# C_2004194EN.01000201.xml

| 30.7.2004 | EN | Official Journal of the European Union | C 194/2 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 June 2004 to 15 July 2004

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93( 1 )

(2004/C 194/02)

—   Issuing of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93): accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| ---------------------- | ----------------------------- | ------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 29.6.2004 | Erbitux | Merck KgaA Frankfurter Straße 250 D-64293 Darmstadt | Merck KgaA | Frankfurter Straße 250 |
| Merck KgaA | | | | |
| Frankfurter Straße 250 | | | | |
| D-64293 Darmstadt | | | | |
| 6.7.2004 | Lyrica | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 12.7.2004 | 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 | | | | |

—   Modification of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93): accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------- |
| 17.6.2004 | GONAL-f | 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 | | | | |
| 17.6.2004 | Beromun | 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 | | | | |
| 17.6.2004 | Tractocile | Ferring AB Soldattorpsvägen 5 Box 30047 S-200 61 Limhamn | Ferring AB | Soldattorpsvägen 5 |
| Ferring AB | | | | |
| Soldattorpsvägen 5 | | | | |
| Box 30047 | | | | |
| S-200 61 Limhamn | | | | |
| 17.6.2004 | Tritanrix HepB | GlaxoSmithKline Biologicals sa Rue de l'Institut 89 B-1330 Rixensart | GlaxoSmithKline Biologicals sa | Rue de l'Institut 89 |
| GlaxoSmithKline Biologicals sa | | | | |
| Rue de l'Institut 89 | | | | |
| B-1330 Rixensart | | | | |
| 23.6.2004 | Emtriva | Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB1 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 23.6.2004 | Kogenate Bayer | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 24.6.2004 | Helixate NexGen | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 6.7.2004 | Ammonaps | Orphan Europe, Immeuble ‘Le Guillaumet’ F-92046 Paris-La Défense | Orphan Europe, Immeuble ‘Le Guillaumet’ | F-92046 Paris-La Défense |
| Orphan Europe, Immeuble ‘Le Guillaumet’ | | | | |
| F-92046 Paris-La Défense | | | | |
| 6.7.2004 | Cialis | Lilly ICOS Limited 25 New Street Square London EC4A 3LN United Kingdom | Lilly ICOS Limited | 25 New Street Square |
| Lilly ICOS Limited | | | | |
| 25 New Street Square | | | | |
| London EC4A 3LN | | | | |
| United Kingdom | | | | |
| 7.7.2004 | Novomix 30 | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 12.7.2004 | Betaferon | Schering AG Pharma D-13342 Berlin | Schering AG Pharma | D-13342 Berlin |
| Schering AG Pharma | | | | |
| D-13342 Berlin | | | | |
| 13.7.2004 | Aldurazyme | Genzyme Europe BV Gooimeer 10 1411 DD Naarden Nederland | Genzyme Europe BV | Gooimeer 10 |
| Genzyme Europe BV | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| Nederland | | | | |
| 13.7.2004 | Viramune | 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 | | | | |
| 13.7.2004 | Avandamet | 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 | | | | |
| 13.7.2004 | 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 | | | | |
| 13.7.2004 | Optisulin | Aventis Pharma Deutschland GmbH D-65926 Frankfurt am Main | Aventis Pharma Deutschland GmbH | D-65926 Frankfurt am Main |
| Aventis Pharma Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main | | | | |
| 13.7.2004 | Aldara | 3M Santé Boulevard de l'Oise F-95029 Cergy Pontoise Cedex | 3M Santé | Boulevard de l'Oise |
| 3M Santé | | | | |
| Boulevard de l'Oise | | | | |
| F-95029 Cergy Pontoise Cedex | | | | |
| 13.7.2004 | Sustiva | Bristol-Myers Squibb Pharma EEIG 141-149 Staines Road Hounslow TW3 3JA United Kingdom | Bristol-Myers Squibb Pharma EEIG | 141-149 Staines Road |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| 141-149 Staines Road | | | | |
| Hounslow TW3 3JA | | | | |
| United Kingdom | | | | |
| 13.7.2004 | Lantus | Aventis Pharma Deutschland GmbH D-65926 Frankfurt am Main | Aventis Pharma Deutschland GmbH | D-65926 Frankfurt am Main |
| Aventis Pharma Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main | | | | |
| 13.7.2004 | 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 | | | | |
| 13.7.2004 | Keppra | UCB SA Allée de la recherche 60 B-1070 Bruxelles / Researchdreef, 60 B-1070 Brussel | UCB SA | Allée de la recherche 60 |
| UCB SA | | | | |
| Allée de la recherche 60 | | | | |
| B-1070 Bruxelles / Researchdreef, 60 | | | | |
| B-1070 Brussel | | | | |
| 13.7.2004 | Zyprexa | Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland BV | Grootslag 1-5 |
| Eli Lilly Nederland BV | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 13.7.2004 | 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 | | | | |
| 13.7.2004 | Zyprexa Velotab | Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland BV | Grootslag 1-5 |
| Eli Lilly Nederland BV | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |

—   Withdrawal of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --------------------- | ----------------------------- | ----------------------------------------------- | --------------------------------------------- | --------------------- |
| 13.7.2004 | Taluvian | Abbott SpA Campoverde di Aprilia I-04010 Latina | Abbott SpA | Campoverde di Aprilia |
| Abbott SpA | | | | |
| Campoverde di Aprilia | | | | |
| I-04010 Latina | | | | |

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( 1 )  OJ L 214, 24.8.1993, p. 1.

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