# C_2008220EN.01000501.xml

| 29.8.2008 | EN | Official Journal of the European Union | C 220/5 |
| --------- | -- | -------------------------------------- | ------- |

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2008 to 31 July 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 220/03)

—   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 |
| -------------------------------------- | ----------------------------- | ----------------------------------------- | --------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- | ------------------------------------------------ | ---------------------- |
| 2.7.2008 | RELISTOR | Methylnaltrexone bromide | Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Limited | Huntercombe Lane South | Taplow | Maidenhead |
| Wyeth Europa Limited | | | | | | | |
| Huntercombe Lane South | | | | | | | |
| Taplow | | | | | | | |
| Maidenhead | | | | | | | |
| Berkshire SL6 0PH | | | | | | | |
| United Kingdom | | | | | | | |
| 3.7.2008 | Trevaclyn | Nicotinic acid/laropiprant | 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 | | | | | | | |
| 3.7.2008 | Pelzont | Nicotinic acid/laropiprant | 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 | | | | | | | |
| 3.7.2008 | Tredaptive | Nicotinic acid/laropiprant | 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 | | | | | | | |
| 9.7.2008 | Latixa | Ranolazine | CV Therapeutics Europe Limited 15 Meadway Court Rutherford Close Stevenage Hertfordshire SG1 2EF United Kingdom | CV Therapeutics Europe Limited | 15 Meadway Court | Rutherford Close | Stevenage |
| CV Therapeutics Europe Limited | | | | | | | |
| 15 Meadway Court | | | | | | | |
| Rutherford Close | | | | | | | |
| Stevenage | | | | | | | |
| Hertfordshire SG1 2EF | | | | | | | |
| United Kingdom | | | | | | | |
| 11.7.2008 | Firazyr | Icatibant | Jerini AG Invalidenstr. 130 D-10115 Berlin | Jerini AG | Invalidenstr. 130 | D-10115 Berlin | EU/1/08/461/001 |
| Jerini AG | | | | | | | |
| Invalidenstr. 130 | | | | | | | |
| D-10115 Berlin | | | | | | | |
| 16.7.2008 | Clopidogrel BMS | Clopidogrel | BRISTOL MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom | BRISTOL MYERS SQUIBB PHARMA EEIG | Uxbridge Business Park | Sanderson Road | Uxbridge UB8 1DH |
| BRISTOL MYERS SQUIBB PHARMA EEIG | | | | | | | |
| Uxbridge Business Park | | | | | | | |
| Sanderson Road | | | | | | | |
| Uxbridge UB8 1DH | | | | | | | |
| United Kingdom | | | | | | | |
| 16.7.2008 | Clopidogrel Winthrop | Clopidogrel | 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/1/08/465/001-017 |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | | | | |
| 174, avenue de France | | | | | | | |
| F-75013 Paris | | | | | | | |
| 16.7.2008 | Janumet | Sitagliptin/metformin hydrochloride | 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 | | | | | | | |
| 16.7.2008 | Efficib | Sitagliptin/metformin hydrochloride | 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 | | | | | | | |
| 16.7.2008 | Velmetia | Sitagliptin/metformin hydrochloride | 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 | | | | | | | |
| 25.7.2008 | Bridion | Sugammadex | N.V. Organon Kloosterstraat 6 5349 AB Oss Nederland | N.V. Organon | Kloosterstraat 6 | 5349 AB Oss | Nederland |
| N.V. Organon | | | | | | | |
| Kloosterstraat 6 | | | | | | | |
| 5349 AB Oss | | | | | | | |
| Nederland | | | | | | | |
| 25.7.2008 | Doribax | Doripenem | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 | B-2340 Beerse | EU/1/08/467/001 |
| Janssen-Cilag International NV | | | | | | | |
| Turnhoutseweg, 30 | | | | | | | |
| B-2340 Beerse | | | | | | | |

—   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 |
| ----------------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------- | ------------------------------------------- |
| 2.7.2008 | PritorPlus | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 2.7.2008 | 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 | | | | |
| 2.7.2008 | Pritor | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 2.7.2008 | INCRELEX | Tercica Europe Limited Riverside One Sir John Rogerson's Quay Dublin 2 Ireland | Tercica Europe Limited | Riverside One |
| Tercica Europe Limited | | | | |
| Riverside One | | | | |
| Sir John Rogerson's Quay | | | | |
| Dublin 2 | | | | |
| Ireland | | | | |
| 3.7.2008 | Kinzalkomb | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 3.7.2008 | 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 | | | | |
| 3.7.2008 | 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 | | | | |
| 3.7.2008 | 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 | | | | |
| 4.7.2008 | 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 | | | | |
| 4.7.2008 | Rotarix | 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 | | | | |
| 4.7.2008 | MabCampath | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| Nederland | | | | |
| 4.7.2008 | 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 | | | | |
| 4.7.2008 | 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 | | | | |
| 4.7.2008 | Kinzalmono | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 4.7.2008 | Zometa | 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 | | | | |
| 7.7.2008 | TOVIAZ | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 7.7.2008 | Vasovist | Bayer Schering Pharma AG D-13342 Berlin | Bayer Schering Pharma AG | D-13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| D-13342 Berlin | | | | |
| 7.7.2008 | Kepivance | 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 | | | | |
| 7.7.2008 | 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 | | | | |
| 7.7.2008 | 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 | | | | |
| 7.7.2008 | Tamiflu | 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 | | | | |
| 7.7.2008 | Siklos | Addmedica 84, rue d'Amsterdam F-75009 Paris | Addmedica | 84, rue d'Amsterdam |
| Addmedica | | | | |
| 84, rue d'Amsterdam | | | | |
| F-75009 Paris | | | | |
| 7.7.2008 | 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 | | | | |
| 7.7.2008 | Aldara | Meda AB Pipers väg 2A S-170 73 Solna | Meda AB | Pipers väg 2A |
| Meda AB | | | | |
| Pipers väg 2A | | | | |
| S-170 73 Solna | | | | |
| 7.7.2008 | 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 | | | | |
| 8.7.2008 | 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 | | | | |
| 8.7.2008 | Binocrit | Sandoz GmbH Biochemiestraße 10 A-6250 Kundl | Sandoz GmbH | Biochemiestraße 10 |
| Sandoz GmbH | | | | |
| Biochemiestraße 10 | | | | |
| A-6250 Kundl | | | | |
| 8.7.2008 | 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 | | | | |
| 8.7.2008 | Epoetin alfa Hexal | HEXAL Biotech Forschungs GmbH Industriestraße 25 D-83607 Holzkirchen | HEXAL Biotech Forschungs GmbH | Industriestraße 25 |
| HEXAL Biotech Forschungs GmbH | | | | |
| Industriestraße 25 | | | | |
| D-83607 Holzkirchen | | | | |
| 8.7.2008 | Busilvex | Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex | Pierre Fabre Médicament | 45, Place Abel Gance |
| Pierre Fabre Médicament | | | | |
| 45, Place Abel Gance | | | | |
| F-92654 Boulogne Billancourt Cedex | | | | |
| 9.7.2008 | 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 | | | | |
| 9.7.2008 | Exubera | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 9.7.2008 | Cholestagel | 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 | | | | |
| 9.7.2008 | Circadin | RAD Neurim Pharmaceuticals EEC Limited 6 Fortuna Court Calleva Park Aldermaston Berkshire RG7 8UB United Kingdom | RAD Neurim Pharmaceuticals EEC Limited | 6 Fortuna Court |
| RAD Neurim Pharmaceuticals EEC Limited | | | | |
| 6 Fortuna Court | | | | |
| Calleva Park | | | | |
| Aldermaston | | | | |
| Berkshire RG7 8UB | | | | |
| United Kingdom | | | | |
| 9.7.2008 | Pedea | Orphan Europe SARL Immeuble Le Wilson 70, avenue du Général de Gaulle F-92800 Puteaux | Orphan Europe SARL | Immeuble Le Wilson |
| Orphan Europe SARL | | | | |
| Immeuble Le Wilson | | | | |
| 70, avenue du Général de Gaulle | | | | |
| F-92800 Puteaux | | | | |
| 9.7.2008 | 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 | | | | |
| 9.7.2008 | 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 | | | | |
| 9.7.2008 | 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 | | | | |
| 9.7.2008 | 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 | | | | |
| 10.7.2008 | 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 | | | | |
| 10.7.2008 | 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 | | | | |
| 10.7.2008 | Optaflu | Novartis Vaccines and Diagnostics GmbH & Co. KG Emil-von-Behring-Straße 76 D-35041 Marburg | Novartis Vaccines and Diagnostics GmbH & Co. KG | Emil-von-Behring-Straße 76 |
| Novartis Vaccines and Diagnostics GmbH & Co. KG | | | | |
| Emil-von-Behring-Straße 76 | | | | |
| D-35041 Marburg | | | | |
| 10.7.2008 | ViraferonPeg | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/B-1180 Brussel | | | | |
| 10.7.2008 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |
| 10.7.2008 | Silgard | 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 | | | | |
| 10.7.2008 | PegIntron | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/B-1180 Brussel | | | | |
| 10.7.2008 | Gardasil | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |
| 11.7.2008 | Sustiva | 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 | | | | |
| 11.7.2008 | 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 | | | | |
| 11.7.2008 | Liprolog | 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 | | | | |
| 17.7.2008 | 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 | | | | |
| 17.7.2008 | Humira | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 17.7.2008 | Erbitux | Merck KGaA Frankfurter Straße 250 D-64271 Darmstadt | Merck KGaA | Frankfurter Straße 250 |
| Merck KGaA | | | | |
| Frankfurter Straße 250 | | | | |
| D-64271 Darmstadt | | | | |
| 17.7.2008 | 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 | | | | |
| 22.7.2008 | 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 | | | | |
| 22.7.2008 | Sprycel | 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 | | | | |
| 22.7.2008 | 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 | | | | |
| 23.7.2008 | Prandin | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 23.7.2008 | Exjade | 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 | | | | |
| 23.7.2008 | NovoNorm | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 23.7.2008 | Quadramet | CIS bio international Boîte Postale 32 F-91192 Gif-sur-Yvette | CIS bio international | Boîte Postale 32 |
| CIS bio international | | | | |
| Boîte Postale 32 | | | | |
| F-91192 Gif-sur-Yvette | | | | |
| 24.7.2008 | Keppra | UCB Pharma S.A. Allée de la Recherche, 60/Researchdreef, 60 B-1070 Bruxelles/B-1070 Brussel | UCB Pharma S.A. | Allée de la Recherche, 60/Researchdreef, 60 |
| UCB Pharma S.A. | | | | |
| Allée de la Recherche, 60/Researchdreef, 60 | | | | |
| B-1070 Bruxelles/B-1070 Brussel | | | | |
| 25.7.2008 | Keppra | UCB Pharma S.A. Allée de la Recherche, 60/Researchdreef, 60 B-1070 Bruxelles/B-1070 Brussel | UCB Pharma S.A. | Allée de la Recherche, 60/Researchdreef, 60 |
| UCB Pharma S.A. | | | | |
| Allée de la Recherche, 60/Researchdreef, 60 | | | | |
| B-1070 Bruxelles/B-1070 Brussel | | | | |
| 25.7.2008 | REYATAZ | 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 | | | | |
| 25.7.2008 | Trisenox | Cephalon Europe 5, rue Charles Martigny F-94700 Maisons Alfort Cedex | Cephalon Europe | 5, rue Charles Martigny |
| Cephalon Europe | | | | |
| 5, rue Charles Martigny | | | | |
| F-94700 Maisons Alfort Cedex | | | | |
| 25.7.2008 | Myfenax | Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland | Teva Pharma B.V. | Computerweg 10 |
| Teva Pharma B.V. | | | | |
| Computerweg 10 | | | | |
| DR Utrecht 3542 | | | | |
| Nederland | | | | |
| 25.7.2008 | Valtropin | BioPartners GmbH Eisenstraße 3 D-65428 Rüsselsheim | BioPartners GmbH | Eisenstraße 3 |
| BioPartners GmbH | | | | |
| Eisenstraße 3 | | | | |
| D-65428 Rüsselsheim | | | | |
| 25.7.2008 | Zeffix | 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 | | | | |
| 25.7.2008 | Mycophenolate mofetil Teva | Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 Nederland | Teva Pharma B.V. | Computerweg 10 |
| Teva Pharma B.V. | | | | |
| Computerweg 10 | | | | |
| DR Utrecht 3542 | | | | |
| Nederland | | | | |
| 28.7.2008 | 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 | | | | |
| 28.7.2008 | 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 | | | | |
| 28.7.2008 | 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 | | | | |
| 28.7.2008 | 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 | | | | |
| 28.7.2008 | 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 | | | | |
| 28.7.2008 | 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 | | | | |
| 28.7.2008 | 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 | | | | |
| 28.7.2008 | Vivanza | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 28.7.2008 | Levitra | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 28.7.2008 | Ventavis | Bayer Schering Pharma AG Müllerstraße 170-178 D-13342 Berlin | Bayer Schering Pharma AG | Müllerstraße 170-178 |
| Bayer Schering Pharma AG | | | | |
| Müllerstraße 170-178 | | | | |
| D-13342 Berlin | | | | |
| 28.7.2008 | 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 | | | | |
| 29.7.2008 | Tracleer | Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom | Actelion Registration Ltd | BSI Building 13th Floor |
| Actelion Registration Ltd | | | | |
| BSI Building 13th Floor | | | | |
| 389 Chiswick High Road | | | | |
| London W4 4AL | | | | |
| United Kingdom | | | | |
| 29.7.2008 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |
| 29.7.2008 | 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 | | | | |
| 29.7.2008 | Angiox | The Medicines Company UK Ltd Suite B Park House 11 Milton Park Abingdon Oxfordshire OX14 4RS United Kingdom | The Medicines Company UK Ltd | Suite B |
| The Medicines Company UK Ltd | | | | |
| Suite B | | | | |
| Park House | | | | |
| 11 Milton Park | | | | |
| Abingdon | | | | |
| Oxfordshire OX14 4RS | | | | |
| United Kingdom | | | | |
| 29.7.2008 | INCRELEX | Tercica Europe Limited Riverside One Sir John Rogerson's Quay Dublin 2 Ireland | Tercica Europe Limited | Riverside One |
| Tercica Europe Limited | | | | |
| Riverside One | | | | |
| Sir John Rogerson's Quay | | | | |
| Dublin 2 | | | | |
| Ireland | | | | |
| 29.7.2008 | Naglazyme | BioMarin Europe Limited Axtell House 23-24 Warwick Street London W1B 5NQ United Kingdom | BioMarin Europe Limited | Axtell House |
| BioMarin Europe Limited | | | | |
| Axtell House | | | | |
| 23-24 Warwick Street | | | | |
| London W1B 5NQ | | | | |
| United Kingdom | | | | |
| 29.7.2008 | Circadin | RAD Neurim Pharmaceuticals EEC Limited 6 Fortuna Court Calleva Park Aldermaston Berkshire RG7 8UB United Kingdom | RAD Neurim Pharmaceuticals EEC Limited | 6 Fortuna Court |
| RAD Neurim Pharmaceuticals EEC Limited | | | | |
| 6 Fortuna Court | | | | |
| Calleva Park | | | | |
| Aldermaston | | | | |
| Berkshire RG7 8UB | | | | |
| United Kingdom | | | | |
| 29.7.2008 | 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 | | | | |
| 29.7.2008 | Pylobactell | Torbet Laboratories Limited Unit 14D Wendover Road Rackheath Industrial Estate Norwich Norfolk NR13 6LH United Kingdom | Torbet Laboratories Limited | Unit 14D |
| Torbet Laboratories Limited | | | | |
| Unit 14D | | | | |
| Wendover Road | | | | |
| Rackheath Industrial Estate | | | | |
| Norwich | | | | |
| Norfolk NR13 6LH | | | | |
| United Kingdom | | | | |
| 31.7.2008 | 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 | | | | |
| 31.7.2008 | DuoTrav | 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 | | | | |
| 31.7.2008 | ADROVANCE | 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 | | | | |

—   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 |
| ------------------------- | ----------------------------- | ----------------------------------------- | -------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- | ------------------------------------------------ | -------------------- |
| 8.7.2008 | Reconcile | Fluoxétine | Eli Lilly and Company Ltd Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom | Eli Lilly and Company Ltd | Priestley Road | Basingstoke | Hampshire RG24 9NL |
| Eli Lilly and Company Ltd | | | | | | | |
| Priestley Road | | | | | | | |
| Basingstoke | | | | | | | |
| Hampshire RG24 9NL | | | | | | | |
| United Kingdom | | | | | | | |
| 24.7.2008 | ZACTRAN | Gamithromycine | MERIAL 29, avenue Tony Garnier F-69007 Lyon | MERIAL | 29, avenue Tony Garnier | F-69007 Lyon | EU/2/08/082/001-003 |
| MERIAL | | | | | | | |
| 29, avenue Tony Garnier | | | | | | | |
| F-69007 Lyon | | | | | | | |

—   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 |
| -------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 11.7.2008 | Equilis Te | 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 | | | | |
| 11.7.2008 | Equilis Prequenza Te | 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 | | | | |
| 11.7.2008 | ProMeris | 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 | | | | |
| 31.7.2008 | Poulvac FluFend H5N3 RG | Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH United Kingdom | Fort Dodge Animal Health Ltd | Flanders Road |
| Fort Dodge Animal Health Ltd | | | | |
| Flanders Road | | | | |
| Hedge End | | | | |
| Southampton SO30 4QH | | | | |
| United Kingdom | | | | |

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| ----------------------------- |
| 7, Westferry Circus |
| Canary Wharf |
| London E14 4HB |
| United Kingdom |

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

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