# C_2008245EN.01001501.xml

| 26.9.2008 | EN | Official Journal of the European Union | C 245/15 |
| --------- | -- | -------------------------------------- | -------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2008 to 31 August 2008

(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 245/03)

—   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 |
| ------------------------------------------- | ----------------------------- | ----------------------------------------- | ------------------------------------------------------------------------------------ | --------------------------------------------- | ------------------------------------------- | ------------------------------------------------ | -------------------- |
| 28.8.2008 | INTELENCE | Etravirine | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 | B-2340 Beerse | EU/1/08/468/001 |
| Janssen-Cilag International NV | | | | | | | |
| Turnhoutseweg, 30 | | | | | | | |
| B-2340 Beerse | | | | | | | |
| 29.8.2008 | Vimpat | Lacosamide | UCB S.A. Allée de la Recherche, 60/Researchdreef, 60 B-1070 Bruxelles/B-1070 Brussel | UCB S.A. | Allée de la Recherche, 60/Researchdreef, 60 | B-1070 Bruxelles/B-1070 Brussel | EU/1/08/470/001-013 |
| UCB S.A. | | | | | | | |
| Allée de la Recherche, 60/Researchdreef, 60 | | | | | | | |
| B-1070 Bruxelles/B-1070 Brussel | | | | | | | |
| EU/1/08/470/014-015 | Syrup | | | | | | |
| EU/1/08/470/016 | Solution for infusion | | | | | | |

—   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 |
| --------------------------------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------- |
| 4.8.2008 | Neupro | Schwarz Pharma Ltd Shannon Industrial Estate Co.Clare Ireland | Schwarz Pharma Ltd | Shannon |
| Schwarz Pharma Ltd | | | | |
| Shannon | | | | |
| Industrial Estate | | | | |
| Co.Clare | | | | |
| Ireland | | | | |
| 8.8.2008 | 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 | | | | |
| 8.8.2008 | Vectibix | 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 | | | | |
| 8.8.2008 | 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 | | | | |
| 8.8.2008 | Evista | 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 | | | | |
| 8.8.2008 | 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 | | | | |
| 11.8.2008 | Optruma | 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 | | | | |
| 13.8.2008 | Silapo | STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel | STADA Arzneimittel AG | Stadastrasse 2-18 |
| STADA Arzneimittel AG | | | | |
| Stadastrasse 2-18 | | | | |
| D-61118 Bad Vilbel | | | | |
| 13.8.2008 | Retacrit | HOSPIRA Enterprises B.V. Taurusavenue 19-21b 2132 LS Hoofddorp Nederland | HOSPIRA Enterprises B.V. | Taurusavenue 19-21b |
| HOSPIRA Enterprises B.V. | | | | |
| Taurusavenue 19-21b | | | | |
| 2132 LS Hoofddorp | | | | |
| Nederland | | | | |
| 13.8.2008 | Humira | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 13.8.2008 | Hepsera | 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 | | | | |
| 13.8.2008 | 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 | | | | |
| 13.8.2008 | Cervarix | 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 | | | | |
| 22.8.2008 | Evista | DAIICHI SANKYO EUROPE GmbH Zielstattstrasse 48 D-81379 München | DAIICHI SANKYO EUROPE GmbH | Zielstattstrasse 48 |
| DAIICHI SANKYO EUROPE GmbH | | | | |
| Zielstattstrasse 48 | | | | |
| D-81379 München | | | | |
| Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5 | 3991 RA Houten | Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 22.8.2008 | Kaletra | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 22.8.2008 | Baraclude | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge UB8 1DH | | | | |
| United Kingdom | | | | |
| 22.8.2008 | 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 | | | | |
| 22.8.2008 | 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 | | | | |
| 22.8.2008 | Zalasta | KRKA d.d. Šmarješka cesta 6 SLO-8501 Novo mesto | KRKA d.d. | Šmarješka cesta 6 |
| KRKA d.d. | | | | |
| Šmarješka cesta 6 | | | | |
| SLO-8501 Novo mesto | | | | |
| 22.8.2008 | Arixtra | 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 | | | | |
| 22.8.2008 | Revlimid | Celgene Europe Limited Morgan House Madeira Walk Windsor Berkshire SL4 1EP United Kingdom | Celgene Europe Limited | Morgan House |
| Celgene Europe Limited | | | | |
| Morgan House | | | | |
| Madeira Walk | | | | |
| Windsor | | | | |
| Berkshire SL4 1EP | | | | |
| United Kingdom | | | | |
| 25.8.2008 | 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 | | | | |
| 25.8.2008 | TARGRETIN | Eisai Limited 3 Shortlands London W6 8EE United Kingdom | Eisai Limited | 3 Shortlands |
| Eisai Limited | | | | |
| 3 Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 25.8.2008 | Emselex | 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 | | | | |
| 25.8.2008 | 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 | | | | |
| 25.8.2008 | Humira | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 25.8.2008 | Revatio | Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Sandwich |
| Pfizer Limited | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 25.8.2008 | Prialt | Eisai Limited 3 Shortlands London W6 8EE United Kingdom | Eisai Limited | 3 Shortlands |
| Eisai Limited | | | | |
| 3 Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 25.8.2008 | 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 | | | | |
| 26.8.2008 | Viagra | Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Sandwich |
| Pfizer Limited | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 28.8.2008 | Rasilez | 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 | | | | |
| 28.8.2008 | Tekturna | 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 | | | | |
| 28.8.2008 | Raptiva | 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 | | | | |
| 28.8.2008 | ISENTRESS | Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Limited | Hertford Road |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire EN11 9BU | | | | |
| United Kingdom | | | | |
| 28.8.2008 | Enviage | 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 | | | | |
| 28.8.2008 | Sprimeo | 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 | | | | |
| 28.8.2008 | Riprazo | 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 | | | | |
| 29.8.2008 | 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 | | | | |
| 29.8.2008 | 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 | | | | |
| 29.8.2008 | Enbrel | Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Limited | Huntercombe Lane |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane | | | | |
| South Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 29.8.2008 | 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 | | | | |
| 29.8.2008 | Humira | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 29.8.2008 | 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 | | | | |
| 29.8.2008 | 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 | | | | |
| 29.8.2008 | 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 | | | | |
| 29.8.2008 | 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 | | | | |

—   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 |
| -------------------------------- | ----------------------------- | ---------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 22.8.2008 | Protopy | Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München | Astellas Pharma GmbH | Neumarkter Str. 61 |
| Astellas Pharma GmbH | | | | |
| Neumarkter Str. 61 | | | | |
| D-81673 München | | | | |
| 28.8.2008 | 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 | | | | |

—   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 |
| -------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- |
| 13.8.2008 | Dexdomitor | Orion Corporation Orionintie 1 FI-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FI-02200 Espoo | | | | |
| 22.8.2008 | Suvaxyn Aujeszky | Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp Nederland | Fort Dodge Animal Health Holland | C.J. van Houtenlaan 36 |
| Fort Dodge Animal Health Holland | | | | |
| C.J. van Houtenlaan 36 | | | | |
| 1381 CP Weesp | | | | |
| Nederland | | | | |
| 25.8.2008 | Zubrin | Schering-Plough Limited Schering-Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom | Schering-Plough Limited | Schering-Plough House |
| Schering-Plough Limited | | | | |
| Schering-Plough House | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| Hertfordshire AL7 1TW | | | | |
| United Kingdom | | | | |
| 25.8.2008 | Circovac | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 25.8.2008 | 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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