# C_2008019EN.01000401.xml

| 25.1.2008 | EN | Official Journal of the European Union | C 19/4 |
| --------- | -- | -------------------------------------- | ------ |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2007 to 31 December 2007

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

(2008/C 19/04)

—   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 |
| -------------------------------------------------------------------- | ------------------------------------------- | ----------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------- | ------------------- | ------------------------------------------------ | ---------------------- |
| 11.12.2007 | NEVANAC | Nepafenac | 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 | | | | | | | |
| 11.12.2007 | Pioglitazone/metformin hydrochloride Takeda | Pioglitazone/metformin hydrochloride | 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 | London WC2R 3DA |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | | | | |
| Arundel Great Court | | | | | | | |
| 2 Arundel Street | | | | | | | |
| London WC2R 3DA | | | | | | | |
| United Kingdom | | | | | | | |
| 12.12.2007 | Olanzapine Teva | Olanzapine | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht Nederland | Teva Pharma B.V. | Computerweg 10 | 3542 DR Utrecht | Nederland |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10 | | | | | | | |
| 3542 DR Utrecht | | | | | | | |
| Nederland | | | | | | | |
| EU/1/07/427023-037 | Orodispersible tablets | | | | | | |
| 13.12.2007 | Atripla | Efavirenz/emtricitabine/tenofovir disoproxil fumarate | Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited Unit 13 Stillorgan Industrial Park Blackrock, Co.Dublin Ireland | Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited | Unit 13 | Stillorgan Industrial Park | Blackrock, Co.Dublin |
| Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited | | | | | | | |
| Unit 13 | | | | | | | |
| Stillorgan Industrial Park | | | | | | | |
| Blackrock, Co.Dublin | | | | | | | |
| Ireland | | | | | | | |
| 18.12.2007 | Retacrit | Epoetin zeta | HOSPIRA Enterprises B.V. Taurusavenue 19-21b 2132 LS Hoofddorp Nederland | HOSPIRA Enterprises B.V. | Taurusavenue 19-21b | 2132 LS Hoofddorp | Nederland |
| HOSPIRA Enterprises B.V. | | | | | | | |
| Taurusavenue 19-21b | | | | | | | |
| 2132 LS Hoofddorp | | | | | | | |
| Nederland | | | | | | | |
| 18.12.2007 | Silapo | Epoetin zeta | STADA Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel | STADA Arzneimittel AG | Stadastraße 2-18 | D-61118 Bad Vilbel | EU/1/07/432/001-019 |
| STADA Arzneimittel AG | | | | | | | |
| Stadastraße 2-18 | | | | | | | |
| D-61118 Bad Vilbel | | | | | | | |
| 20.12.2007 | ISENTRESS | Raltegravir | Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Limited | Hertford Road | Hoddesdon | Hertfordshire EN11 9BU |
| Merck Sharp & Dohme Limited | | | | | | | |
| Hertford Road | | | | | | | |
| Hoddesdon | | | | | | | |
| Hertfordshire EN11 9BU | | | | | | | |
| 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 |
| ---------------------------------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------- | ------------------------- |
| 11.12.2007 | RotaTeq | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |
| 11.12.2007 | TARGRETIN | Eisai Limited 3, Shortlands London W6 8EE United Kingdom | Eisai Limited | 3, Shortlands |
| Eisai Limited | | | | |
| 3, Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 11.12.2007 | Quintanrix | GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart | GlaxoSmithKline Biologicals s.a. | rue de l'Institut 89 |
| GlaxoSmithKline Biologicals s.a. | | | | |
| rue de l'Institut 89 | | | | |
| B-1330 Rixensart | | | | |
| 11.12.2007 | Tandemact | 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 | | | | |
| 11.12.2007 | Procomvax | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |
| 11.12.2007 | 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 | | | | |
| 12.12.2007 | Quadramet | CIS bio international Boite Postale 32 F-91192 Gif-sur-Yvette | CIS bio international | Boite Postale 32 |
| CIS bio international | | | | |
| Boite Postale 32 | | | | |
| F-91192 Gif-sur-Yvette | | | | |
| 12.12.2007 | Sonata | Meda AB Pipers väg 2A S-170 09 Solna | Meda AB | Pipers väg 2A |
| Meda AB | | | | |
| Pipers väg 2A | | | | |
| S-170 09 Solna | | | | |
| Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Limited | Huntercombe Lane South | Taplow | Maidenhead |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 14.12.2007 | Avastin | 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 | | | | |
| 14.12.2007 | Ariclaim | Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5 |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 14.12.2007 | 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 | | | | |
| 14.12.2007 | Diacomit | Biocodex 7, avenue Gallieni F-94250 Gentilly | Biocodex | 7, avenue Gallieni |
| Biocodex | | | | |
| 7, avenue Gallieni | | | | |
| F-94250 Gentilly | | | | |
| 14.12.2007 | RotaTeq | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |
| 14.12.2007 | Rebif | Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom | Serono Europe Limited | 56, Marsh Wall |
| Serono Europe Limited | | | | |
| 56, Marsh Wall | | | | |
| London E14 9TP | | | | |
| United Kingdom | | | | |
| 14.12.2007 | Velcade | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 18.12.2007 | 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 | | | | |
| 18.12.2007 | Xelevia | 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 | | | | |
| 18.12.2007 | Infanrix Penta | GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart | GlaxoSmithKline Biologicals s.a. | rue de l'Institut 89 |
| GlaxoSmithKline Biologicals s.a. | | | | |
| rue de l'Institut 89 | | | | |
| B-1330 Rixensart | | | | |
| 18.12.2007 | Lyrica | Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT 13 9NJ | | | | |
| United Kingdom | | | | |
| 18.12.2007 | Prezista | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 18.12.2007 | Betaferon | Bayer Schering Pharma AG Müllerstraße 170-178 D-13342 Berlin | Bayer Schering Pharma AG | Müllerstraße 170-178 |
| Bayer Schering Pharma AG | | | | |
| Müllerstraße 170-178 | | | | |
| D-13342 Berlin | | | | |
| 18.12.2007 | Helixate NexGen | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 18.12.2007 | KOGENATE Bayer | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 18.12.2007 | Zonegran | Eisai Limited 3, Shortlands London W6 8EE United Kingdom | Eisai Limited | 3, Shortlands |
| Eisai Limited | | | | |
| 3, Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 18.12.2007 | NovoMix | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 18.12.2007 | Insuman | 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 | | | | |
| 18.12.2007 | Truvada | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT | | | | |
| United Kingdom | | | | |
| 19.12.2007 | CUBICIN | 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 | | | | |
| 19.12.2007 | Humira | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 19.12.2007 | Tygacil | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Ltd | Huntercombe Lane South |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 19.12.2007 | MabCampath | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| Nederland | | | | |
| 19.12.2007 | Lucentis | 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 | | | | |
| 19.12.2007 | REYATAZ | 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 | | | | |
| 19.12.2007 | Januvia | 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 | | | | |
| 19.12.2007 | Aptivus | 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 | | | | |
| 20.12.2007 | Infanrix Hexa | GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart | GlaxoSmithKline Biologicals s.a. | rue de l'Institut 89 |
| GlaxoSmithKline Biologicals s.a. | | | | |
| rue de l'Institut 89 | | | | |
| B-1330 Rixensart | | | | |
| 20.12.2007 | Aldurazyme | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| Nederland | | | | |
| 20.12.2007 | Insulin Human Winthrop | 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 | | | | |
| 21.12.2007 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |
| 21.12.2007 | Keppra | UCB Pharma SA. Allée de la Recherche 60 B-1070 Bruxelles Researchdreef, 60 B-1070 Brussel | UCB Pharma SA. | Allée de la Recherche 60 |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60 | | | | |
| B-1070 Bruxelles | | | | |
| Researchdreef, 60 | | | | |
| B-1070 Brussel | | | | |
| 21.12.2007 | Mimpara | 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 | | | | |
| 21.12.2007 | Macugen | Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT 13 9NJ | | | | |
| United Kingdom | | | | |
| 21.12.2007 | Somavert | Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT 13 9NJ | | | | |
| United Kingdom | | | | |
| 21.12.2007 | Parareg | 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 | | | | |
| 21.12.2007 | GONAL-F | Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom | Serono Europe Limited | 56, Marsh Wall |
| Serono Europe Limited | | | | |
| 56, Marsh Wall | | | | |
| London E14 9TP | | | | |
| United Kingdom | | | | |
| 21.12.2007 | HBVAXPRO | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004)

| 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 |
| ----------------------- | ----------------------------- | --------------------------------------------------------------- | --------------------------------------------- | ----------------------- |
| 18.12.2007 | Levviax | Aventis Pharma S.A 20, avenue Raymond Aron F-92165 Antony Cedex | Aventis Pharma S.A | 20, avenue Raymond Aron |
| Aventis Pharma S.A | | | | |
| 20, avenue Raymond Aron | | | | |
| F-92165 Antony Cedex | | | | |

—   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 |
| ----------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------- | -------------------- |
| 14.12.2007 | Suprelorin | Cyton Biosciences Ltd Hyland Mews 21 High Street Clifton Bristol BS8 2YF United Kingdom VIRBAC S.A. 1èreAvenue 2065 m L.I.D F-06516 Carros | Cyton Biosciences Ltd | Hyland Mews |
| Cyton Biosciences Ltd | | | | |
| Hyland Mews | | | | |
| 21 High Street | | | | |
| Clifton | | | | |
| Bristol BS8 2YF | | | | |
| United Kingdom | | | | |
| VIRBAC S.A. | | | | |
| 1èreAvenue 2065 m L.I.D | | | | |
| F-06516 Carros | | | | |
| 19.12.2007 | Aivlosin | ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | ECO Animal Health Ltd | 78 Coombe Road |
| ECO Animal Health Ltd | | | | |
| 78 Coombe Road | | | | |
| New Malden | | | | |
| Surrey KT3 4QS | | | | |
| 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, 30.4.2004, p. 1.

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