Journal Officiel De L'union Européenne 23.9.2003
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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.