTY CARE) LIMITED

VICKS VAPOSYRUP FOR TICKLY ORAL SOLUTION 0.125% W/V PROCTER & GAMBLE UNITED KINGDOM COUGHS (HEALTH & BEAUTY CARE) LIMITED

VICKS VAPOUR RUB BALM NA PROCTOR & GAMBLE PAKISTAN

VICOMBIL SYRUP NA BIAL — PRODUTOS PORTUGAL FARMACEUTICOS

VICOMBIL SYRUP SYRUP NA BIAL — ARISTEGUI, PORTUGAL PRODUTOS FARMACEUTICOS, SA

VIDENE ANTISEPTIC SOLUTION TOPICAL SOLUTION 10% W/W ADAMS HEALTHCARE UNITED KINGDOM LIMITED

VIDENE ANTISEPTIC TINCTURE TOPICAL SOLUTION 10% W/W ADAMS HEALTHCARE UNITED KINGDOM LIMITED

VIDENE SURGICAL SCRUB CUTANEOUS SPONGE 7.5% W/W ADAMS HEALTHCARE UNITED KINGDOM LIMITED

VIDEO-LIGHT EYE DROPS 0.01G/100ML FARMILA FARMACEUTICI ITALY MILANO S.P.A.

VIDEO-MILL EYE DROPS 0.1% W/V FARMILA FARMACEUTICI ITALY MILANO S.P.A.

VIDERMINA OVULES 5MG ISTITUTO GANASSINI ITALY S.P.A DI RICERCHE BIOCHIMICHE

VIDEX TABLETS 100MG BRISTOL-MYERS SQUIBB ESTONIA EESTI AS 23.9.2003 FR Journal officiel de l'Union européenne 743

Trade Name Dosage Form Dose MA Holder Country

VIDEX CHEWABLE BUFFERED 100MG BRISTOL-MYERS SQUIBB UNITED STATES OF TABLETS COMPANY — USA AMERICA

VIDISEPT EYE DROPS 50MG/ML DR. GERHARD MANN, GERMANY CHEM.-PHARM. FABRIK GMBH

VIDISIC EYE GEL 2MG/1G DR.GERHARD MANN, GERMANY CHEM-PHARM. FABRIK GMBH

VIGAM LIQUID SOLUTION FOR 5% W/V BIOPRODUCTS UNITED KINGDOM INJECTION LABORATORY (BPL)

VIGAM-S, INTRAVENOUS HUMAN POWDER FOR INJECTION 5%W/V BPI, BIO PRODUCTS UNITED KINGDOM IGG LABORATORY

VIGORAN CAPSULE N/A LABORATOIRE GOLAZ SWITZERLAND SA

VIGORAN CAPSULES NA LABORATOIRE GOLAZ SWITZERLAND SA

VILONIT EMUGEL 1% W/W KLEVA LTD GREECE

VINBLASTINE INJECTION SOLUTION FOR 10MG/10ML F.H. FAULDING & CO. UNITED KINGDOM INJECTION LTD. (T/A DAVID BULL LABS)

VINBLASTINE SULPHATE INJ. SOLU- SOLUTION FOR 1MG/1ML FAULDING UNITED KINGDOM TION INJECTION PHARMACEUTICALS PLC

VINCRISTINE SOLUTION FOR 1MG/ML TEVA PHARMA BV NETHERLANDS INJECTION

VINCRISTINE PIERRE FABRE INJECTABLE SOLUTION 1MG/1ML PIERRE FABRE FRANCE MEDICAMENT

VINCRISTINE SULFATE SOLUTION FOR 2MG/2ML F.H. FAULDING & CO. AUSTRALIA INJECTION LTD. (T/A DAVID BULL LABS)

VINCRISTINE SULFATE 2MG/2ML SOLUTION FOR 1MG/ML PHARMACIA & UPJOHN AUSTRALIA INJECTION (PERTH) PTY LTD.

VINCRISTINE SULFATE SOL. FOR SOLUTION FOR N/A ABIC LTD. ISRAEL INJECTION INJECTION PHARMACEUTICAL & CHEMICAL INDUSTRIES

VINCRISTINE SULPHATE F/INJ LYOPHILISED CAKE FOR 1MG/VIAL M/S SERUM INSTITUTE OF INDIA LYOPHILISED INJ INDIA LIMITED

VINCRISTINE SULPHATE FOR POWDER FOR INJECTION 1MG SERUM INSTITUTE OF INDIA INJECTION BP INDIA LTD

VINCRISTINE SULPHATE FOR POWDER FOR INJECTION 2MG SERUM INSTITUTE OF INDIA INJECTION BP INDIA LTD

VINCRISTINE SULPHATE INJECTION SOLUTION FOR 1MG/ML FAULDING UNITED KINGDOM INJECTION PHARMACEUTICALS PLC

VIOXX 12.5MG TABLETS TABLET 12.5MG MERCK SHARP & DOHME UNITED KINGDOM LTD.

VIOXX 12.5MG/5ML ORAL ORAL SUSPENSION 12.5MG/5ML MERCK SHARP & DOHME UNITED KINGDOM SUSPENSION LTD.

VIOXX 25MG TABLETS TABLET 25MG MERCK SHARP & DOHME UNITED KINGDOM LTD.

VIOXX 25MG/5ML ORAL ORAL SUSPENSION 25MG/5ML MERCK SHARP & DOHME UNITED KINGDOM SUSPENSION LTD. 744 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

VIOXXACUTE TABLETS 50 MG MERCK SHARP AND UNITED KINGDOM DOHME LIMITED

VIPROLOX TABLETS 250MG AEGIS LTD CYPRUS

VIRACEPT POWDER FOR ORAL SOL. N/A ROCHE PHARMA SWITZERLAND (SCHWEIZ) LTD

VIRACEPT TABLET 250MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) LTD.

VIRAMUNE TABLETS 200MG BOEHRINGER INGELHEIM GERMANY INTERNATIONAL GMBH

VIRATIN TABLET 40MG RAZA MANUFACTURING MALAYSIA BERHAD

VIRGAN GEL 0.15% N/A LABORATOIRES THEA FRANCE

VIRORMONE INJECTION SOLUTION FOR 100MG/2ML FERRING UNITED KINGDOM INJECTION PHARMACEUTICALS LIMITED

VIROX TABLET 200MG SM PHARMACEUTICALS MALAYSIA SDN. BHD.

VIRUCID 200 TABLETS 200MG AEGIS LTD. CYPRUS

VIRUCID 400 TABLETS 400MG AEGIS LTD. CYPRUS

VIRUCID 800 TABLETS 800MG AEGIS LTD. CYPRUS

VIRU-MERZ SEROL GEL 0.1/10G MERZ+CO. GMBH & CO. GERMANY

VISCOAT OCULAR VISCOELASTIC N/A S.A ALCON-COUVREUR BELGIUM SOLN. N.V.

VISIPAQUE SOLUTION FOR 150MG I/ML NYCOMED IMAGING AS NORWAY INJECTION

VISIPAQUE SOLUTION FOR 270MG I/ML NYCOMED IMAGING AS NORWAY INJECTION

VISIPAQUE SOLUTION FOR 320MG I/ML NYCOMED IMAGING AS NORWAY INJECTION

VISIPAQUE SOLUTION FOR SEE REMARKS AMERSHAM HEALTH AS NORWAY INJECTION

VISIPAQUE SOLUTION FOR SEE REMARKS AMERSHAM HEALTH AS NORWAY INJECTION

VISKALDIX TABLETS N/A NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

VISKALDIX TABLET N/A SANDOZ PAKISTAN

VISKALDIX TABLETS NA NOVARTIS PAKISTAN

VISKALDIX TABLETS NA NOVARTIS PHARMA GERMANY GMBH

VISTACARPINE EYE DROPS 2%W/V EYE DROPS 2%W/V MARTINDALE UNITED KINGDOM PHARMACEUTICALS LTD

VISTACARPINE EYE DROPS 4% W/V EYE DROPS 4%W/V MARTINDALE UNITED KINGDOM PHARMACEUTICALS LTD

VISTAMETHASONE DROPS EYE DROPS 0.1%W/V MARTINDALE UNITED KINGDOM PHARMACEUTICALS LTD 23.9.2003 FR Journal officiel de l'Union européenne 745

Trade Name Dosage Form Dose MA Holder Country

VISTA-METHASONE N DROPS EYE DROPS N/A MARTINDALE UNITED KINGDOM F/EYE,EAR AND NOSE PHARMACEUTICALS LTD

VISTAPHENICOL EYE DROPS 0.5% EYE DROPS 0.5%W/V MARTINDALE UNITED KINGDOM BP PHARMACEUTICALS LTD

VISUDYNE POWDER FOR SOLN. FOR 15MG CIBA VISION AG SWITZERLAND INJ.

VISUDYNE POWDER F/SOL 15MG NOVARTIS SWITZERLAND F/INFUSION OPHTHALMICS AG

VIT A N OPHTHALMIC OINTMENT 25000 IU/100G FARMIGEA SPA ITALY

VIT B DENK FILM COATED TABLET NA E.DENK OHG GERMANY

VITAMIN 15 SOLCO COATED TABLETS N/A SOLCO BASLE LTD. SWITZERLAND

VITAMIN A EYE OINTMENT 10.0MG/G NOVARTIS SWITZERLAND OPHTHALMICS AG

VITAMIN A 10 000 E/G DISPERSA EYE OINTMENT 10 000IU/G CIBA VISION AG SWITZERLAND

VITAMIN B CO. BPC TABLET N/A SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

VITAMIN B COMPOUND TABLETS N/A REMEDICA LTD CYPRUS

VITAMIN B COMPOUND TABLETS NA PHARMAMED LTD. MALTA

VITAMIN C 100 TABLETS 100MG AEGIS CYPRUS

VITAMIN C 1000MG OBERLIN EFFERVESCENT TABLETS 1000MG LABORATOIRES FRANCE OBERLIN

VITAMIN C 50 TABLETS 50MG AEGIS LTD. CYPRUS

VITAMIN C 500 TABLETS 500MG AEGIS LTD. CYPRUS

VITAMIN C EFFERVESCENT TABLET 1000MG KRUGER GMBH & CO. KG GERMANY

VITAMIN C RED ORANGE TABLET 1000MG KRUGER GMBH & CO. KG GERMANY EFFERVESCENT

VITAMIN C UPSA EFFERVESCENT EFFERVESCENT TABLETS 1000MG LABORATOIRES UPSA FRANCE 1000MG

VITAMIN D 5000 CAPSULE 5MG SLOVAKOPHARMA AS SLOVAK REPUBLIC HLOHOVEC

VITAMIN D 800 CAPSULES 0.8MG SLOVAKPHARMA A.S. SLOVAK REPUBLIC HLOHOVEC

VITAMIN K1 SOLUTION FOR 2MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

VITAMIN K1 SOLUTION FOR 10MG/ML ABBOTT LABORATORIES UNITED STATES OF INJECTION AMERICA

VITAMIN K1 INJECTION SOLUTION FOR 1MG/0.5ML ABBOTT LABORATORIES UNITED STATES OF (PHYTONADIONE INJ USP) INJECTION AMERICA

VITAPLUS C PLUS TABLETS N/A ADCOCK INGRAM LTD SOUTH AFRICA

VITARNIN EFFERVESCENT TABLET N/A DR.GROSSMANN AG SWITZERLAND PHARMACA

VITATHION EFFERVESCENT GRANULES N/A LES LABORATOIRES FRANCE SERVIER

VITIRON SUSCAPS N/A MEPHA PHARMA AG SWITZERLAND 746 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

VITLIPID N ADULT EMULSION FOR INFUSION NA FRESENIUS KABI LIMITED UNITED KINGDOM

VITLIPID N ADULT EMULSION FOR EMULSION FOR INFUSION N/A FRESENIUS KABI LIMITED UNITED KINGDOM INJECTION

VITLIPID N INFANT EMULSION EMULSION FOR INFUSION NA FRESENIUS KABI LIMITED UNITED KINGDOM

VITREOLENT EYE DROPS N/A CIBA VISION AG SWITZERLAND

VITREOLENT EYE DROPS NA NOVARTIS SWITZERLAND OPHTHALMICS AG

VITRIMIX INTRAVENOUS INFUSION N/A PHARMACIA & UPJOHN SWEDEN SVERIGE AB

VITRITE/SEVEN SEAS/MINADEX ORAL SOLUTION N/A SEVEN SEAS LIMITED UNITED KINGDOM MULTIVIT. SYR

VIVALAN COATED TABLETS 50MG ZENECA LIMITED UNITED KINGDOM

VIVIDRIN ANTI-ALLERGIC SOLUTION 20MG/ML DR. GERHARD MANN, GERMANY EYEDROPS CHEM.-PHARM. FABRIK GMBH

VIVIOPTAL CAPSULES NA DR.GERHARD MANN, GERMANY CHEM.PHARM. FABRIK GMBH

VIVOTIF BERNA CAPS FOR ORAL N/A SWISS SERUM AND SWITZERLAND IMMUNISAT. VACCINE INSTITUTE

VIVOTIF BERNA CAPSULE N/A ISTITUTO ITALY SIEROTERAPICO BERNA S.R.L.

VOLMAX CONTROLLED RELEASE 4MG GLAXOSMITHKLINE GERMANY TABLET GMBH & CO KG

VOLMAX CONTROLLED RELEASE 4MG GLAXO ALLEN S.P.A. ITALY TABLET

VOLMAX 4MG MODIFIED RELEASE 4MG GLAXO WELLCOME UK UNITED KINGDOM TABLETS LIMITED

VOLMAX 8MG MODIFIED RELEASE 8MG GLAXO WELLCOME UK UNITED KINGDOM TABLETS LIMITED

VOLMAX TABLETS 4MG MODIFIED RELEASE 4MG GLAXO WELLCOME UK UNITED KINGDOM TABLET LTD T/A ALLEN & HANBURYS

VOLMAX TABLETS 8MG MODIFIED RELEASE 8MG GLAXO WELLCOME UK UNITED KINGDOM TABLET LTD T/A ALLEN & HANBURYS

VOLTAMICIN EYE DROPS N/A CIBA VISION AG SWITZERLAND

VOLTAMICIN EYE DROPS NA NOVARTIS SWITZERLAND OPHTHALMICS AG

VOLTAREN EMUGEL 10MG/G NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

VOLTAREN ENTERIC COATED 25MG NOVARTIS PHARMA SWITZERLAND TABLETS SCHWEIZ AG

VOLTAREN ENTERIC COATED 50MG NOVARTIS PHARMA SWITZERLAND TABLETS SCHWEIZ AG 23.9.2003 FR Journal officiel de l'Union européenne 747

Trade Name Dosage Form Dose MA Holder Country

VOLTAREN SUPPOSITORIES 12.5MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

VOLTAREN SUPPOSITORIES 50MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

VOLTAREN SUPPOSITORIES 100MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

VOLTAREN TABLET 25MG GEIGY PAKISTAN

VOLTAREN TABLET 50MG GEIGY PAKISTAN

VOLTAREN EMULGEL N/A GEIGY PAKISTAN

VOLTAREN E/C TABLETS 50MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

VOLTAREN DISPERSABLE TABLETS 50MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

VOLTAREN AMPOULES 75MG NOVARTIS NV — BELGIUM BELGIUM

VOLTAREN SUPPOSITORY 100MG NOVARTIS PHARMA GERMANY GMBH

VOLTAREN SUPPOSITORY 50MG NOVARTIS PHARMA GERMANY GMBH

VOLTAREN FILM COATED TABLETS 25MG NOVARTIS PHARMA AUSTRIA GMBH

VOLTAREN FILM COATED TABLETS 50MG NOVARTIS PHARMA AUSTRIA GMBH

VOLTAREN GASTRO-RESISTANT 50MG NOVARTIS FARMA SPA ITALY TABLETS

VOLTAREN DISPERSABLE TABLETS 50MG NOVARTIS (HELLAS) SACL GREECE

VOLTAREN 1% EMULGEL 1G/100G NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

VOLTAREN 1.5% ORAL DROPS (SUSP.) 15MG/ML NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

VOLTAREN DISPERS TABLETS 50MG NOVARTIS PHARMA AUSTRIA GMBH

VOLTAREN OPHTHA EYE DROPS 1MG/ML NOVARTIS PHARMA SWITZERLAND (SCHWEIZ) AG

VOLTAREN OPHTHA EYE DROPS 1.00MG/ML NOVARTIS SWITZERLAND OPHTHALMICS AG

VOLTAREN RETARD S.R. FILM COATED 100MG NOVARTIS PHARMA SWITZERLAND TABLETS SCHWEIZ AG

VOLTAREN RETARD FILM COATED TABLETS 75MG NOVARTIS PHARMA UNITED KINGDOM SCHWIEZ

VOLTAREN RETARD FILM COATED TABLET 100MG NOVARTIS GMBH AUSTRIA

VOLTAREN RETARD FILM COATED TABLETS 75MG NOVARTIS PHARMA AUSTRIA GMBH

VOLTAREN SR SLOW RELEASE TABLETS 75MG NOVARTIS FARMA SPA ITALY 748 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

VOLTAROL SUPPOSITORIES SUPPOSITORIES 12.5 MG NOVARTIS IRELAND PHARMACEUTICALS UK LIMITED

VOLTRAL TABLETS 50MG NOVARTIS PAKISTAN

VOLTRAL TABLET 25MG NOVARTIS PAKISTAN

VOLTRAL EMUGEL 1G/100G NOVARTIS PAKISTAN

VOMILUX TABLETS 10MG ATCO LABORATORIES PAKISTAN (PVT) LTD

VOMILUX SUSPENSION 1MG/1ML ATCO LABORATORIES PAKISTAN (PVT) LTD

VOSTAR 100 MG SUPPOSITORY SUPPOSITORY 100 MG DELTA HF ICELAND

VOSTAR 25 MG TABLETS 25MG DELTA HF ICELAND GASTRO-RESISTANT TABLETS

VOSTAR 50 MG TABLET 50 MG DELTA HF ICELAND GASTRO-RESISTANT TABLETS

VOSTAR 50 MG SUPPOSITORY SUPPOSITORY 50 MG DELTA HF ICELAND

VOSTAR-R 100MG PROLONGED TABLET 100 MG DELTA HF ICELAND RELEASE

VOSTAR-R 75 MG PROLONGED TABLET 75MG DELTA HF ICELAND RELEASE

V-PLEX TABLET TABLET N/A THE ACME LABRATORIES BANGLADESH LTD — BANGLADESH

WARFARIN TABLETS 1MG NORTON UNITED KINGDOM PHARMACEUTICALS LIMITED

WARFARIN TABLETS 3MG NORTON UNITED KINGDOM PHARMACEUTICALS LIMITED

WARFARIN TABLETS 5MG NORTON HEALTHCARE UNITED KINGDOM LIMITED

WARFARIN 1MG TABLETS TABLET 1MG FORLEY GENERICS LTD UNITED KINGDOM

WARFARIN 3MG TABLETS TABLETS 3MG FORLEY GENERICS LTD UNITED KINGDOM

WARFARIN 5MG TABLETS TABLETS 5MG FORLEY GENERICS UNITED KINGDOM LIMITED

WARIACTIV SPRAY 88G/100ML WALTER RITTER GMBH + GERMANY CO

WARI-FIGURAN-M SUGAR COATED TABLET N/A ARTESAN PHARMA GERMANY GMBH & CO. KG

WARI-PROCOMIL S/C TABLETS N/A WALTER RITTER GMBH + GERMANY CO.

WARTEX OINTMENT N/A J PICKLES (HARROGATE) UNITED KINGDOM LIMITED

WARTICON TOPICAL SOLUTION 0.5%W/W STIEFEL LABORATORIES UNITED KINGDOM UK LIMITED

WARTICON CREAM CREAM 0.15%W/W STIEFEL LABORATORIES UNITED KINGDOM UK LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 749

Trade Name Dosage Form Dose MA Holder Country

WARTICON FEM TOPICAL SOLUTION 0.5%W/V STIEFEL LABORATORIES UNITED KINGDOM (UK) LIMITED

WASP-EZE SPRAY N/A MUNDIPHARMA CYPRUS PHARMACEUTICALS LTD

WATER FOR INJECTION WATER FOR INJECTION NO ACTIVE INGR. LABORATOIRE FRANCE AGUETTANT AGUETTANT

WATER FOR INJECTION PE SOLUTION FOR NO ACTIVE INGR. POLPHARMA S.A. POLAND INJECTION

WATER FOR INJECTION/DEMO SOLUTION FOR NO ACTIVE ING. DEMO ABEE GREECE INJECTION

WATER FOR INJECTION/DEMO SOLUTION FOR NO ACTIVE ING. DEMO ABEE GREECE INJECTION

WATER FOR INJECTIONS SOLVENT FOR NA PHARMAMED MALTA PARENTERAL US PARENTERALS LTD.

WATER FOR INJECTIONS BP SOLUTION FOR NO ACTIVE ING. B.BRAUN MELSUNGEN GERMANY INJECTION

WATER FOR INJECTIONS BP SOLUTION FOR NO ACTIVE ING. B.BRAUN MELSUNGEN GERMANY INJECTION AG

WATERLEX TABLETS COATED TABLET N/A CATHAY OF UNITED KINGDOM BOURNEMOUTH LTD

WAXSOL SOLUTION 0.5%W/V NORGINE LIMITED UNITED KINGDOM

WAXSOL EAR DROPS 0.5% W/V NORGINE LIMITED UNITED KINGDOM

WAXWANE EAR DROPS EAR DROPS N/A THORNTON & ROSS LTD UNITED KINGDOM

WELLBUTRIN SR SUSTAINED RELEASE 150MG GLAXO WELLCOME INC. CANADA TABLET

WELLFERON INTERFERON SOLUTION FOR 10MU/ML THE WELLCOME UNITED KINGDOM ALFA-NI (1NS) 10MU INJECTION FOUNDATION LTD.

WELLFERON INTERFERON SOLUTION FOR 3MU/1ML THE WELLCOME UNITED KINGDOM ALFA-NI (1NS) 3MU INJECTION FOUNDATION LTD.

WHITE SOFT PARAFFIN BP OINTMENT NA BELL SONS & CO UNITED KINGDOM (DRUGGISTS) LIMITED

WHITFIELD'S OINTMENT OINTMENT N/A BELL SONS & CO UNITED KINGDOM (DRUGGISTS) LIMITED

WILPRAFEN SUSPENSION 3G/100ML YAMANOUCHI PHARMA GERMANY GMBH

WILPRAFEN FILM-COATED TABLETS 500MG YAMANOUCHI PHARMA GERMANY GMBH

WILPRAFEN FORTE SUSPENSION 6G/100ML YAMANOUCHI PHARMA GERMANY GMBH

WINRHO SDF — KIT PWS (1500IU) POWDER FOR INJECTION N/A CANGENE CANADA CORPORATION

WINRHO SDF-KIT PWS 1500IU POWDER FOR REC. 1500IU/2.5ML CANGENE CANADA CORPORATION

WINRHO SDF-KIT PWS(600IU) POWDER FOR REC. 600IU/2.5ML CANGENE CANADA CORPORATION

WITCH DOCTOR GEL GEL 81.539%W/W E C DE WITT & CO LTD UNITED KINGDOM

WITCH DOCTOR STIK SOLID STICK 15.88%W/W E C DE WITT & CO LTD UNITED KINGDOM 750 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

WITCH HAZEL DISTILLED BPC 1973 TOPICAL SOLUTION 100%V/V LCM LTD UNITED KINGDOM

WOBE-MUGOS E ENTERIC COATED TABLET N/A MUCOS PHARMA GMBH GERMANY & CO.

WOBENZYM N SUG. COAT. GAST-RES. N/A MUCOS PHARMA GMBH GERMANY TABL & CO.

WOODWARD'S GRIPE WATER — ORAL SOLUTION N/A SETON PRODUCTS LTD. UNITED KINGDOM ALC. AND SUGAR FR

WOODWARD'S GRIPE WATER — ORAL SOLUTION N/A SETON PRODUCTS LTD. UNITED KINGDOM ALCOHOL FREE

XALACOM EYE DROPS NA PHARMACIA NV/SA BELGIUM

XALATAN EYE DROPS 50MCG/ML PHARMACIA & UPJOHN BELGIUM AB

XALATAN EYE DROPS 0.005% W/V PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

XANAX TABLETS 0.25MG PHARMACIA N.V./S.A. BELGIUM

XANAX TABLETS 0.5MG PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

XANAX TABLETS 1MG PHARMACIA & UPJOHN BELGIUM N.V. / S.A.

XANOMEL 150 FILM-COATED TABLETS 150MG CLONMEL HEALTHCARE IRELAND LIMITED

XATRAL LP 10MG PROLONGED RELEASE 10MG LABORATOIRES FRANCE TABLET SYNTHELABO

XATRAL SR 5MG SR FILM-COATED TABLET 5MG LABORATOIRES FRANCE SYNTHELABO

XELODA 150MG FILM COATED TABLETS 150MG ROCHE PHARMA SWITZERLAND SCHWEIZ LTD.

XELODA 500MG FILM COATED TABLETS 500MG ROCHE PHARMA SWITZERLAND SCHWEIZ LTD.

XENAR TABLETS 250MG ALFA WASSERMANN ITALY S.P.A.

XENAR CONTROLLED RELEASE 750MG ALFA WASSERMANN ITALY TABLET S.P.A.

XENICAL CAPSULES 120MG ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG

XEPIN CREAM 5% W / W BIOGLAN UNITED KINGDOM LABORATORIES LTD

XIGRIS POWDER FOR SOLUTION 2MG/ML ELI LILLY NEDERLAND BV EUROPEAN COMMUNITY FOR INFUSION

XITHRONE CAPSULES 250MG AMOUN PHARMACEUTI- EGYPT CALS CO SAE

XYLOCAIN SOLUTION FOR 10MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION

XYLOCAIN SOLUTION FOR 20MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION

XYLOCAIN SPRAY SOLUTION 10MG/DOSE ASTRA LAKEMEDEL AB SWEDEN 23.9.2003 FR Journal officiel de l'Union européenne 751

Trade Name Dosage Form Dose MA Holder Country

XYLOCAIN GEL 2% W/W ASTRA LAKEMEDEL AB SWEDEN

XYLOCAIN OINTMENT 5% W/W ASTRA LAKEMEDEL AB SWEDEN

XYLOCAIN SOLUTION FOR 10MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION

XYLOCAIN SOLUTION FOR 20MG/ML ASTRA LAKEMEDEL AB SWEDEN INJECTION

XYLOCAIN ADRENALIN SOLUTION FOR N/A ASTRA LAKEMEDEL AB SWEDEN INJECTIONS

XYLOCAIN ADRENALIN SOLUTION FOR N/A ASTRA LAKEMEDEL SWEDEN INJECTION

XYLOCAIN ADRENALIN SOLUTION FOR N/A ASTRA LAKEMEDEL AB SWEDEN INJECTION

XYLOCAIN ADRENALIN SOLUTION FOR 20MG ASTRAZENECA SVERIGE SWEDEN INJECTION AB

XYLOCARD SOLUTION FOR 20MG/ML HASSLE LAKEMEDEL AB SWEDEN INJECTION

XYLOCARD CONCENTRATE FOR 200MG/ML HASSLE LAKEMEDEL AB SWEDEN INFUSION

XYLONOR SOLUTION FOR DENTAL N/A LABORATOIRES FRANCE USE SEPTODONT

XYLONOR GINGIVAL GEL N/A LABORATOIRES FRANCE SEPTODONT

XYLOPROCT OINTMENT N/A TIKA LAKEMEDEL AB SWEDEN

XYLOPROCT SUPPOSITORIES N/A TIKA LAKEMEDEL AB SWEDEN

XYZAL FILM-COATED TABLETS 5MG UCB-PHARMA AG SWITZERLAND

YASMIN FILM-COATED TABLETS N/A SCHERING AG GERMANY

YEAST 300MG BPC TABLET 300MG SUSSEX UNITED KINGDOM PHARMACEUTICAL LIMITED

YESAN EYE DROPS SOLUTION 0.5% W/V RAFARM GREECE

YUTOPAR TABLET 10MG SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

YUTOPAR INJECTION FLUID 10MG/ML SOLVAY P NETHERLANDS HARMACEUTICALS B.V.

YUTOPAR SR CAPSULE 40MG SOLVAY NETHERLANDS PHARMACEUTICALS B.V.

ZACIN CREAM 0.025% CREAM 0.025% W/W BIOGLAN UNITED KINGDOM LABORATORIES LTD

ZACLOFEN TABLET 10MG ALFARES SYRIA PHARMACEUTICALS

ZACLOFEN TABLETS TABLETS 10 MG ALFARES SYRIA PHARMACEUTICALS

ZACTIN CAPSULE 20MG ALPHAPHARM PTY AUSTRALIA LIMITED

ZACTOLINE TABLETS 5MG BIOGLAN IRELAND LABORATORIES LTD 752 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ZACTOLINE TABLETS 10MG BIOGLAN IRELAND LABORATORIES LTD

ZADAXIN SOLUTION FOR 1.6MG/ML SCICLONE ITALY INJECTIONS PHARMACEUTICALS ITALY S.R.L.

ZADITEN EYE DROPS 0.25MG/ML CIBA VISION AG SWITZERLAND

ZADITEN ORAL SOLUTION 1MG/ML NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

ZADITEN TABLETS 1MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG

ZADITEN HARD CAPSULES 1MG NOVARTIS FARMA — PORTUGAL PRODUTOS FARMACEUTICOS S.A.

ZADITEN 0.025% OPHTHA EYE DROPS NA NOVARTIS SWITZERLAND OPHTHALMICS AG

ZADITEN TABLETS 1MG TABLETS 1MG NOVARTIS PHARM. UK. UNITED KINGDOM LTD. T/A SANDOZ PHARM.

ZADORIN SUSCAPS 100MG MEPHA PHARMA AG SWITZERLAND

ZAMADOL CAPSULES 50MG ASTA MEDICA LTD UNITED KINGDOM

ZAMADOL INJECTION SOLUTION FOR 50MG/ML ASTA MEDICA LTD UNITED KINGDOM INJECTION

ZAMADOL SR CAPSULES 100MG MODIFIED RELEASE 100MG ASTA MEDICA LTD UNITED KINGDOM CAPSULE

ZAMADOL SR CAPSULES 150MG MDIFIED RELEASE 150MG ASTA MEDICA LTD UNITED KINGDOM CAPSULE

ZAMADOL SR CAPSULES 200MG MODIFIED RELEASE 200MG ASTA MEDICA LTD. UNITED KINGDOM CAPSULE

ZAMADOL SR CAPSULES 50MG MODIFIED RELEASE 50MG ASTA MEDICA LIMITED UNITED KINGDOM CAPSULE

ZANTAC TABLET 150MG GLAXO WELLCOME PAKISTAN

ZANTAC FILM-COATED TABLETS 75 MG DUNCAN SPAIN FARMACEUTICA S. A

ZANTAC EFFERVESCENT TABLETS 150MG LABORATOIRES FRANCE GLAXOSMITHKLINE

ZANTAC EFFERVESCENT TABLETS 300MG LABORATOIRES FRANCE GLAXOSMITHKLINE

ZANTAC TABLETS 300MG GLAXO LABORATORIES UNITED KINGDOM LIMITED

ZANTAC TABLETS 150MG GLAXO LABORATORIES UNITED KINGDOM LIMITED

ZANTAC SYRUP NA GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZANTAC 150 FILM-COATED TABLET 150MG GLAXO WELLCOME S.A. SPAIN TABLET

ZANTAC 300MG COATED TABLETS 300MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED 23.9.2003 FR Journal officiel de l'Union européenne 753

Trade Name Dosage Form Dose MA Holder Country

ZANTAC 75 RELIEF TABLETS 75MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZANTAC 75MG TABLETS 75MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZANTAC EFFERVESCENT TABLETS EFFERVESCENT TABLETS 150MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZANTAC INJECTION SOLUTION FOR 50MG/5ML GLAXO WELLCOME UK UNITED KINGDOM INJECTION LIMITED

ZANTAC INJECTION SOLUTION FOR 50MG/2ML GLAXO WELLCOME UK UNITED KINGDOM INJECTION LIMITED

ZANTAC INJECTION (50MG/2ML) SOLUTION FOR 50MG/2ML GLAXO WELLCOME UK UNITED KINGDOM INJECTION LTD T/A GLAXO LABS

ZANTAC SYRUP ORAL SOLUTION 150MG GLAXO WELLCOME UK UNITED KINGDOM LTD

ZANTAC SYRUP ORAL SOLUTION 150MG/10ML GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZANTAC SYRUP ORAL SOLUTION 150MG/DOSE GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZANTAC TABLETS TABLET 150MG GLAXO WELLCOME PAKISTAN

ZANTAC TABLETS COATED TABLETS 150MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZANTAC TABLETS 150MG COATED TABLET 150MG GLAXO WELLCOME UK UNITED KINGDOM LTD

ZANTAC TABLETS 300MG COATED TABLET 300MG GLAXO WELLCOME UK UNITED KINGDOM LTD

ZANTAC TABLETS 75MG TABLET 75MG GLAXO WELLCOME UK UNITED KINGDOM LTD

ZARONTIN CAPSULES 250MG CAPSULE 250MG WARNER LAMBERT (UK) UNITED KINGDOM LIMITED

ZAVEDOS POWDER FOR INJECTION 5MG/VIAL PHARMACIA & UPJOHN ITALY S.P.A.

ZAVEDOS POWDER FOR INJECTION 10MG/VIAL PHARMACIA & UPJOHN ITALY S.P.A

ZAVEDOS CAPSULES 5MG PHARMACIA & UPJOHN ITALY S.P.A.

ZAVEDOS CAPSULES 10MG PHARMACIA & UPJOHN ITALY S.P.A.

ZAVEDOS CAPSULE 25MG PHARMACIA & UPJOHN ITALY S.P.A.

ZAVERA TABLET 240MG ZAFA PAKISTAN

ZELMAC TABLETS 6MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AB

ZELOXIM TABLET 7.5MG BILIM ILAC SANAYIIA VE TURKEY ATICARET AS

ZELOXIM 15MG FORT TABLET 15MG BILIM ILAC SANANYII VE TURKEY TICARET AS

ZENALB (TM) 4.5 HUMAN SOLUTION FOR 4.5% W/V BPL, BIO PRODUCTS UNITED KINGDOM ALBUMIN 4.5% INJECTION LABORATORY 754 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ZENALB-20, 20% HUMAN STERILE LIQ. FOR INFU- N/A BPL, BIO PRODUCTS UNITED KINGDOM ALBUMIN SOLUTION SION LABORATORY

ZENTEL 0.4G/10ML ORAL SUSPENSION 0.4G/10ML LABORATOIRES FRANCE SMITHKLINE BEECHAM

ZENTEL 400MG FILM-COATED TABLET 400MG LABORATOIRES FRANCE SMITHKLINE BEECHAM

ZEPHOLIN TABLETS 10MG GENEPHARM S.A. GREECE

ZERIT CAPSULES 30MG BRISTOL-MYERS SQUIBB UNITED STATES OF COMPANY AMERICA

ZERIT CAPSULES 40MG BRISTOL-MYERS SQUIBB EUROPEAN COMMUNITY PHARMA EEIG

ZESTORETIC 20 TABLET N/A ZENECA LIMITED UNITED KINGDOM

ZESTORETIC-20 TABLETS N/A ZENECA LIMITED UNITED KINGDOM

ZESTRIL TABLET 5MG ZENECA LIMITED UNITED KINGDOM

ZESTRIL TABLET 10MG ZENECA LIMITED UNITED KINGDOM

ZESTRIL TABLETS 20MG ZENECA LIMITED UNITED KINGDOM

ZESTRIL 5MG TABLETS 5MG ICI PAKISTAN

ZESTRIL TABLETS 10MG TABLET 10MG ZENECA LIMITED UNITED KINGDOM

ZESTRIL TABLETS 20MG TABLET 20MG ZENECA LIMITED UNITED KINGDOM

ZESTRIL TABLETS 5MG TABLET 5MG ZENECA LIMITED UNITED KINGDOM

ZETAGAL POWDER FOR INJECTION 750MG/VIAL ELPEN S.A. GREECE

ZETAGAL POWDER FOR INJECTION 250MG/VIAL ELPEN S.A GREECE

ZETALAX SUPPOSITORIES 2.25G ZETA FARMACEUTICI ITALY S.P.A.

ZETRIZIN FILM COATED TABLET 10MG ALFARES SYRIA PHARMACEUTICALS

ZETRIZIN SYRUP 5MG/5ML ALFARES SYRIA PHARMACEUTICALS

ZETRIZIN FILM — COATED FILM-COATED TABLETS 10 MG ALFARES SYRIA TABLETS PHARMACEUTICALS

ZETRIZIN SYRUP SYRUP 5MG ALFARES SYRIA PHARMACEUTICALS

ZIAGEN FILM COATED TABLETS 300MG GLAXO GROUP LTD. UNITED KINGDOM

ZIAGEN ORAL SOLUTION 20MG/ML GLAXO GROUP LTD. UNITED KINGDOM

ZIDEPRIL TABLETS 50MG/25MG MINERVA GREECE PHARMACEUTICAL S.A.

ZIDOVAL VAGINAL GEL 0.75% W/W 3M HEALTH CARE UNITED KINGDOM LIMITED

ZIDOVIR 100 CAPSULES 100MG CIPLA LTD INDIA

ZIDOVUDINE COMBINO PHARM CAPSULES 100MG COMBINO PHARM SL SPAIN 23.9.2003 FR Journal officiel de l'Union européenne 755

Trade Name Dosage Form Dose MA Holder Country

ZILISTEN DRY POWDER 750MG/VIAL DEMO ABEE GREECE F/INJECTION

ZILISTEN VIAL DRY POWDER 1500 MG DEMO S.A. GREECE

ZIMOR CAPSULES 20MG LABORATORIOS RUBIO SPAIN S.A

ZINACEF POWDER FOR INJECTION 750MG GLAXO OPERATIONS UK UNITED KINGDOM LIMITED

ZINACEF POWDER FOR INJECTION 250MG GLAXO OPERATIONS UK UNITED KINGDOM LIMITED

ZINACEF «250» IM FLAC 250MG POWDER AND SOL FOR N/A GLAXOSMITHKLINE S.P.A ITALY + 1FIALA 1ML INJ.

ZINACEF «750» IM FLAC 750MG + POWDER AND SOL FOR N/A GLAXOSMITHKLINE S.P.A ITALY F3ML INJ.

ZINACEF INJECTION 1.5G POWDER FOR INJECTION 1.5G GLAXO OPERATIONS UK UNITED KINGDOM LTD

ZINACEF INJECTION 250MG POWDER FOR INJECTION 250MG GLAXO OPERATIONS UK UNITED KINGDOM LTD

ZINACEF INJECTION 750MG POWDER FOR INJECTION 750MG GLAXO OPERATIONS UK UNITED KINGDOM LTD

ZINC AND CASTOR OIL OINTMENT 7.5% W/W ADAMS HEALTHCARE UNITED KINGDOM OINTMENT BP LIMITED

ZINC AND CASTOR OIL OINTMENT N/A LCM LTD UNITED KINGDOM OINTMENT BP

ZINCABAND PASTE BANDAGE PAD 15% W/W SETON HEALTHCARE UNITED KINGDOM GROUP PLC

ZINCAST OINTMENT N/A BELL, SONS & CO UNITED KINGDOM (DRUGGISTS) LIMITED

ZINCAST BABY CREAM OINTMENT N/A BELL SONS & CO UNITED KINGDOM (DRUGGISTS) LIMITED

ZINCOMETIL EYE DROPS N/A FARMILA FARMACEUTICI ITALY MILANO S.P.A.

ZINDOLIN TABLETS 250MG REMEDICA LTD CYPRUS

ZINELI EYE DROPS SOLUTION 2% W/V RAFARM GREECE

ZINERYT LOTION N/A YAMANOUCHI PHARMA NETHERLANDS B.V.

ZINNAT SUSPENSION N/A GLAXO WELLCOME PAKISTAN

ZINNAT TABLET 250MG GLAXO WELLCOME PAKISTAN

ZINNAT COATED TABLETS 500MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZINNAT TABLETS 500MG GLAXO LABORATORIES UNITED KINGDOM LIMITED

ZINNAT ORAL SUSPENSION 250MG/5ML GLAXO LABORATORIES UNITED KINGDOM LIMITED

ZINNAT SUSPENSION GRANULES F/ORAL SUSP. 250MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LIMITED 756 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ZINNAT SUSPENSION GRANULES F/ORAL SOLN 125MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZINNAT SUSPENSION GRANULES FOR ORAL 125MG/5ML GLAXO WELLCOME UK UNITED KINGDOM SOLN LIMITED

ZINNAT SUSPENSION 125MG/5ML GRANULES FOR ORAL 125MG/5ML GLAXO WELLCOME UK UNITED KINGDOM SOLN. LTD

ZINNAT SUSPENSION 250MG/5ML GRANULES FOR ORAL 250MG/5ML GLAXO WELLCOME UK UNITED KINGDOM SUSP. LTD

ZINNAT TABLETS TABLETS 250MG GLAXOWELLCOME PAKISTAN

ZINNAT TABLETS COATED TABLETS 125MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZINNAT TABLETS COATED TABLETS 250MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZINNAT TABLETS 125MG COATED TABLET 125MG GLAXO WELLCOME UK UNITED KINGDOM LTD

ZINNAT TABLETS 250MG COATED TABLET 250MG GLAXO WELLCOME UK UNITED KINGDOM LTD

ZITAZONIUM 10MG TABLETS 10MG EGIS PHARMACEUTICALS HUNGARY LTD.

ZITAZONIUM 20MG TABLETS 20MG EGIS PHARMACEUTICALS HUNGARY LTD.

ZITHROMAX CAPSULE 250MG PFIZER LIMITED UNITED KINGDOM

ZITHROMAX POWDER FOR ORAL N/A PFIZER LIMITED UNITED KINGDOM SUSPENSIO

ZITHROMAX TABLETS 500MG COATED TABLETS 500MG PFIZER LIMITED UNITED KINGDOM

ZIVIR CAPSULE 100MG OKASA PHARMA PVT INDIA LTD- INDIA

ZOCOR TABLET 10MG M.S.D. PAKISTAN

ZOCOR TABLETS 40MG MERCK SHARP & DOHME NETHERLANDS B.V.

ZOCOR 10MG TABLET 10MG MERCK SHARP & DOHME NETHERLANDS B.V.

ZOCOR 10MG TABLETS 10MG MERCH SHARP & DOHME PAKISTAN

ZOCOR 20MG TABLET 20MG MERCK SHARP & DOHME NETHERLANDS

ZOCOR 20MG TABLETS 20MG MERCH SHARP & DOHME PAKISTAN

ZOFRAN INJECTION SOLUTION FOR 2MG/ML GLAXO OPERATIONS UK UNITED KINGDOM INJECTION LIMITED

ZOFRAN INJECTION 2MG/ML SOLUTION FOR 2MG/ML GLAXO OPERATIONS UK UNITED KINGDOM INJECTION LTD

ZOFRAN SYRUP SYRUP 0.1% W/V GLAXO WELLCOME UK UNITED KINGDOM LTD

ZOFRAN SYRUP ORAL LIQUID 4MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LTD

ZOFRAN SYRUP ORAL LIQUID 4MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LTD 23.9.2003 FR Journal officiel de l'Union européenne 757

Trade Name Dosage Form Dose MA Holder Country

ZOFRAN SYRUP ORAL LIQUID 4 MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LTD

ZOFRAN SYRUP ORAL LIQUID 4MG/5ML GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZOFRAN TABLETS COATED TABLET 8MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZOFRAN TABLETS COATED TABLETS 4MG GLAXO WELLCOME UK UNITED KINGDOM LIMITED

ZOFRAN TABLETS 4MG COATED TABLET 4MG GLAXO WELLCOME UK UNITED KINGDOM LTD

ZOFRAN TABLETS 8MG COATED TABLET 8MG GLAXO WELLCOME UK UNITED KINGDOM LTD

ZOIRAL TABLETS 10MG AEGIS LTD CYPRUS

ZOIRAL TABLETS 25MG AEGIS LTD CYPRUS

ZOIRAL 10 CAPSULES 10MG AEGIS LTD. CYPRUS

ZOIRAL 25 CAPSULES 25MG AEGIS LTD CYPRUS

ZOIRAL 50 CAPSULES 50MG AEGIS LTD. CYPRUS

ZOLADEX SOLUTION FOR 3.6MG ZENECA LIMITED UNITED KINGDOM INJECTION

ZOLADEX LA SUSTAINED RELEASE 10.8MG ZENECA LIMITED UNITED KINGDOM DEPOT

ZOLADEX LA SOLUTION FOR 10.8MG ZENECA LIMITED UNITED KINGDOM INJECTION

ZOLAREM 0.25 TABLETS 0.25MG AEGIS LTD. CYPRUS

ZOLAREM 0.5 TABLETS 0.5MG AEGIS LTD. CYPRUS

ZOLAREM 1 TABLET 1MG AEGIS LTD. CYPRUS

ZOMETA POWDER F/SOLUTION 4MG/VIAL NOVARTIS PHARMA SWITZERLAND F/INF. SCHWEIZ AG

ZOMETA POWDER AND SOLVENT 4MG/VIAL NOVARTIS EUROPHARM EUROPEAN COMMUNITY F/INF LIMITED

ZOMIG COATED TABLETS 2.5MG ZENECA LIMITED UNITED KINGDOM

ZOTON CAPSULES 15MG CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD.

ZOTON CAPSULES 30MG CYANAMID OF GREAT UNITED KINGDOM BRITAIN LTD.

ZOVIRAX CREAM 0.05G/G GLAXO WELLCOME PAKISTAN

ZOVIRAX SUSPENSION 200MG/5ML GLAXO WELLCOME GERMANY GMBH & CO

ZOVIRAX TABLETS 200MG GLAXOSMITHKLINE AB SWEDEN

ZOVIRAX TABLETS 400MG GLAXOSMITHKLINE AB SWEDEN

ZOVIRAX TABLETS 800MG GLAXOSMITHKLINE AB SWEDEN

ZOVIRAX COLD SORE CREAM CREAM 5% W/W THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED 758 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ZOVIRAX CREAM CREAM 0.5%W/W GLAXOWELLCOME PAKISTAN

ZOVIRAX EYE OINTMENT 3% W/W EYE OINTMENT 3% W/W THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

ZOVIRAX I.V. 250MG POWDER FOR INJECTION 250MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

ZOVIRAX SUSPENSION ORAL SUSPENSION 200MG/5ML THE WELLCOME UNITED KINGDOM 200MG/5ML FOUNDATION LIMITED

ZOVIRAX TABLETS 200MG TABLETS 200MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

ZOVIRAX TABLETS 400MG TABLETS 400MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

ZOVIRAX TABLETS 800MG TABLETS 800MG THE WELLCOME UNITED KINGDOM FOUNDATION LIMITED

ZYBAN SUSTAINED RELEASE 150MG GLAXO WELLCOME INC. CANADA TABLETS

ZYBAN PROLONGED RELEASE 150MG GLAXO WELLCOME UK UNITED KINGDOM TABLETS LTD

ZYLORIC TABLETS 100MG THE WELLCOME UNITED KINGDOM FOUNDATION LTD.

ZYLORIC TABLETS 300MG THE WELLCOME UNITED KINGDOM FOUNDATION

ZYLORIC TABLET 100MG GLAXO WELLCOME PAKISTAN

ZYLORIC TABLET 100MG GLAXO WELLCOME PAKISTAN

ZYLORIC TABLETS 100MG GLAXO WELLCOME SPA ITALY

ZYLORIC SCORED TABLETS 300MG GLAXO WELLCOME SPA ITALY

ZYMAFLUOR TABLETS 0.25MG NOVARTIS CONSUMER SWITZERLAND HEALTH SA

ZYMAFLUOR TABLETS 1MG NOVARTIS CONSUMER SWITZERLAND HEALTH SA

ZYMOPLEX TABLET 10MG GENEPHARM S.A. GREECE

ZYOMET GEL 0.75%W/W GOLDSHIELD UNITED KINGDOM PHARMACEUTICALS LIMITED

ZYPREXA COATED TABLETS 15MG ELI LILLY NEDERLAND BV EUROPEAN COMMUNITY

ZYPREXA 10MG COATED TABLET 10MG ELI LILLY NEDERLAND BV NETHERLANDS

ZYPREXA 10MG TABLETS 10MG LILLY PAKISTAN

ZYPREXA 5MG COATED TABLET 5MG ELI LILLY NEDERLAND BV NETHERLANDS

ZYPREXA 7.5MG COATED TABLET 7.5MG ELI LILLY NEDERLAND BV NETHERLANDS

ZYRTEC TABLET 10MG UCB PHARMA S.A. FRANCE 23.9.2003 FR Journal officiel de l'Union européenne 759

Trade Name Dosage Form Dose MA Holder Country

ZYRTEC ORAL SOLUTION 2.5MG/2.5ML UCB PHARMA S.A. FRANCE

ZYRTEC TABLET 10MG UNITED CHEMICALS OF PAKISTAN BELGIUM

ZYRTEC TABLET 10MG UCB PAKISTAN

ZYRTEC ORAL SOLUTION 5MG/5ML UCB PAKISTAN

ZYRTEC ORAL SOLUTION 2.5MG/2.5ML UCB PHARMA FRANCE

ZYRTEC FILM COATED TABLETS 10MG UCB PHARMA FRANCE

ZYRTEC SYRUP SYRUP 1MG/1ML UNITED CHEMICALS OF PAKISTAN BELGIUM

ZYTRAM XL TABLETS 300MG MODIFIED RELEASE 300MG NAPP LABORATORIES UNITED KINGDOM TABLET LIMITED

ZYTRAM XL TABLETS 400MG COATED TABLET 400MG NAPP LABORATORIES UNITED KINGDOM LIMITED

ZYTRAM-XL TABLETS 150MG MODIFIED RELEASE 150MG NAPP LABORATORIES UNITED KINGDOM TABLET LIMITED

ZYTRAM-XL TABLETS 200MG MODIFIED RELEASE 200MG NAPP LABORATORIES UNITED KINGDOM TABLETS LIMITED

ZYVOX ORAL SUSPENSION NA PHARMACIA & UPJOHN UNITED STATES OF COMPANY AMERICA

ZYVOX TABLETS 400MG PHARMACIA & UPJOHN UNITED STATES OF COMPANY AMERICA

ZYVOX SOLUTION FOR INFUSION 2MG/ML PHARMACIA NORGE AS NORWAY

ZYVOX FILM COATED TABLETS 600MG PHARMACIA LIMITED UNITED KINGDOM

ZYVOX SOLUTION FOR INFUSION 2MG/ML PHARMACIA NORGE AS NORWAY

ZYVOXID FILM-COATED TABLETS 600MG PHARMACIA NV/SA BELGIUM

DAIVOBET OINTMENT NA LEO PHARMACEUTICAL DENMARK PRODUCTS

ACTOPHLEM COUGH SYRUP SYRUP NA ADCOCK INGRAM PARK SOUTH AFRICA

INGRAMS CAMPHOR CREAM CREAM 0.67G/100G ADCOCK INGRAM SOUTH AFRICA LIMITED

LOCAINE A SOLUTION FOR NA ADCOCK INGRAM SOUTH AFRICA INJECTION LIMITED

REMICAINE JELLY TOPICAL JELLY 2G/100G ADCOCK INGRAM SOUTH AFRICA IMITED

COMPRAL HEADACHE TABLETS TABLETS NA ADCOCK INGRAM SOUTH AFRICA LIMITED

TEEJEL GEL NA ADCOCK INGRAM SOUTH AFRICA LIMITED

SOLPHYLLEX SYRUP SYRUP NA ADCOCK INGRAM SOUTH AFRICA LIMITED

GRIPPON CAPSULES CAPSULE NA ADCOCK INGRAM SOUTH AFRICA LIMITED 760 FR Journal officiel de l'Union européenne 23.9.2003

Trade Name Dosage Form Dose MA Holder Country

ADCO-ACYCLOVIR 200MG TABLETS 200MG ADCOCK INGRAM SOUTH AFRICA LIMITED

BIOPLUS S SYRUP NA ADCOCK INGRAM SOUTH AFRICA LIMITED

MYPRODOL SUSPENSION SUSPENSION NA ADCOCK INGRAM SOUTH AFRICA LIMITED

URIZONE 3 G GRANULES 3G/SACHET ADCOCK INGRAM SOUTH AFRICA LIMITED

MEDI-KEEL A HONEY AND LEMON LOZENGES NA ADCOCK INGRAM SOUTH AFRICA THROAT LOZENGES LIMITED

MEDI-KEEL A BLACKCURRANT LOZENGES NA ADCOCK INGRAM SOUTH AFRICA THROAT LOZENGES LIMITED

NAZENE NASAL SPRAY NASAL SPRAY NA ADCOCK INGRAM SOUTH AFRICA LIMITED

BIDOMAK FE LIQUID NA ADCOCK INGRAM SOUTH AFRICA LIMITED

SABAX FOSENEMA SOLUTION NA ADCOCK INGRAM SOUTH AFRICA CRITICAL CARE (PTY) LTD

LOTEM SUSPENSION SUSPENSION NA ADCOCK INGRAM SOUTH AFRICA LIMITED

ADCO-ACYCLOVIR TOPICAL CREAM 250MG/5G ADCOCK INGRAM SOUTH AFRICA CREAM LIMITED

ADCO-SODASOL GRANULES NA ADCOCK INGRAM SOUTH AFRICA LIMITED

UNICROM 2% EYE DROPS BTL/5ML EYE DROPS 2% W/V UNIMED LABORATORY TUNISIA

CALCIUM CHLORIDE 10%-UNIMED SOLUTION FOR 10% W/V UNIMED LABORATORY TUNISIA INJECTION

MYDRICOL 0.5% EYE DROPS EYE DROPS 0.5% W/V UNIMED LABORATORY TUNISIA BTL/5ML

TUSSCODIN RETARD — SYRUP 0.3G/100ML LANNACHER HEILMITTEL AUSTRIA HUSTENSAFT GmbH

LEUKERAN 2MG TABLETS 2.1MG GLAXO WELLCOME GERMANY GmbH & Co

ALLERGOTIN-EYE DROPS SOLUTION 2%W/V COOPER SA GREECE

CIPRALEX FILM-COATED TABLETS TABLETS 20MG H. LUNDBECK A/S DENMARK 20MG

CIPRALEX FILM-COATED TABLETS TABLETS 15MG H. LUNDBECK A/S DENMARK 15MG

CIPRALEX FILM-COATED TABLETS TABLETS 10MG H. LUNDBECK A/S DENMARK 10MG

CIPRALEX FILM-COATED TABLETS TABLETS 5MG H. LUNDBECK A/S DENMARK 5MG

URO VAXOM CAPSULES 6MG OM PHARMA SWITZERLAND 23.9.2003 FR Journal officiel de l'Union européenne 761

Trade Name Dosage Form Dose MA Holder Country

HAEMOKION INJECTION SOLUTION FOR 10MG/ML AMOUN EGYPT INJECTION PHARMACEUTICALS CO. S.A.E.

LYSOVIR 100MG CAPSULES CAPSULES 100MG ALLIANCE UNITED KINGDOM PHARMACEUTICALS LIMI- TED

AQUEOUS CREAM BP CREAM CREAM 30% W/W JM LOVERIDGE PLC UNITED KINGDOM

TUSCALMAN SYRUP NA LABORATORIO AUSTRIA FARMACEUTICO S.I.T.