# C_2007115EN.01000301.xml

| 25.5.2007 | EN | Official Journal of the European Union | C 115/3 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2007 to 30 April 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 115/03)

—   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 |
| -------------------------- | ----------------------------- | ----------------------------------------- | --------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- | ------------------------------------------------ | -------------------- |
| 20.4.2007 | TOVIAZ | fesoterodine | Schwarz Pharma AG Alfred-Nobel Straße 10 D-40789 Monheim | Schwarz Pharma AG | Alfred-Nobel Straße 10 | D-40789 Monheim | EU/1/07/386/001-010 |
| Schwarz Pharma AG | | | | | | | |
| Alfred-Nobel Straße 10 | | | | | | | |
| D-40789 Monheim | | | | | | | |
| 20.4.2007 | Docetaxel Winthrop | docetaxel | Aventis Pharma S.A. 20, avenue Raymond Aron F-92165 Antony Cedex | Aventis Pharma S.A. | 20, avenue Raymond Aron | F-92165 Antony Cedex | EU/1/07/384/001-002 |
| Aventis Pharma S.A. | | | | | | | |
| 20, avenue Raymond Aron | | | | | | | |
| F-92165 Antony Cedex | | | | | | | |
| 23.4.2007 | Advagraf | Tacrolimus | Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München | Astellas Pharma GmbH | Neumarkter Str. 61 | D-81673 München | EU/1/07/387/001-008 |
| Astellas Pharma GmbH | | | | | | | |
| Neumarkter Str. 61 | | | | | | | |
| D-81673 München | | | | | | | |
| 24.4.2007 | Sebivo | telbivudine | 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 | | | | | | | |

—   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 |
| --------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------- |
| 2.4.2007 | 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 | | | | |
| 2.4.2007 | 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 | | | | |
| 2.4.2007 | Xigris | 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 | | | | |
| 2.4.2007 | AZILECT | Teva Pharma GmbH Kandelstraße 10 D-79199 Kirchzarten | Teva Pharma GmbH | Kandelstraße 10 |
| Teva Pharma GmbH | | | | |
| Kandelstraße 10 | | | | |
| D-79199 Kirchzarten | | | | |
| 2.4.2007 | 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 | | | | |
| 4.4.2007 | Cerezyme | 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 | | | | |
| 11.4.2007 | Panretin | 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 | | | | |
| Eisai Ltd 3 Shortlands London W6 8EE United Kingdom | Eisai Ltd | 3 Shortlands | London W6 8EE | United Kingdom |
| Eisai Ltd | | | | |
| 3 Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 11.4.2007 | 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 | | | | |
| Eisai Ltd 3 Shortlands London W6 8EE United Kingdom | Eisai Ltd | 3 Shortlands | London W6 8EE | United Kingdom |
| Eisai Ltd | | | | |
| 3 Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 13.4.2007 | 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 | | | | |
| 13.4.2007 | 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 | | | | |
| 13.4.2007 | Foscan | Biolitec pharma Ltd United Drug House Magna Drive Dublin 24 Ireland | Biolitec pharma Ltd | United Drug House |
| Biolitec pharma Ltd | | | | |
| United Drug House | | | | |
| Magna Drive | | | | |
| Dublin 24 | | | | |
| Ireland | | | | |
| 13.4.2007 | 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 | | | | |
| 13.4.2007 | Glivec | 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 | | | | |
| 17.4.2007 | Cystagon | Orphan Europe Immeuble ‘Le Guillaumet’ F-92046 Paris La Défense | Orphan Europe | Immeuble ‘Le Guillaumet’ |
| Orphan Europe | | | | |
| Immeuble ‘Le Guillaumet’ | | | | |
| F-92046 Paris La Défense | | | | |
| 17.4.2007 | Teslascan | GE Healthcare AS Nycoveien 1-2 P.O.Box 4220 Nydalen N-0401 Oslo | GE Healthcare AS | Nycoveien 1-2 |
| GE Healthcare AS | | | | |
| Nycoveien 1-2 | | | | |
| P.O.Box 4220 Nydalen | | | | |
| N-0401 Oslo | | | | |
| 17.4.2007 | 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 | | | | |
| 20.4.2007 | Quixidar | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 20.4.2007 | Arixtra | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 20.4.2007 | Omnitrope | Sandoz GmbH Biochemiestraße 10 A-6250 Kundl | Sandoz GmbH | Biochemiestraße 10 |
| Sandoz GmbH | | | | |
| Biochemiestraße 10 | | | | |
| A-6250 Kundl | | | | |
| 23.4.2007 | Azomyr | 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 | | | | |
| 23.4.2007 | Neoclarityn | 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 | | | | |
| 23.4.2007 | Aerius | 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 | | | | |
| 23.4.2007 | 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 | | | | |
| 23.4.2007 | Dynastat | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 23.4.2007 | M-M-RVAXPRO | Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD | SNC |
| Sanofi Pasteur MSD | | | | |
| SNC | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |
| 23.4.2007 | 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 | | | | |
| 23.4.2007 | Kinzalkomb | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 23.4.2007 | 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 | | | | |
| 24.4.2007 | 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 | | | | |
| 24.4.2007 | Kineret | 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 | | | | |
| 24.4.2007 | Truvada | Gilead Sciences International Limited Cambridge CB21 6G United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6G |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6G | | | | |
| United Kingdom | | | | |
| 24.4.2007 | 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 | | | | |
| 24.4.2007 | NovoMix | Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsvaerd | | | | |
| 24.4.2007 | 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 | | | | |
| 24.4.2007 | DaTSCAN | GE Healthcare Limited Little Chalfont Bucks HP7 9NA United Kingdom | GE Healthcare Limited | Little Chalfont |
| GE Healthcare Limited | | | | |
| Little Chalfont | | | | |
| Bucks HP7 9NA | | | | |
| United Kingdom | | | | |
| 25.4.2007 | Bondenza | 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 | | | | |
| 25.4.2007 | Bonviva | 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 | | | | |
| 25.4.2007 | Xigris | 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 | | | | |
| 25.4.2007 | Emtriva | 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 | | | | |
| 26.4.2007 | Baraclude | 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 | | | | |
| 26.4.2007 | Lysodren | Laboratoire HRA Pharma 15, rue Béranger F-75003 Paris | Laboratoire HRA Pharma | 15, rue Béranger |
| Laboratoire HRA Pharma | | | | |
| 15, rue Béranger | | | | |
| F-75003 Paris | | | | |
| 26.4.2007 | Champix | 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 | | | | |
| 26.4.2007 | 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 | | | | |

—   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 |
| -------------------- | ----------------------------- | ----------------------------------------- | -------------------------------------------------------------- | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------- |
| 13.4.2007 | Slentrol | Dirlotapide | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pfizer Ltd | Ramsgate Road | Sandwich | Kent CT13 9NJ |
| Pfizer Ltd | | | | | | | |
| Ramsgate Road | | | | | | | |
| Sandwich | | | | | | | |
| Kent CT13 9NJ | | | | | | | |
| 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 |
| ----------------------------------- | ----------------------------- | --------------------------------------------------------------------- | --------------------------------------------- | -------------------------- |
| 20.4.2007 | Metacam | Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein | Boehringer Ingelheim Vetmedica GmbH | D-55216 Ingelheim am Rhein |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| 24.4.2007 | Oxyglobin | Biopure Netherlands B.V. Drentestraat 24BG 1083HK Amsterdam Nederland | Biopure Netherlands B.V. | Drentestraat 24BG |
| Biopure Netherlands B.V. | | | | |
| Drentestraat 24BG | | | | |
| 1083HK Amsterdam | | | | |
| Nederland | | | | |

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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