# C_2008132EN.01000401.xml

| 30.5.2008 | EN | Official Journal of the European Union | C 132/4 |
| --------- | -- | -------------------------------------- | ------- |

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2008 to 30 April 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 132/03)

—   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 |
| -------------------------------------- | ----------------------------- | ----------------------------------------- | ----------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------ | ------------------------------------------------ | -------------------- |
| 4.4.2008 | Effentora | Fentanyl citrate | Cephalon Europe 5, Rue Charles Martigny F-94700 Maisons Alfort | Cephalon Europe | 5, Rue Charles Martigny | F-94700 Maisons Alfort | EU/1/08/441/001-010 |
| Cephalon Europe | | | | | | | |
| 5, Rue Charles Martigny | | | | | | | |
| F-94700 Maisons Alfort | | | | | | | |
| 16.4.2008 | Thalidomide Pharmion | Thalidomide | 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 | | | | | | | |
| 21.4.2008 | Volibris | Ambrisentan | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford | Middlesex UB6 0NN | United Kingdom |
| Glaxo Group Ltd | | | | | | | |
| Greenford | | | | | | | |
| Middlesex UB6 0NN | | | | | | | |
| United Kingdom | | | | | | | |
| 21.4.2008 | Adenuric | Febuxostat | Ipsen Manufacturing Ireland Ltd (IMIL) Blanchardstown Industrial Park Snugboro Road Dublin 15 Ireland | Ipsen Manufacturing Ireland Ltd (IMIL) | Blanchardstown Industrial Park | Snugboro Road | Dublin 15 |
| Ipsen Manufacturing Ireland Ltd (IMIL) | | | | | | | |
| Blanchardstown Industrial Park | | | | | | | |
| Snugboro Road | | | | | | | |
| Dublin 15 | | | | | | | |
| Ireland | | | | | | | |
| 25.4.2008 | Mycamine | Micafungin | Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München | Astellas Pharma GmbH | Neumarkter Str. 61 | D-81673 München | EU/1/08/448/001-002 |
| Astellas Pharma GmbH | | | | | | | |
| Neumarkter Str. 61 | | | | | | | |
| D-81673 München | | | | | | | |
| 25.4.2008 | Privigen | Human normal immunoglobulin (IVIg) | CSL Behring GmbH Emil von Behring Straße 76 D-35041 Marburg | CSL Behring GmbH | Emil von Behring Straße 76 | D-35041 Marburg | EU/1/08/446/001-003 |
| CSL Behring GmbH | | | | | | | |
| Emil von Behring Straße 76 | | | | | | | |
| D-35041 Marburg | | | | | | | |

—   Issuing 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 |
| ---------------------- | ----------------------------- | ------------------------------------------------------------------------------------------ | --------------------------------------------- | ---------------------- |
| 14.4.2008 | Mylotarg | 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 | | | | |

—   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 |
| ---------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------- | ---------------------------------- |
| 1.4.2008 | PritorPlus | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 1.4.2008 | Kineret | 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 | | | | |
| 1.4.2008 | Hepsera | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT | | | | |
| United Kingdom | | | | |
| 2.4.2008 | 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 | | | | |
| 2.4.2008 | Zalasta | KRKA, d.d. Novo mesto Šmarješka cesta 6 SLO-8501 Novo mesto | KRKA, d.d. | Novo mesto |
| KRKA, d.d. | | | | |
| Novo mesto | | | | |
| Šmarješka cesta 6 | | | | |
| SLO-8501 Novo mesto | | | | |
| 2.4.2008 | Osigraft | Howmedica International S. de R.L. Division of Stryker Corporation Raheen Industrial Estate Raheen Limerick Ireland | Howmedica International S. de R.L. | Division of Stryker Corporation |
| Howmedica International S. de R.L. | | | | |
| Division of Stryker Corporation | | | | |
| Raheen Industrial Estate | | | | |
| Raheen | | | | |
| Limerick | | | | |
| Ireland | | | | |
| 4.4.2008 | Karvezide | 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 | | | | |
| 4.4.2008 | Pergoveris | 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 | | | | |
| 4.4.2008 | 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 | | | | |
| 4.4.2008 | Bondronat | 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 | | | | |
| 4.4.2008 | 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 | | | | |
| 4.4.2008 | 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 | | | | |
| 8.4.2008 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |
| 8.4.2008 | Alimta | Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5 |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 8.4.2008 | Inovelon | Eisai Limited 3, Shortlands London W6 8EE United Kingdom | Eisai Limited | 3, Shortlands |
| Eisai Limited | | | | |
| 3, Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 8.4.2008 | Rebetol | 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 | | | | |
| 10.4.2008 | 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 | | | | |
| 10.4.2008 | 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 | | | | |
| 14.4.2008 | Intrinsa | Procter & Gamble Pharmaceuticals UK Ltd Rusham Park Technical Centre Whitehall Lane Egham Surrey TW20 9NW United Kingdom | Procter & Gamble Pharmaceuticals UK Ltd | Rusham Park Technical Centre |
| Procter & Gamble Pharmaceuticals UK Ltd | | | | |
| Rusham Park Technical Centre | | | | |
| Whitehall Lane | | | | |
| Egham | | | | |
| Surrey TW20 9NW | | | | |
| United Kingdom | | | | |
| 14.4.2008 | Livensa | Procter & Gamble Pharmaceuticals — Germany GmbH Dr Otto-Röhm-Straße 2-4 D-64331 Weiterstadt | Procter & Gamble Pharmaceuticals — Germany GmbH | Dr Otto-Röhm-Straße 2-4 |
| Procter & Gamble Pharmaceuticals — Germany GmbH | | | | |
| Dr Otto-Röhm-Straße 2-4 | | | | |
| D-64331 Weiterstadt | | | | |
| 14.4.2008 | 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 | | | | |
| 14.4.2008 | 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 | | | | |
| 14.4.2008 | Revasc | Canyon Pharmaceuticals Ltd 20-22 Bedford Row London WC1R 4JS United Kingdom | Canyon Pharmaceuticals Ltd | 20-22 Bedford Row |
| Canyon Pharmaceuticals Ltd | | | | |
| 20-22 Bedford Row | | | | |
| London WC1R 4JS | | | | |
| United Kingdom | | | | |
| 14.4.2008 | 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 | | | | |
| 16.4.2008 | Iscover | 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 | | | | |
| 17.4.2008 | 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 | | | | |
| 17.4.2008 | REYATAZ | 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 | | | | |
| 18.4.2008 | 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 | | | | |
| 18.4.2008 | Zevalin | Bayer Schering Pharma AG D-13342 Berlin | Bayer Schering Pharma AG | D-13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| D-13342 Berlin | | | | |
| 18.4.2008 | Nexavar | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 18.4.2008 | Levemir | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 18.4.2008 | Insulatard | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 18.4.2008 | Neupopeg | 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 | | | | |
| 18.4.2008 | 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 | | | | |
| 18.4.2008 | 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 | | | | |
| 21.4.2008 | Stalevo | Orion Corporation Orionintie 1 FI-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FI-02200 Espoo | | | | |
| 21.4.2008 | Neulasta | 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 | | | | |
| 21.4.2008 | 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 | | | | |
| 21.4.2008 | 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 | | | | |
| 21.4.2008 | Rapamune | 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 | | | | |
| 21.4.2008 | REYATAZ | 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 | | | | |
| 21.4.2008 | 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 | | | | |
| 21.4.2008 | Hepsera | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT | | | | |
| United Kingdom | | | | |
| 21.4.2008 | 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 | | | | |
| 22.4.2008 | Invega | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 22.4.2008 | Wilzin | Orphan Europe S.àr.l. Gaulle F-92800 Puteaux | Orphan Europe S.àr.l. | Gaulle |
| Orphan Europe S.àr.l. | | | | |
| Gaulle | | | | |
| F-92800 Puteaux | | | | |
| 22.4.2008 | IntronA | 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 | | | | |
| 22.4.2008 | Viraferon | 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 | | | | |
| 22.4.2008 | Rilutek | Aventis Pharma S.A. 20, avenue Raymond Aron F-92165 Antony Cedex | Aventis Pharma S.A. | 20, avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20, avenue Raymond Aron | | | | |
| F-92165 Antony Cedex | | | | |
| 22.4.2008 | Intrinsa | Procter & Gamble Pharmaceuticals UK Ltd Rusham Park Technical Centre Whitehall Lane Egham Surrey TW20 9NW United Kingdom | Procter & Gamble Pharmaceuticals UK Ltd | Rusham Park Technical Centre |
| Procter & Gamble Pharmaceuticals UK Ltd | | | | |
| Rusham Park Technical Centre | | | | |
| Whitehall Lane | | | | |
| Egham Surrey TW20 9NW | | | | |
| United Kingdom | | | | |
| 22.4.2008 | 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 | | | | |
| 22.4.2008 | 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 | | | | |
| 22.4.2008 | 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 | | | | |
| 23.4.2008 | Viread | 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 | | | | |
| 23.4.2008 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |
| 23.4.2008 | Emselex | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road | | | | |
| Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| United Kingdom | | | | |
| 23.4.2008 | MIRCERA | 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 | | | | |
| 23.4.2008 | 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 | | | | |
| 23.4.2008 | 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 | | | | |
| 23.4.2008 | Visudyne | 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 | | | | |
| 23.4.2008 | Ferriprox | Apotex Europe B.V. Darwingweg 20 2333 CR Leiden Nederland | Apotex Europe B.V. | Darwingweg 20 |
| Apotex Europe B.V. | | | | |
| Darwingweg 20 | | | | |
| 2333 CR Leiden | | | | |
| Nederland | | | | |
| 23.4.2008 | 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 | | | | |
| 23.4.2008 | 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 | | | | |
| 25.4.2008 | Cystagon | Orphan Europe S.à.rl. Immeuble Le Wilson 70, Avenue du Général de Gaulle F-92800 Puteaux | Orphan Europe S.à.rl. | Immeuble Le Wilson |
| Orphan Europe S.à.rl. | | | | |
| Immeuble Le Wilson | | | | |
| 70, Avenue du Général de Gaulle | | | | |
| F-92800 Puteaux | | | | |
| 25.4.2008 | NovoSeven | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 25.4.2008 | TESAVEL | 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 | | | | |
| 25.4.2008 | Tysabri | Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland | Elan Pharma International Ltd | Monksland |
| Elan Pharma International Ltd | | | | |
| Monksland | | | | |
| Athlone | | | | |
| County Westmeath | | | | |
| Ireland | | | | |
| 25.4.2008 | Protaphane | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 25.4.2008 | Livensa | Procter & Gamble Pharmaceuticals — Germany GmbH Dr Otto-Röhm-Straße 2-4 D-64331 Weiterstadt | Procter & Gamble Pharmaceuticals — Germany GmbH | Dr Otto-Röhm-Straße 2-4 |
| Procter & Gamble Pharmaceuticals — Germany GmbH | | | | |
| Dr Otto-Röhm-Straße 2-4 | | | | |
| D-64331 Weiterstadt | | | | |

—   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 |
| ---------------------------- | ----------------------------- | --------------------------------------------------------------- | --------------------------------------------- | ------------------------- |
| 10.4.2008 | Previcox | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 10.4.2008 | Clomicalm | Novartis Tiergesundheit GmbH Zielstattstraße 40 D-81379 München | Novartis Tiergesundheit GmbH | Zielstattstraße 40 |
| Novartis Tiergesundheit GmbH | | | | |
| Zielstattstraße 40 | | | | |
| D-81379 München | | | | |
| 16.4.2008 | Rabigen SAG2 | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. F-06516 Carros | VIRBAC S.A. | 1ère Avenue 2065 m L.I.D. |
| VIRBAC S.A. | | | | |
| 1ère Avenue 2065 m L.I.D. | | | | |
| F-06516 Carros | | | | |
| 17.4.2008 | Virbagen Omega | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. F-06516 Carros | VIRBAC S.A. | 1ère Avenue 2065 m L.I.D. |
| VIRBAC S.A. | | | | |
| 1ère Avenue 2065 m L.I.D. | | | | |
| F-06516 Carros | | | | |
| 25.4.2008 | ProteqFlu Te | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 25.4.2008 | ProteqFlu | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |

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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