# C_2006124EN.01000401.xml

| 25.5.2006 | EN | Official Journal of the European Union | C 124/4 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2006 to 30 April 2006

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )

(2006/C 124/03)

| — | Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004) — Accepted |
| - | ------------------------------------------------------------------------------------------- |

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ------------------------------ | ----------------------------- | ---------------------------------------------------- | -------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------ | ----------------------------------------------- | -------------------- |
| 6.4.2006 | ProQuad | Measles, Mumps, Rubella and Varicella Vaccine (Live) | Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD | SNC | 8, rue Jonas Salk | F-69007 Lyon |
| Sanofi Pasteur MSD | | | | | | | |
| SNC | | | | | | | |
| 8, rue Jonas Salk | | | | | | | |
| F-69007 Lyon | | | | | | | |
| 12.4.2006 | Omnitrope | Somatropin | Sandoz GmbH Biochemiestraße 10 A-6250 Kundl | Sandoz GmbH | Biochemiestraße 10 | A-6250 Kundl | EU/1/06/332/001-003 |
| Sandoz GmbH | | | | | | | |
| Biochemiestraße 10 | | | | | | | |
| A-6250 Kundl | | | | | | | |
| 24.4.2006 | Valtropin | Somatropin | BioPartners GmbH Eisenstraße 3 D-65428 Rüsselsheim | BioPartners GmbH | Eisenstraße 3 | D-65428 Rüsselsheim | EU/1/06/335/001 |
| BioPartners GmbH | | | | | | | |
| Eisenstraße 3 | | | | | | | |
| D-65428 Rüsselsheim | | | | | | | |
| 24.4.2006 | Preotact | Parathyroid hormone | Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde | Nycomed Danmark ApS | Langebjerg 1 | DK-4000 Roskilde | EU/1/06/339/001-002 |
| Nycomed Danmark ApS | | | | | | | |
| Langebjerg 1 | | | | | | | |
| DK-4000 Roskilde | | | | | | | |
| 24.4.2006 | DuoTrav | Travoprost/Timolol | Alcon Laboratories (UK) Ltd Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom | Alcon Laboratories (UK) Ltd | Boundary Way | Hemel Hempstead | Herts HP2 7UD |
| Alcon Laboratories (UK) Ltd | | | | | | | |
| Boundary Way | | | | | | | |
| Hemel Hempstead | | | | | | | |
| Herts HP2 7UD | | | | | | | |
| United Kingdom | | | | | | | |
| 24.4.2006 | Tygacil | Tigecycline | Wyeth Europa Ltd Huntercombe Lane South, Taplow Maidenhead, Berkshire SL6 0PH United Kingdom | Wyeth Europa Ltd | Huntercombe Lane South, Taplow | Maidenhead, Berkshire SL6 0PH | United Kingdom |
| Wyeth Europa Ltd | | | | | | | |
| Huntercombe Lane South, Taplow | | | | | | | |
| Maidenhead, Berkshire SL6 0PH | | | | | | | |
| United Kingdom | | | | | | | |

| — | Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004) — 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 |
| ----------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------- |
| 3.4.2006 | Kogenate Bayer | Bayer HealthCare AG D-51368 Leverkusen Bayer AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 3.4.2006 | Helixate NexGen | Bayer HealthCare AG D-51368 Leverkusen Bayer AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 3.4.2006 | Enbrel | Wyeth Europa Limited Huntercombe Lane South Taplow, Maidenhead, Berkshire, SL6 0PH United Kingdom | Wyeth Europa Limited | Huntercombe Lane South |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South | | | | |
| Taplow, | | | | |
| Maidenhead, Berkshire, SL6 0PH | | | | |
| United Kingdom | | | | |
| 6.4.2006 | NeuroBloc | Solstice Neurosciences Ltd Fitzwilton House Wilton Place, Dublin 2, Ireland | Solstice Neurosciences Ltd | Fitzwilton House |
| Solstice Neurosciences Ltd | | | | |
| Fitzwilton House | | | | |
| Wilton Place, Dublin 2, | | | | |
| Ireland | | | | |
| 6.4.2006 | Sifrol | Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein | Boehringer Ingelheim International GmbH | Binger Straße 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173 | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| 6.4.2006 | Rapamune | Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Limited | Huntercombe Lane South |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 6.4.2006 | Kaletra | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 6.4.2006 | Mirapexin | Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein | Boehringer Ingelheim International GmbH | Binger Straße 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173 | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| 10.4.2006 | Trizivir | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 10.4.2006 | Zerit | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge UD8 1DH | | | | |
| United Kingdom | | | | |
| 12.4.2006 | Prevenar | Wyeth-Lederle Vaccines S.A. Rue du Bosquet 15 B-1348 Louvain-La-Neuve | Wyeth-Lederle Vaccines S.A. | Rue du Bosquet 15 |
| Wyeth-Lederle Vaccines S.A. | | | | |
| Rue du Bosquet 15 | | | | |
| B-1348 Louvain-La-Neuve | | | | |
| 18.4.2006 | Vaniqa | Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham, Basingstoke Hampshire RG24 8EP United Kingdom | Shire Pharmaceutical Contracts Ltd | Hampshire International Business Park |
| Shire Pharmaceutical Contracts Ltd | | | | |
| Hampshire International Business Park | | | | |
| Chineham, Basingstoke | | | | |
| Hampshire RG24 8EP | | | | |
| United Kingdom | | | | |
| 18.4.2006 | Orfadin | Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm | Swedish Orphan International AB | Drottninggatan 98 |
| Swedish Orphan International AB | | | | |
| Drottninggatan 98 | | | | |
| S-111 60 Stockholm | | | | |
| 18.4.2006 | Telzir | Glaxo Group Ltd Greenford Road Greenford, Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford Road |
| Glaxo Group Ltd | | | | |
| Greenford Road | | | | |
| Greenford, Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 24.4.2006 | Zavesca | Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom | Actelion Registration Ltd | BSI Building 13th Floor |
| Actelion Registration Ltd | | | | |
| BSI Building 13th Floor | | | | |
| 389 Chiswick High Road | | | | |
| London W4 4AL | | | | |
| United Kingdom | | | | |
| 24.4.2006 | SonoVue | Bracco International BV Strawinskylaan 3051 1077 ZX Amsterdam Nederland | Bracco International BV | Strawinskylaan 3051 |
| Bracco International BV | | | | |
| Strawinskylaan 3051 | | | | |
| 1077 ZX Amsterdam | | | | |
| Nederland | | | | |
| 24.4.2006 | Xigris | Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland BV | Grootslag 1-5 |
| Eli Lilly Nederland BV | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 24.4.2006 | Ammonaps | Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm Orphan Europe, Immeuble ‘Le Guillaumet’ F-92046 Paris La Défense | Swedish Orphan International AB | Drottninggatan 98 |
| Swedish Orphan International AB | | | | |
| Drottninggatan 98 | | | | |
| S-111 60 Stockholm | | | | |
| Orphan Europe, Immeuble ‘Le Guillaumet’ | | | | |
| F-92046 Paris La Défense | | | | |
| 24.4.2006 | Trazec | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road | | | | |
| Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| United Kingdom | | | | |
| 24.4.2006 | Starlix | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road Horsham |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| United Kingdom | | | | |
| 24.4.2006 | Trisenox | Cephalon UK Ltd 20 Alan Turing Road Surrey Research Park Guildford Surrey, GU2 7YF United Kingdom Cell Therapeutics (UK) Limited 100 Pall Mall London SW1Y 5HP United Kingdom | Cephalon UK Ltd | 20 Alan Turing Road |
| Cephalon UK Ltd | | | | |
| 20 Alan Turing Road | | | | |
| Surrey Research Park | | | | |
| Guildford | | | | |
| Surrey, GU2 7YF | | | | |
| United Kingdom | | | | |
| Cell Therapeutics (UK) Limited | | | | |
| 100 Pall Mall | | | | |
| London SW1Y 5HP | | | | |
| United Kingdom | | | | |
| 24.4.2006 | Zometa | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road | | | | |
| Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| United Kingdom | | | | |
| 24.4.2006 | TARGRETIN | Ligand Pharmaceuticals UK Ltd Innovis House 108 High Street, Crawley West Sussex RH10 1BB United Kingdom | Ligand Pharmaceuticals UK Ltd | Innovis House |
| Ligand Pharmaceuticals UK Ltd | | | | |
| Innovis House | | | | |
| 108 High Street, Crawley | | | | |
| West Sussex RH10 1BB | | | | |
| United Kingdom | | | | |
| 24.4.2006 | Xolair | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road | | | | |
| Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| United Kingdom | | | | |
| 27.4.2006 | Emtriva | Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB1 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 27.4.2006 | Aldara | Laboratoires 3M Santé Boulevard de l'Oise F-95029 Cergy Pontoise Cedex | Laboratoires 3M Santé | Boulevard de l'Oise |
| Laboratoires 3M Santé | | | | |
| Boulevard de l'Oise | | | | |
| F-95029 Cergy Pontoise Cedex | | | | |
| 27.4.2006 | Comtess | Orion Corporation, Orionintie 1 FIN-02200 Espoo | Orion Corporation, Orionintie 1 | FIN-02200 Espoo |
| Orion Corporation, Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| 27.4.2006 | Rebetol | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles, — Stallestraat, 73 — B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles, — Stallestraat, 73 — B-1180 Brussel | | | | |
| 27.4.2006 | Axura | Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104, D-60318 Frankfurt/Main | Merz Pharmaceuticals GmbH | Eckenheimer Landstr. 100-104, |
| Merz Pharmaceuticals GmbH | | | | |
| Eckenheimer Landstr. 100-104, | | | | |
| D-60318 Frankfurt/Main | | | | |
| 27.4.2006 | Abilify | Otsuka Pharmaceutical Europe Ltd Commonwealth House 2 Chalkhill Road Hammersmith London W6 8DW United Kingdom | Otsuka Pharmaceutical Europe Ltd | Commonwealth House |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Commonwealth House | | | | |
| 2 Chalkhill Road | | | | |
| Hammersmith | | | | |
| London W6 8DW | | | | |
| United Kingdom | | | | |
| 27.4.2006 | Lumigan | Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo Ireland | Allergan Pharmaceuticals Ireland | Castlebar Road |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road | | | | |
| Westport | | | | |
| Co. Mayo | | | | |
| Ireland | | | | |
| 27.4.2006 | Ebixa | H. Lundbeck A/S, Ottiliavej 9 DK-2500 Valby | H. Lundbeck A/S, Ottiliavej 9 | DK-2500 Valby |
| H. Lundbeck A/S, Ottiliavej 9 | | | | |
| DK-2500 Valby | | | | |
| 27.4.2006 | Levviax | Aventis Pharma SA 20 Avenue Raymond Aron F-92160 Antony | Aventis Pharma SA | 20 Avenue Raymond Aron |
| Aventis Pharma SA | | | | |
| 20 Avenue Raymond Aron | | | | |
| F-92160 Antony | | | | |
| 27.4.2006 | Ketek | Aventis Pharma SA 20 Avenue Raymond Aron F-92160 Antony | Aventis Pharma SA | 20 Avenue Raymond Aron |
| Aventis Pharma SA | | | | |
| 20 Avenue Raymond Aron | | | | |
| F-92160 Antony | | | | |
| 27.4.2006 | Taxotere | Aventis Pharma SA 20 avenue Raymond Aron F-92165 Antony Cedex | Aventis Pharma SA | 20 avenue Raymond Aron |
| Aventis Pharma SA | | | | |
| 20 avenue Raymond Aron | | | | |
| F-92165 Antony Cedex | | | | |
| 27.4.2006 | Fasturtec | Sanofi-Aventis, 174 avenue de France F-75013 Paris | Sanofi-Aventis, | 174 avenue de France |
| Sanofi-Aventis, | | | | |
| 174 avenue de France | | | | |
| F-75013 Paris | | | | |
| 27.4.2006 | PegIntron | Schering Plough Europe Rue de Stalle 73 B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | Schering Plough Europe | Rue de Stalle 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle 73 | | | | |
| B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | | | | |
| 27.4.2006 | ViraferonPeg | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | | | | |
| 27.4.2006 | Viraferon | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | | | | |
| 27.4.2006 | IntronA | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | | | | |
| 27.4.2006 | Keppra | UCB SA Allée de la recherche, 60 B-1070 Bruxelles | UCB SA | Allée de la recherche, 60 |
| UCB SA | | | | |
| Allée de la recherche, 60 | | | | |
| B-1070 Bruxelles | | | | |

| — | Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004) — Accepted |
| - | ------------------------------------------------------------------------------------------- |

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ------------------------ | ----------------------------- | ---------------------------------------- | --------------------------------------------------------------------- | --------------------------------------------- | ------------------- | ----------------------------------------------- | -------------------- |
| 10.4.2006 | Flexicam | Meloxicam | Omnipharm Ltd, The Spire Egypt Road Nottingham NG7 7GD United Kingdom | Omnipharm Ltd, The Spire | Egypt Road | Nottingham NG7 7GD | United Kingdom |
| Omnipharm Ltd, The Spire | | | | | | | |
| Egypt Road | | | | | | | |
| Nottingham NG7 7GD | | | | | | | |
| United Kingdom | | | | | | | |

| — | Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004) — 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 |
| ------------------------------ | ----------------------------- | ------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 10.4.2006 | Porcilis Porcoli | Intervet International BV (NL) Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International BV (NL) | Wim de Körverstraat 35 |
| Intervet International BV (NL) | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 18.4.2006 | Eurican Herpes 205 | Merial, 29 avenue Tony Garnier F-69007 Lyon | Merial, 29 avenue Tony Garnier | F-69007 Lyon |
| Merial, 29 avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 24.4.2006 | Sevoflo | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |

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 Medicines Agency |
| --------------------------------- |
| 7, Westferry Circus, Canary Wharf |
| London E14 4HB |
| United Kingdom |

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( 1 )  OJ L 136 of 30.4.2004, p. 1.

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