# C_2007228EN.01000201.xml

| 28.9.2007 | EN | Official Journal of the European Union | C 228/2 |
| --------- | -- | -------------------------------------- | ------- |

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2007 to 31 August 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 228/02)

—   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 |
| --------------------------------------- | ----------------------------- | ----------------------------------------- | ----------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------- | ------------------------------------------------ | -------------------- |
| 3.8.2007 | INCRELEX | Mecasermin | Tercica Europe Limited 2 Harbourmaster Place International Financial Services Centre Dublin 1 Ireland | Tercica Europe Limited | 2 Harbourmaster Place | International Financial Services Centre | Dublin 1 |
| Tercica Europe Limited | | | | | | | |
| 2 Harbourmaster Place | | | | | | | |
| International Financial Services Centre | | | | | | | |
| Dublin 1 | | | | | | | |
| Ireland | | | | | | | |
| 22.8.2007 | Enviage | Aliskiren | 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 | | | | | | | |
| 22.8.2007 | Riprazo | Aliskiren | 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 | | | | | | | |
| 22.8.2007 | Sprimeo | Aliskiren | 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 | | | | | | | |
| 22.8.2007 | Rasilez | Aliskiren | 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 | | | | | | | |
| 22.8.2007 | Tekturna | Aliskiren | 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 | | | | | | | |
| 22.8.2007 | Atriance | Nelarabine | Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Limited | Berkeley Avenue | Greenford | Middlesex UB6 0NN |
| Glaxo Group Limited | | | | | | | |
| Berkeley Avenue | | | | | | | |
| Greenford | | | | | | | |
| Middlesex UB6 0NN | | | | | | | |
| United Kingdom | | | | | | | |
| 23.8.2007 | Flebogammadif | Human normal immunoglobulin | Instituto Grifols S.A. Can Guasch 2 — Parets del Vallès E-08150 Barcelona | Instituto Grifols S.A. | Can Guasch | 2 — Parets del Vallès | E-08150 Barcelona |
| Instituto Grifols S.A. | | | | | | | |
| Can Guasch | | | | | | | |
| 2 — Parets del Vallès | | | | | | | |
| E-08150 Barcelona | | | | | | | |
| 28.8.2007 | Abseamed | Epoetin alfa | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn | Medice Arzneimittel Pütter GmbH & Co KG | Kuhloweg 37 | D-58638 Iserlohn | EU/1/07/412/001-016 |
| Medice Arzneimittel Pütter GmbH & Co KG | | | | | | | |
| Kuhloweg 37 | | | | | | | |
| D-58638 Iserlohn | | | | | | | |
| 28.8.2007 | Binocrit | Epoetin alfa | Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl | Sandoz GmbH | Biochemiestrasse 10 | A-6250 Kundl | EU/1/07/410/001-016 |
| Sandoz GmbH | | | | | | | |
| Biochemiestrasse 10 | | | | | | | |
| A-6250 Kundl | | | | | | | |
| 28.8.2007 | Epoetin alfa hexal | Epoetin alfa | HEXAL Biotech Forschungs GmbH Industriestrasse 25 D-83607 Holzkirchen | HEXAL Biotech Forschungs GmbH | Industriestrasse 25 | D-83607 Holzkirchen | EU/1/07/411/001-016 |
| HEXAL Biotech Forschungs GmbH | | | | | | | |
| Industriestrasse 25 | | | | | | | |
| D-83607 Holzkirchen | | | | | | | |

—   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 |
| ---------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------- | ----------------------------- |
| 1.8.2007 | Keppra | UCB S.A. Allée de la Recherche, 60 B-1070 Bruxelles Researchdreef, 60 B-1070 Brussel UCB Pharma SA. 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 | | | | |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60 | | | | |
| B-1070 Bruxelles | | | | |
| Researchdreef, 60 | | | | |
| B-1070 Brussel | | | | |
| 3.8.2007 | TachoSil | Nycomed Austria GMBH St.-Peter-Straße 25 A-4020 Linz | Nycomed Austria GMBH | St.-Peter-Straße 25 |
| Nycomed Austria GMBH | | | | |
| St.-Peter-Straße 25 | | | | |
| A-4020 Linz | | | | |
| 7.8.2007 | BeneFIX | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Ltd | Huntercombe Lane South Taplow |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane South Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 10.8.2007 | Norvir | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 10.8.2007 | Fasturtec | Sanofi-Aventis 174, avenue de France F-75013 Paris | Sanofi-Aventis | 174, avenue de France |
| Sanofi-Aventis | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 10.8.2007 | Ceprotin | Baxter AG Industriestraße 67 A-1220 Vienna | Baxter AG | Industriestraße 67 |
| Baxter AG | | | | |
| Industriestraße 67 | | | | |
| A-1220 Vienna | | | | |
| 10.8.2007 | Cellcept | 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 | | | | |
| 10.8.2007 | 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 | | | | |
| 10.8.2007 | Tritanrix HepB | 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 | | | | |
| 10.8.2007 | Cialis | Lilly ICOS Limited St Bride's House 10 Salisbury Square London EC4Y 8EH United Kingdom | Lilly ICOS Limited | St Bride's House |
| Lilly ICOS Limited | | | | |
| St Bride's House | | | | |
| 10 Salisbury Square | | | | |
| London EC4Y 8EH | | | | |
| United Kingdom | | | | |
| 20.8.2007 | 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 | | | | |
| 20.8.2007 | 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 | | | | |
| 20.8.2007 | 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 | | | | |
| 21.8.2007 | Forsteo | 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 | | | | |
| 21.8.2007 | Nexavar | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 21.8.2007 | Opatanol | Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom | Alcon Laboratories (UK) Ltd | Pentagon Park |
| Alcon Laboratories (UK) Ltd | | | | |
| Pentagon Park | | | | |
| Boundary Way | | | | |
| Hemel Hempstead | | | | |
| Herts HP2 7UD | | | | |
| United Kingdom | | | | |
| 21.8.2007 | NeuroBloc | Solstice Neurosciences Ltd Fitzwilton House Wilton Place Dublin 2 Ireland | Solstice Neurosciences Ltd | Fitzwilton House |
| Solstice Neurosciences Ltd | | | | |
| Fitzwilton House | | | | |
| Wilton Place | | | | |
| Dublin 2 | | | | |
| Ireland | | | | |
| 21.8.2007 | 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 | | | | |
| 21.8.2007 | Kiovig | Baxter AG Industriestraße 67 A-1220 Vienna | Baxter AG | Industriestraße 67 |
| Baxter AG | | | | |
| Industriestraße 67 | | | | |
| A-1220 Vienna | | | | |
| 22.8.2007 | Sprycel | 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 | | | | |
| 22.8.2007 | Luminity | Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185 B-1170 Brussel | Bristol-Myers Squibb Pharma Belgium Sprl | Chaussée de la Hulpe, 185 |
| Bristol-Myers Squibb Pharma Belgium Sprl | | | | |
| Chaussée de la Hulpe, 185 | | | | |
| B-1170 Brussel | | | | |
| 22.8.2007 | 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 | | | | |
| 22.8.2007 | 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 | | | | |
| 23.8.2007 | Inovelon | Eisai Limited, 3 Shortlands London W6 8EE United Kingdom | Eisai Limited, 3 | Shortlands |
| Eisai Limited, 3 | | | | |
| Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 23.8.2007 | 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 | | | | |
| 23.8.2007 | 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 | | | | |
| 23.8.2007 | Orfadin | Swedish Orphan International AB Drottninggatan 98 S-111 60 Stockholm | Swedish Orphan International AB | Drottninggatan 98 |
| Swedish Orphan International AB | | | | |
| Drottninggatan 98 | | | | |
| S-111 60 Stockholm | | | | |
| 27.8.2007 | Kivexa | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 27.8.2007 | Ziagen | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 27.8.2007 | Rapamune | Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Limited | Huntercombe Lane South Taplow |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 27.8.2007 | 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 | | | | |
| 27.8.2007 | 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 | | | | |
| 27.8.2007 | 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 | | | | |
| 27.8.2007 | 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 | | | | |
| 27.8.2007 | Ebixa | H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby | H. Lundbeck A/S | Ottiliavej 9 |
| H. Lundbeck A/S | | | | |
| Ottiliavej 9 | | | | |
| DK-2500 Valby | | | | |
| 29.8.2007 | Enbrel | Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Limited | Huntercombe Lane South Taplow |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 28.8.2007 | Cymbalta | 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 | | | | |
| 28.8.2007 | Xeristar | 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 | | | | |
| 28.8.2007 | YENTREVE | 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 | | | | |
| 28.8.2007 | 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 | | | | |
| 29.8.2007 | Stalevo | Orion Corporation Orionintie 1 FIN-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| 29.8.2007 | Exubera | 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 | | | | |
| 29.8.2007 | Vistide | Pfizer Enterprises SARL 51, Avenue Kennedy Rond Point du Kirchberg L-1855 Luxembourg | Pfizer Enterprises SARL | 51, Avenue Kennedy |
| Pfizer Enterprises SARL | | | | |
| 51, Avenue Kennedy | | | | |
| Rond Point du Kirchberg | | | | |
| L-1855 Luxembourg | | | | |
| 29.8.2007 | Evoltra | Bioenvision Limited Bassett House 5 Southwell Park Road Camberley Surrey GU15 3PU United Kingdom | Bioenvision Limited | Bassett House |
| Bioenvision Limited | | | | |
| Bassett House | | | | |
| 5 Southwell Park Road | | | | |
| Camberley | | | | |
| Surrey GU15 3PU | | | | |
| United Kingdom | | | | |
| 29.8.2007 | 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 | | | | |
| 29.8.2007 | 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 | | | | |
| 29.8.2007 | Quixidar | 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 | | | | |
| 29.8.2007 | Quixidar | 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 | | | | |
| 29.8.2007 | 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 | | | | |
| 29.8.2007 | 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 | | | | |
| 30.8.2007 | 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 | | | | |
| 30.8.2007 | BYETTA | 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 | | | | |
| 30.8.2007 | Agenerase | Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Limited | Berkeley Avenue |
| Glaxo Group Limited | | | | |
| Berkeley Avenue | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 30.8.2007 | 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 | | | | |
| 30.8.2007 | NovoRapid | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 30.8.2007 | 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 | | | | |
| 30.8.2007 | Zyprexa | 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 | | | | |
| 30.8.2007 | Zyprexa Velotab | 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 | | | | |
| 30.8.2007 | InductOs | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Ltd | Huntercombe Lane South Taplow |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane South Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 30.8.2007 | 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 | | | | |
| Meda AB Pipers väg 2A S-170 73 Solna | Meda AB | Pipers väg 2A | S-170 73 Solna | 5.9.2007 |
| Meda AB | | | | |
| Pipers väg 2A | | | | |
| S-170 73 Solna | | | | |
| 31.8.2007 | Karvea | 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 | | | | |
| 31.8.2007 | Aprovel | 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 | | | | |
| 31.8.2007 | 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 | | | | |
| 31.8.2007 | 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 | | | | |
| 31.8.2007 | 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 | | | | |
| 31.8.2007 | 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 | | | | |
| 31.8.2007 | 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 | | | | |
| 31.8.2007 | Zimulti | Sanofi-Aventis 174, avenue de France F-75013 Paris | Sanofi-Aventis | 174, avenue de France |
| Sanofi-Aventis | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 31.8.2007 | ACOMPLIA | Sanofi-Aventis 174, avenue de France F-75013 Paris | Sanofi-Aventis | 174, avenue de France |
| Sanofi-Aventis | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 31.8.2007 | Prevenar | Wyeth-Lederle Vaccines S.A. Rue du Bosquet B-15-1348 Louvain-La-Neuve | Wyeth-Lederle Vaccines S.A. | Rue du Bosquet |
| Wyeth-Lederle Vaccines S.A. | | | | |
| Rue du Bosquet | | | | |
| B-15-1348 Louvain-La-Neuve | | | | |

—   Suspension of a marketing authorization (Article 20 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 |
| -------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 6.8.2007 | 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 | | | | |

—   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 |
| ---------------------------------------------------------- | ----------------------------- | ---------------------------------------------------------------------- | --------------------------------------------- | ----------------------- |
| 2.8.2007 | Dexdomitor | Orion Corporation Orionintie 1 FIN-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| 13.8.2007 | Advocate | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 23.8.2007 | PRAC-TIC | Novartis Sanidad Animal S.L. Calle de la Marina, 206 E-08013 Barcelona | Novartis Sanidad Animal S.L. | Calle de la Marina, 206 |
| Novartis Sanidad Animal S.L. | | | | |
| Calle de la Marina, 206 | | | | |
| E-08013 Barcelona | | | | |
| 27.8.2007 | Yarvitan | Janssen Animal Health B.V.B.A. Turnhoutseweg, 30 B-2340 Beerse | Janssen Animal Health B.V.B.A. | Turnhoutseweg, 30 |
| Janssen Animal Health B.V.B.A. | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| Janssen Pharmaceutica N.V. Turnhoutseweg, 30 B-2340 Beerse | Janssen Pharmaceutica N.V. | Turnhoutseweg, 30 | B-2340 Beerse | 29.8.2007 |
| Janssen Pharmaceutica N.V. | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |

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 |

---

( 1 )  OJ L 136, 30.4.2004, p. 1.

---