# C_2004215EN.01000701.xml

| 27.8.2004 | EN | Official Journal of the European Union | C 215/7 |
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Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2004 to 15 August 2004

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93( 1 ))

(2004/C 215/05)

| — | Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93
( 1 )
) Accepted
Date of the decision
Name of the medicinal product
Holder of the marketing authorization
Number of the entry in the Community Register
Date of notification 29.7.2004
Pedea
Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense, France
EU/1/04/284/001
2.8.2004 11.8.2004
Yentreve
Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland
EU/1/04/280/001-006.
13.8.2004 11.8.2004
Ariclaim
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland
EU/1/04/283/001-006
13.8.2004 | Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification | 29.7.2004 | Pedea | Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense, France | EU/1/04/284/001 | 2.8.2004 | 11.8.2004 | Yentreve | Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/04/280/001-006. | 13.8.2004 | 11.8.2004 | Ariclaim | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/04/283/001-006 | 13.8.2004 |
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| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification | | | | | | | | | | | | | | | | | |
| 29.7.2004 | Pedea | Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense, France | EU/1/04/284/001 | 2.8.2004 | | | | | | | | | | | | | | | | | |
| 11.8.2004 | Yentreve | Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/04/280/001-006. | 13.8.2004 | | | | | | | | | | | | | | | | | |
| 11.8.2004 | Ariclaim | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/04/283/001-006 | 13.8.2004 | | | | | | | | | | | | | | | | | |

| — | Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93
( 1 )
) Accepted
Date of the decision
Name of the medicinal product
Holder of the marketing authorization
Number of the entry in the Community Register
Date of notification 19.7.2004
Reyataz
Bristol - Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom
EU/1/03/267/001-007
21.07.2004 19.7.2004
Humira
Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom
EU/1/03/256/001-006
21.07.2004 19.7.2004
Trudexa
Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom
EU/1/03/257/001-006
21.07.2004 19.7.2004
Nyracta
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom
EU/1/00/139/001-012
21.07.2004 19.7.2004
Avandia
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom
EU/1/00/137/001-012
21.07.2004 19.7.2004
Venvia
SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom
EU/1/00/138/001-012
21.07.2004 20.7.2004
Rebif
Serono Europe Ltd., 56, Marsh Wall, London E14 9TP, United Kingdom
EU/1/98/063/001-006
23.07.2004 20.7.2004
Replagal
TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige
EU/1/01/189/001-003
23.07.2004 20.7.2004
Refacto
Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom
EU/1/99/103/001-004
23.07.2004 22.7.2004
Mirapexin
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland
Pfizer Enterprises SARL, 6, Circuit de la Foire Internationale, 1347 Luxembourg, Grand-Duché du Luxembourg
EU/1/97/051/001-006 EU/1/97/051/009-012
26.07.2004 23.7.2004
Enbrel
Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom
EU/1/99/126/001-003
27.07.2004 23.7.2004
Enbrel
Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom
EU/1/99/126/001-003
27.07.2004 29.7.2004
ReFacto
Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom
EU/1/99/103/001-004
2.8.2004 29.7.2004
Replagal
TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige
EU/1/01/189/004-006
2.8.2004 2.8.2004
Procomvax
Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France
EU/1/99/104/001
4.8.2004 2.8.2004
CoAprovel
Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France
EU/1/98/086/001-020
4.8.2004 2.8.2004
Aprovel
Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France
EU/1/97/046/001-030
4.8.2004 2.8.2004
Karvezide
Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom
EU/1/98/085/001-020
4.8.2004 2.8.2004
Karvea
Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom
EU/1/97/049/001-030
4.8.2004 2.8.2004
MabThera
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom
EU/1/98/067/001-002
4.8.2004 2.8.2004
Plavix
Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France
EU/1/98/069/001a-001b, EU/1/98/069/002a-002b, EU/1/98/069/003a-003b, EU/1/98/069/004a-004b
4.8.2004 2.8.2004
Iscover
Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom
EU/1/98/070/001a-001b, EU/1/98/070/002a-002b, EU/1/98/070/003a-003b, EU/1/98/070/004a-004b
4.8.2004 2.8.2004
Prevenar
Wyeth-Lederle Vaccines S.A., Rue du Bosquet, 15 - 1348 Louvain-La-Neuve - Belgique
EU/1/00/167/001-007
4.8.2004 2.8.2004
Actrapid
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
EU/1/02/230/001-017
4.8.2004 2.8.2004
Mixtard
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
EU/1/02/231/001-037
4.8.2004 2.8.2004
Insulatard
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
EU/1/02/233/001-017
4.8.2004 2.8.2004
Velosulin
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
EU/1/02/232/001-003
4.8.2004 2.8.2004
Protaphane
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
EU/1/02/234/001-017
4.8.2004 2.8.2004
Puregon
Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland
EU/1/96/008/038-039
4.8.2004 2.8.2004
Puregon,
Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland
EU/1/96/008/040-041
4.8.2004 2.8.2004
Viread
Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom
EU/1/01/200/001
4.8.2004 2.8.2004
Emtriva
Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom
EU/1/03/261/001-003
4.8.2004 2.8.2004
Actraphane
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
EU/1/02/229/001-037
4.8.2004 2.8.2004
Norvir
Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United-Kingdom
EU/1/96/016/001 and EU/1/96/016/003
4.8.2004 2.8.2004
Starlix
Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom
EU/1/01/174/001-021
4.8.2004 2.8.2004
Cellcept
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom
EU/1/96/005/001-006
4.8.2004 2.8.2004
Protopy
Fujisawa GmbH, Neumarkter Str. 61, D-81673 München, Deutschland
EU/1/02/202/001-007
4.8.2004 2.8.2004
Inomax
INO Therapeutics AB, SE-181 81 Lidingö, Sverige
EU/1/01/194/001-002
4.8.2004 2.8.2004
Trazec
Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom
EU/1/01/175/001-021
4.8.2004 4.8.2004
Insuman
Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, Deutschland
EU/1/97/030/030, EU/1/97/030/035, EU/1/97/030/040, EU/1/97/030/045, EU/1/97/030/050, EU/1/97/030/055-064
6.8.2004 4.8.2004
Somavert
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom
EU/1/02/240/001-004
6.8.2004 9.8.2004
Fabrazyme
Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland
EU/1/01/188/001-006
12.8.2004 11.8.2004
Vfend
Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
EU/1/02/212/001-026
13.8.2004 12.8.2004
Infergen
Yamanouchi Europe B.V., Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland
EU/1/98/087/001-003
16.8.2004 12.8.2004
Optison
Amersham Health AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, 0401 Oslo, Norway
EU/1/98/065/001-002
16.8.2004 | Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification | 19.7.2004 | Reyataz | Bristol - Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom | EU/1/03/267/001-007 | 21.07.2004 | 19.7.2004 | Humira | Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom | EU/1/03/256/001-006 | 21.07.2004 | 19.7.2004 | Trudexa | Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom | EU/1/03/257/001-006 | 21.07.2004 | 19.7.2004 | Nyracta | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/139/001-012 | 21.07.2004 | 19.7.2004 | Avandia | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/137/001-012 | 21.07.2004 | 19.7.2004 | Venvia | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/138/001-012 | 21.07.2004 | 20.7.2004 | Rebif | Serono Europe Ltd., 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063/001-006 | 23.07.2004 | 20.7.2004 | Replagal | TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige | EU/1/01/189/001-003 | 23.07.2004 | 20.7.2004 | Refacto | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/103/001-004 | 23.07.2004 | 22.7.2004 | Mirapexin | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland
Pfizer Enterprises SARL, 6, Circuit de la Foire Internationale, 1347 Luxembourg, Grand-Duché du Luxembourg | EU/1/97/051/001-006 EU/1/97/051/009-012 | 26.07.2004 | 23.7.2004 | Enbrel | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-003 | 27.07.2004 | 23.7.2004 | Enbrel | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-003 | 27.07.2004 | 29.7.2004 | ReFacto | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/103/001-004 | 2.8.2004 | 29.7.2004 | Replagal | TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige | EU/1/01/189/004-006 | 2.8.2004 | 2.8.2004 | Procomvax | Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France | EU/1/99/104/001 | 4.8.2004 | 2.8.2004 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France | EU/1/98/086/001-020 | 4.8.2004 | 2.8.2004 | Aprovel | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France | EU/1/97/046/001-030 | 4.8.2004 | 2.8.2004 | Karvezide | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom | EU/1/98/085/001-020 | 4.8.2004 | 2.8.2004 | Karvea | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom | EU/1/97/049/001-030 | 4.8.2004 | 2.8.2004 | MabThera | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/98/067/001-002 | 4.8.2004 | 2.8.2004 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France | EU/1/98/069/001a-001b, EU/1/98/069/002a-002b, EU/1/98/069/003a-003b, EU/1/98/069/004a-004b | 4.8.2004 | 2.8.2004 | Iscover | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom | EU/1/98/070/001a-001b, EU/1/98/070/002a-002b, EU/1/98/070/003a-003b, EU/1/98/070/004a-004b | 4.8.2004 | 2.8.2004 | Prevenar | Wyeth-Lederle Vaccines S.A., Rue du Bosquet, 15 - 1348 Louvain-La-Neuve - Belgique | EU/1/00/167/001-007 | 4.8.2004 | 2.8.2004 | Actrapid | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/230/001-017 | 4.8.2004 | 2.8.2004 | Mixtard | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/231/001-037 | 4.8.2004 | 2.8.2004 | Insulatard | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/233/001-017 | 4.8.2004 | 2.8.2004 | Velosulin | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/232/001-003 | 4.8.2004 | 2.8.2004 | Protaphane | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/234/001-017 | 4.8.2004 | 2.8.2004 | Puregon | Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland | EU/1/96/008/038-039 | 4.8.2004 | 2.8.2004 | Puregon, | Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland | EU/1/96/008/040-041 | 4.8.2004 | 2.8.2004 | Viread | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | EU/1/01/200/001 | 4.8.2004 | 2.8.2004 | Emtriva | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | EU/1/03/261/001-003 | 4.8.2004 | 2.8.2004 | Actraphane | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/229/001-037 | 4.8.2004 | 2.8.2004 | Norvir | Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United-Kingdom | EU/1/96/016/001 and EU/1/96/016/003 | 4.8.2004 | 2.8.2004 | Starlix | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/174/001-021 | 4.8.2004 | 2.8.2004 | Cellcept | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/96/005/001-006 | 4.8.2004 | 2.8.2004 | Protopy | Fujisawa GmbH, Neumarkter Str. 61, D-81673 München, Deutschland | EU/1/02/202/001-007 | 4.8.2004 | 2.8.2004 | Inomax | INO Therapeutics AB, SE-181 81 Lidingö, Sverige | EU/1/01/194/001-002 | 4.8.2004 | 2.8.2004 | Trazec | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/175/001-021 | 4.8.2004 | 4.8.2004 | Insuman | Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, Deutschland | EU/1/97/030/030, EU/1/97/030/035, EU/1/97/030/040, EU/1/97/030/045, EU/1/97/030/050, EU/1/97/030/055-064 | 6.8.2004 | 4.8.2004 | Somavert | Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/240/001-004 | 6.8.2004 | 9.8.2004 | Fabrazyme | Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland | EU/1/01/188/001-006 | 12.8.2004 | 11.8.2004 | Vfend | Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/212/001-026 | 13.8.2004 | 12.8.2004 | Infergen | Yamanouchi Europe B.V., Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | EU/1/98/087/001-003 | 16.8.2004 | 12.8.2004 | Optison | Amersham Health AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, 0401 Oslo, Norway | EU/1/98/065/001-002 | 16.8.2004 |
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| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 19.7.2004 | Reyataz | Bristol - Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom | EU/1/03/267/001-007 | 21.07.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 19.7.2004 | Humira | Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom | EU/1/03/256/001-006 | 21.07.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 19.7.2004 | Trudexa | Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom | EU/1/03/257/001-006 | 21.07.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 19.7.2004 | Nyracta | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/139/001-012 | 21.07.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 19.7.2004 | Avandia | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/137/001-012 | 21.07.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 19.7.2004 | Venvia | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/138/001-012 | 21.07.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 20.7.2004 | Rebif | Serono Europe Ltd., 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063/001-006 | 23.07.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 20.7.2004 | Replagal | TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige | EU/1/01/189/001-003 | 23.07.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 20.7.2004 | Refacto | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/103/001-004 | 23.07.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 22.7.2004 | Mirapexin | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland
Pfizer Enterprises SARL, 6, Circuit de la Foire Internationale, 1347 Luxembourg, Grand-Duché du Luxembourg | EU/1/97/051/001-006 EU/1/97/051/009-012 | 26.07.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 23.7.2004 | Enbrel | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-003 | 27.07.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 23.7.2004 | Enbrel | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-003 | 27.07.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 29.7.2004 | ReFacto | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/103/001-004 | 2.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 29.7.2004 | Replagal | TKT Europe-5S AB, Rinkebyvägen 11B, SE 182 36 Danderyd, Sverige | EU/1/01/189/004-006 | 2.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Procomvax | Aventis Pasteur MSD, 8, rue Jonas Salk, 69007 Lyon, France | EU/1/99/104/001 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France | EU/1/98/086/001-020 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Aprovel | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France | EU/1/97/046/001-030 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Karvezide | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom | EU/1/98/085/001-020 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Karvea | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom | EU/1/97/049/001-030 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | MabThera | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/98/067/001-002 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France - 75013 Paris, France | EU/1/98/069/001a-001b, EU/1/98/069/002a-002b, EU/1/98/069/003a-003b, EU/1/98/069/004a-004b | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Iscover | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom | EU/1/98/070/001a-001b, EU/1/98/070/002a-002b, EU/1/98/070/003a-003b, EU/1/98/070/004a-004b | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Prevenar | Wyeth-Lederle Vaccines S.A., Rue du Bosquet, 15 - 1348 Louvain-La-Neuve - Belgique | EU/1/00/167/001-007 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Actrapid | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/230/001-017 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Mixtard | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/231/001-037 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Insulatard | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/233/001-017 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Velosulin | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/232/001-003 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Protaphane | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/234/001-017 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Puregon | Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland | EU/1/96/008/038-039 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Puregon, | Organon N.V., P.O. Box 20, 5340 BH Oss, Nederland | EU/1/96/008/040-041 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Viread | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | EU/1/01/200/001 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Emtriva | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | EU/1/03/261/001-003 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Actraphane | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark | EU/1/02/229/001-037 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Norvir | Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United-Kingdom | EU/1/96/016/001 and EU/1/96/016/003 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Starlix | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/174/001-021 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Cellcept | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/96/005/001-006 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Protopy | Fujisawa GmbH, Neumarkter Str. 61, D-81673 München, Deutschland | EU/1/02/202/001-007 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Inomax | INO Therapeutics AB, SE-181 81 Lidingö, Sverige | EU/1/01/194/001-002 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 2.8.2004 | Trazec | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/175/001-021 | 4.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 4.8.2004 | Insuman | Aventis Pharma Deutschland GmbH, Brueningstrasse 50, D-65926 Frankfurt am Main, Deutschland | EU/1/97/030/030, EU/1/97/030/035, EU/1/97/030/040, EU/1/97/030/045, EU/1/97/030/050, EU/1/97/030/055-064 | 6.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 4.8.2004 | Somavert | Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/240/001-004 | 6.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 9.8.2004 | Fabrazyme | Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland | EU/1/01/188/001-006 | 12.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 11.8.2004 | Vfend | Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/212/001-026 | 13.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 12.8.2004 | Infergen | Yamanouchi Europe B.V., Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | EU/1/98/087/001-003 | 16.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 12.8.2004 | Optison | Amersham Health AS, Nycoveien 1-2, P.O. Box 4220 Nydalen, 0401 Oslo, Norway | EU/1/98/065/001-002 | 16.8.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| — | Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93
( 1 )
) Accepted
Date of the decision
Name of the medicinal product
Holder of the marketing authorization
Number of the entry in the Community Register
Date of notification 23.07.2004
Eurifel RCP FeL V
Merial, 29 avenue Tony Garnier, 69007 Lyon, France
EU/2/02/031/001-002
27.07.2004 29-07-2004
Virbagen Omega
VIRBAC S.A., 1ere Avenue 2065 m L.I.D. - 06516 Carros - France
EU/2/01/030/001-002
02-08-2004 11-08-2004
Porcilis Porcoli
Intervet International B.V. (NL), Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland
EU/2/96/001/009-010
13-08-2004 | Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification | 23.07.2004 | Eurifel RCP FeL V | Merial, 29 avenue Tony Garnier, 69007 Lyon, France | EU/2/02/031/001-002 | 27.07.2004 | 29-07-2004 | Virbagen Omega | VIRBAC S.A., 1ere Avenue 2065 m L.I.D. - 06516 Carros - France | EU/2/01/030/001-002 | 02-08-2004 | 11-08-2004 | Porcilis Porcoli | Intervet International B.V. (NL), Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/96/001/009-010 | 13-08-2004 |
| -------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ | --------------------------------------------- | ------------------------------------- | --------------------------------------------- | -------------------- | ---------- | ----------------- | -------------------------------------------------- | ------------------- | ---------- | ---------- | -------------- | -------------------------------------------------------------- | ------------------- | ---------- | ---------- | ---------------- | ------------------------------------------------------------------------------------ | ------------------- | ---------- |
| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification | | | | | | | | | | | | | | | | | |
| 23.07.2004 | Eurifel RCP FeL V | Merial, 29 avenue Tony Garnier, 69007 Lyon, France | EU/2/02/031/001-002 | 27.07.2004 | | | | | | | | | | | | | | | | | |
| 29-07-2004 | Virbagen Omega | VIRBAC S.A., 1ere Avenue 2065 m L.I.D. - 06516 Carros - France | EU/2/01/030/001-002 | 02-08-2004 | | | | | | | | | | | | | | | | | |
| 11-08-2004 | Porcilis Porcoli | Intervet International B.V. (NL), Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/96/001/009-010 | 13-08-2004 | | | | | | | | | | | | | | | | | |

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Agency for the Evaluation of Medicinal products |
| ------------------------------------------------------------ |
| 7, Westferry Circus, Canary Wharf |
| UK - LONDON E14 4HB |

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( 1 )  OJ L 214 of 24.8.1993, p. 1.

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