# C_2008164EN.01000601.xml

| 27.6.2008 | EN | Official Journal of the European Union | C 164/6 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2008 to 31 May 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 164/08)

—   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 |
| -------------------------------- | ----------------------------- | --------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------- | ------------------------------------------------ | -------------------- |
| 14.5.2008 | Prepandrix | Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14 | GlaxoSmithKline Biologicals s.a. rue de l'Institut, 89 B-1330 Rixensart | GlaxoSmithKline Biologicals s.a. | rue de l'Institut, 89 | B-1330 Rixensart | EU/1/08/453/001 |
| GlaxoSmithKline Biologicals s.a. | | | | | | | |
| rue de l'Institut, 89 | | | | | | | |
| B-1330 Rixensart | | | | | | | |
| 20.5.2008 | Pandemrix | Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14 | GlaxoSmithKline Biologicals s.a. rue de l'Institut, 89 B-1330 Rixensart | GlaxoSmithKline Biologicals s.a. | rue de l'Institut, 89 | B-1330 Rixensart | EU/1/08/452/001 |
| GlaxoSmithKline Biologicals s.a. | | | | | | | |
| rue de l'Institut, 89 | | | | | | | |
| B-1330 Rixensart | | | | | | | |
| 20.5.2008 | Extavia | Interferon beta-1b | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road | Horsham | West Sussex RH12 5AB |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road | | | | | | | |
| Horsham | | | | | | | |
| West Sussex RH12 5AB | | | | | | | |
| United Kingdom | | | | | | | |

—   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 |
| ------------------------- | ----------------------------- | ------------------------------------------------------------------------------------ | --------------------------------------------- | ------------------------- |
| 21.5.2008 | CIMZIA | UCB S.A. Allée de la Recherche, 60 B-1070 Bruxelles Researchdreef, 60 B-1070 Brussel | UCB S.A. | Allée de la Recherche, 60 |
| UCB S.A. | | | | |
| Allée de la Recherche, 60 | | | | |
| B-1070 Bruxelles | | | | |
| Researchdreef, 60 | | | | |
| B-1070 Brussel | | | | |
| 22.5.2008 | Rhucin | Pharming Group N.V. Darwinweg 24 2333 CR Leiden Nederland | Pharming Group N.V. | Darwinweg 24 |
| Pharming Group N.V. | | | | |
| Darwinweg 24 | | | | |
| 2333 CR Leiden | | | | |
| Nederland | | | | |

—   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 |
| ------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------- |
| 8.5.2008 | 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 | | | | |
| 8.5.2008 | 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 | | | | |
| 8.5.2008 | Axura | Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 D-60318 Frankfurt/Main | Merz Pharmaceuticals GmbH | Eckenheimer Landstr. 100-104 |
| Merz Pharmaceuticals GmbH | | | | |
| Eckenheimer Landstr. 100-104 | | | | |
| D-60318 Frankfurt/Main | | | | |
| 8.5.2008 | Axura | Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 D-60318 Frankfurt/Main | Merz Pharmaceuticals GmbH | Eckenheimer Landstr. 100-104 |
| Merz Pharmaceuticals GmbH | | | | |
| Eckenheimer Landstr. 100-104 | | | | |
| D-60318 Frankfurt/Main | | | | |
| 21.5.2008 | Prometax | 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 | | | | |
| 21.5.2008 | Xagrid | 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 | | | | |
| 21.5.2008 | Foscan | Biolitec pharma Ltd United Drug House Magna Drive Dublin 24 Ireland | Biolitec pharma Ltd | United Drug House |
| Biolitec pharma Ltd | | | | |
| United Drug House | | | | |
| Magna Drive | | | | |
| Dublin 24 | | | | |
| Ireland | | | | |
| 22.5.2008 | Zevalin | Bayer Schering Pharma AG D-13342 Berlin | Bayer Schering Pharma AG | D-13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| D-13342 Berlin | | | | |
| 22.5.2008 | Advate | Baxter AG Industriesstraße 67 A-1220 Vienna | Baxter AG | Industriesstraße 67 |
| Baxter AG | | | | |
| Industriesstraße 67 | | | | |
| A-1220 Vienna | | | | |
| 20.5.2008 | 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 | | | | |
| 20.5.2008 | Carbaglu | Orphan Europe Immeuble Le Wilson 70, Avenue du Général de Gaulle F-92800 Puteaux | Orphan Europe | Immeuble Le Wilson |
| Orphan Europe | | | | |
| Immeuble Le Wilson | | | | |
| 70, Avenue du Général de Gaulle | | | | |
| F-92800 Puteaux | | | | |
| 20.5.2008 | Exelon | 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 | | | | |
| 20.5.2008 | Refludan | Pharmion Limited Riverside House Riverside Walk Windsor SL4 1NA United Kingdom | Pharmion Limited | Riverside House |
| Pharmion Limited | | | | |
| Riverside House | | | | |
| Riverside Walk | | | | |
| Windsor SL4 1NA | | | | |
| United Kingdom | | | | |
| 20.5.2008 | Cystadane | Orphan Europe S.a.r.l. Immeuble Le Wilson 70, Avenue du Général de Gaulle F-92800 Puteaux | Orphan Europe S.a.r.l. | Immeuble Le Wilson |
| Orphan Europe S.a.r.l. | | | | |
| Immeuble Le Wilson | | | | |
| 70, Avenue du Général de Gaulle | | | | |
| F-92800 Puteaux | | | | |
| 20.5.2008 | Zavesca | 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 | | | | |
| 20.5.2008 | 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 | | | | |
| 20.5.2008 | Aldurazyme | 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 | | | | |
| 20.5.2008 | 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 | | | | |
| 20.5.2008 | Rebif | Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom | Serono Europe Limited | 56, Marsh Wall |
| Serono Europe Limited | | | | |
| 56, Marsh Wall | | | | |
| London E14 9TP | | | | |
| United Kingdom | | | | |

—   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 |
| ----------------------------------- | ----------------------------- | ---------------------------------------------------------------------------- | --------------------------------------------- | -------------------------- |
| 21.5.2008 | Nobilis IB 4-91 | 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 | | | | |
| 21.5.2008 | METACAM | Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein | Boehringer Ingelheim Vetmedica GmbH | D-55216 Ingelheim am Rhein |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| D-55216 Ingelheim am Rhein | | | | |

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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