# C_2006287EN.01000701.xml

| 24.11.2006 | EN | Official Journal of the European Union | C 287/7 |
| ---------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.10.2006 to 31.10.2006

(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 287/03)

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
| ------------------------------------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------- | ------------------------------------- |
| 4.10.2006 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom | Otsuka Pharmaceutical Europe Ltd | Hunton House |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House | | | | |
| Highbridge Business Park | | | | |
| Oxford Road | | | | |
| Uxbridge | | | | |
| Middlesex UB8 1HU | | | | |
| United Kingdom | | | | |
| 4.10.2006 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom | Otsuka Pharmaceutical Europe Ltd | Hunton House |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House | | | | |
| Highbridge Business Park | | | | |
| Oxford Road | | | | |
| Uxbridge | | | | |
| Middlesex UB8 1HU | | | | |
| United Kingdom | | | | |
| 6.10.2006 | Travatan | Alcon Laboratories (UK) Ltd. Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom | Alcon Laboratories (UK) Ltd. | Boundary Way |
| Alcon Laboratories (UK) Ltd. | | | | |
| Boundary Way | | | | |
| Hemel Hempstead | | | | |
| Herts HP2 7UD | | | | |
| United Kingdom | | | | |
| 11.10.2006 | Invirase | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City AL7 1TW | | | | |
| United Kingdom | | | | |
| 17.10.2006 | Cetrotide | Serono Europe Ltd. 56, Marsh Wall London E14 9TP United Kingdom | Serono Europe Ltd. | 56, Marsh Wall |
| Serono Europe Ltd. | | | | |
| 56, Marsh Wall | | | | |
| London E14 9TP | | | | |
| United Kingdom | | | | |
| 19.10.2006 | 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 | | | | |
| 19.10.2006 | Zevalin | Schering AG Müllerstrasse 170-178 D-13342 Berlin | Schering AG | Müllerstrasse 170-178 |
| Schering AG | | | | |
| Müllerstrasse 170-178 | | | | |
| D-13342 Berlin | | | | |
| 20.10.2006 | Herceptin | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City AL7 1TW | | | | |
| United Kingdom | | | | |
| 20.10.2006 | PritorPlus | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 20.10.2006 | 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 | | | | |
| 20.10.2006 | Caelyx | 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 | | | | |
| 20.10.2006 | Avonex | Biogen Idec Ltd 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kingdom | Biogen Idec Ltd | 5 Roxborough Way |
| Biogen Idec Ltd | | | | |
| 5 Roxborough Way | | | | |
| Foundation Park | | | | |
| Maidenhead | | | | |
| Berkshire SL6 3UD | | | | |
| United Kingdom | | | | |
| 20.10.2006 | Faslodex | AstraZeneca UK Limited Alderley Park Macclesfield Cheshire SK10 4TG United Kingdom | AstraZeneca UK Limited | Alderley Park |
| AstraZeneca UK Limited | | | | |
| Alderley Park | | | | |
| Macclesfield | | | | |
| Cheshire SK10 4TG | | | | |
| United Kingdom | | | | |
| 20.10.2006 | 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 | | | | |
| 23.10.2006 | Taxotere | Aventis Pharma S.A., 20 Avenue Raymond Aron, Antony Cedex 92165, France | EU/1/95/002/001-002 | 25.10.2006 |
| 23.10.2006 | PhotoBarr | Axcan Pharma International BV Engelenkampstraat 72 6131 JJ Sittard Nederland | Axcan Pharma International BV | Engelenkampstraat 72 |
| Axcan Pharma International BV | | | | |
| Engelenkampstraat 72 | | | | |
| 6131 JJ Sittard | | | | |
| Nederland | | | | |
| 23.10.2006 | Dynepo | 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 | | | | |
| 24.10.2006 | 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 | | | | |
| 24.10.2006 | AVANDIA | SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom | SmithKline Beecham plc | 980 Great West Road |
| SmithKline Beecham plc | | | | |
| 980 Great West Road | | | | |
| Brentford | | | | |
| Middlesex TW8 9GS | | | | |
| United Kingdom | | | | |
| 24.10.2006 | Aclasta | 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 | | | | |
| 24.10.2006 | Prometax | 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 | | | | |
| 24.10.2006 | Invanz | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire EN11 9BU | | | | |
| United Kingdom | | | | |
| 24.10.2006 | Apidra | Sanofi-Aventis Deutschland GmbH Brueningstrasse, 50 D-65926 Frankfurt am Main | Sanofi-Aventis Deutschland GmbH | Brueningstrasse, 50 |
| Sanofi-Aventis Deutschland GmbH | | | | |
| Brueningstrasse, 50 | | | | |
| D-65926 Frankfurt am Main | | | | |
| 24.10.2006 | Fuzeon | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City AL7 1TW | | | | |
| United Kingdom | | | | |
| 24.10.2006 | Avandamet | SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom | SmithKline Beecham plc | 980 Great West Road |
| SmithKline Beecham plc | | | | |
| 980 Great West Road | | | | |
| Brentford | | | | |
| Middlesex TW8 9GS | | | | |
| United Kingdom | | | | |
| 26.10.2006 | Ketek | Aventis Pharma S.A. 20 Avenue Raymond Aron F-92160 Antony | Aventis Pharma S.A. | 20 Avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20 Avenue Raymond Aron | | | | |
| F-92160 Antony | | | | |
| 26.10.2006 | Levviax | Aventis Pharma S.A. 20 Avenue Raymond Aron F-92160 Antony | Aventis Pharma S.A. | 20 Avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20 Avenue Raymond Aron | | | | |
| F-92160 Antony | | | | |
| 26.10.2006 | Actos | Takeda Global Research and Development Centre (Europe) Ltd, Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd, Arundel Great Court | 2 Arundel Street |
| Takeda Global Research and Development Centre (Europe) Ltd, Arundel Great Court | | | | |
| 2 Arundel Street | | | | |
| London WC2R 3DA | | | | |
| United Kingdom | | | | |
| 26.10.2006 | Glustin | Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd | Arundel Great Court |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| Arundel Great Court | | | | |
| 2 Arundel Street | | | | |
| London WC2R 3DA | | | | |
| United Kingdom | | | | |
| 26.10.2006 | Sustiva | 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 | | | | |
| 26.10.2006 | Stocrin | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire EN11 9BU | | | | |
| United Kingdom | | | | |
| 26.10.2006 | Exelon | 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 | | | | |
| 26.10.2006 | Helixate NexGen | Bayer AG D-51368 Leverkusen, | Bayer AG | D-51368 Leverkusen, |
| Bayer AG | | | | |
| D-51368 Leverkusen, | | | | |
| 26.10.2006 | Vfend | Pfizer Limited, Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited, Sandwich | Kent CT13 9NJ |
| Pfizer Limited, Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 27.10.2006 | Pritor | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 27.10.2006 | Ariclaim | Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein | Eli Lilly Nederland B.V. | Grootslag 1-5 |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| 27.10.2006 | 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 | | | | |
| 27.10.2006 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |
| 27.10.2006 | Avaglim | SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom | SmithKline Beecham plc | 980 Great West Road |
| SmithKline Beecham plc | | | | |
| 980 Great West Road | | | | |
| Brentford | | | | |
| Middlesex TW8 9GS | | | | |
| United Kingdom | | | | |
| 27.10.2006 | Viramune | 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 | | | | |
| 27.10.2006 | Invirase | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City AL7 1TW | | | | |
| United Kingdom | | | | |
| 27.10.2006 | Tracleer | 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 | | | | |
| 30.10.2006 | FOSAVANCE | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire EN11 9BU | | | | |
| United Kingdom | | | | |
| 30.10.2006 | Lyrica | PFIZER Ltd, Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom | PFIZER Ltd, Ramsgate Road | Sandwich |
| PFIZER Ltd, Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT 13 9NJ | | | | |
| United Kingdom | | | | |
| 30.10.2006 | NutropinAq | IPSEN Limited, 190 Bath Road Slough, Berkshire SLI 3XE United Kingdom | IPSEN Limited, 190 Bath Road | Slough, Berkshire SLI 3XE |
| IPSEN Limited, 190 Bath Road | | | | |
| Slough, Berkshire SLI 3XE | | | | |
| United Kingdom | | | | |
| 30.10.2006 | Keppra | UCB S.A. Allée de la recherche 60 B-Bruxelles 1070 Researchdreef, 60 B-Brussel 1070 | UCB S.A. | Allée de la recherche 60 |
| UCB S.A. | | | | |
| Allée de la recherche 60 | | | | |
| B-Bruxelles 1070 | | | | |
| Researchdreef, 60 | | | | |
| B-Brussel 1070 | | | | |
| 30.10.2006 | Noxafil | SP Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat 73 B-1180 Brussel | SP Europe | Rue de Stalle, 73 |
| SP Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat 73 | | | | |
| B-1180 Brussel | | | | |
| 30.10.2006 | Posaconazole SP | SP Europe Rue de Stalle 73 B-1180 Bruxelles Stallestraat 73 — B-1180 Brussel | SP Europe | Rue de Stalle 73 |
| SP Europe | | | | |
| Rue de Stalle 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat 73 — B-1180 Brussel | | | | |
| 30.10.2006 | Nespo | Dompé Biotec S.p.A. Via San Martino 12 I-20122 Milano | Dompé Biotec S.p.A. | Via San Martino 12 |
| Dompé Biotec S.p.A. | | | | |
| Via San Martino 12 | | | | |
| I-20122 Milano | | | | |
| 30.10.2006 | Aranesp | Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland | Amgen Europe B.V. | Minervum 7061 |
| Amgen Europe B.V. | | | | |
| Minervum 7061 | | | | |
| 4817 ZK Breda | | | | |
| Nederland | | | | |
| 31.10.2006 | Lantus | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main | | | | |
| 31.10.2006 | Insuman | Aventis Pharma Deutschland GmbH Brueningstrasse 50 D-65926 Frankfurt am Main | Aventis Pharma Deutschland GmbH | Brueningstrasse 50 |
| Aventis Pharma Deutschland GmbH | | | | |
| Brueningstrasse 50 | | | | |
| D-65926 Frankfurt am Main | | | | |
| 31.10.2006 | Optruma | 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 | | | | |
| 31.10.2006 | Evista | 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 | | | | |
| 31.10.2006 | 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 | | | | |

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 April 2004, page 1

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