# C_2004320EN.01002301.xml

| 24.12.2004 | EN | Official Journal of the European Union | C 320/23 |
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Summary of Community decisions on marketing authorisations in respect of medicinal products for the period 15 November 2004 to 15 December 2004

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

(2004/C 320/13)

| — | Issuing of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93): accepted
Date of the decision
Name of the medicinal product
Holder of the marketing authorisation
Number of the entry in the Community Register
Date of notification 16.11.2004
Xagrid
Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom
EU/1/04/295/001
18.11.2004 | Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification | 16.11.2004 | Xagrid | Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295/001 | 18.11.2004 |
| -------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------- | ------------------------------------- | --------------------------------------------- | -------------------- | ---------- | ------ | ------------------------------------------------------------------------------------------------------------------------------------ | --------------- | ---------- |
| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification | | | | | | | |
| 16.11.2004 | Xagrid | Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295/001 | 18.11.2004 | | | | | | | |

| — | Modification of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93): accepted
Date of the decision
Name of the medicinal product
Holder of the marketing authorisation
Number of the entry in the Community Register
Date of notification 16.11.2004
Tamiflu
Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom
EU/1/02/222/001
18.11.2004 17.11.2004
Trizivir
Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom
EU/1/00/156/001-003
19.11.2004 17.11.2004
Targretin
Ligand Pharmaceuticals UK Ltd, Innovis House, 108 High Street, Crawley, West Sussex, RH10 1BB, United Kingdom
EU/1/01/178/001
19.11.2004 25.11.2004
Bextra
Pharmacia-Pfizer EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom
EU/1/02/239/001-024
29.11.2004 25.11.2004
ReFacto
Wyeth Europa Ltd, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom
EU/1/99/103/001-004
29.11.2004 30.11.2004
Xigris
Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland
EU/1/02/225/001-002
2.12.2004 30.11.2004
Tracleer
Actelion Registration Ltd, BSI Building, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom
EU/1/02/220/001-005
2.12.2004 30.11.2004
Cialis
Lilly ICOS Limited, St Bride's House, 10 Salisbury Square, London, EC4Y 8EH, United Kingdom
EU/1/02/237/001
EU/1/02/237/005
2.12.2004 1.12.2004
Micardis
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein
EU/1/98/090/001-014
3.12.2004 6.12.2004
Integrilin
Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, United Kingdom
Schering Plough Europe, Rue de Stalle 73, B-1180 Bruxelles, Stallestraat 73, B-1180 Brussel
EU/1/99/109/001-002
8.12.2004 6.12.2004
Epivir
Glaxo Group Ltd, Greenford Road, Greenford, Middlesex, UB6 0NN, United Kingdom
EU/1/96/015/001-005
8.12.2004 6.12.2004
Dynastat
Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom
EU/1/02/209/001-008
8.12.2004 6.12.2004
Sustiva
Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow, TW3 3JA, United Kingdom
EU/1/99/110/001-009
8.12.2004 6.12.2004
NutropinAq
IPSEN Limited, 190 Bath Road, Slough, Berkshire, SLI 3XE, United Kingdom
EU/1/00/164/001-005
8.12.2004 6.12.2004
Strocrin
Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom
EU/1/99/111/001-009
8.12.2004 6.12.2004
Dynastat
Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom
EU/1/02/209/001-008
8.12.2004 6.12.2004
Panretin
Ligand Pharmaceuticals UK Ltd, Innovis House, 108 High Street, Crawley, West Sussex, RH10 1BB, United Kingdom
EU/1/00/149/001
8.12.2004 6.12.2004
Arava
Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main
EU/1/99/118/001-010
8.12.2004 6.12.2004
Viread
Gilead Sciences International Limited, Cambridge, CB1 6GT United Kingdom
EU/1/01/200/001
8.12.2004 6.12.2004
Rayzon
Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom
EU/1/02/210/001-008
8.12.2004 6.12.2004
Rayzon 6m
Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom
EU/1/02/210/001-008
8.12.2004 7.12.2004
Kinzalmono
Bayer AG, D-51368 Leverkusen
EU/1/98/091/001-014
9.12.2004 7.12.2004
Micardis
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein
EU/1/98/090/001-014
10.12.2004 7.12.2004
Pritor
Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom
EU/1/98/089/001-016
9.12.2004 | Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification | 16.11.2004 | Tamiflu | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom | EU/1/02/222/001 | 18.11.2004 | 17.11.2004 | Trizivir | Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom | EU/1/00/156/001-003 | 19.11.2004 | 17.11.2004 | Targretin | Ligand Pharmaceuticals UK Ltd, Innovis House, 108 High Street, Crawley, West Sussex, RH10 1BB, United Kingdom | EU/1/01/178/001 | 19.11.2004 | 25.11.2004 | Bextra | Pharmacia-Pfizer EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/239/001-024 | 29.11.2004 | 25.11.2004 | ReFacto | Wyeth Europa Ltd, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/103/001-004 | 29.11.2004 | 30.11.2004 | Xigris | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/02/225/001-002 | 2.12.2004 | 30.11.2004 | Tracleer | Actelion Registration Ltd, BSI Building, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220/001-005 | 2.12.2004 | 30.11.2004 | Cialis | Lilly ICOS Limited, St Bride's House, 10 Salisbury Square, London, EC4Y 8EH, United Kingdom | EU/1/02/237/001
EU/1/02/237/005 | 2.12.2004 | 1.12.2004 | Micardis | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein | EU/1/98/090/001-014 | 3.12.2004 | 6.12.2004 | Integrilin | Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, United Kingdom
Schering Plough Europe, Rue de Stalle 73, B-1180 Bruxelles, Stallestraat 73, B-1180 Brussel | EU/1/99/109/001-002 | 8.12.2004 | 6.12.2004 | Epivir | Glaxo Group Ltd, Greenford Road, Greenford, Middlesex, UB6 0NN, United Kingdom | EU/1/96/015/001-005 | 8.12.2004 | 6.12.2004 | Dynastat | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/209/001-008 | 8.12.2004 | 6.12.2004 | Sustiva | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow, TW3 3JA, United Kingdom | EU/1/99/110/001-009 | 8.12.2004 | 6.12.2004 | NutropinAq | IPSEN Limited, 190 Bath Road, Slough, Berkshire, SLI 3XE, United Kingdom | EU/1/00/164/001-005 | 8.12.2004 | 6.12.2004 | Strocrin | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom | EU/1/99/111/001-009 | 8.12.2004 | 6.12.2004 | Dynastat | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/209/001-008 | 8.12.2004 | 6.12.2004 | Panretin | Ligand Pharmaceuticals UK Ltd, Innovis House, 108 High Street, Crawley, West Sussex, RH10 1BB, United Kingdom | EU/1/00/149/001 | 8.12.2004 | 6.12.2004 | Arava | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main | EU/1/99/118/001-010 | 8.12.2004 | 6.12.2004 | Viread | Gilead Sciences International Limited, Cambridge, CB1 6GT United Kingdom | EU/1/01/200/001 | 8.12.2004 | 6.12.2004 | Rayzon | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/210/001-008 | 8.12.2004 | 6.12.2004 | Rayzon 6m | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/210/001-008 | 8.12.2004 | 7.12.2004 | Kinzalmono | Bayer AG, D-51368 Leverkusen | EU/1/98/091/001-014 | 9.12.2004 | 7.12.2004 | Micardis | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein | EU/1/98/090/001-014 | 10.12.2004 | 7.12.2004 | Pritor | Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom | EU/1/98/089/001-016 | 9.12.2004 |
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| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 16.11.2004 | Tamiflu | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom | EU/1/02/222/001 | 18.11.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 17.11.2004 | Trizivir | Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom | EU/1/00/156/001-003 | 19.11.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 17.11.2004 | Targretin | Ligand Pharmaceuticals UK Ltd, Innovis House, 108 High Street, Crawley, West Sussex, RH10 1BB, United Kingdom | EU/1/01/178/001 | 19.11.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 25.11.2004 | Bextra | Pharmacia-Pfizer EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/239/001-024 | 29.11.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 25.11.2004 | ReFacto | Wyeth Europa Ltd, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/103/001-004 | 29.11.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 30.11.2004 | Xigris | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/02/225/001-002 | 2.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 30.11.2004 | Tracleer | Actelion Registration Ltd, BSI Building, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220/001-005 | 2.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 30.11.2004 | Cialis | Lilly ICOS Limited, St Bride's House, 10 Salisbury Square, London, EC4Y 8EH, United Kingdom | EU/1/02/237/001
EU/1/02/237/005 | 2.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 1.12.2004 | Micardis | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein | EU/1/98/090/001-014 | 3.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6.12.2004 | Integrilin | Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, United Kingdom
Schering Plough Europe, Rue de Stalle 73, B-1180 Bruxelles, Stallestraat 73, B-1180 Brussel | EU/1/99/109/001-002 | 8.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6.12.2004 | Epivir | Glaxo Group Ltd, Greenford Road, Greenford, Middlesex, UB6 0NN, United Kingdom | EU/1/96/015/001-005 | 8.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6.12.2004 | Dynastat | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/209/001-008 | 8.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6.12.2004 | Sustiva | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow, TW3 3JA, United Kingdom | EU/1/99/110/001-009 | 8.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6.12.2004 | NutropinAq | IPSEN Limited, 190 Bath Road, Slough, Berkshire, SLI 3XE, United Kingdom | EU/1/00/164/001-005 | 8.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6.12.2004 | Strocrin | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom | EU/1/99/111/001-009 | 8.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6.12.2004 | Dynastat | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/209/001-008 | 8.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6.12.2004 | Panretin | Ligand Pharmaceuticals UK Ltd, Innovis House, 108 High Street, Crawley, West Sussex, RH10 1BB, United Kingdom | EU/1/00/149/001 | 8.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6.12.2004 | Arava | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main | EU/1/99/118/001-010 | 8.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6.12.2004 | Viread | Gilead Sciences International Limited, Cambridge, CB1 6GT United Kingdom | EU/1/01/200/001 | 8.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6.12.2004 | Rayzon | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/210/001-008 | 8.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 6.12.2004 | Rayzon 6m | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/210/001-008 | 8.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 7.12.2004 | Kinzalmono | Bayer AG, D-51368 Leverkusen | EU/1/98/091/001-014 | 9.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 7.12.2004 | Micardis | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein | EU/1/98/090/001-014 | 10.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 7.12.2004 | Pritor | Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom | EU/1/98/089/001-016 | 9.12.2004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| — | Withdrawal of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93)
Date of the decision
Name of the medicinal product
Holder of the marketing authorisation
Number of the entry in the Community Register
Date of notification 8.12.2004
Venvia
SmithKline Beecham plc, New Horizons Court, Brentford, Middlesex, United Kingdom TW8 9EP
EU/1/00/138/001-012
10.12.2004 7.12.2004
Nyracta
SmithKline Beecham plc, New Horizons Court, Brentford, Middlesex, United Kingdom TW8 9EP
EU/1/00/139/001-012
9.12.2004 | Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification | 8.12.2004 | Venvia | SmithKline Beecham plc, New Horizons Court, Brentford, Middlesex, United Kingdom TW8 9EP | EU/1/00/138/001-012 | 10.12.2004 | 7.12.2004 | Nyracta | SmithKline Beecham plc, New Horizons Court, Brentford, Middlesex, United Kingdom TW8 9EP | EU/1/00/139/001-012 | 9.12.2004 |
| -------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------- | --------------------------------------------- | -------------------- | --------- | ------ | ---------------------------------------------------------------------------------------- | ------------------- | ---------- | --------- | ------- | ---------------------------------------------------------------------------------------- | ------------------- | --------- |
| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification | | | | | | | | | | | | |
| 8.12.2004 | Venvia | SmithKline Beecham plc, New Horizons Court, Brentford, Middlesex, United Kingdom TW8 9EP | EU/1/00/138/001-012 | 10.12.2004 | | | | | | | | | | | | |
| 7.12.2004 | Nyracta | SmithKline Beecham plc, New Horizons Court, Brentford, Middlesex, United Kingdom TW8 9EP | EU/1/00/139/001-012 | 9.12.2004 | | | | | | | | | | | | |

| — | Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93): 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 25.11.2004
Nobivac Bb
Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland
EU/2/02/034/001
29.11.2004 25.11.2004
Halocur
Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland
EU/2/99/013/001-002
29.11.2004 7.12.2004
Stronghold
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
EU/2/99/014/001-012
10.12.2004 7.12.2004
Oxyglobin
Biopure Netherlands BV, Prinses Irenestraat 59, 1077 WV Amsterdam, Nederland
EU/2/99/015/001
9.12.2004 | 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 | 25.11.2004 | Nobivac Bb | Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/02/034/001 | 29.11.2004 | 25.11.2004 | Halocur | Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/99/013/001-002 | 29.11.2004 | 7.12.2004 | Stronghold | Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/2/99/014/001-012 | 10.12.2004 | 7.12.2004 | Oxyglobin | Biopure Netherlands BV, Prinses Irenestraat 59, 1077 WV Amsterdam, Nederland | EU/2/99/015/001 | 9.12.2004 |
| -------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------- | --------------------------------------------- | -------------------- | ---------- | ---------- | ----------------------------------------------------------------------------- | --------------- | ---------- | ---------- | ------- | ----------------------------------------------------------------------------- | ------------------- | ---------- | --------- | ---------- | ------------------------------------------------------------------- | ------------------- | ---------- | --------- | --------- | ---------------------------------------------------------------------------- | --------------- | --------- |
| 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 | | | | | | | | | | | | | | | | | | | | | | |
| 25.11.2004 | Nobivac Bb | Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/02/034/001 | 29.11.2004 | | | | | | | | | | | | | | | | | | | | | | |
| 25.11.2004 | Halocur | Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/99/013/001-002 | 29.11.2004 | | | | | | | | | | | | | | | | | | | | | | |
| 7.12.2004 | Stronghold | Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/2/99/014/001-012 | 10.12.2004 | | | | | | | | | | | | | | | | | | | | | | |
| 7.12.2004 | Oxyglobin | Biopure Netherlands BV, Prinses Irenestraat 59, 1077 WV Amsterdam, Nederland | EU/2/99/015/001 | 9.12.2004 | | | | | | | | | | | | | | | | | | | | | | |

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

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