# C_2004115EN.01002001.xml

| 30.4.2004 | EN | Official Journal of the European Union | C 115/20 |
| --------- | -- | -------------------------------------- | -------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 March 2004 to 15 April 2004

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

(2004/C 115/10)

—   Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93): 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 |
| ----------------------------- | ----------------------------- | ---------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 25.3.2004 | PhotoBarr | Axcan Pharma International BV Engelenkampstraat 72 6131 JJ Sittard Nederland | Axcan Pharma International BV | Engelenkampstraat 72 |
| Axcan Pharma International BV | | | | |
| Engelenkampstraat 72 | | | | |
| 6131 JJ Sittard | | | | |
| Nederland | | | | |
| 14.4.2004 | Litak | Lipomed GmbH Schönaugasse 11 D-79713 Bad Säckingen | Lipomed GmbH | Schönaugasse 11 |
| Lipomed GmbH | | | | |
| Schönaugasse 11 | | | | |
| D-79713 Bad Säckingen | | | | |

—   Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93): 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 |
| -------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------- |
| 16.3.2004 | ViraferonPeg | Schering Plough Europe
Rue de Stalle, 73
1180 Bruxelles | EU/1/00/132/031-050 | 18.3.2004 |
| 16.3.2004 | PegIntron | Schering Plough Europe Rue de Stalle, 73 1180 Bruxelles | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| 1180 Bruxelles | | | | |
| 19.3.2004 | Mabthera | Roche Registration Limited 40 Broadwater Road Welwyn Garden City Hertfordshire AL7 3AY United Kingdom | Roche Registration Limited | 40 Broadwater Road |
| Roche Registration Limited | | | | |
| 40 Broadwater Road | | | | |
| Welwyn Garden City | | | | |
| Hertfordshire AL7 3AY | | | | |
| United Kingdom | | | | |
| 19.3.2004 | 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 | | | | |
| 25.3.2004 | Norvir | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 25.3.2004 | Xeloda | Roche Registration Limited 40 Broadwater Road Welwyn Garden City Hertfordshire AL7 3AY United Kingdom | Roche Registration Limited | 40 Broadwater Road |
| Roche Registration Limited | | | | |
| 40 Broadwater Road | | | | |
| Welwyn Garden City | | | | |
| Hertfordshire AL7 3AY | | | | |
| United Kingdom | | | | |
| 25.3.2004 | Synagis | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 25.3.2004 | Infergen | Yamanouchi Europe B.V. Elisabethhof 19 2353 EW Leiderdorp Nederland | Yamanouchi Europe B.V. | Elisabethhof 19 |
| Yamanouchi Europe B.V. | | | | |
| Elisabethhof 19 | | | | |
| 2353 EW Leiderdorp | | | | |
| Nederland | | | | |
| 31.3.2004 | Glivec | Novartis Europharm Limited Wimblehurst Road, Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| United Kingdom | | | | |
| 31.3.2004 | NovoNorm | Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsvaerd | | | | |
| 31.3.2004 | Sonata | 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 | | | | |
| 31.3.2004 | Regranex | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 31.3.2004 | Zerene | Wyeth Research (UK) Limited Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH United Kingdom | Wyeth Research (UK) Limited | Huntercombe Lane South |
| Wyeth Research (UK) Limited | | | | |
| Huntercombe Lane South | | | | |
| Taplow, Maidenhead | | | | |
| Berkshire, SL6 0PH | | | | |
| United Kingdom | | | | |
| 31.3.2004 | Ambirix | 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 | | | | |
| 5.4.2004 | Prandin | Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsvaerd | | | | |
| 7.4.2004 | NovoRapid W28-29 | Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsvaerd | | | | |
| 13.4.2004 | Ventavis | Schering AG Müllerstrasse 170-178 D-13342 Berlin | Schering AG | Müllerstrasse 170-178 |
| Schering AG | | | | |
| Müllerstrasse 170-178 | | | | |
| D-13342 Berlin | | | | |
| 14.4.2004 | Aranesp | 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 | | | | |
| 14.4.2004 | Nespo | 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 | | | | |
| 14.4.2004 | Zenapax | Roche Registration Ltd 40 Broadwater Road Welwyn Garden City Hertfordshire, AL7 3AY | Roche Registration Ltd | 40 Broadwater Road |
| Roche Registration Ltd | | | | |
| 40 Broadwater Road | | | | |
| Welwyn Garden City | | | | |
| Hertfordshire, AL7 3AY | | | | |
| 14.4.2004 | Forcaltonin | Unigene UK Limited 63 High Road Bushey Heath, Herts, WD2 1EE | Unigene UK Limited | 63 High Road |
| Unigene UK Limited | | | | |
| 63 High Road | | | | |
| Bushey Heath, Herts, WD2 1EE | | | | |
| 15.4.2004 | NovoMix 30 | Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsvaerd | | | | |

—   Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93): 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 |
| ----------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------- |
| 15.3.2004 | Suvaxyn Aujeszky 783 +O/W | Fort Dodge Animal Health Holland 36, C. J. van Houtenlaan 1381 CP Weesp Nederland | Fort Dodge Animal Health Holland | 36, C. J. van Houtenlaan |
| Fort Dodge Animal Health Holland | | | | |
| 36, C. J. van Houtenlaan | | | | |
| 1381 CP Weesp | | | | |
| Nederland | | | | |
| 15.3.2004 | Quadrisol | Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International BV | Wim de Körverstraat 35 |
| Intervet International BV | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 19.3.2004 | Gonazon | Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International BV | Wim de Körverstraat 35 |
| Intervet International BV | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 19.3.2004 | Porcilis Pesti | Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International BV | Wim de Körverstraat 35 |
| Intervet International BV | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 19.3.2004 | Nobilis OR inac | Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International BV | Wim de Körverstraat 35 |
| Intervet International BV | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 19.3.2004 | 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 | | | | |
| 19.3.2004 | Nobivac Bb | Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International BV | Wim de Körverstraat 35 |
| Intervet International BV | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 25.3.2004 | Gallivac HVT IBD | Merial 29 avenue Tony Garnier F-69007 Lyon | Merial | 29 avenue Tony Garnier |
| Merial | | | | |
| 29 avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 31.3.2004 | Econor | Novartis Animal Health Austria GmbH Biochemiestrasse 10 A-6250 Kundl | Novartis Animal Health Austria GmbH | Biochemiestrasse 10 |
| Novartis Animal Health Austria GmbH | | | | |
| Biochemiestrasse 10 | | | | |
| A-6250 Kundl | | | | |
| 7.4.2004 | IBAFLIN | Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International BV | Wim de Körverstraat 35 |
| Intervet International BV | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 7.4.2004 | Incurin | Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International BV | Wim de Körverstraat 35 |
| Intervet International BV | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 13.4.2004 | Advocate | 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 | | | | |
| 14.4.2004 | Nobilis IB 4-91 | Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International BV | Wim de Körverstraat 35 |
| Intervet International BV | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 14.4.2004 | Pruban | Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International BV | Wim de Körverstraat 35 |
| Intervet International BV | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 14.4.2004 | Porcilis AR-T DF | Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International BV | Wim de Körverstraat 35 |
| Intervet International BV | | | | |
| 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 Agency for the Evaluation of Medicinal products |
| ------------------------------------------------------------ |
| 7, Westferry Circus |
| Canary Wharf |
| London E14 4HB |
| United Kingdom |

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

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