# C_2008305EN.01000301.xml

| 28.11.2008 | EN | Official Journal of the European Union | C 305/3 |
| ---------- | -- | -------------------------------------- | ------- |

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2008 to 31 October 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 305/04)

—   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 |
| ----------------------------------------------- | ------------------------------- | ----------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------- | ------------------------------------------------ | --------------------- |
| 1.10.2008 | Tadalafil Lilly | Tadalafil | Eli Lilly Nederlan B.V. Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederlan B.V. | Grootslag 1-5 | 3991 RA Houten | Nederland |
| Eli Lilly Nederlan B.V. | | | | | | | |
| Grootslag 1-5 | | | | | | | |
| 3991 RA Houten | | | | | | | |
| Nederland | | | | | | | |
| 6.10.2008 | EVICEL | Human fibrinogen/ human thrombin | OMRIX biopharmaceuticals S.A./N.V. 200 Chaussée de Waterloo/Waterloosesteenweg 200 B-1640 Rhode-St-Genèse/Sint-Genesius-Rode | OMRIX biopharmaceuticals S.A./N.V. | 200 Chaussée de Waterloo/Waterloosesteenweg 200 | B-1640 Rhode-St-Genèse/Sint-Genesius-Rode | EU/1/08/473/001-003 |
| OMRIX biopharmaceuticals S.A./N.V. | | | | | | | |
| 200 Chaussée de Waterloo/Waterloosesteenweg 200 | | | | | | | |
| B-1640 Rhode-St-Genèse/Sint-Genesius-Rode | | | | | | | |
| 6.10.2008 | Fluticasone furoate GSK | Fluticasone furoate | Glaxo Group Ltd Greenford Middlesex UB6 ONN United Kingdom | Glaxo Group Ltd | Greenford | Middlesex UB6 ONN | United Kingdom |
| Glaxo Group Ltd | | | | | | | |
| Greenford | | | | | | | |
| Middlesex UB6 ONN | | | | | | | |
| United Kingdom | | | | | | | |
| 7.10.2008 | Olanzapine Mylan | Olanzapine | Generics [UK] Limited Station Close Potters Bar Hertfordshire EN6 1TL United Kingdom | Generics [UK] Limited | Station Close | Potters Bar | Hertfordshire EN6 1TL |
| Generics [UK] Limited | | | | | | | |
| Station Close | | | | | | | |
| Potters Bar | | | | | | | |
| Hertfordshire EN6 1TL | | | | | | | |
| United Kingdom | | | | | | | |
| 7.10.2008 | Ceplene | Histamine dihydrochloride | EpiCept GmbH Goethestraße 4 D-80336 München | EpiCept GmbH | Goethestraße 4 | D-80336 München | EU/1/08/477/001 |
| EpiCept GmbH | | | | | | | |
| Goethestraße 4 | | | | | | | |
| D-80336 München | | | | | | | |
| 8.10.2008 | Duloxetine Boehringer Ingelheim | Duloxetine | Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein | Boehringer Ingelheim International GmbH | Binger Straße 173 | D-55216 Ingelheim am Rhein | EU/1/08/471/001-012 |
| Boehringer Ingelheim International GmbH | | | | | | | |
| Binger Straße 173 | | | | | | | |
| D-55216 Ingelheim am Rhein | | | | | | | |

—   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 |
| -------------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------- |
| 1.10.2008 | Karvezide | 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 | | | | |
| 1.10.2008 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris | Sanofi Pharma Bristol-Myers Squibb SNC | 174, avenue de France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 8.10.2008 | Simulect | 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 | | | | |
| 9.10.2008 | Tasmar | Valeant Pharmaceuticals Limited Cedarwood Chineham Business Park Crockford lane Basingstoke RG24 8WD United Kingdom | Valeant Pharmaceuticals Limited | Cedarwood |
| Valeant Pharmaceuticals Limited | | | | |
| Cedarwood | | | | |
| Chineham Business Park | | | | |
| Crockford lane | | | | |
| Basingstoke RG24 8WD | | | | |
| United Kingdom | | | | |
| 13.10.2008 | Yondelis | Pharma Mar, S.A. Avda. de los Reyes 1 Polígono Industrial La Mina E-28770 Colmenar Viejo (Madrid) | Pharma Mar, S.A. | Avda. de los Reyes 1 |
| Pharma Mar, S.A. | | | | |
| Avda. de los Reyes 1 | | | | |
| Polígono Industrial La Mina | | | | |
| E-28770 Colmenar Viejo (Madrid) | | | | |
| 13.10.2008 | HBVAXPRO | 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 | | | | |
| 13.10.2008 | Galvus | 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 | | | | |
| 14.10.2008 | DepoCyte | Pacira Limited MG House Rumbolds Hill Midhurst West Sussex GU29 9BY United Kingdom | Pacira Limited MG House | Rumbolds Hill |
| Pacira Limited MG House | | | | |
| Rumbolds Hill | | | | |
| Midhurst | | | | |
| West Sussex GU29 9BY | | | | |
| United Kingdom | | | | |
| 20.10.2008 | Onsenal | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 20.10.2008 | Thalidomide Pharmion | Celgene Europe Limited Riverside House Riverside Walk Windsor SL4 1NA United Kingdom | Celgene Europe Limited | Riverside House |
| Celgene Europe Limited | | | | |
| Riverside House | | | | |
| Riverside Walk | | | | |
| Windsor SL4 1NA | | | | |
| United Kingdom | | | | |
| Pharmion Ltd Riverside House Riverside Walk Windsor SL4 1NA United Kingdom | Pharmion Ltd | Riverside House | Riverside Walk | Windsor SL4 1NA |
| Pharmion Ltd | | | | |
| Riverside House | | | | |
| Riverside Walk | | | | |
| Windsor SL4 1NA | | | | |
| United Kingdom | | | | |
| 21.10.2008 | 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 | | | | |
| 21.10.2008 | 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 | | | | |
| 22.10.2008 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn | Medice Arzneimittel Pütter GmbH & Co KG | Kuhloweg 37 |
| Medice Arzneimittel Pütter GmbH & Co KG | | | | |
| Kuhloweg 37 | | | | |
| D-58638 Iserlohn | | | | |
| 23.10.2008 | NeoRecormon | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City AL7 1TW | | | | |
| United Kingdom | | | | |
| 23.10.2008 | 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 | | | | |
| 24.10.2008 | 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 | | | | |
| 24.10.2008 | 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 | | | | |
| 27.10.2008 | Myocet | Cephalon Europe 5, Rue Charles Martigny F-94700 Maisons Alfort | Cephalon Europe | 5, Rue Charles Martigny |
| Cephalon Europe | | | | |
| 5, Rue Charles Martigny | | | | |
| F-94700 Maisons Alfort | | | | |
| 27.10.2008 | Revlimid | Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA United Kingdom | Celgene Europe Limited | Riverside House |
| Celgene Europe Limited | | | | |
| Riverside House | | | | |
| Riverside Walk | | | | |
| Windsor | | | | |
| Berkshire SL4 1NA | | | | |
| United Kingdom | | | | |
| 27.10.2008 | 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 | | | | |
| 27.10.2008 | Lucentis | 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 | | | | |
| 28.10.2008 | 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 | | | | |
| 28.10.2008 | RotaTeq | 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 | | | | |
| 28.10.2008 | CELSENTRI | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 28.10.2008 | Valtropin | BioPartners GmbH Eisenstraße 3 D-65428 Rüsselsheim | BioPartners GmbH | Eisenstraße 3 |
| BioPartners GmbH | | | | |
| Eisenstraße 3 | | | | |
| D-65428 Rüsselsheim | | | | |
| 28.10.2008 | 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 | | | | |
| 28.10.2008 | Zavesca | Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom | Actelion Registration Ltd | BSI Building |
| Actelion Registration Ltd | | | | |
| BSI Building | | | | |
| 13th Floor | | | | |
| 389 Chiswick High Road | | | | |
| London W4 4AL | | | | |
| United Kingdom | | | | |
| 28.10.2008 | Advagraf | Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19 |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19 | | | | |
| 2353 EW Leiderdorp | | | | |
| Nederland | | | | |
| 28.10.2008 | Agenerase | 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 | | | | |
| 28.10.2008 | Ketek | Aventis Pharma S.A. 20, avenue Raymond Aron F-92160 Antony Cedex | Aventis Pharma S.A. | 20, avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20, avenue Raymond Aron | | | | |
| F-92160 Antony Cedex | | | | |
| 28.10.2008 | Aranesp | Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland | Amgen Europe B.V. | Minervum 7061 4817 ZK Breda |
| Amgen Europe B.V. | | | | |
| Minervum 7061 4817 ZK Breda | | | | |
| Nederland | | | | |
| 29.10.2008 | 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 | | | | |
| 29.10.2008 | Mimpara | Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland | Amgen Europe B.V. | Minervum 7061 4817 ZK Breda |
| Amgen Europe B.V. | | | | |
| Minervum 7061 4817 ZK Breda | | | | |
| Nederland | | | | |
| 29.10.2008 | Binocrit | Sandoz GmbH Biochemiestrasse 10 A-Kundl 6250 | Sandoz GmbH | Biochemiestrasse 10 |
| Sandoz GmbH | | | | |
| Biochemiestrasse 10 | | | | |
| A-Kundl 6250 | | | | |
| 29.10.2008 | Betaferon | 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 | | | | |
| 29.10.2008 | Crixivan | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire EN11 9BU | | | | |
| United Kingdom | | | | |
| 29.10.2008 | 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 | | | | |
| 30.10.2008 | Rapamune | 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 | | | | |
| 30.10.2008 | Kaletra | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 30.10.2008 | Tysabri | Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland | Elan Pharma International Ltd | Monksland |
| Elan Pharma International Ltd | | | | |
| Monksland | | | | |
| Athlone | | | | |
| County Westmeath | | | | |
| Ireland | | | | |
| 30.10.2008 | Tygacil | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Ltd | Huntercombe Lane |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane | | | | |
| South Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 30.10.2008 | Eucreas | 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 | | | | |
| 30.10.2008 | PEGASYS | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City AL7 1TW | | | | |
| United Kingdom | | | | |
| 30.10.2008 | 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 | | | | |
| 30.10.2008 | Hycamtin | 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 | | | | |
| 30.10.2008 | Myozyme | 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 | | | | |
| 30.10.2008 | 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 | | | | |
| 31.10.2008 | Sebivo | 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 | | | | |
| 31.10.2008 | 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 | | | | |
| 31.10.2008 | 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 | | | | |
| 31.10.2008 | 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 | | | | |
| 31.10.2008 | 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 | | | | |
| 31.10.2008 | CELSENTRI | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 31.10.2008 | Xeloda | 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 | | | | |
| 31.10.2008 | Rebetol | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/1180 Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/1180 Brussel | | | | |
| 31.10.2008 | Galvus | 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 | | | | |
| 31.10.2008 | 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 | | | | |
| 31.10.2008 | Insulin human Winthrop | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main | | | | |
| 31.10.2008 | ViraferonPeg | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/1180 Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/1180 Brussel | | | | |
| 31.10.2008 | PegIntron | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/1180 Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/1180 Brussel | | | | |

—   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 |
| ---------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------- |
| 13.10.2008 | Viraferon | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/1180 Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/1180 Brussel | | | | |
| 29.10.2008 | Forcaltonin | Unigene UK Limited 191 Sparrows Herne Bushey Heath Hertfordshire WD23 1AJ United Kingdom | Unigene UK Limited | 191 Sparrows Herne |
| Unigene UK Limited | | | | |
| 191 Sparrows Herne | | | | |
| Bushey Heath | | | | |
| Hertfordshire WD23 1AJ | | | | |
| 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 |
| ----------------------- | ----------------------------- | ----------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- |
| 9.10.2008 | SevoFlo | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 13.10.2008 | Vaxxitek HVT + IBD | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 17.10.2008 | Previcox | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 20.10.2008 | Aivlosin | ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | ECO Animal Health Ltd | 78 Coombe Road |
| ECO Animal Health Ltd | | | | |
| 78 Coombe Road | | | | |
| New Malden | | | | |
| Surrey KT3 4QS | | | | |
| United Kingdom | | | | |
| 21.10.2008 | Convenia | 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 | | | | |

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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