TREATY OF ACCESSION: ANNEX XI

Transcription

1 NEGOTIATIONS ON ACCESSION BY THE CZECH REPUBLIC, ESTONIA, CYPRUS, LATVIA, LITHUANIA, HUNGARY, MALTA, POLAND, SLOVENIA AND SLOVAKIA TO THE EUROPEAN UNION Brussels, 31 January 2003 (OR. en) AA 38/03 ADD 1 TREATY OF ACCESSION: ANNEX XI DRAFT LEGISLATIVE ACTS AND OTHER INSTRUMENTS Delegations will find attached the draft Treaty of Accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia to the European Union: ANNEX XI. Source document(s): MD 74/1/02 REV 1, 449/3/03 REV 3, 605/1/03 AA 38/03 ADD 1 JUR CDR/JF/mb EN

2 MD 74/1/02 REV 1 Appendix A referred to in Title I: Free Movement of Goods, paragraph 2 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 TO BE INCLUDED UNDER THE ARRANGEMENT NEGOTIATED UNDER CHAPTER 1 Trade Name Dosage Form Dose MA Holder Country 0.45% SODIUM CHLORIDE INFUSION N/A B.BRAUN GERMANY IN 5% GLUCOSE MELSUNGEN AG 0.45% SODIUM CHLORIDE FOR 0.45% ABBOTT UNITED STATES OF USP AMERICA 0.45% SODIUM CHLORIDE FOR 4.5MG/ML ABBOTT UNITED STATES OF, USP IV AMERICA 0.9% SOD. CHLORIDE AND FOR N/A BAXTER 5% GLUCOSE 0.9% SODIUM CHLORIDE INFUSION N/A B.BRAUN GERMANY AND 5% GLUCOSE IV INF MELSUNGEN AG 0.9% SODIUM CHLORIDE FOR 9MG/ML ABBOTT UNITED STATES OF INJ AMERICA 0.9% SODIUM CHLORIDE FOR 0.9% ABBOTT UNITED STATES OF USP AMERICA 0.9% SODIUM CHLORIDE FOR 0.9% ABBOTT UNITED STATES OF USP AMERICA 0.9% SODIUM CHLORIDE IRRIGATION FOR IRRIGATION 9MG/ML ABBOTT UNITED STATES OF AMERICA AA 38/03 ADD 1 Act/Annex XI/en 1

3 0.9% SODIUM CHLORIDE IRRIGATION USP FOR IRRIGATION 0.9% W/V SODIUM FOR CHLORIDE BP 0.9% W/V SODIUM IRRIGATION CHLORIDE IRRIGATION SOL. 0.9% W/V SODIUM INFUSION CHLORIDE IV INFUSION BP 1% W/V LIDOCAINE 1.5% GLYCINE IRRIGATION IRRIGATION USP 1.5% GLYCINE IRRIGATION FOR USP IRRIGATION 1.5% W/V GLYCINE IRRIGATION IRRIGATION SOL. BP 1/2 STRENGTH CMPD. FOR SODIUM LACTATE + GLUC 10% CALCIUM CHLORIDE FOR 10% CALCIUM CHLORIDE FOR USP (ABBOJECT ) 10% DEXTROSE AND FOR 0.225% SODIUM CHLORIDE US 10% DEXTROSE AND FOR 0.225% SODIUM CHLORIDE USP 10% DEXTROSE FOR USP 10% DEXTROSE FOR USP 10% MANNITOL I.V. FOR 10% MANNITOL IV FOR 10% MANNITOL IV FOR USP 0.9% ABBOTT UNITED STATES OF AMERICA 0.9% W/V B.BRAUN GERMANY MELSUNGEN AG 0.9% W/V B.BRAUN GERMANY MELSUNGEN AG 0.9% W/V B.BRAUN GERMANY MELSUNGEN AG 1% W/V B.BRAUN GERMANY MELSUNGEN AG 15MG/ML ABBOTT UNITED STATES OF AMERICA 15MG/ML ABBOTT UNITED STATES OF AMERICA 1.5% W/V B.BRAUN GERMANY MELSUNGEN AG N/A BAXTER 100MG/ML ABBOTT UNITED STATES OF AMERICA 100MG/ML ABBOTT UNITED STATES OF AMERICA N/A ABBOTT UNITED STATES OF AMERICA NA ABBOTT UNITED STATES OF AMERICA 100MG/ML ABBOTT UNITED STATES OF AMERICA 10% ABBOTT UNITED STATES OF AMERICA 100MG/ML ABBOTT UNITED STATES OF. AMERICA 10% ABBOTT UNITED STATES OF AMERICA 10% ABBOTT UNITED STATES OF AMERICA AA 38/03 ADD 1 Act/Annex XI/en 2

4 10% W/V CALCIUM 10% W/V B.BRAUN GERMANY GLUCONATE BP MELSUNGEN AG 10% W/V GLUCOSE INTRAVENOUS INFUSION BP INFUSION 10% W/V B.BRAUN MELSUNGEN AG GERMANY 10%DEXTROSE AND 0.225% FOR N/A ABBOTT UNITED STATES OF SODIUM CHLORIDE INJ IV 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 USP FOR 20MG/ML ABBOTT UNITED STATES OF AMERICA 2% W/V LIDOCAINE 2% W/V B.BRAUN MELSUNGEN AG GERMANY 20% DEXTROSE FOR 20% ABBOTT UNITED STATES OF USP AMERICA 20% DEXTROSE, FOR 200MG/ML ABBOTT UNITED STATES OF USP IV AMERICA 20% MANNITOL IV FOR 20% MANNITOL IV FOR USP 20% W/V CALCIUM FOR GLUCONATE BP 20% W/V GLUCOSE INFUSION INTRAVENOUS BP 30% W/V GLUCOSE INFUSION BP 37.5%W/V GLUCOSE WITH INFUSION ELECTROLYTES IVI 3-CIF POWDER FOR 4.2% W/V SODIUM INFUSION BICARBONATE IVI BP 40% W/V GLUCOSE INFUSION BP CONCENT 40% W/V GLUCOSE INFUSION INTRAVENOUS INFUSION BP 200MG/ML ABBOTT UNITED STATES OF AMERICA 20% ABBOTT UNITED STATES OF AMERICA 20% W/V B.BRAUN GERMANY MELSUNGEN AG 20% W/V B.BRAUN GERMANY MELSUNGEN AG 30% W/V B.BRAUN GERMANY MELSUNGEN AG N/A B.BRAUN GERMANY MELSUNGEN AG 1000MG ELSAAD PHARMA SYRIA N/A B.BRAUN GERMANY MELSUNGEN AG 40% W/V B.BRAUN GERMANY MELSUNGEN AG 40% W/V B.BRAUN GERMANY MELSUNGEN AG AA 38/03 ADD 1 Act/Annex XI/en 3

5 5% DEXTROSE AND 0.225% FOR NA ABBOTT UNITED STATES OF NACL AMERICA 5% DEXTROSE AND 0.225% FOR N/A ABBOTT UNITED STATES OF SODIUM CHLORIDE INJ AMERICA 5% DEXTROSE AND 0.45% FOR NA ABBOTT UNITED STATES OF NACL INJ. AMERICA 5% DEXTROSE AND 0.45% FOR N/A ABBOTT UNITED STATES OF SODIUM CHLORIDE INJ IV INJ AMERICA 5% DEXTROSE AND 0.9% FOR NA ABBOTT UNITED STATES OF NACL INJ. AMERICA 5% DEXTROSE AND 0.9% FOR N/A ABBOTT UNITED STATES OF SODIUM CHLORIDE INJ IV INJ AMERICA 5% DEXTROSE AND FOR N/A ABBOTT UNITED STATES OF LACTATED RINGER'S INJ IV INFUSION AMERICA USP 5% DEXTROSE FOR 5% ABBOTT UNITED STATES OF USP AMERICA 5% DEXTROSE, FOR 50MG/ML ABBOTT UNITED STATES OF USP AMERICA 5% W/V GLUCOSE FOR 5% W/V B.BRAUN GERMANY BP MELSUNGEN AG 5% W/V GLUCOSE INFUSION 5% W/V B.BRAUN GERMANY INTRAVENOUS INFUSION MELSUNGEN AG BP 5.85% W/V SODIUM FOR 5.85% W/V B.BRAUN GERMANY CHLORIDE BP MELSUNGEN AG 50% DEXTROSE FOR 50% W/V ABBOTT UNITED STATES OF USP AMERICA 50% DEXTROSE FOR 50% ABBOTT UNITED STATES OF USP AMERICA 50% DEXTROSE, FOR 500MG/ML ABBOTT UNITED STATES OF USP AMERICA 50% MAGNESIUM SULFATE FOR 500MG/ML ABBOTT UNITED STATES OF IV/IM INJ AMERICA 50% MAGNESIUM SULFATE FOR 4 MEQ MG++ ABBOTT UNITED STATES OF, USP /ML AMERICA 50% MAGNESIUM FOR 50% ABBOTT UNITED STATES OF SULPHATE INJ USP AMERICA 50% W/V GLUCOSE INFUSION 50% W/V B.BRAUN GERMANY BP MELSUNGEN AG AA 38/03 ADD 1 Act/Annex XI/en 4

6 50% W/V GLUCOSE BP INFUSION CONCENT 7.45% W/V POTASSIUM FOR CHLORIDE 70% W/V GLUCOSE INFUSION BP 8.4% SODIUM BICARBONATE INJ USP F/ 8.4% SODIUM FOR BICARBONATE INJ USP 8.4% SODIUM FOR BICARBONATE IV,USP 8.4% W/V SODIUM INFUSION SOL. BICARBONATE CONCENTRATE BP 8.4%W/V SODIUM INFUSION BICARBONATE IV INFUSION AAA MOUTH AND THROAT OROMUCOSAL SPRAY SPRAY AB-ACICLOVIR 250 POWDER FOR AB-DICLOFENAC 75 FOR ABDINE COLD RELIEF POWDER FOR POWDER ORAL AB-ERYTHROMYCIN 1000 POWDER FOR AB-HYDROCORTISONE 100 POWDER FOR 50% W/V B.BRAUN MELSUNGEN AG 7.45% W/V B.BRAUN MELSUNGEN AG 70% W/V B.BRAUN MELSUNGEN AG 84MG/ML ABBOTT 8.4% ABBOTT 84MG/ML ABBOTT 8.4% W/V B.BRAUN MELSUNGEN AG 8.4% W/V B.BRAUN MELSUNGEN AG 1.5MG/SP MANX PHARMA 250MG/VIAL ASTRAPIN PHARMA GMBH & CO. KG 75MG/3ML ASTRAPIN PHARMA GMBH & CO.KG 650MG BELL SONS & CO (DRUGGISTS) 1000MG ASTRAPIN PHARMA GMBH & CO.KG 100MG ASTRAPIN PHARMA GMBH & CO. KG ABIDEC DROPS ORAL N/A WARNER-LAMBERT CONSUMER ABIDEC DROPS ORAL N/A PFIZER CONSUMER AB- SUSPENSION FOR 40MG/ML ASTRAPIN PHARMA METHYLPREDNISOLONE GMBH & CO. KG ACETATE 40 GERMANY GERMANY GERMANY UNITED STATES OF AMERICA UNITED STATES OF AMERICA UNITED STATES OF AMERICA GERMANY GERMANY GERMANY GERMANY GERMANY GERMANY GERMANY AA 38/03 ADD 1 Act/Annex XI/en 5

7 AB-METOCLOPRAMIDE FOR 10MG/2ML ASTRAPIN PHARMA GERMANY HCL 10 GMBH & CO. KG ABSINT 2MG 2MG MEDOCHEMIE CYPRUS ABSINT 2MG CAPSULE 2MG MEDOCHEMIE CYPRUS ACCOLATE FILM COATED 20MG ZENECA ACCOLATE FILM COATED 40MG ZENECA ACCOLATE COATED 20MG ZENECA ACESAL 300MG GEYMONAT SPA ITALY ACETAZOLAMIDE 250MG 250MG MEDOCHEMIE CYPRUS ACETAZOLAMIDE BP 250MG REMEDICA CYPRUS 250MG ACETAZONE FORTE TAB N/A TECHNILAB INC. CANADA ACETOAMINOPHEN 500MG TEVA ISRAEL (ACAMOL) PHARMACEUTICAL INDUSTRIES ACETYSALICYLIC ACID 300MG PHARMAMED. MALTA (ASPIRIN) 300MG ACIC CREME FUR LIPPENHERPES CREAM 50MG/G HEXAL AG GERMANY ACICLOSTAD CREAM 50MG/1G STADAPHARM GMBH GERMANY ACICLOSTAD MG STADAPHARM GMBH GERMANY ACICLOSTAD MG STADAPHARM GERMANY ACICLOVIR 800MG DISPERSIBLE BP ACICLOVIR BP 200MG ACICLOVIR BP 200MG ACICLOVIR BP 400MG ACICLOVIR BP 800MG 800MG SANOFI WINTHROP 200MG SANOFI WINTHROP 200MG SANOFI WINTHROP 400MG SANOFI WINTHROP 800MG CP ACIVIR EYE OINTMENT NA CIPLA INDIA ACNE AID SOAP SOAP 6.38% W/W STIEFEL (UK) AA 38/03 ADD 1 Act/Annex XI/en 6

8 ACQUA PER PREPARAZIONI INIETTABILI FOR NA INDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L. ITALY ACRICEPT 5MG COATED 5MG EISAI ACTAL 360MG SEVEN SEAS T/A MERCK CONSUMER HEALTH ACT-HIB, VACCIN HAEMOPHILUS TYPE B CONJU FOR I.M. & S.C. N/A PASTEUR MERIEUX SERUMS ET VACCINS FRANCE ACTIFED DM LINCTUS ORAL N/A GLAXO WELLCOME UK ACTIFED EXPECTORANT ORAL N/A GLAXO WELLCOME UK ACTIFED SYRUP SYRUP N/A GLAXO WELLCOME UK ACTIFED N/A GLAXO WELLCOME UK ACTIFED N/A GLAXOSMITHKLINE BELGIUM SA ACTIFED NA GLAXO WELLCOME BELGIUM BELGIUM S.A. ACTILYSE VIALS 50MG BOEHRINGER GERMANY INGELHEIM PHARMA KG ACTIVELLE -28 NA NOVO NORDISK A/S DENMARK ACTONEL FILM-COATED 5MG GRUPPO LEPETIT ITALY SPA ACTONEL FILM-COATED 30MG GRUPPO LEPETIT ITALY SPA ACTONORM GEL ORAL N/A WALLACE SUSPENSION MANUFACTURING CHEMISTS ACTOS 15MG TAKEDA EUROPE R&D CENTRE ACTOS 30MG TAKEDA EUROPE R&D CENTRE ACTRAPID HM 1001U/ML1OML VIAL FOR 1001UML10ML VIAL NOVO NORDISK DENMARK AA 38/03 ADD 1 Act/Annex XI/en 7

9 ACTRAPID HM PENFILL FOR 100IU/ML NOVO NORDISK A/S DENMARK ACULAR (KETOROLAC TROMETHAMINE) 0.5% EYE DROPS, 0.5% W/V ALLERGAN (IRELAND)., INC. IRELAND ACUPAN COATED 30MG 3M HEALTH CARE ACYCLOVIR DENK MG E.DENK OHG GERMANY ACYCLOVIR DENK MG E.DENK OHG GERMANY ACYCLOVIR DENK 5% CREAM 5% E.DENK OHG GERMANY CREAM ACYPRONT EFFERVESCENT 200MG HEINRICH MACK GERMANY NACHF. 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 33MG BAYER AG GERMANY ADALAT LA 30MG MODIFIED RELEASE 30MG BAYER PLC ADALAT LA 60MG RETARD 66MG BAYER AG GERMANY ADALAT LA 60MG MODIFIED RELEASE 60MG BAYER PLC ADALAT RETARD RETARD 20MG BAYER VITAL GMBH GERMANY & CO. KG ADALAT RETARD 20MG BAYER PAKISTAN ADALAT RETARD LACQUER COATED 20MG BAYER PAKISTAN ADALAT RETARD 10MG COATED 10MG BAYER PLC ADCO-AMOXYCILLIN SUSPENSION 250MG/5ML ADCOCK INGRAM SOUTH AFRICA 250MG/5ML ADCO-AMOXYCILLIN CAPSULES 500MG ADCOCK INGRAM SOUTH AFRICA 500MG ADCO-LOPERAMIDE 2MG ADCOCK INGRAM SOUTH AFRICA ADD-ACTEN N/A MEDOCHEMIE CYPRUS ADDITIVA VITAMIN C PINK EFFERVESCENT 1000MG KRUGER GMBH & GERMANY GRAPEFRUIT CO. KG AA 38/03 ADD 1 Act/Annex XI/en 8

10 ADDITRACE CONCENTRATE N/A FRESENIUS KABI FOR INFUSION ADDITRACE, CONCENTRATE N/A FRESENIUS KABI CONCENTRATE FOR INFUSION FOR INFUSION -UK ADENOCOR FOR 3MG/ML SANOFI WINTHROP 3MG/ML ADIOS COATED NA BROME AND SCHIMMER T/A DIOMED HERBALS ADIZEM-XL CAPSULES MODIFIED 120MG NAPP 120MG RELEASE CAPSULE ADIZEM-XL CAPSULES MODIFIED 180MG NAPP 180MG RELEASE CAPSULE ADIZEM-XL CAPSULES MODIFIED 240MG NAPP 240MG RELEASE CAPSULE ADIZEM-XL CAPSULES MODIFIED 300MG NAPP 300MG RELEASE CAPSULE AD-MUC OINTMENT N/A MERZ+CO. GMBH & CO. GERMANY ADRENALINE AGUETTANT INJECTABLE 1MG/1ML LABORATOIRE AGUETTANT FRANCE ADRENALINE BP 1/1000 ADRENALINE BP 1/1000 ADRENALINE /DEMO ADRENALINE TARTRATE BP ADRIBLASTINA ADRIBLASTINA FOR 1MG/1ML ANTIGEN IRELAND FOR 1.0MG/ML ANTIGEN IRELAND FOR 1MG/1ML DEMO ABEE GREECE FOR 1 IN 1000 EVANS MEDICAL POWDER FOR 10MG/VIAL PHARMACIA & ITALY UPJOHN S.P.A. POWDER FOR 50MG PHARMACIA ITALIA ITALY SOLN FOR S.P.A AA 38/03 ADD 1 Act/Annex XI/en 9

11 ADRIBLASTINA FOR 10MG/5ML PHARMACIA ITALIA ITALY S.P.A ADRIBLASTINA FOR 50MG/25ML PHARMACIA ITALIA ITALY S.P.A ADRIBLASTINA POWDER AND 10MG/5ML PHARMACIA ITALIA ITALY SOLVENT FOR IV INJ. S.P.A ADRIBLASTINA RTU FOR 10MG/5ML PHARMACIA & ITALY UPJOHN S.P.A. ADRIBLASTINA RD FOR 50MG/25ML PHARMACIA & ITALY UPJOHN S.P.A. ADRIBLASTINA RTU POWDER FOR 50MG/VIAL PHARMACIA & ITALY UPJOHN S.P.A. ADULT DIFTAVAX INJECTABLE SUSPENSION N/A PASTEUR MERIEUX FRANCE ADULT MELTUS DRY ORAL N/A CUPAL TICKLY COUGHS/CATARRH ADULT MELTUS CHESTY ORAL N/A CUPAL COUGH W/DECONGESTANT ADULT MELTUS CHESTY ORAL N/A CUPAL COUGH WITH DECONGEST ADULT MELTUS FOR CHESTY COUGHS AND CATARRH ORAL N/A CUPAL ADULT MELTUS FOR DRY ORAL LIQUID N/A CUPAL TICKLY COUGHS AND CAT ADULT MELTUS NIGHT SYRUP N/A CUPAL TIME ADVANTAN FATTY 1MG/G SCHERING AG ITALY OINTMENT 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 0.1% W/W SCHERING SPA ITALY OINTMENT ADVANTAN CREAM 0.1% W/W SCHERING SPA ITALY ADVIL 200MG WHITEHALL INTERNATIONAL INC. CANADA ADVIL COLD AND SINUS CAPLETS N/A WHITEHALL-ROBINS CANADA INC. AA 38/03 ADD 1 Act/Annex XI/en 10

12 ADVIL IBUPROFEN TAB 200MG 200MG WHITEHALL-ROBINS CANADA INC. A-E-MULSIN FORTE EMULSION N/A MUCOS PHARMA GERMANY GMBH & CO. AERANNE LIQUID FOR 100% V/V PHARMACIA INHALATION AERIUS FILM-COATED 5MG SCHERING-PLOUGH S.P.A. AERIUS FILM-COATED 5MG SCHERING-PLOUGH ITALY S.P.A. AEROCROM INHALER MET. DOSE N/A FISONS T/A PRESS. AEROSOL RHONE-POULENC RORER AEROCROM INHALER AEROSOL N/A FISONS T/A RHONE-POULENC RORER AERODIOL NASAL SPRAY 150MCG/DOSE LES LABORATOIRES SERVIER FRANCE AEROLID NEBULIZER 0.1% W/V VECCHI & C. PIAM ITALY S.A.P.A. AERO-OM 40MG OM PORTUGUESA PORTUGAL AERO-OM ORAL 100MG/ML OM PORTOGUESA PORTUGAL AERO-OM 40MG OM PORTUGUESA PORTUGAL AERO-OM ORAL 100MG/ML OM PORTUGUESA PORTUGAL AETHOXYSKLEROL 0.5% FOR 0.5% W/V CHEMISCHE FABRIK GERMANY KREUSSLER & CO GMBH AETHOXYSKLEROL 1% FOR 1% W/V CHEMISCHE FABRIK GERMANY KREUSSIER & CO GMBH AETHOXYSKLEROL 2% FOR 2% W/V CHEMISCHE FABRIK GERMANY KREUSSIER & CO GMBH AETHOXYSKLEROL 3% FOR 3% W/V CHEMISCHE FABRIK GERMANY KREUSSIER & CO GMBH AETHOXYSKLEROL 4% FOR 4% W/V CHEMISCHE FABRIK KREUSSIER & CO GMBH GERMANY AETHROMA-30 TIME RELEASE 30MG MEPHA PHARMA AG SWITZERLAND AA 38/03 ADD 1 Act/Annex XI/en 11

13 AFLOXAN CAPSULE 150MG ROTTA RESEARCH ITALY LABORATORIUM SPA AFLOXAN CREAM 5% W/W ROTTAPHARM S.R.L ITALY AFRAZINE NASAL SPRAY NASAL SPRAY 0.05% W/V SCHERING-PLOUGH 0.05% AGELMIN 10MG KLEVA. GREECE AGGRASTAT 0.25MG/ML CONC. FOR 0.25MG/ML MERCK SHARP & NETHERLANDS SOLN. FOR INFUS DOHME B.V. AGIOLAX POWDER FOR ORAL SUSP. NA MADAUS AG GERMANY AGRIMONY (BACH) ORAL LIQUID N/A NELSON A. & CO AILAX ORAL N/A GALEN SUSPENSION AIMAFIX D.I. FOR N/A ISTITUTO ITALY IV SIEROVACCINOGEN O ITALIANO I.S.I. S.P.A. AIMKIN (BB-K8) INJECTABLE 500MG/2ML BRISTOL MYERS ITALY SQUIBB S.P.A AIRCORT NASAL SPRAY 100MCG ITALCHIMICI SPA ITALY AIRCORT SUSPENSION FOR 40MG ITALCHIMICI SPA ITALY INHALATION AKAMIN 50MG ALPHAPHARM PTY AUSTRALIA AKAMIN CAPSULE 100MG ALPHAPHARM PTY AUSTRALIA AKAMON 1.5MG 1.5MG MEDOCHEMIE CYPRUS AKAMON 3MG 3MG MEDOCHEMIE CYPRUS AKAMON 6MG 6MG MEDOCHEMIE CYPRUS AKATINOL MEMANTINE 10 MG MERZ + CO. GMBH & GERMANY CO. AKILEN 40MG 40MG MEDOCHEMIE CYPRUS AKLONIL 0.5MG 0.5MG MEDOCHEMIE CYPRUS AKLONIL 2MG 2MG MEDOCHEMIE CYPRUS AKTIFERRIN-F SUSCAPS N/A MEPHA PHARMA AG SWITZERLAND ALBUMIN 20% - GCPD 50ML FOR 20% GREENCROSS PLASMA DERIVATIVES CORP. KOREA REPUBLIC ALBUMIN PHARMACIA FOR INFUSION N/A PHARMACIA & UPJOHN AB SWEDEN AA 38/03 ADD 1 Act/Annex XI/en 12

14 ALBUMIN PHARMACIA FOR 200MG/ML BIOVITRUM AB SWEDEN INFUSION ALCITON METER DOSE NASAL SPRAY 100IU/DOSE KLEVA GREECE ALDACTIDE COATED N/A MONSANTO PLC ALDACTIDE 25 N/A MONSANTO PLC T/A SEARLE ALDACTONE 100MG MONSANTO PLC T/A SEARLE ALDACTONE COATED 25MG MONSANTO PLC ALDACTONE COATED 100MG MONSANTO PLC T/A SEARLE ALDACTONE 25MG MONSANTO PLC T/A SEARLE ALDACTONE 100MG MONSANTO PLC T/A SEARLE ALDACTONE 100MG MONSANTO PLC T/A SEARLE ALDACTONE 25MG MONSANTO PLC T/A SEARLE ALDACTONE 100 MG COATED 100 MG PHARMACIA ALDACTONE 100MG 100MG SEARLE PAKISTAN ALDACTONE 25 MG COATED 25 MG PHARMACIA ALDACTONE A 25MG SEARLE PAKISTAN ALDARA CREAM NA 3M EUROPEAN COMMUNITY ALDIX 40MG 40MG MEDOCHEMIE CYPRUS ALDOMET 250MG M.S.D. PAKISTAN ALDOMET 250MG 250MG MERCK SHARP & NETHERLANDS DOHME B.V. ALDOMET 250MG MSD PAKISTAN ALENOST 10MG MACLEODS INDIA ALEXAN FOR NA HEINRICH MACK GERMANY NACHF ALFACALCIDOL (ALPHA D3) CAPSULE 1MCG TEVA PHARMACEUTICAL INDUSTRIES ISRAEL AA 38/03 ADD 1 Act/Annex XI/en 13

15 ALFACIP-0.25MCG CAPSULES 0.25MCG CIPLA. INDIA CAPSULES ALFINOR 8MG 8MG MEDOCHEMIE CYPRUS ALFOXAN CAPSULES 250MG REMEDICA CYPRUS ALFOXAN SYRUP 50MG/5ML REMEDICA CYPRUS ALFOXAN 500 F.C. 500MG REMEDICA CYPRUS ALGESAL SURACTIVE CREAM N/A LABORATOIRES FRANCE SOLVAY PHARMA ALGICON N/A RORER. ALGIPAN CREAM N/A WYETH-LEDERLE PAKISTAN A-LICES SHAMPOO NA HOE SDN BHD MALAYSIA A-LICES SCALP AND BODY HYGIENE SHAMPOO ALKA-SELTZER ALKA-SELTZER EFFERVESCENT ALKA-SELTZER ORIGINAL ALKERAN ALKERAN ALKERAN SHAMPOO 1% W/V HOE SDN. BHD MALAYSIA EFFERVESCENT 324MG BAYER VITAL GMBH & CO. KG EFFERVESCENT N/A BAYER DIAGNOSTICS MANUFACTURING EFFERVESCENT N/A BAYER DIAGNOSTICS MANUFACTURING COMPRESSION- 2MG WELLCOME COATED FOUNDATION. COMPRESSION- 5MG WELLCOME COATED FOUNDATION. POWDER FOR 50MG WELLCOME FOUNDATION. ALKERAN COATED 2MG THE WELLCOME FOUNDATION. T/A GLAXO WELLCOME ALKERAN COATED 2MG THE WELLCOME FOUNDATION AA 38/03 ADD 1 Act/Annex XI/en 14

16 ALKERAN POWDER AND NA GLAXOSMITHKLINE ITALY SOLVENT F/ F/ SPA ALLERGAN CREAM 2G/100G SPA ITALIANA ITALY LABORATORI BOUTY ALLERGO-COMOD EYE DROPS 20MG/ML URSAPHARM GERMANY ARZNEIMITTEL GMBH ALLERGOCROM, EYE 20MG/ML URSAPHARM GERMANY DROPS ARZNEIMITTEL GMBH ALLERGOPOS N EYE DROPS N/A URSAPHARM GERMANY ARZNEIMITTEL GMBH ALLO MG CAMDEN MALAYSIA INDUSTRIES (M) SDN BHD ALLOPURINOL 300MG DANBURY PHARMACAL INC. PUERTO RICO ALLOPURINOL 100MG ALLOPURINOL 300MG ALLOPURINOL BP ALLOPURINOL BP ALLOPURINOL BP 100MG ALLOPURINOL BP 300MG ALLUMAG MPS SUSPENSION 100MG NORTON 300MG NORTON 100MG CP. 300MG CP 100MG CP 300MG CP SUSPENSION N/A CAMDEN MALAYSIA INDUSTRIES (M) SDN BHD AA 38/03 ADD 1 Act/Annex XI/en 15

17 ALLUPOL 100MG GRODZISK POLAND PHARMACEUTICAL WORKS POLFA ALMIRAL 100MG SUPPOSITORY 100MG MEDOCHEMIE CYPRUS ALMIRAL 25MG 25MG MEDOCHEMIE CYPRUS ALMIRAL 50MG 50MG MEDOCHEMIE CYPRUS ALMIRAL 50MG SUPPOSITORY 50MG MEDOCHEMIE CYPRUS ALMIRAL 75MG/3ML LIQUID FOR 75MG/3ML MEDOCHEMIE CYPRUS ALMIRAL SR 100MG 100MG MEDOCHEMIE CYPRUS ALMORA POWD. FOR 5.9G/SACHET ELPEN S.A. GREECE ORAL SD. ALOMIDE OPHTHALMIC 1MG/ML S.A. ALCON- BELGIUM COUVREUR N.V. ALOPEXY 2% SOLUTN. FOR 2% W/V LABORATOIRES FRANCE CUTANEOUS USE PIERRE FABRE DERMATOLOGIE ALOPRON MG REMEDICA CYPRUS ALOPRON MG REMEDICA CYPRUS ALPHA D3 CAPSULE 0.25MCG TEVA ISRAEL (ALFACALCIDOL) PHARMACEUTICAL INDUSTRIES ALPHADINE FILM-COATED 150MG MINERVA PHARMACEUTICAL S.A. GREECE ALPHAGAN (BRIMONIDINE OPHTHALMIC 0.2% W/V ALLERGAN IRELAND TARTRATE) 0.2% (IRELAND)., INC. ALPHAMOX POWDER FOR 125MG/ML ALPHAPHARM PTY AUSTRALIA ORAL LIQUID ALPHAMOX POWDER FOR 250MG/ML ALPHAPHARM PTY AUSTRALIA ORAL LIQUID ALPHAMOX 250 CAPSULE 250MG ALPHAPHARM PTY AUSTRALIA ALPHAMOX 500 CAPSULE 500MG ALPHAPHARM PTY AUSTRALIA ALPHOSYL CREAM N/A STAFFORD-MILLER ALPHOSYL 2 IN 1 SHAMPOO 5% W/W STAFFORD-MILLER ALPHOSYL 2 IN 1 SHAMPOO SHAMPOO 5%W/W STAFFORD MILLER AA 38/03 ADD 1 Act/Annex XI/en 16

18 ALPHOSYL CREAM CREAM NA STAFFORD MILLER ALPHOSYL HC CREAM N/A STAFFORD-MILLER ALPHOSYL HC CREAM CREAM NA STAFFORD-MILLER ALPHOSYL LOTION TOPICAL N/A STAFFORD-MILLER EMULSION ALPHOSYL LOTION TOPICAL NA STAFFORD MILLER EMULSION ALPRENOLOL HCL BP 50MG REMEDICA CYPRUS 50MG ALUDROX LIQUID ORAL GEL 4.16% W/W UNICLIFFE T/A PFIZER CONSUMER ALUMINIUM HYDROXIDE SOLVENT 1MG/0.5ML CHIRON S.P.A ITALY SOLVENT F/PARENTERAL USE ALUTRIL CHEWABLE N/A REMEDICA CYPRUS ALVEOFACT SUSPENSION 54MG/1.2ML BOEHRINGER GERMANY INGELHEIM PHARMA KG ALVERCOL GRANULES GRANULES N/A NORGINE ALVERIX 5 5MG REMEDICA CYPRUS ALVITYL COATED N/A LABORATOIRES SOLVAY PHARMA ALVITYL SYRUP N/A LABORATOIRES SOLVAY PHARMA ALYRANE INHALATION 99.9% W/V PHARMACIA LIQUID AMAREL 1MG 1MG LABORATOIRES HOECHST AMAREL 2MG 2MG LABORATOIRES HOECHST AMAREL 3MG 3MG LABORATOIRES HOECHST AMAREL 4MG 4MG LABORATOIRES HOECHST FRANCE FRANCE FRANCE FRANCE FRANCE FRANCE AA 38/03 ADD 1 Act/Annex XI/en 17

19 AMBISONE POWDER FOR 50MG NEXSTAR IRELAND. AMBISONE LYOPH. PWDR. 50MG GILEAD SCIENCES IRELAND FOR IV INF INTERNATIONAL AMBROHEXAL RETARD SLOW RELEASE 75MG HEXAL AG GERMANY CAPSULE AMBROHEXAL SAFT 3MG/ML HEXAL AG GERMANY AMBROLITIC SYRUP 300MG/100ML CHIESI SPAIN WASSERMANN S.A. AMBROLITIC 20 CAPSULE 30MG CHIESI SPAIN WASSERMANN S.A. AMBROLITIC 20 CAPSULES 30MG CHIESI ESPANA S.A. SPAIN AMBROLITIC SYRUP SYRUP 328.9MG/100ML CHIESI ESPANA S.A. SPAIN AMEN 100MG 100MG MEDOCHEMIE. - CYPRUS AMERSCAN (DMSA) AGENT POWDER FOR 1MG/VIAL NYCOMED AMERSHAM PLC AMERSCAN MEDRONATE II POWDER FOR 6.25MG/VIAL NYCOMED AGENT AMERSHAM PLC AMERSCAN PENTETATE II POWDER FOR 20.6MG/10ML NYCOMED AMERSHAM PLC AMERSCAN STANNOUS POWDER FOR 4MG/VIAL NYCOMED AGENT AMERSHAM PLC A-METHAPRED POWDER FOR 40MG/VIAL ABBOTT INJ. WITH SOLV AMICLAV 250/125 MG FILM COATED GENERICS (UK) TAB CYPRUS UNITED STATES OF AMERICA AMIDATE (SINGLE DOSE FOR AMPUL) AMIDATE (SINGLE DOSE FOR FLIPTOP VIAL) AMIDATE FOR AMIKACINE MERCK 500MG POWDER FOR AMIKALEM FOR AMIKIN INJECTABLE 20MG (2MG/ML) 20MG (2MG/ML) 2MG/ML 500MG/VIAL 100MG/250MG/ MG/2ML ABBOTT ABBOTT ABBOTT MERCK GENERIQUES FRANCE LEMERY S.A. DE C.V MEXICO UNITED STATES OF AMERICA UNITED STATES OF AMERICA UNITED STATES OF AMERICA BRISTOL-MYERS ESTONIA SQUIBB EESTI AS AA 38/03 ADD 1 Act/Annex XI/en 18

20 AMIL-CO N/A NORTON AMILORETIC N/A PHARMACARE SOUTH AFRICA AMILORIDE HCL 5MG NORTON 5MG AMILORIDE BP 5MG CP. AMILORIDE BP 5MG CP 5MG AMINOPHYLLIN IV- FOR 250MG/10ML BODENE SOUTH AFRICA FRESENIUS (PROPIETARY) T/A INTRAMED- SOUTH AFRICA AMINOPHYLLINE FOR 250MG/10ML DEMO ABEE GREECE AMINOPHYLLINE 225MG NORTON AMINOPHYLLINE FOR 250MG PHARMAMED MALTA PARENTERALS. AMINOPHYLLINE BP 250MG REMEDICA CYPRUS 250MG AMINOPHYLLINE BP SUPPOSITORIES 360MG REMEDICA CYPRUS 360MG AMINOPHYLLINE N/A B.BRAUN GERMANY 240MG BP MELSUNGEN AG AMINOPHYLLINE FOR 250MG/10ML EVANS MEDICAL BP AMINOPHYLLINE FOR 250MG/10ML ANTIGEN IRELAND BP AMINOPHYLLINE BP MINIJET FOR N/A INTERNATIONAL MEDICATION SYSTEMS AA 38/03 ADD 1 Act/Annex XI/en 19

21 AMINOPHYLLINE FOR N/A INTERNATIONAL MINIJET MEDICATION SYSTEMS (UK) AMINOPHYLLINE MINJET FOR N/A INTERNATIONAL MEDICATION SYSTEMS (UK) AMINOPHYLLINE 100MG NORTON 100MG AMINOPLASMAL 10% INFUSION N/A B.BRAUN GERMANY MELSUNGEN AG AMINOPLASMAL 10% E INFUSION N/A B.BRAUN GERMANY SOLTION MELSUNGEN AG AMINOPLASMAL 12.5% E INFUSION N/A B.BRAUN GERMANY MELSUNGEN AG AMINOPLASMAL 15% INFUSION N/A B.BRAUN GERMANY MELSUNGEN AG AMINOPLASMAL 15% E INFUSION N/A B.BRAUN GERMANY MELSUNGEN AG AMINOPLASMAL 5% E INFUSION N/A B.BRAUN MELSUNGEN AG GERMANY AMINOPLASMAL HEPA 10% INFUSION N/A B.BRAUN GERMANY MELSUNGEN AG AMINOSYN 10% SOL. FOR I.V. INFUSION N/A ABBOTT UNITED STATES OF AMERICA AMINOSYN 8.5% WITH ELECTROLYTES FOR N/A ABBOTT UNITED STATES OF AMERICA AMINOSYN II 10% SOL. FOR I.V. N/A ABBOTT UNITED STATES OF AMERICA AMINOSYN II 4.25% M IN 10% DEXTROSE INJ. FOR N/A ABBOTT UNITED STATES OF AMERICA AMIODARONE 200MG 200MG MEDOCHEMIE CYPRUS AMIROL 10 10MG REMEDICA CYPRUS AMIROL 25 25MG REMEDICA CYPRUS AMITRIPTYLIN G SLOVAKOFARMA SLOVAK REPUBLIC SLOVAKOFARMA AMITRIPTYLINE SUGAR COATED 25MG EXTRACTUM- PHARMA CO. HUNGARY AA 38/03 ADD 1 Act/Annex XI/en 20

22 AMITRIPTYLINE 25MG 25MG CAMDEN INDUSTRIES (M) SDN BHD MALAYSIA AMITRYPTYLLIN COATED 25MG ICN POLFA RZESZOW POLAND S.A. PHARMACEUTICAL WORKS AMLO 10 MG, 10 MG OMEGA FARMA EHF ICELAND AMLO 2.5 MG, 2.5 MG OMEGA FARMA EHF. ICELAND AMLO 5 MG, 5 MG OMEGA FARMA EHF. ICELAND AMOCLAN 375MG HIKMA JORDAN AMOCLAN POWDER FOR NA HIKMA JORDAN AMOX CAPSULE 250MG CAPSULE 250MG CAMDEN MALAYSIA INDUSTRIES (M) SDN BHD AMOXAPEN 125 ORAL 125MG/5ML REMEDICA CYPRUS SUSPENSION AMOXAPEN 250 CAPSULES 250MG REMEDICA CYPRUS AMOXAPEN 250 ORAL 250MG/5ML REMEDICA CYPRUS SUSPENSION AMOXAPEN 250 F.C. 250MG REMEDICA CYPRUS AMOXAPEN 500 CAPSULES 500MG REMEDICA CYPRUS AMOXAPEN 500 F.C. 500MG REMEDICA CYPRUS AMOXICILLIN CAPSULES CAPSULE 250MG GENERICS (UK) 250MG AMOXICILLINE CAPSULE 250MG PHARMACEUTICAL WORKS POLFA- KRAKOW S.A. POLAND AMOXICILLIN- GRANULES FOR 250MG/5ML RATIOPHARM GMBH GERMANY RATIOPHARM 250 TS ORAL SUSPN. AMOXICILLIN- RATIOPHARM 500 FILM COATED 500MG RATIOPHARM GMBH GERMANY AMOXICOMP,,GENERICON FILM COATED 625 MG GENERICON PHARMA GES.M.B.H. GERMANY AMOXIHEXAL 500 FILM-COATED 500MG HEXAL AG GERMANY AMOXIHEXAL SAFT DRY SUBSTANCE 200MG/5ML HEXAL AG GERMANY FOR SUSP AMOXIL CAPSULE 250MG SMITH KLINE BEECHAM PAKISTAN AA 38/03 ADD 1 Act/Annex XI/en 21

23 AMOXIL CAPSULE 500MG SMITH KLINE PAKISTAN BEECHAM AMOXIL SYRUP IN 125MG/5ML SMITH KLINE & PAKISTAN POWDER FORM BEECHAM AMOXIL CAPSULE 250MG SMITH KLINE & PAKISTAN BEECHAM AMOXIL CAPSULE 500MG SMITH KLINE & BEECHAM PAKISTAN AMOXIL CAPSULES 250MG CAPSULE 250MG BEECHAM GROUP PLC AMOXIL CAPSULES 500MG CAPSULE 500MG BEECHAM GROUP PLC AMOXIL FORTE SYRUP IN POWDER FORM 250MG/5ML SMITH KLINE & BEECHAM PAKISTAN AMOXIL PAEDIATRIC SUSPENSION POWDER FOR ORAL AMOXIL SACHET 3G GRANULES FOR SUCROSE-FREE ORAL SOLN. AMOXIL SYRUP SUCROSE- POWDER FOR FREE SUSPENSION ORAL SUSPEN. AMOXIL SYRUP SUCROSE- POWDER FOR FREE SUSPENSION ORAL SUSPEN. AMOXIL VIALS FOR POWDER FOR 250MG AMOXIL VIALS FOR POWDER FOR 500MG 125MG/1.25ML BEECHAM GROUP PLC 3G BEECHAM GROUP PLC 125MG/5ML BEECHAM GROUP PLC 250MG/5ML BEECHAM GROUP PLC 250MG BEECHAM GROUP PLC 500MG BEECHAM GROUP PLC AMOXYCILLIN CAPSULES 250MG NORTON AMOXYCILLIN CAPSULES 500MG NORTON IRELAND AMOXYCILLIN CAPSULE 250MG PLIVA PAKISTAN AMOXYCILLIN 3GM SACHETS S.F. AMOXYCILLIN CAPSULES B.P.500MG POWDER FOR ORAL 3GM NORTON CAPSULES 500MG ATHLONE IRELAND AMOXYCILLIN MIXTURE ORAL 125MG/5ML NORTON AA 38/03 ADD 1 Act/Annex XI/en 22

24 AMOXYCILLIN MIXTURE ORAL 250MG/5ML NORTON 250MG/5ML AMOXYCILLIN S/F ORAL 125MG/5ML NORTON MIXTURE 125MG/5ML AMOXYCILLIN S/F MIXTURE 250MG/5ML ORAL 250MG/5ML NORTON AMOXYCILLIN S/F POWDER FOR 3MG/5ML NORTON SACHETS RECONSTITUTIO N AMOXYCILLIN SUGAR SUGAR FREE 125MG/5ML ATHLONE IRELAND FREE SUSPENSION B.P. SUSPENSION AMOXYDAR CAPSULES 250MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO AMOXYDAR 125 GRANULES FOR ORAL SUSPEN. 125MG/5ML DAR AL DAWA DEVELOPMENT AND INVESTMENT CO. JORDAN AMPHOCIL POWDER FOR FOR INFUSION 50MG INTERMUNE EUROPE AMPICILLIN CAPSULES CAPSULES 250MG NORTON 250MG AMPICILLIN CAPSULES 500MG CAPSULES 500MG NORTON AMPICLLIN CAPSULES B.P. CAPSULES 500MG ATHLONE IRELAND AMPICLOX CAPSULE N/A SMITH KLINE & PAKISTAN BEECHAM AMPICLOX CAPSULES CAPSULE N/A BEECHAM GROUP 500MG PLC AMPICLOX 500MG POWDER FOR N/A BEECHAM GROUP PLC AA 38/03 ADD 1 Act/Annex XI/en 23

25 AMPICLOX NEONATAL POWDER FOR N/A BEECHAM GROUP PLC AMPICLOX NEONATAL POWDER FOR N/A BEECHAM GROUP SUSPENSION ORAL SUSPEN. PLC AMPICLOX SYRUP POWDER FOR N/A BEECHAM GROUP SYRUP PLC AMPISUL 250 CAPSULES 250MG AEGIS. CYPRUS AMPISUL 500 CAPSULES 500MG AEGIS. CYPRUS AMSIDINE 50 MG/ML FOR 50 MG/ML GOLDSHIELD GROUP PLC T/A GOLDSHIELD AMSIDINE FOR 50MG/ML GOLDSHIELD AMURETIC NA DAR ALA DAWA JORDAN DEVELOPMENT AND INVESTMENT CO ANABACT GEL 0.75% W / W BIOGLAN METRONIDAZOLE TOPICAL GEL 0.75% ANACAINE 1% FOR 10MG/ML SM MALAYSIA SDN. BHD. ANACAL RECTAL RECTAL N/A SANKYO PHARMA OINTMENT OINTMENT UK ANACAL SUPPOSITORIES SUPPOSITORY N/A SANKYO PHARMA UK ANADIN N/A WHITEHALL ANADIN EXTRA / POWERIN N/A WHITEHALL ANADIN PARACETAMOL 500MG WHITEHALL ANAFRANIL SUGAR COATED 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG ANAFRANIL SUGAR COATED 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG ANAFRANIL 10MG NOVARTIS PAKISTAN ANAFRANIL 25MG GEIGY PAKISTAN ANAFRANIL 25MG NOVARTIS PAKISTAN AA 38/03 ADD 1 Act/Annex XI/en 24

26 ANAFRANIL S/C 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG ANAFRANIL FIM-COATED 75MG NOVARTIS SPAIN FARMACEUTICA S.A. - SPAIN ANAFRANIL SUGAR-COATED 10MG NOVARTIS SPAIN FARMACEUTICA S.A ANAFRANIL SUGAR-COATED 25MG NOVARTIS SPAIN FARMACEUTICA S.A ANAFRANIL SUGAR (FILM)- 10MG NOVARTIS FARMA ITALY COATED SPA ANAFRANIL SUGAR (FILM)- 25MG NOVARTIS FARMA ITALY COATED SPA ANAFRANIL SR 75 DIVITABS 75MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG ANAPRIN 75MG OPAL PAKISTAN ANARGIL 100MG CAPSULE 100MG MEDOCHEMIE CYPRUS ANARGIL 200MG CAPSULE 200MG MEDOCHEMIE CYPRUS ANATOXAL DI TE BERNA SOUTION FOR N/A ISTITUTO ITALY SIEROTERAPICO BERNA S.R.L. ANCID CHEWING 500MG HEXAL AG GERMANY ANCOPIR N/A DR.GROSSMANN AG SWITZERLAND PHARMACA ANCOTIL FOR 2.5G/250ML ICN ANCOTIL FOR 2.5G/250ML ICN ANCOTIL 2.5G/250ML FOR N/A ICN ANDRACTIM GEL N/A BESINS FRANCE INTERNATIONAL ANDREWS ANTACID N/A SMITHKLINE BEECHAM (SWG) T/A STERLING HEALTH AA 38/03 ADD 1 Act/Annex XI/en 25

27 ANDRIOL CAPSULES 40MG N.V. ORGANON NETHERLANDS ANDROCUR 50MG SCHERING AG GERMANY ANDROCUR 50MG SCHERING S.A. FRANCE ANDROCUR-10 10MG SCHERING AG GERMANY ANDROCUR-DEPOT OILY SOLN FOR 100MG/ML SCHERING AG GERMANY IM INJECT. ANECTINE FOR 5%W/V THE WELLCOME FOUNDATION ANECTINE FOR 5%W/W THE WELLCOME FOUNDATION ANECTINE (MIDARINE) FOR 5% W/V WELLCOME FOUNDATION. ANEXATE AQUEOSUS 0.5MG/5ML ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG ANGINESIN LIQUID N/A DR. GROSSMAN AG SWITZERLAND PHARMACA ANGINOVAG AEROSOL N/A LABORATORIOS SPAIN NOVAG, S.A. ANGIOCIS POWDER FOR N/A CIS BIO FRANCE INTERNATIONAL ANGISED 0.5MG GLAXOWELLCOME PAKISTAN ANGISED 0.5MG GLAXOSMITHKLINE SOUTH AFRICA SOUTH AFRICA (PTY) ANGISPRAY SPRAY SOLN N/A LABORATOIRES FRANCE F/ORAL CAVITY MONOT ANTACID PLUS ANTIFLATULENT SUSPENSION N/A STANLEY CANADA ANTHISAN CREAM 2% W/W CREAM 2% W/W MAY & BAKER (T/A RHONE-POULENC RORER) ANTIBIOPTAL EYE DROPS N/A FARMILA ITALY FARMACEUTICI MILANO S.P.A. ANTIBIOTIC OINTMENT OINTMENT N/A STANLEY CANADA ANTIBLUT S.R.F.C. 20MG GENEPHARM S.A. GREECE AA 38/03 ADD 1 Act/Annex XI/en 26

28 ANTIDOL COATED 500MG LABORATORIOS SPAIN CINFA S.A ANTIGREG 250MG VECCHI & C PIAM ITALY S.A.P.A. ANTIGREG 250MG VECCHI & C PIAM ITALY ANTILIPID FILM COATED 600MG KLEVA GREECE ANTIPEOL OINTMENT OINTMENT N/A MEDICO- BIOLOGICAL LABS ANTIPHLOGISTINE PASTE FOR N/A LABORATOIRES FRANCE TOPICAL APPLIC. FUMOUZE ANTIPREX 5MG ELPEN PHARM. CO. GREECE INC. ANTIRRINUM NASAL SPRAY NA LABORATORIO REIG SPAIN JOFRE S.A ANTISPASMINA COLICA GASTRORESISTA N/A RECORDATI ITALY NT INDUSTRIA CHIMICA FARMACEUTICA S.P.A. ANTISPASMINA COLICA (FORTE) GASTRORESISTA NT N/A RECORDATI INDUSTRIA CHIMICA FARMACEUTICA S.P.A. ITALY ANTITHROMBIN III HUMAN FOR N/A BAXTER AG AUSTRIA THROMBHIBIN ANTI-THYROX 5MG MACLEODS INDIA ANTORAL FOR 0.05G/100ML RECORDATI ITALY BUCCAL USE INDUSTRIA CHIMICA FARMACEUTICA S.P.A. ANTORAL LOZENGE 5MG RECORDATI ITALY (THROAT) INDUSTRIA CHIMICA FARMACEUTICA S.P.A. ANUSOL SUPPOSITORY N/A PARKE DAVIS FRANCE ANUSOL RECTAL OINTMENT N/A PARKE DAVIS FRANCE AA 38/03 ADD 1 Act/Annex XI/en 27

29 ANUSOL SUPPOSITORIES SUPPOSITORY N/A WARNER-LAMBERT CONSUMER ANXETIN CAPSULES 20MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO ANXIOLAN 10MG 10MG MEDOCHEMIE CYPRUS ANZEMET 100MG/5ML FOR IV 100MG/5ML LABORATOIRES AVENTIS FRANCE ANZEMET 12.5MG/0.625ML FOR IV 12.5MG/0.625M L LABORATOIRES AVENTIS FRANCE ANZEMET 200MG COATED 200MG LABORATOIRES ROUSSEL DIAMANT FRANCE APIOCOLINA CREAM 106MG/100G BRUSCHETTINI SRL ITALY APIOCOLINA SUPPOSITORY 4MG BRUSCHETTINI SRL ITALY APO ACETAZOLAMIDE TAB 250MG 250MG APOTEX INC CANADA APO ALLOPURINOL 100MG 100MG APOTEX INC CANADA APO AMPI CAPSULES CAPSULE 500MG APOTEX INC CANADA 500MG APO CIMETIDINE TAB 200MG 200MG APOTEX INC CANADA APO FOLIC ACID TAB 5MG 5MG APOTEX INC CANADA APO GLYBURIDE TAB 2.5MG APOTEX INC CANADA 2.5MG APO IMIPRAMINE TAB 10MG APOTEX INC CANADA 10MG APO IMIPRAMINE TAB 25MG APOTEX INC CANADA 25MG APO ISDN 10MG APOTEX INC CANADA APO PRIMIDONE 250MG APOTEX INC CANADA APO SULFATRIM TAB N/A APOTEX INC CANADA APO TETRA CAP 250MG CAPSULE 250MG APOTEX INC CANADA APO THIORIDAZINE 10MG APOTEX INC CANADA APO TRIHEX TAB 2MG 2MG APOTEX INC CANADA APO ZIDOVUDINE CAP CAPSULE 100MG APOTEX INC CANADA 100MG APO-ALPRAZ TAB 0.5MG 0.5MG APOTEX INC CANADA APO-AMITRIPTYLINE HCL TAB 25MG 25MG APOTEX INC CANADA AA 38/03 ADD 1 Act/Annex XI/en 28

30 APO-AMOXI CAP 500MG CAPSULE 500MG APOTEX INC CANADA APO-ATENOLOL 100MG APOTEX INC CANADA APO-CEPHALEX TAB 500MG APOTEX INC CANADA 500MG APO-CLOMIPRAMINE 10MG APOTEX INC CANADA 10MG APO-CLOMIPRAMINE 25MG APOTEX INC CANADA 25MG APO-DICLO SR 100MG MODIFIED 100MG APOTEX INC CANADA RELEASE APO-DOXY CAP 100MG CAPSULE 100MG APOTEX INC CANADA APO-FLUOXETINE - CAP 20MG CAPSULE 20MG APOTEX INC CANADA APO-GLYBURIDE TAB 5MG 5MG APOTEX INC CANADA APO-PREDNISONE 5MG 5MG APOTEX INC CANADA APO-RANITIDINE 300MG 300MG APOTEX INC CANADA APO-RANITIDINE TAB 150MG APOTEX INC CANADA 150MG APRAZOL CAPSULES 30MG HUSNU ARSAN TURKEY ILACLARI A.S. APRAZOL ENTERIC 30MG HUSNU ARSAN TURKEY COATED CAPSULE30M ILACLARI A.S.- TURKEY APRESOLINE SUGAR COATED 10MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG APRESOLINE SUGAR COATED 25MG NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG APROTININ FOR 10 KIU/ML FERRING APROVEL 150MG TABETS 150MG SANOFI PHARMA BRISTOL-MYERS SQUIBB SNC FRANCE APROVEL 300MG 300MG SANOFI PHARMA BRISTOL-MYERS SQUIBB SNC FRANCE APROVEL75MG 75MG SANOFI PHARMA BRISTOL-MYERS SQUIBB SNC FRANCE AA 38/03 ADD 1 Act/Annex XI/en 29

31 AQUEOUS CREAM BP CREAM 9% W/W ADAMS AQUEOUS CREAM BP CREAM NO ACTIVE THORNTON & ROSS ING. AQUEOUS CREAM BP CREAM N/A RUSCO T/A RUSCO ARAVA FILM-COATED 10MG HOECHST MARION GERMANY ROUSSEL DEUTSCHLAND GMBH ARAVA FILM-COATED 20MG HOECHST MARION GERMANY ROUSSEL DEUTSCHLAND GMBH ARAVA FILM-COATED 100MG HOECHST MARION GERMANY ROUSSEL DEUTSCHLAND GMBH ARCALION 200MG SERVIER PAKISTAN ARCALION 200MG COATED SERVIER EGYPT INDUSTRIES EGYPT ARCALION 200MG COATED 200MG LABORATOIRES SERVIER FRANCE ARCALION 200MG SERVIER PAKISTAN ARCOXIA FILM-COATED 120MG MERCK SHARP AND DOHME ARCOXIA FILM COATED 90MG MERCK SHARP & DOHME ARCOXIA FILM COATED 60MG MERCK SHARP & DOHME AREDIA DRY SUBSTANCE 15MG/VIAL NOVARTIS PHARMA SWITZERLAND FOR INJ. SCHWEIZ AG AREDIA POWDER FOR 30MG/VIAL NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG AREDIA POWDER FOR 60MG/VIAL NOVARTIS PHARMA SWITZERLAND SCHWEIZ AG AREDIA POWDER FOR 90MG/VIAL NOVARTIS PHARMA SCHWEIZ AG SWITZERLAND AA 38/03 ADD 1 Act/Annex XI/en 30

32 AREDIA POWDER FOR 15MG NOVARTIS SPAIN INFUSION FARMACEUTICA S.A. - SPAIN AREDIA POWDER FOR 30MG NOVARTIS SPAIN INFUSION FARMACEUTICA S.A. -SPAIN AREDIA POWDER FOR 60 MG NOVARTIS SPAIN INFUSION FARMACEUTICA S.A. - SPAIN AREDIA POWDER FOR 90MG NOVARTIS SPAIN INFUSION FARMACEUTICA S.A. -SPAIN ARESTON 50MG MEDOCHEMIE. CYPRUS ARFEN SUSPENSION 120MG/5ML MEDOCHEMIE CYPRUS ARFEN 125MG SUPPOSITORY 125MG MEDOCHEMIE CYPRUS ARFEN 250MG SUPPOSITORY 250MG MEDOCHEMIE CYPRUS ARFEN 500MG 500MG MEDOCHEMIE CYPRUS ARFEN 500MG SUPPOSITORY 500MG MEDOCHEMIE CYPRUS ARICEPT 10MG COATED 10MG EISAI ARIDIL N/A CP. ARIDIL N/A CP. ARIDIL N/A CP. ARIDIL N/A CP ARIDIL N/A CP ARIDIL N/A CP ARILVAX - YELOW FEVER VACCINE FREEZE DRIED PREP F/INJ N/A EVANS MEDICAL ARIMIDEX COATED 1MG ZENECA AA 38/03 ADD 1 Act/Annex XI/en 31

33 ARISTIN-C INJ. OF 200MG/100ML ANFARM HELLAS GREECE INFUSION S.A. ARISTIN-C FILM COATED 500MG ANFARM HELLAS S.A. GREECE ARISTIN-C FILM-COATED 250MG ANFARM HELLAS S.A GREECE ARNETIN 150MG 150MG MEDOCHEMIE CYPRUS ARNETIN 50MG/2ML LIQUID FOR 50MG/2ML MEDOCHEMIE CYPRUS ARNICA CREAM 9% A NELSON AND COMPANY AROMASIN COATED 25MG PHARMACIA & ITALY UPJOHN AROMASIN FILM-COATED 25MG PHARMACIA ITALIA SPA ITALY ARPHOS ORAL N/A FOURNIER S.A. FRANCE ART CAPSULE 50MG LABORATOIRES FRANCE NEGMA ART 50 CAPSULES 50MG NEGMA-LERADS FRANCE ARTANE 2MG CYANAMID OF GREAT BRITAIN. ARTEX 5MG SCORED COATED 5MG LES LABORATOIRES FRANCE SERVIER ARTHRINAL F.C. 20MG REMEDICA CYPRUS ARTHROTEC 50 N/A MONSANTO PLC ARTHROTEC 50 GASTRO- N/A MONSANTO PLC T/A RESISTANT SEARLE ARTHROTEC 50 GASTRO- N/A PHARMACIA RESISTANT ARTHROTEC 75 N/A MONSANTO PLC T/A SEARLE ARTHROTEC 75 GASTRO NA MONSANTO PLC T/A RESISTANT SEARLE ARTHROTEC NA SEARLE PAKISTAN ARTHROXEN 250MG CP AA 38/03 ADD 1 Act/Annex XI/en 32

34 ARTHROXEN 500MG CP ARTROSILENE FOAM N/A DOMPE ITALY FARMACEUTICI SPA ARTROSILENE GEL N/A DOMPE ITALY FARMACEUTICI SPA ARTROSILENE "RETARD" 320MG DOMPE ITALY CAPSULES FARMACEUTICI SPA ARTROXICAM CAPSULE 20MG FONTEN ITALY FARMACEUTICI S.R.L. ASCARD 75MG ATCO PAKISTAN (PVT) ASCARD 300MG ATCO PAKISTAN (PVT) ASCARD 150MG ATCO PAKISTAN (PVT) ASCORBIC ACID 100MG 100MG PHARMAMED. MALTA ASCORBIC ACID 250MG 250MG PHARMAMED. MALTA ASCORBIC ACID 500MG CHEWABLE 500MG PHARMAMED. MALTA ASCORBIC ACID BP 100MG 100MG SUSSEX PHARMACEUTICAL ASCORBIC ACID BP 200MG 200MG SUSSEX PHARMACEUTICAL ASCORBIC ACID BP 500MG 500MG SUSSEX PHARMACEUTICAL ASCORBIC ACID BP 50MG 50MG SUSSEX PHARMACEUTICAL ASCORBIC ACID FOR 500MG/5ML F.H. FAULDING & CO AUSTRALIA AMPOULE (T/A DAVID BULL LABS) ASCORBIC ACID BPC FOR 500MG/5ML EVANS MEDICAL AA 38/03 ADD 1 Act/Annex XI/en 33

35 ASCOSAL EFFERVESCENT N/A DR. GROSSMAN AG SWITZERLAND PHARMACA ASCRIPTIN N/A RORER. (T/A RHONE POULENC RORER) ASERBINE TOPICAL NA FORLEY T/A FORLEY ASERBINE CREAM NA FORLEY T/A FORLEY ASILONE ANTACID LIQUID ORAL SUSPENSION N/A SETON PRODUCTS ASILONE ANTACID ASILONE HEARTBURN LIQUID ASILONE HEARTBURN ASMABEC ASMABEC CLICKHALER ASMABEC CLICKHALER 100 ASMASAL CLICKHALER N/A SETON PRODUCTS ORAL N/A SETON PRODUCTS SUSPENSION N/A SETON PRODUCTS INHALATION 50MCG/AC MEDEVA PHARMA POWDER INHALATION 250MCG/AC MEDEVA PHARMA POWDER INHALATION 100MCG/AC MEDEVA PHARMA POWDER INHALATION 95MCG/AC MEDEVA PHARMA POWDER ASMOVAL 10MG REMEDICA CYPRUS ASPARAGINASE MEDAC ASPEGIC 500MG ASPEGIC FOR 500MG/5ML POWDER FOR 10000IU MEDAC GMBH GERMANY POWDER FOR 500MG/SACHE ORAL SOL. T POWDER FOR 500MG/5ML INJECTABLE SOL LABORATOIRES FRANCE SYNTHELABO LABORATOIRES FRANCE SYNTHELABO ASPIREM 125 SUPPOSITORIES 125MG REMEDICA CYPRUS ASPIREM 150 E.C. 150MG REMEDICA CYPRUS ASPIREM 300 E.C. 300MG REMEDICA CYPRUS ASPIREM 75 E.C. 75MG REMEDICA CYPRUS ASPIRIN ENTERIC COATED 75MG THE WALLIS LABORATORY AA 38/03 ADD 1 Act/Annex XI/en 34

36 ASPIRIN 75MG PHARMAMED. MALTA ASPIRIN 75MG PHARMAMED. MALTA ASPIRIN 300MG M & A PHARMACHEM ASPIRIN BP 300MG 300MG SUSSEX PHARMACEUTICAL ASPIRIN BP 75MG 75MG SUSSEX PHARMACEUTICAL ASPIRIN PLUS C EFFERVESCENT N/A BAYER VITAL GMBH GERMANY & CO. KG ASPIRIN PROTECT 100 ENTERIC 100MG BAYER VITAL GMBH GERMANY COATED & CO. KG ASPIRIN PROTECT 300 ENTERIC COATED 300MG BAYER VITAL GMBH GERMANY & CO. KG ASPIRIN 75MG EC GASTRO- 75MG THE WALLIS RESISTANT TABS LABORATORY ASPIRIN DISPERSIBLE 75MG CP DISPERSIBLE BP. ASPRO 320MG 320MG LABORATOIRES FRANCE ROCHE NICHOLAS S.A. ASPRO 500MG EFFERVESCENT 500MG LABORATOIRES FRANCE ROCHE NICHOLAS S.A. ASTHALIN 4 4MG CIPLA. INDIA ASTHALIN INHALER INHALATION AEROSOL 100MCG/DOSE CIPLA INDIA ASTHALIN RESPIRATOR RESPIRATOR 5MG/1ML CIPLA INDIA ASTHALIN SYRUP SYRUP N/A CIPLA INDIA ASTIZOL 10MG DAR AL DAWA JORDAN DEVELOPMENT AND INVESTMENT CO ASTRIX 100 CAPSULE 100MG FAULDING AUSTRALIA ASYRAN 150MG DELTA HF ICELAND AA 38/03 ADD 1 Act/Annex XI/en 35

37 ASYRAN 300MG DELTA HF ICELAND ATACAND 16MG ASTRA SWEDEN ATACAND 8MG 8MG ASTRA SWEDEN ATALINE 2.5MG 2.5MG MEDOCHEMIE CYPRUS ATARAX FILM-COATED 25MG U.C.B. S.A. BELGIUM ATARAX SYRUP 2MG/ML U.C.B. S.A. BELGIUM ATARAX 25MG UNITED CHEMICALS PAKISTAN OF BELGIUM ATENOLOL 50MG NORTON ATENOLOL 100MG NORTON ATENOLOL 100MG PHARMAMED. MALTA ATENOLOL 50MG PHARMAMED. MALTA ATENOLOL COATED 100MG GENERICS (UK) ATENOLOL DELTA 25MG DELTA HF ICELAND ATENOLOL DELTA 50MG DELTA HF ICELAND ATENOLOL DELTA 100MG DELTA HF ICELAND ATENOLOL DENK 50 FILM-COATED 50MG E.DENK OHG GERMANY ATENSIN 10MG 10MG MEDOCHEMIE CYPRUS ATENSIN 40MG 40MG MEDOCHEMIE CYPRUS ATIVAN 2.5MG JOHN WYETH & IRELAND BROTHER T/A WYETH ATIVAN 1MG 1MG WYETH-PHARMA GERMANY GMBH ATIVAN 1MG 1MG JOHN WYETH AND BROTHER T/A WYETH ATIVAN 2MG 2MG WYETH-PHARMA GMBH GERMANY AA 38/03 ADD 1 Act/Annex XI/en 36

38 ATIVAN 2MG 2MG JOHN WYETH AND IRELAND BROTHER T/A WYETH ATODEL 1MG REMEDICA. CYPRUS ATODEL 2MG REMEDICA. CYPRUS ATODEL 1 1MG REMEDICA CYPRUS ATODEL 2 2MG REMEDICA CYPRUS ATODEL 5 5MG REMEDICA CYPRUS ATOMASE AQUEOUS NASAL SPRAY 50MCG/DOSE DOUGLAS NEW ZEALAND NASAL SPRAY. ATROMID-S CAPSULES 500MG ZENECA ATROPINA 1% FARMIGEA OPHTHALMIC 5MG FARMIGEA SPA ITALY DROPS ATROPINE FOR 0.5MG/ML PHARMAMED MALTA PARENTERALS. 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 BP FOR N/A INTERNATIONAL MINIJECT MEDICATION SYSTEMS (UK) ATROPINE BP FOR 0.1MG/ML INTERNATIONAL MINIJET MEDICATION SYSTEMS ATROPINE MINIJET FOR 0.1MG/ML INTERNATIONAL MEDICATION SYSTEMS (UK) ATROPINE SULFATE USP FOR 0.1MG/ML ABBOTT UNITED STATES OF AMERICA ATROPINE SULPHATE 600 MCG CP ATROPINE SULPHATE 600MCG CP. ATROPINE SULPHATE FOR 600MCG/ML ANTIGEN IRELAND AA 38/03 ADD 1 Act/Annex XI/en 37

39 ATROPINE SULPHATE 0.5MG ATROPINE SULPHATE 1MG ATROPINE SULPHATE BP ATROPINE SULPHATE BP 600MCG/ML ATROVENT ATROVENT N METERED AEROSOL ATROVENT NASAL PUMP SPRAY 0.03% FOR S FOR NEBULISER 0.05% W/V B.BRAUN MELSUNGEN AG GERMANY 0.1% W/V B.BRAUN GERMANY MELSUNGEN AG 600MCG/1ML ANTIGEN IRELAND 600MCG/ML MACARTHYS T/A MARTINDALE 500MCG/2ML BOEHRINGER INGELHEIM PUFF 20MCG BOEHRINGER INGELHEIM PHARMA KG - GERMANY GERMANY NASAL PUMP 0.314MG/ML BOEHRINGER GERMANY SPRAY INGELHEIM PHARMA KG AUDAX EAR DROPS DROPS N/A MUNDIPHARMA CYPRUS. AUGMENTIN 375MG SMITH KLINE & PAKISTAN BEECHAM AUGMENTIN N/A SMITH KLINE & PAKISTAN BEECHAM AUGMENTIN 1.2G IV POWDER FOR N/A BEECHAM GROUP PLC AUGMENTIN 156MG SUSPENSION POWDER FOR ORAL N/A BEECHAM GROUP PLC AUGMENTIN 1G COATED N/A BEECHAM GROUP PLC AUGMENTIN 228MG POWDER FOR N/A SMITHKLINE SUSPENSION ORAL SUSPEN. BEECHAM PLC AUGMENTIN 312MG POWDER FOR N/A BEECHAM PLC SUSPENSION ORAL AUGMENTIN 457MG POWDER FOR N/A SMITHKLINE SUSPENSION ORAL SUSPEN. BEECHAM PLC AUGMENTIN 600MG IV POWDER FOR N/A BEECHAM GROUP PLC AA 38/03 ADD 1 Act/Annex XI/en 38

40 AUGMENTIN 625MG COATED N/A BEECHAM GROUP PLC AUGMENTIN 625MG TABS. TWICE DAILY DOSING COATED N/A BEECHAM GROUP PLC AUGMENTIN DISPERSIBLE 375MG AUGMENTIN INFANT DROPS AUGMENTIN 375MG FOR N/A BEECHAM GROUP ORAL PLC POWDER FOR ORAL N/A BEECHAM GROUP PLC COATED N/A BEECHAM GROUP PLC AULIN 100MG HELSINN BIREX IRELAND. AULIN ORAL POWDER 100MG/SACHE HELSINN BIREX IRELAND FOR RECON. T. AUNATIV FOR 250IU/ML PHARMACIA & SWEDEN UPJOHN AB AUNATIV FOR FOR 200IU/ML BIOVITRUM SWEDEN AUREOMYCIN OINTMENT OINTMENT 3% W/W CYANAMID OF GREAT BRITAIN. AUREOMYCIN SALBE OINTMENT 3G/100G LEDERLE ARZNEIMITTEL GMBH & CO GERMANY AUREOMYCINE MONOT 3% OINTMENT 3% LABORATOIRES MONOT FRANCE AURIGOUTTE EAR DROPS N/A LABORAOIRES MONOT FRANCE AVALOX 400MG FILM-COATED 400MG BAYER VITAL GMBH GERMANY & CO. KG AVANDIA 2MG SMITHKLINE BEECHAM UNITED STATES OF AMERICA CORPORATION AVANDIA 4MG SMITHKLINE BEECHAM UNITED STATES OF AMERICA CORPORATION AVANDIA 8MG SMITHKLINE BEECHAM UNITED STATES OF AMERICA CORPORATION AVANDIA FILM-COATED 1MG SMITHKLINE BEECHAM PLC EUROPEAN COMMUNITY AA 38/03 ADD 1 Act/Annex XI/en 39

41 AVANDIA FILM-COATED 2MG SMITHKLINE BEECHAM PLC EUROPEAN COMMUNITY AVANDIA FILM COATED 4MG SMITHKLINE BEECHAM PLC EUROPEAN COMMUNITY AVANDIA FILM COATED 8MG SMITHKLINE BEECHAM PLC EUROPEAN COMMUNITY AVANT 1.5MG 1.5MG MEDOCHEMIE CYPRUS AVANT 10MG 10MG MEDOCHEMIE CYPRUS AVANT 5MG 5MG MEDOCHEMIE CYPRUS AVAXIM SUSPENSION FOR 160 AU/0.5ML PASTEUR MERIEUX FRANCE AVELOX FILM-COATED 400MG BAYER VITAL GMBH GERMANY & CO. KG AVERNOL 25MG MEDOCHEMIE. CYPRUS AVIPUR 50,000IU TARO ISRAEL PHARMACEUTICAL INDUSTRIES. AVIPUR 50,000 IU TARO PHARMACEUTICAL INDUSTRIES ISRAEL AVIRAL MG MEPHA PHARMA AG SWITZERLAND AVIRAL MG MEPHA PAHRMA AG SWITZERLAND AVIRAL MG MEPHA PHARMA AG SWITZERLAND AVOCLOR 250MG ZENECA AVOMINE 25MG MANX PHARMA AVOMINE 25MG RHONE-POULENC RORER PAKISTAN (PVT) PAKISTAN AVONEX POWDER + 30UG/ML BIOGEN FRANCE S.A. FRANCE SOLVENT FOR INJ. AVONEX POWDER AND SOLVENT FOR INJ 30MCG BIOGEN FRANCE S.A. EUROPEAN COMMUNITY AXETINE 250MG POWDER FOR 250MG MEDOCHEMIE CYPRUS AXETINE 750MG POWDER FOR 750MG MEDOCHEMIE CYPRUS AXSAIN CREAM 0.075% W / W BIOGLAN AA 38/03 ADD 1 Act/Annex XI/en 40

42 AXURA FILM-COATED 10MG MERZ EUROPEAN COMMUNITY GMBH AXURA ORAL DROPS 10MG/G MERZ EUROPEAN COMMUNITY GMBH AZACTAM POWDER FOR 500MG BRISTOL-MYERS ITALY SQUIBB S.P.A AZACTAM POWDER FOR 1G BRISTOL-MYERS ITALY SQUIBB S.P.A AZACTAM POWDER FOR 1G E R SQUIBB & SONS AZACTAM POWDER FOR 2GM ER SQUIBB & SONS AZAMUN FILM COATED 50MG DOUGLAS NEW ZEALAND AZANTAC 150MG EFFERVESCENT 150MG GLAXO WELLCOME FRANCE AZANTAC 300MG EFFEVESCENT 300MG GLAXO WELLCOME FRANCE AZATHIOPRINE BP FILM COATED 50MG GENERICS (UK) AZATHIOPRINE PCH 50MG PHARMACHEMIE BV NETHERLANDS AZATHIOPRINE 50MG NORTON 50MG AZATHIOPRINE FILM COATED 50MG GENERICS [UK] BP 50MG AZATRILEM 50MG LEMERY S.A. MEXICO AZEE, AZITHROMYCIN CAPSULES 250 MG CIPLA. INDIA CAPSULES USP AZELDERM CREAM 20%W/W KLEVA GREECE AZEPTIL 250MG CAPSULE 250MG MEDOCHEMIE CYPRUS AZEPTIL 500MG CAPSULE 500MG MEDOCHEMIE CYPRUS AZEPTIL 500MG/5ML LIQUID FOR 500MG/5ML MEDOCHEMIE CYPRUS AZITHROMYCIN CAPSULE 250MG PFIZER AZOPT OPHTHALMIC 10MG/ML ALCON UNITED STATES OF SUSPENSION INC. AMERICA AA 38/03 ADD 1 Act/Annex XI/en 41

43 AZOPT EYE DROPS 10MG/ML ALCON UK EUROPEAN COMMUNITY BABY MELTUS FOR BABIES ORAL 0.42 ML CUPAL COUGHS BACLOFEN 10MG 10MG GENERICS [UK] BACLOFEN 10MG 10MG GENERICS [UK] BACLOFEN 10MG 10MG NORTON BACLON 10MG 10MG LEIRAS OY FINLAND BACTROBAN OINTMENT 2% W/W BEECHAM GROUP PLC BACTROBAN CREAM 2% W/W SMITHKLINE BEECHAM UNITED STATES OF AMERICA BACTROBAN CREAM CREAM 2% W/W BEECHAM GROUP PLC BACTROBAN NASAL NASAL 2% W/W BEECHAM GROUP OINTMENT 2% W/W OINTMENT PLC BALANCED SALT (AKORN) IRRIGATING N/A TAYLOR UNITED STATES OF AMERICA BALKIS 0.05% NASAL DROPS 0.05% W/V DOLORGIET GMBH & GERMANY CO. KG BALKIS 0.1% NASAL DROPS 0.1% W/V DOLORGIET GMBH & GERMANY CO. KG BALKIS NASAL SPRAY 1MG/ML DOLORGIET GMBH & GERMANY CO. KG BALKIS NASAL SPRAY NASAL SPRAY 1MG/ML DOLORGIET GMBH & GERMANY CO KG BALMOSA CREAM N/A PHARMAX BALTO FOOT BALM OINTMENT N/A G R LANE HEALTH PRODUCTS BARILUX HD POWDER % W/W GOLDHAM PHARMA GMBH GERMANY 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 AA 38/03 ADD 1 Act/Annex XI/en 42

44 BAYRO GEL GEL NA TROPON GMBH GERMANY BAYROGEL GEL 50MG/G BAYER VITAL GMBH GERMANY & CO. KG BAZUKA EXTRA GEL 26% W/W DIOMED STRENGTH GEL DEVELOPMENTS T/A DERMAL BAZUKA GEL GEL N/A DIOMED DEVELOPMENTS T/A DERMAL BCG VACCINE FREEZE DIRED N/A EVANS MEDICAL INTRADERMAL BP PREP. F/INJ. BCG VACCINE FREEZE DRIED N/A EVANS MEDICAL INTRADERMAL BP ISONIAZID RES PREP F/INJ BCG VACCINE FREEZE DRIED N/A EVANS MEDICAL PERCUTANEOUS BP PREP F/INJ BCG VACCINE SSI POWDER FOR 0.75MG/ML STATENS SERUM DENMARK INSTITUT BEBEGEL RECTAL GEL N/A ASTA MEDICA FRANCE BECADRIL 500 CASULES 500MG REMEDICA CYPRUS BECEDRIL 1G 1G REMEDICA CYPRUS BECEVIT S.C. N/A REMEDICA CYPRUS BECEVIT NA REMEDICA. CYPRUS BECLATE 250 INHALER INHALER 250MCG/ACTU CIPLA INDIA ATIO BECLATE-50 INHALER 50MCG CIPLA INDIA BECLAZONE 100 INHALER 100MCG/DOSE NORTON BECLAZONE 100 CFC-FREE INHALER 100MCG/DOSE NORTON (WATERFORD) IRELAND BECLAZONE 250 INHALER 250MCG/DOSE NORTON BECLAZONE 250 CFC-FREE INHALER INHALER 250MCG/DOSE NORTON (WATERFORD) IRELAND AA 38/03 ADD 1 Act/Annex XI/en 43

45 BECLAZONE 50 INHALER 50MCG/DOSE NORTON BECLAZONE 50 CFC-FREE INHALER BECLAZONE 50 EASI- BREATHE CFC-FREE BECLAZONE EASI- BREATHE CFC-FREE BECLOFORTE INHALER 50MCG/DOSE NORTON (WATERFORD) INHALER 50MCG/DOSE NORTON IRELAND (WATERFORD) INHALER 250MCG/DOSE NORTON IRELAND (WATERFORD) METERED N/A GLAXOWELLCOME PAKISTAN AEROSOL BECLOFORTE INHALER AEROSOL 250 MCG/AC GLAXO WELLCOME UK T/A ALLEN & HANBURYS BECLOFORTE INHALER AEROSOL 250MCG/DOSE GLAXO WELLCOME UK BECLOMETASONE AQUEOUS 0.039%W/V ASHBOURNE DIPROPIONATE 50MCG NASAL SPRAY PHARMACEUTICAL (HOLDINGS) BECLOMETHASONE AQUEOUS 50MCG/DOSE NORTON DIPROPIONATE NASAL SPRAY BECLOMETHASONE DIPROPIONATE AQ. NASAL SP NASAL SPRAY 50MCG/ACTUA TION GENERICS [UK] BECLOMIST NASAL SPRAY NASAL SPRAY 50MCG/ACTUA PARKFIELDS FOR HAYFEVER TION BECONASE ALLERGY NASAL SPRAY 50MCG/AC GLAXO WELLCOME UK T/A ALLEN & HANDURYS BECONASE AQUEOUS NASAL SPRAY 50MCG/AC GLAXO WELLCOME NASAL SPRAY UK T/A ALLEN & HANBURYS BECONASE AQUEOUS NASAL SPRAY 50UG/AC GLAXO WELLCOME NASAL SPRAY UK T/A ALLEN & HANDBURYS BECONASE AQUEOUS NASAL SPRAY 50MCG/DOSE ALLEN SPAIN NASAL SPRAY SUSPENSION FARMACEUTICA S.A. BECONASE HAYFEVER NASAL SPRAY 50MCG/AC GLAXO WELLCOME UK AA 38/03 ADD 1 Act/Annex XI/en 44

46 BECONASE HAYFEVER NASAL SPRAY 50UG/AC GLAXO WELLCOME UK T/A ALLEN & HANDBURYS BECOTIDE AEROSOL F/INH. 50MCG/DOSE GLAXOWELLCOME PAKISTAN BECOTIDE 100 INHALER AEROSOL 100MCG/AC GLAXO WELLCOME UK T/A ALLEN & HANBURYS BECOTIDE 100 INHALER AEROSOL 100UG/AC GLAXO WELLCOME UK BECOTIDE 50 INHALER AEROSOL 50MCG/AC GLAXO WELLCOME UK T/A ALLEN & HANBURYS BECOTIDE 50 INHALER AEROSOL 50MCG/DOSE GLAXO WELLCOME UK BECOZYM FORTE SUGAR-COATED N/A ROCHE PHARMA SWITZERLAND (SCHWEIZ) AG BEECHAM 75MG ASPIRIN 75MG BEECHAM GROUP PLC T/A SMITHKLINE BEECHAM CONSUMER BEECHAM DAY NURSE ORAL N/A BEECHAM GROUP PLC BEECHAMS ALL-IN-ONE ORAL N/A BEECHAM GROUP PLC T/A SMITHKLINE BEECHAM CONSUMER BEECHAMS COLD AND FLU POWDER FOR N/A BEECHAM GROUP HOT BLACKCURRANT ORAL PLC T/A SMITHKLINE BEECHAM CONSUMER BEECHAMS COLD AND FLU POWDER FOR N/A BEECHAM GROUP HOT LEMON ORAL PLC T/A SMITHKLINE BEECHAM CONSUMER AA 38/03 ADD 1 Act/Annex XI/en 45

47 BEECHAMS COLD AND FLU POWDER FOR N/A BEECHAM GROUP HOT LEMON AND HONEY ORAL PLC T/A SMITHKLINE BEECHAM CONSUMER BEECHAMS FLU-PLUS HOT POWDER FOR NA BEECHAM GROUP LEMON ORAL PLC BEECHAMS POWDER POWDER FOR NA BEECHAM GROUP ORAL PLC T/A GLAXOSMITHKLINE CONSUMER BEECHAMS THROAT-PLUS LOZENGES NA BEECHAM GROUP BLACKCURRANT PLC T/A GLAXOSMITHKLINE CONSUMER BEECHAMS THROAT-PLUS LEMON LOZENGES NA BEECHAM GROUP PLC T/A GLAXOSMITHKLINE CONSUMER BEECHAM'S VENO'S ORAL N/A BEECHAM GROUP COUGH MIXTURE PLC T/A SMITHKLINE BEECHAM CONSUMER BEECHAMS VENO'S EXPECTORANT ORAL N/A BEECHAM GROUP PLC T/A SMITHKLINE BEECHAM CONSUMER BEECHAMS VENO'S HONEY ORAL N/A BEECHAM GROUP AND LEMON PLC T/A SMITHKLINE BEECHAM CONSUMER BEECHAMS WARMERS BLACKCURRANT POWDER FOR ORAL N/A BEECHAM GROUP PLC T/A SMITHKLINE BEECHAM CONSUMER AA 38/03 ADD 1 Act/Annex XI/en 46

48 BEECHAMS WARMERS POWDER FOR N/A BEECHAM GROUP LEMON ORAL PLC T/A SMITHKLINE BEECHAM CONSUMER BEECHAMS WARMERS POWDER FOR N/A BEECHAM GROUP LEMON AND HONEY ORAL PLC T/A SMITHKLINE BEECHAM CONSUMER BEGROCIT EFFERVESCENT N/A DR.GROSSMANN AG SWITZERLAND PHARMACA BELARAMINE EXPECTORANT SYRUP N/A REMEDICA CYPRUS BELL'S CHILDRENS COUGH ORAL LIQUID 100MG/5ML BELL SONS & CO SYRUP (DRUGGISTS) BELL'S WINTERGREEN OINTMENT N/A BELL SONS & CO OINTMENT (DRUGGISTS) BENADRYL ALLERGY CAPSULE 8MG WARNER-LAMBERT RELIEF CONSUMER BENDROFLUAZIDE 5MG CAMDEN INDUSTRIES (M) SDN.BHD MALAYSIA BENDROFLUAZIDE BP 5MG 5MG SUSSEX PHARMACEUTICAL BENDROFLUAZIDE 5MG CP BP 5MG BENOXYL 5 LOTION / TOPICAL 5% W/W STIEFEL PANOXYL 5 LOTION EMULSION (UK) BENT 5MG 5MG MEDOCHEMIE CYPRUS BENXHEXOL 2 2MG REMEDICA CYPRUS BENYLIN CHESTY COUGHS SYRUP N/A WARNER-LAMBERT (NON-DROWSY) CONSUMER AA 38/03 ADD 1 Act/Annex XI/en 47