# C_2007039EN.01000701.xml

| 23.2.2007 | EN | Official Journal of the European Union | C 39/7 |
| --------- | -- | -------------------------------------- | ------ |

---

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

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

(2007/C 39/09)

—   Issuing 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 | 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 |
| ------------------------------------------------------------------------------------------------------- | --------------------------------------- | ----------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------- | ------------------------- | ------------------------------------------------------------- | ---------------------- |
| 4.1.2007 | ADROVANCE | Alendronate sodium/Colecalciferol | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road | Hoddesdon | Hertfordshire EN11 9BU |
| Merck Sharp & Dohme Ltd | | | | | | | |
| Hertford Road | | | | | | | |
| Hoddesdon | | | | | | | |
| Hertfordshire EN11 9BU | | | | | | | |
| United Kingdom | | | | | | | |
| 4.1.2007 | Diacomit | Stiripentol | Biocodex 7, avenue Gallieni F-94250 Gentilly | Biocodex | 7, avenue Gallieni | F-94250 Gentilly | EU/1/06/367/001-006 |
| Biocodex | | | | | | | |
| 7, avenue Gallieni | | | | | | | |
| F-94250 Gentilly | | | | | | | |
| EU/1/06/367/007-012 | Powder for oral suspension | | | | | | |
| 8.1.2007 | Elaprase | Idursulfase | Shire Human Genetic Therapies AB Rinkebyvägen 11B SE-182 36 Danderyd | Shire Human Genetic Therapies AB | Rinkebyvägen 11B | SE-182 36 Danderyd | EU/1/06/365/001-003 |
| Shire Human Genetic Therapies AB | | | | | | | |
| Rinkebyvägen 11B | | | | | | | |
| SE-182 36 Danderyd | | | | | | | |
| 8.1.2007 | Tandemact | Pioglitazone/Glimepiride | 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 | | | | | | | |
| 16.1.2007 | Inovelon | rufinamide | Eisai Limited 3, Shortlands London W6 8EE United Kingdom | Eisai Limited | 3, Shortlands | London W6 8EE | United Kingdom |
| Eisai Limited | | | | | | | |
| 3, Shortlands | | | | | | | |
| London W6 8EE | | | | | | | |
| United Kingdom | | | | | | | |
| 16.1.2007 | Dafiro | amlodipine/valsartan | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road | Horsham | West Sussex RH12 5AB |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road | | | | | | | |
| Horsham | | | | | | | |
| West Sussex RH12 5AB | | | | | | | |
| United Kingdom | | | | | | | |
| 16.1.2007 | Copalia | amlodipine/valsartan | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road | Horsham | West Sussex RH12 5AB |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road | | | | | | | |
| Horsham | | | | | | | |
| West Sussex RH12 5AB | | | | | | | |
| United Kingdom | | | | | | | |
| 17.1.2007 | Exforge | amlodipine/valsartan | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road | Horsham | West Sussex RH12 5AB |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road | | | | | | | |
| Horsham | | | | | | | |
| West Sussex RH12 5AB | | | | | | | |
| United Kingdom | | | | | | | |
| 17.1.2007 | Imprida | amlodipine/valsartan | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road | Horsham | West Sussex RH12 5AB |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road | | | | | | | |
| Horsham | | | | | | | |
| West Sussex RH12 5AB | | | | | | | |
| United Kingdom | | | | | | | |
| 17.1.2007 | Insulin Human Winthrop | insulin human | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main | EU/1/06/368/001-002
EU/1/06/368/011-015
EU/1/06/368/056-057 | Solution for injection |
| Sanofi-Aventis Deutschland GmbH | | | | | | | |
| D-65926 Frankfurt am Main | | | | | | | |
| EU/1/06/368/003-010
EU/1/06/368/020-024
EU/1/06/368/029-033
EU/1/06/368/038-042
EU/1/06/368/047-051 | Suspension for injection | | | | | | |
| EU/1/06/368/016-019
EU/1/06/368/025-028
EU/1/06/368/034-037
EU/1/06/368/043-046
EU/1/06/368/052-055 | OptiSet, solution for injection | | | | | | |
| 19.1.2007 | Irbesartan BMS | irbesartan | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park | Sanderson Road | Uxbridge UD8 1DH |
| Bristol-Myers Squibb Pharma EEIG | | | | | | | |
| Uxbridge Business Park | | | | | | | |
| Sanderson Road | | | | | | | |
| Uxbridge UD8 1DH | | | | | | | |
| United Kingdom | | | | | | | |
| EU/1/06/375/016-033 | Film-coated tablets | | | | | | |
| 19.1.2007 | Irbesartan Hydrochlorothiazide BMS | irbesartan/hydrochlorothiazide | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park | Sanderson Road | Uxbridge UD8 1DH |
| Bristol-Myers Squibb Pharma EEIG | | | | | | | |
| Uxbridge Business Park | | | | | | | |
| Sanderson Road | | | | | | | |
| Uxbridge UD8 1DH | | | | | | | |
| United Kingdom | | | | | | | |
| EU/1/06/369/011-028 | Film-coated tablets | | | | | | |
| 19.1.2007 | Irbesartan Winthrop | Irbesartan | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174, avenue de France F-75013 Paris | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | 174, avenue de France | F-75013 Paris | EU/1/06/376/001-015 |
| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | | | | | | | |
| 174, avenue de France | | | | | | | |
| F-75013 Paris | | | | | | | |
| EU/1/06/376/016-033 | Film-coated tablets | | | | | | |
| 19.1.2007 | Irbesartan Hydrochlorothiazide Winthrop | irbesartan/hydrochlorothiazide | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174, avenue de France F-75013 Paris | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | 174, avenue de France | F-75013 Paris | EU/1/06/377/001-010 |
| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | | | | | | | |
| 174, avenue de France | | | | | | | |
| F-75013 Paris | | | | | | | |
| EU/1/06/377/011-028 | Film-coated tablets | | | | | | |
| 22.1.2007 | Lucentis | ranibizumab | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road | Horsham | West Sussex RH12 5AB |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road | | | | | | | |
| Horsham | | | | | | | |
| West Sussex RH12 5AB | | | | | | | |
| United Kingdom | | | | | | | |

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| 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 |
| ------------------------- | ----------------------------- | ------------------------------------------------------------------ | --------------------------------------------- | -------------------- |
| 16.1.2007 | Thymanax | Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine | Les Laboratoires Servier | 22, rue Garnier |
| Les Laboratoires Servier | | | | |
| 22, rue Garnier | | | | |
| F-92200 Neuilly-sur-Seine | | | | |
| 16.1.2007 | Valdoxan | Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine | Les Laboratoires Servier | 22, rue Garnier |
| Les Laboratoires Servier | | | | |
| 22, rue Garnier | | | | |
| F-92200 Neuilly-sur-Seine | | | | |

—   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 |
| ---------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------- | -------------------------- |
| 3.1.2007 | MicardisPlus | 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 | | | | |
| 3.1.2007 | Neulasta | 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 | | | | |
| 3.1.2007 | Neupopeg | 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 | | | | |
| 3.1.2007 | 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 | | | | |
| 3.1.2007 | Ceprotin | Baxter AG Industriesstrasse 67 A-1220 Vienna | Baxter AG | Industriesstrasse 67 |
| Baxter AG | | | | |
| Industriesstrasse 67 | | | | |
| A-1220 Vienna | | | | |
| 3.1.2007 | Ambirix | 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 | | | | |
| 3.1.2007 | 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 | | | | |
| 3.1.2007 | Zostavax | 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 | | | | |
| 3.1.2007 | Nexavar | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 3.1.2007 | 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 | | | | |
| 4.1.2007 | Twinrix Paediatric | 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 | | | | |
| 4.1.2007 | NovoSeven | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 4.1.2007 | PEGASYS | 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 | | | | |
| 4.1.2007 | Kinzalmono | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 4.1.2007 | Twinrix Adult | 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 | | | | |
| 4.1.2007 | NeoRecormon | 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 | | | | |
| 4.1.2007 | Micardis | 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 | | | | |
| 4.1.2007 | 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 | | | | |
| 4.1.2007 | Competact | 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 | | | | |
| 4.1.2007 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |
| 4.1.2007 | 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 | | | | |
| 4.1.2007 | 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 | | | | |
| 4.1.2007 | Temodal | 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 | | | | |
| 4.1.2007 | Keppra | UCB S.A. Allée de la recherche, 60 B-1070 Bruxelles Researchdreef 60 B-1070 Brussel | UCB S.A. | Allée de la recherche, 60 |
| UCB S.A. | | | | |
| Allée de la recherche, 60 | | | | |
| B-1070 Bruxelles | | | | |
| Researchdreef 60 | | | | |
| B-1070 Brussel | | | | |
| 4.1.2007 | Kinzalkomb | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 8.1.2007 | PritorPlus | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 8.1.2007 | Pritor | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 8.1.2007 | DepoCyte | SkyePharma PLC 105 Piccadilly London W1J 7NJ United Kindgom | SkyePharma PLC | 105 Piccadilly |
| SkyePharma PLC | | | | |
| 105 Piccadilly | | | | |
| London W1J 7NJ | | | | |
| United Kindgom | | | | |
| 8.1.2007 | Agenerase | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 8.1.2007 | 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 | | | | |
| 8.1.2007 | Viread | 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 | | | | |
| 9.1.2007 | Puregon | Organon N.V. P.O. Box 20 5340 BH Oss Nederland | Organon N.V. | P.O. Box 20 |
| Organon N.V. | | | | |
| P.O. Box 20 | | | | |
| 5340 BH Oss | | | | |
| Nederland | | | | |
| 9.1.2007 | Neupro | Schwarz Pharma Ltd Shannon, Industrial Estate Co.Clare Ireland | Schwarz Pharma Ltd | Shannon, Industrial Estate |
| Schwarz Pharma Ltd | | | | |
| Shannon, Industrial Estate | | | | |
| Co.Clare | | | | |
| Ireland | | | | |
| 9.1.2007 | 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 | | | | |
| 9.1.2007 | Thyrogen | 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 | | | | |
| 11.1.2007 | Karvezide | 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 | | | | |
| 11.1.2007 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris | Sanofi Pharma Bristol-Myers Squibb SNC | 174, avenue de France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 11.1.2007 | Sutent | 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 | | | | |
| 11.1.2007 | Viracept | 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 | | | | |
| 11.1.2007 | 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 | | | | |
| 11.1.2007 | Karvezide | 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 | | | | |
| 12.1.2007 | MabThera | 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 | | | | |
| 12.1.2007 | Truvada | Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited | Granta Park Abington |
| Gilead Sciences International Limited | | | | |
| Granta Park Abington | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 12.1.2007 | Emtriva | Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited | Granta Park Abington |
| Gilead Sciences International Limited | | | | |
| Granta Park Abington | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 12.1.2007 | Norvir | Abbott laboratories Ltd Queenborough Kent ME11 5EL United-Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United-Kingdom | | | | |
| 15.1.2007 | 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 | | | | |
| 15.1.2007 | 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 | | | | |
| 15.1.2007 | 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 | | | | |
| 15.1.2007 | Viread | 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 | | | | |
| 16.1.2007 | 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 | | | | |
| 16.1.2007 | Kaletra | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 17.1.2007 | REYATAZ | Bristol-Myers Squibb Pharma EEIG 141-149 Staines Road Hounslow TW3 3JA United Kingdom | Bristol-Myers Squibb Pharma EEIG | 141-149 Staines Road |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| 141-149 Staines Road | | | | |
| Hounslow TW3 3JA | | | | |
| United Kingdom | | | | |
| 17.1.2007 | Revatio | 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. | | | | |
| 17.1.2007 | SUTENT | 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 | | | | |
| 17.1.2007 | Kivexa | Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Berkeley Avenue |
| Glaxo Group Ltd | | | | |
| Berkeley Avenue | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 17.1.2007 | 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 | | | | |
| 17.1.2007 | Advate | Baxter AG Industriestraße 67 A-1221 Wien | Baxter AG | Industriestraße 67 |
| Baxter AG | | | | |
| Industriestraße 67 | | | | |
| A-1221 Wien | | | | |
| 17.1.2007 | Ziagen | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 18.1.2007 | Telzir | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 18.1.2007 | 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 | | | | |
| 18.1.2007 | 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 | | | | |
| 19.1.2007 | 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 | | | | |
| 24.1.2007 | Stalevo | Orion Corporation Orionintie 1 FIN-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| 24.1.2007 | Paxene | Norton Healthcare Limited Albert Basin Royal Docks London E16 2QJ United Kingdom | Norton Healthcare Limited | Albert Basin |
| Norton Healthcare Limited | | | | |
| Albert Basin | | | | |
| Royal Docks | | | | |
| London E16 2QJ | | | | |
| United Kingdom | | | | |
| 24.1.2007 | Comtess | Orion Corporation Orionintie 1 FIN-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| 24.1.2007 | 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 | | | | |
| 24.1.2007 | TRIZIVIR | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 24.1.2007 | Agenerase | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 24.1.2007 | Fabrazyme | 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 | | | | |
| 24.1.2007 | Tarceva | 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 | | | | |
| 24.1.2007 | 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 | | | | |
| 24.1.2007 | 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 | | | | |
| 24.1.2007 | Nexavar | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 24.1.2007 | Crixivan | 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 | | | | |
| 25.1.2007 | Evra | Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| B-2340 Beerse | | | | |
| 25.1.2007 | Epivir | 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 | | | | |
| 26.1.2007 | Alimta | 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 | | | | |
| 26.1.2007 | 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 |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| Arundel Great Court | | | | |
| 2 Arundel Street | | | | |
| London WC2R 3DA | | | | |
| United Kingdom | | | | |
| 26.1.2007 | Combivir | 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 | | | | |
| 26.1.2007 | Helixate NexGen | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 26.1.2007 | 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 | | | | |
| 29.1.2007 | KOGENATE Bayer | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 31.1.2007 | Avonex | Biogen Idec Ltd 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kindgom | Biogen Idec Ltd | 5 Roxborough Way |
| Biogen Idec Ltd | | | | |
| 5 Roxborough Way | | | | |
| Foundation Park | | | | |
| Maidenhead | | | | |
| Berkshire SL6 3UD | | | | |
| United Kindgom | | | | |

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
| ------------------------ | ----------------------------- | ----------------------------------------- | ------------------------------------------------------- | --------------------------------------------- | ------------------------ | ------------------------------------------------ | -------------------- |
| 9.1.2007 | Cortavance | Hydrocortisone aceponate | VIRBAC S.A. 1ère Avenue 2065 m L.I.D F-06516 Carros | VIRBAC S.A. | 1ère Avenue 2065 m L.I.D | F-06516 Carros | EU/2/06/069/001 |
| VIRBAC S.A. | | | | | | | |
| 1ère Avenue 2065 m L.I.D | | | | | | | |
| F-06516 Carros | | | | | | | |
| 11.1.2007 | Yposane | Osaterone acetate | VIRBAC S.A. 1ère Avenue 2065 m L.I.D F-06516 Carros | VIRBAC S.A. | 1ère Avenue 2065 m L.I.D | F-06516 Carros | EU/2/06/068/001-004 |
| VIRBAC S.A. | | | | | | | |
| 1ère Avenue 2065 m L.I.D | | | | | | | |
| F-06516 Carros | | | | | | | |
| 15.1.2007 | Meloxicam CEVA | Meloxicam | CEVA SANTE ANIMALE Z.I. la Ballastière F-33500 Libourne | CEVA SANTE ANIMALE | Z.I. la Ballastière | F-33500 Libourne | EU/2/06/070/001-003 |
| CEVA SANTE ANIMALE | | | | | | | |
| Z.I. la Ballastière | | | | | | | |
| F-33500 Libourne | | | | | | | |

—   Modification of a marketing authorization (Article 38 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 |
| --------------------------- | ----------------------------- | ---------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- |
| 4.1.2007 | Previcox | Merial 29, avenue Tony Garnier F-69007 Lyon | Merial | 29, avenue Tony Garnier |
| Merial | | | | |
| 29, avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 16.1.2007 | Equilis StrepE | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International B.V. | Wim de Körverstraat 35 |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 11.1.2007 | Gonazon | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International B.V. | Wim de Körverstraat 35 |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 16.1.2007 | Profender | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |

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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