450 Official Journal of the European Union 23.9.2003
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450EN Official Journal of the European Union 23.9.2003 Appendix A referred to in Chapter 1, point 2 of Annex XI (*) Lists as provided by Malta in one language of pharmaceutical products for which a marketing authorisation issued under Maltese law prior to the date of accession shall remain valid until it is renewed in compliance with the acquis or until 31 December 2006, whichever is the earlier. Mention on this list does not prejudge whether or not the pharmaceutical product in question has a marketing authorisation in compliance with the acquis. LIST OF PHARMACEUTICALS TO BE INCLUDED UNDER THE ARRANGEMENT NEGOTIATED UNDER CHAPTER 1 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 (*) For the text of Annex XI see OJ L 236, 23.9.2003, p. 859. 23.9.2003EN Official Journal of the European Union 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 SOLUTION FOR 10% ABBOTT LABORATORIES UNITED STATES OF USP INJECTION AMERICA 10% W/V CALCIUM GLUCONATE INJECTION SOLUTION 10% W/V B.BRAUN MELSUNGEN GERMANY INJECTION BP AG 10% W/V GLUCOSE INFUSION SOLUTION 10% W/V B.BRAUN MELSUNGEN GERMANY INTRAVENOUS 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 SOLUTION FOR 20% ABBOTT LABORATORIES UNITED STATES OF USP INJECTION AMERICA 20% W/V CALCIUM GLUCONATE SOLUTION FOR 20% W/V B.BRAUN MELSUNGEN GERMANY INJECTION BP INJECTION AG 20% W/V GLUCOSE INFUSION SOLUTION 20% W/V B.BRAUN MELSUNGEN GERMANY INTRAVENOUS SOLUTION BP AG 30% W/V GLUCOSE INJECTION BP INFUSION SOLUTION 30% W/V B.BRAUN MELSUNGEN GERMANY AG 452EN Official Journal of the European Union 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 INFUSION SOLUTION 40% W/V B.BRAUN MELSUNGEN GERMANY INTRAVENOUS 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% SOLUTION FOR IV INJ N/A ABBOTT LABORATORIES UNITED STATES OF SODIUM 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 23.9.2003EN Official Journal of the European Union 453 Trade Name Dosage Form Dose MA Holder Country 7.45% W/V POTASSIUM SOLUTION FOR 7.45% W/V B.BRAUN MELSUNGEN GERMANY CHLORIDE 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. 8.4% W/V B.BRAUN MELSUNGEN GERMANY INJECTION BP CONCENTRATE AG 8.4%W/V SODIUM BICARBONATE INFUSION SOLUTION 8.4% W/V B.BRAUN MELSUNGEN GERMANY IV INFUSION AG AAA MOUTH AND THROAT OROMUCOSAL SPRAY 1.5MG/SP MANX PHARMA LIMITED UNITED KINGDOM SPRAY 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.