# C_2008188EN.01000601.xml

| 25.7.2008 | EN | Official Journal of the European Union | C 188/6 |
| --------- | -- | -------------------------------------- | ------- |

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2008 to 30 June 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 188/04)

—   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 |
| -------------------- | ----------------------------- | ----------------------------------------- | ------------------------------------------------------------------------------ | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------- |
| 10.6.2008 | Tyverb | Lapatinib | 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 | | | | | | | |

—   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 |
| ------------------------------------------------------------------------ | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------ | ------------------------------------------ |
| 2.6.2008 | Xyrem | UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE United Kingdom | UCB Pharma Ltd | 208 Bath Road |
| UCB Pharma Ltd | | | | |
| 208 Bath Road | | | | |
| Slough | | | | |
| Berkshire SL1 3WE | | | | |
| United Kingdom | | | | |
| 2.6.2008 | Dafiro | 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 | | | | |
| 2.6.2008 | Copalia | 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 | | | | |
| 3.6.2008 | Exforge | 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 | | | | |
| 3.6.2008 | Imprida | 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 | | | | |
| 4.6.2008 | 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 | | | | |
| Genzyme Europe BV Gooimeer 10 1411 DD Naarden Nederland | Genzyme Europe BV | Gooimeer 10 | 1411 DD Naarden | Nederland |
| Genzyme Europe BV | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| Nederland | | | | |
| 6.6.2008 | Vaniqa | Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom | Shire Pharmaceutical Contracts Ltd | Hampshire International Business Park |
| Shire Pharmaceutical Contracts Ltd | | | | |
| Hampshire International Business Park | | | | |
| Chineham | | | | |
| Basingstoke | | | | |
| Hampshire RG24 8EP | | | | |
| United Kingdom | | | | |
| Laboratorios Almirall S.A. Ronda General Mitre, no 151 E-08022 Barcelona | Laboratorios Almirall S.A. | Ronda General Mitre, no 151 | E-08022 Barcelona | 11.6.2008 |
| Laboratorios Almirall S.A. | | | | |
| Ronda General Mitre, no 151 | | | | |
| E-08022 Barcelona | | | | |
| 10.6.2008 | Olanzapine Neopharma | Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF United Kingdom | Neopharma Limited | 57 High Street |
| Neopharma Limited | | | | |
| 57 High Street | | | | |
| Odiham | | | | |
| Hampshire RG29 1LF | | | | |
| United Kingdom | | | | |
| 10.6.2008 | Imprida | 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 | | | | |
| 10.6.2008 | Irbesartan BMS | 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 | | | | |
| 10.6.2008 | Exforge | 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 | | | | |
| 10.6.2008 | Copalia | 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 | | | | |
| 10.6.2008 | 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 | | | | |
| 10.6.2008 | Olanzapine 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 | | | | |
| 10.6.2008 | Karvea | 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 | | | | |
| 10.6.2008 | 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 | | | | |
| 10.6.2008 | 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 | | | | |
| 10.6.2008 | Irbesartan HCT BMS | 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 | | | | |
| 10.6.2008 | Irbesartan HCT Winthrop | 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 | | | | |
| 10.6.2008 | Dafiro | 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 | | | | |
| 11.6.2008 | Irbesartan Winthrop | 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 | | | | |
| 12.6.2008 | Optison | GE Healthcare AS Nycoveien 1-2 P.O.Box 4220 Nydalen N-0401 Oslo | GE Healthcare AS | Nycoveien 1-2 |
| GE Healthcare AS | | | | |
| Nycoveien 1-2 | | | | |
| P.O.Box 4220 Nydalen | | | | |
| N-0401 Oslo | | | | |
| 17.6.2008 | Xenical | 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 | | | | |
| 18.6.2008 | Insuman - | 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 | | | | |
| 18.6.2008 | 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 | | | | |
| 18.6.2008 | 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 | | | | |
| 18.6.2008 | Norvir | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 18.6.2008 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |
| 18.6.2008 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited Unit 13 Stillorgan Industrial Park Blackrock Co. Dublin Ireland | Bristol-Myers Squibb and Gilead Sciences Limited | Unit 13 |
| Bristol-Myers Squibb and Gilead Sciences Limited | | | | |
| Unit 13 | | | | |
| Stillorgan Industrial Park | | | | |
| Blackrock Co. | | | | |
| Dublin | | | | |
| Ireland | | | | |
| 18.6.2008 | 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 | | | | |
| 18.6.2008 | 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 | | | | |
| 18.6.2008 | 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 | | | | |
| 18.6.2008 | Renagel | 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 | | | | |
| 19.6.2008 | Twinrix Paediatric | 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 | | | | |
| 19.6.2008 | 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 | | | | |
| 19.6.2008 | 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 | | | | |
| 19.6.2008 | Plavix | 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 | | | | |
| 19.6.2008 | Iscover | 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 | | | | |
| 19.6.2008 | InductOs | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Ltd | Huntercombe Lane South |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 19.6.2008 | Paxene | Norton Healthcare Limited Albert Basin Royal Docks London E16 2QJ United Kingdom | Norton Healthcare Limited | Albert Basin |
| Norton Healthcare Limited | | | | |
| Albert Basin | | | | |
| Royal Docks | | | | |
| London E16 2QJ | | | | |
| United Kingdom | | | | |
| 19.6.2008 | 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 | | | | |
| 19.6.2008 | Twinrix Adult | 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 | | | | |
| 20.6.2008 | 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 | | | | |
| 20.6.2008 | 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 | | | | |
| 20.6.2008 | Azopt | 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 | | | | |
| 20.6.2008 | Tysabri | Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland | Elan Pharma International Ltd | Monksland |
| Elan Pharma International Ltd | | | | |
| Monksland | | | | |
| Athlone | | | | |
| County Westmeath | | | | |
| Ireland | | | | |
| 20.6.2008 | 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 | | | | |
| 20.6.2008 | Evra | Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| B-2340 Beerse | | | | |
| 20.6.2008 | 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 | | | | |
| 20.6.2008 | Apidra | Sanofi-Aventis Deutschland GmbH Brueningstrasse, 50 D-65926 Frankfurt am Main | Sanofi-Aventis Deutschland GmbH | Brueningstrasse, 50 |
| Sanofi-Aventis Deutschland GmbH | | | | |
| Brueningstrasse, 50 | | | | |
| D-65926 Frankfurt am Main | | | | |
| 20.6.2008 | 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 | | | | |
| 20.6.2008 | ProQuad | 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 | | | | |
| 20.6.2008 | 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 | | | | |
| 20.6.2008 | M-M-RVAXPRO | 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 | | | | |
| 20.6.2008 | Puregon | Organon N.V. Kloosterstraat 6 Postbus 20 5340 BH Oss Nederland | Organon N.V. | Kloosterstraat 6 |
| Organon N.V. | | | | |
| Kloosterstraat 6 | | | | |
| Postbus 20 | | | | |
| 5340 BH Oss | | | | |
| Nederland | | | | |
| 20.6.2008 | Kaletra | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 20.6.2008 | Vistide | Pfizer Enterprises SARL 51, Avenue Kennedy-Rond Point du Kirchberg L-1855 Luxembourg | Pfizer Enterprises SARL | 51, Avenue Kennedy-Rond Point du Kirchberg |
| Pfizer Enterprises SARL | | | | |
| 51, Avenue Kennedy-Rond Point du Kirchberg | | | | |
| L-1855 Luxembourg | | | | |
| 20.6.2008 | 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 | | | | |
| 20.6.2008 | Prevenar | Wyeth-Lederle Vaccines S.A. Rue du Bosquet 15 B-1348 Louvain-La-Neuve | Wyeth-Lederle Vaccines S.A. | Rue du Bosquet 15 |
| Wyeth-Lederle Vaccines S.A. | | | | |
| Rue du Bosquet 15 | | | | |
| B-1348 Louvain-La-Neuve | | | | |
| 20.6.2008 | Rapilysin | 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 | | | | |
| Actavis Group PTC ehf. Reykjavikurvegi 76-78 IS-220 Hafnarfjordur | Actavis Group PTC ehf. | Reykjavikurvegi 76-78 | IS-220 Hafnarfjordur | 24.6.2008 |
| Actavis Group PTC ehf. | | | | |
| Reykjavikurvegi 76-78 | | | | |
| IS-220 Hafnarfjordur | | | | |
| 20.6.2008 | Avonex | Biogen Idec Ltd 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kindgom | Biogen Idec Ltd | 5 Roxborough Way |
| Biogen Idec Ltd | | | | |
| 5 Roxborough Way | | | | |
| Foundation Park | | | | |
| Maidenhead | | | | |
| Berkshire SL6 3UD | | | | |
| United Kindgom | | | | |
| 20.6.2008 | Vfend | 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 | | | | |
| 20.6.2008 | 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 | | | | |
| 23.6.2008 | Humira | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 25.6.2008 | Optisulin | 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 | | | | |
| 25.6.2008 | 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 | | | | |
| 25.6.2008 | Lantus | 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 | | | | |
| 25.6.2008 | Temodal | 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 | | | | |
| 25.6.2008 | Elaprase | Shire Human Genetic Therapies AB Rinkebyvägen 11B S-182 36 Danderyd | Shire Human Genetic Therapies AB | Rinkebyvägen 11B |
| Shire Human Genetic Therapies AB | | | | |
| Rinkebyvägen 11B | | | | |
| S-182 36 Danderyd | | | | |
| 27.6.2008 | 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 | | | | |
| 30.6.2008 | 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 | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Rejected

| 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 |
| ---------------------- | ----------------------------- | ------------------------------------------------------------------------------------------ | --------------------------------------------- | ---------------------- |
| 25.6.2008 | Tygacil | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Ltd | Huntercombe Lane South |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004) (applicable with effect from 1 January 2009)

| 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 |
| -------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 10.6.2008 | Zenapax | 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 | | | | |

—   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 |
| ----------------------- | ----------------------------- | ---------------------------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- | ------------------------------------------------ | --------------------- |
| 23.6.2008 | Posatex | Orbifloxacin, Mometasone furoate, Posaconazole | S-P Veterinary Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom | S-P Veterinary | Shire Park | Welwyn Garden City | Hertfordshire AL7 1TW |
| S-P Veterinary | | | | | | | |
| Shire Park | | | | | | | |
| Welwyn Garden City | | | | | | | |
| Hertfordshire AL7 1TW | | | | | | | |
| United Kingdom | | | | | | | |
| 25.6.2008 | EQUIOXX | Firocoxib | MERIAL 29, avenue Tony Garnier F-69007 Lyon | MERIAL | 29, avenue Tony Garnier | F-69007 Lyon | EU/2/08/083/001 |
| 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 |
| --------------------------- | ----------------------------- | ----------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 3.6.2008 | 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 | | | | |
| 4.6.2008 | 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 | | | | |
| 13.6.2008 | Gonazon | 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 | | | | |
| 20.6.2008 | DRAXXIN | 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 | | | | |
| 23.6.2008 | Nobilis Influenza H7N1 | 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 | | | | |

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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