# C_2006102EN.01000201.xml

| 28.4.2006 | EN | Official Journal of the European Union | C 102/2 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.3.2006 to 31.3.2006

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )

(2006/C 102/02)

—   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 |
| -------------------- | ----------------------------- | ----------------------------------------- | --------------------------------------------------------- | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------- |
| 29.3.2006 | Myozyme | alglucosidase alpha | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland | Genzyme Europe B.V. | Gooimeer 10 | 1411 DD Naarden | Nederland |
| Genzyme Europe B.V. | | | | | | | |
| Gooimeer 10 | | | | | | | |
| 1411 DD Naarden | | | | | | | |
| 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 |
| ------------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------- |
| 2.3.2006 | 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 | | | | |
| 8.3.2006 | Litak | Lipomed GmbH Schönaugasse 11 D-79713 Bad Säckingen | Lipomed GmbH | Schönaugasse 11 |
| Lipomed GmbH | | | | |
| Schönaugasse 11 | | | | |
| D-79713 Bad Säckingen | | | | |
| 9.3.2006 | Kentera | Nicobrand Limited 189 Casteroe Road Coleraine Northern Ireland BT51 3 RP | Nicobrand Limited | 189 Casteroe Road |
| Nicobrand Limited | | | | |
| 189 Casteroe Road | | | | |
| Coleraine | | | | |
| Northern Ireland BT51 3 RP | | | | |
| 13.3.2006 | 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 | | | | |
| 13.3.2006 | Enbrel | 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 | | | | |
| 15.3.2006 | Angiox | The Medicines Company UK Ltd Suite B Park House 11 Milton Park Abingdon Oxfordshire OX14 4RS United Kingdom | The Medicines Company UK Ltd | Suite B |
| The Medicines Company UK Ltd | | | | |
| Suite B | | | | |
| Park House | | | | |
| 11 Milton Park | | | | |
| Abingdon | | | | |
| Oxfordshire OX14 4RS | | | | |
| United Kingdom | | | | |
| 20.3.2006 | 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 | | | | |
| 20.3.2006 | Karvezide | 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 | | | | |
| 20.3.2006 | Glivec | 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 | | | | |
| 20.3.2006 | 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 | | | | |
| 20.3.2006 | Prialt | Elan Pharma International Ltd WIL House Shannon Business Park Shannon County Clare Ireland | Elan Pharma International Ltd | WIL House |
| Elan Pharma International Ltd | | | | |
| WIL House | | | | |
| Shannon Business Park | | | | |
| Shannon | | | | |
| County Clare | | | | |
| Ireland | | | | |
| 20.3.2006 | Lyrica | 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 | | | | |
| 20.3.2006 | 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 | | | | |
| 21.3.2006 | NutropinAq | IPSEN Limited 190 Bath Road Slough Berkshire SLI 3XE United Kingdom | IPSEN Limited | 190 Bath Road |
| IPSEN Limited | | | | |
| 190 Bath Road | | | | |
| Slough | | | | |
| Berkshire | | | | |
| SLI 3XE | | | | |
| United Kingdom | | | | |
| 21.3.2006 | Exubera | PFIZER Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom Aventis/Pfizer EEIG Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | PFIZER Ltd | Ramsgate Road |
| PFIZER Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT 13 9NJ | | | | |
| United Kingdom | | | | |
| Aventis/Pfizer EEIG | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 22.3.2006 | Kinzalmono | Bayer HealthCare AG D-51368 Leverkusen Bayer AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 22.3.2006 | NeoSpect | CIS bio international Route Nationale 306 Saclay Boite Postale 32 F-91192 Gifsur-Yvette Amersham Health AS Nycoveien 1-2 P.O. Box 4220 Nydalen N-0401 Oslo | CIS bio international | Route Nationale 306 |
| CIS bio international | | | | |
| Route Nationale 306 | | | | |
| Saclay | | | | |
| Boite Postale 32 | | | | |
| F-91192 Gifsur-Yvette | | | | |
| Amersham Health AS | | | | |
| Nycoveien 1-2 | | | | |
| P.O. Box 4220 Nydalen | | | | |
| N-0401 Oslo | | | | |
| 22.3.2006 | Tarceva | 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 | | | | |
| 22.3.2006 | Kinzalkomb | Bayer HealthCare AG D-51368 Leverkusen Bayer AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 22.3.2006 | Pritor | Bayer HealthCare AG D-51368 Leverkusen Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 22.3.2006 | PritorPlus | Bayer HealthCare AG D-51368 Leverkusen Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| Glaxo Group Ltd | | | | |
| Greenford Road | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 22.3.2006 | Levviax | Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 Antony | Aventis Pharma S.A. | 20, Avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20, Avenue Raymond Aron | | | | |
| F-92160 Antony | | | | |
| 22.3.2006 | Ketek | Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 Antony | Aventis Pharma S.A. | 20, Avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20, Avenue Raymond Aron | | | | |
| F-92160 Antony | | | | |
| 22.3.2006 | Avonex | Biogen Idec Ltd 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kingdom | Biogen Idec Ltd | 5 Roxborough Way |
| Biogen Idec Ltd | | | | |
| 5 Roxborough Way | | | | |
| Foundation Park | | | | |
| Maidenhead | | | | |
| Berkshire | | | | |
| SL6 3UD | | | | |
| United Kingdom | | | | |
| 23.3.2006 | Cancidas | 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 | | | | |
| 29.3.2006 | Actos | Takeda Europe R&D Centre Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom | Takeda Europe R&D Centre Ltd | Arundel Great Court |
| Takeda Europe R&D Centre Ltd | | | | |
| Arundel Great Court | | | | |
| 2 Arundel Street | | | | |
| London WC2R 3DA | | | | |
| United Kingdom | | | | |
| 29.3.2006 | IntronA | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 29.3.2006 | 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 | | | | |
| 29.3.2006 | 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 | | | | |
| 29.3.2006 | Viraferon | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 29.3.2006 | Glustin | Takeda Europe R&D Centre Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom | Takeda Europe R&D Centre Ltd | Arundel Great Court |
| Takeda Europe R&D Centre Ltd | | | | |
| Arundel Great Court | | | | |
| 2 Arundel Street | | | | |
| London WC2R 3DA | | | | |
| United Kingdom | | | | |
| 29.3.2006 | Ariclaim | 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 | | | | |
| 29.3.2006 | 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 | | | | |
| 29.3.2006 | Hepsera | 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 | | | | |
| 29.3.2006 | Erbitux | Merck KGaA Frankfurter Straße 250 D-64293 Darmstadt | Merck KGaA | Frankfurter Straße 250 |
| Merck KGaA | | | | |
| Frankfurter Straße 250 | | | | |
| D-64293 Darmstadt | | | | |
| 29.3.2006 | Keppra | UCB S.A. Allée de la recherche, 60/Researchdreef, 60 B-1070 Bruxelles/Brussel | UCB S.A. | Allée de la recherche, 60/Researchdreef, 60 |
| UCB S.A. | | | | |
| Allée de la recherche, 60/Researchdreef, 60 | | | | |
| B-1070 Bruxelles/Brussel | | | | |
| 29.3.2006 | Rebetol | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 29.3.2006 | Protopy | Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München | Astellas Pharma GmbH | Neumarkter Str. 61 |
| Astellas Pharma GmbH | | | | |
| Neumarkter Str. 61 | | | | |
| D-81673 München | | | | |
| 29.3.2006 | Protopic | Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München | Astellas Pharma GmbH | Neumarkter Str. 61 |
| Astellas Pharma GmbH | | | | |
| Neumarkter Str. 61 | | | | |
| D-81673 München | | | | |
| 29.3.2006 | 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 | | | | |
| 29.3.2006 | Bondenza | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way Shire Park |
| Roche Registration Limited | | | | |
| 6 Falcon Way Shire Park | | | | |
| Welwyn Garden City | | | | |
| Hertfordshire AL7 1TW | | | | |
| United Kingdom | | | | |
| 29.3.2006 | 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 | | | | |
| 29.3.2006 | 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 | | | | |
| 29.3.2006 | Prialt | Elan Pharma International Ltd WIL House Shannon Business Park Shannon County Clare Ireland | Elan Pharma International Ltd | WIL House |
| Elan Pharma International Ltd | | | | |
| WIL House | | | | |
| Shannon Business Park | | | | |
| Shannon | | | | |
| County Clare | | | | |
| Ireland | | | | |
| 29.3.2006 | 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 | | | | |
| 29.3.2006 | 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 | | | | |
| 29.3.2006 | Pedea | Orphan Europe Immeuble «Le Guillaumet» F-92046 Paris La Défense | Orphan Europe | Immeuble «Le Guillaumet» |
| Orphan Europe | | | | |
| Immeuble «Le Guillaumet» | | | | |
| F-92046 Paris La Défense | | | | |
| 29.3.2006 | Bonviva | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way Shire Park |
| Roche Registration Limited | | | | |
| 6 Falcon Way Shire Park | | | | |
| Welwyn Garden City | | | | |
| Hertfordshire AL7 1TW | | | | |
| United Kingdom | | | | |
| 29.3.2006 | 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 | | | | |
| 29.3.2006 | 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 | | | | |
| 29.3.2006 | Truvada | Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited | Granta Park |
| Gilead Sciences International Limited | | | | |
| Granta Park | | | | |
| Abington Cambridge CB1 6GT | | | | |
| 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 |
| ----------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------- |
| 15.3.2006 | Zubrin | Schering Plough Limited Schering Plough House Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom | Schering Plough Limited | Schering Plough House |
| Schering Plough Limited | | | | |
| Schering Plough House | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| Hertfordshire | | | | |
| AL7 1TW | | | | |
| United Kingdom | | | | |
| 21.3.2006 | Porcilis Pesti | 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 | | | | |
| 23.3.2006 | 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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