# C_2006152EN.01000801.xml

| 30.6.2006 | EN | Official Journal of the European Union | C 152/8 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.5.2006 to 31.5.2006

(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 152/07)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) — 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 |
| -------------------------------- | ----------------------------------------------------------------------- | ----------------------------------------- | ------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------- | ----------------------------------------------- | -------------------- |
| 5.5.2006 | M-M-RVAXPRO | Measles, Mumps and Rubella Vaccine (Live) | Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD | SNC | 8, rue Jonas Salk | F-69007 Lyon |
| Sanofi Pasteur MSD | | | | | | | |
| SNC | | | | | | | |
| 8, rue Jonas Salk | | | | | | | |
| F-69007 Lyon | | | | | | | |
| 19.5.2006 | Zostavax | Zoster vaccine (Live) | Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD | SNC | 8, rue Jonas Salk | F-69007 Lyon |
| Sanofi Pasteur MSD | | | | | | | |
| SNC | | | | | | | |
| 8, rue Jonas Salk | | | | | | | |
| F-69007 Lyon | | | | | | | |
| EU/1/06/341/003-013 | Powder and solvent for suspension for injection in a pre-filled syringe | | | | | | |
| 19.5.2006 | Ganfort | bimatoprost/timolol | Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo Ireland | Allergan Pharmaceuticals Ireland | Castlebar Road | Westport | Co. Mayo |
| Allergan Pharmaceuticals Ireland | | | | | | | |
| Castlebar Road | | | | | | | |
| Westport | | | | | | | |
| Co. Mayo | | | | | | | |
| Ireland | | | | | | | |
| 29.5.2006 | Evoltra | clofarabine | Bioenvision Limited Bassett House 5 Southwell Park Road Camberley Surrey, GU15 3PU United Kingdom | Bioenvision Limited | Bassett House | 5 Southwell Park Road | Camberley |
| Bioenvision Limited | | | | | | | |
| Bassett House | | | | | | | |
| 5 Southwell Park Road | | | | | | | |
| Camberley | | | | | | | |
| Surrey, GU15 3PU | | | | | | | |
| United Kingdom | | | | | | | |

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) — 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 |
| -------------------------- | ----------------------------- | --------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 19.5.2006 | Zelnorm | 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 | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) — 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 |
| --------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------- |
| 2.5.2006 | Agenerase | Glaxo Group Ltd, Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd, | Greenford |
| Glaxo Group Ltd, | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 2.5.2006 | Ventavis | Schering AG Müllerstraße 170-178 D-13342 Berlin | Schering AG | Müllerstraße 170-178 |
| Schering AG | | | | |
| Müllerstraße 170-178 | | | | |
| D-13342 Berlin | | | | |
| 5.5.2006 | Vivanza | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 5.5.2006 | AVANDIA | 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 | | | | |
| 5.5.2006 | Lantus | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main | | | | |
| 5.5.2006 | Dynastat | Pfizer Ltd, Ramsgate Road Sandwich, Kent CT 13 9NJ United Kingdom Pharmacia Europe EEIG Sandwich Kent, CT13 9NJ United Kingdom | Pfizer Ltd, | Ramsgate Road |
| Pfizer Ltd, | | | | |
| Ramsgate Road | | | | |
| Sandwich, Kent CT 13 9NJ | | | | |
| United Kingdom | | | | |
| Pharmacia Europe EEIG | | | | |
| Sandwich | | | | |
| Kent, CT13 9NJ | | | | |
| United Kingdom | | | | |
| 5.5.2006 | Insuman | Aventis Pharma Deutschland GmbH Brueningstraße 50 D-65926 Frankfurt am Main | Aventis Pharma Deutschland GmbH | Brueningstraße 50 |
| Aventis Pharma Deutschland GmbH | | | | |
| Brueningstraße 50 | | | | |
| D-65926 Frankfurt am Main | | | | |
| 5.5.2006 | Apidra | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main | | | | |
| 5.5.2006 | Levitra | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 10.5.2006 | 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 | | | | |
| 10.5.2006 | Forcaltonin | Unigene UK Limited 191 Sparrows Herne Bushey Heath Hertfordshire WD23 1AJ United Kingdom | Unigene UK Limited | 191 Sparrows Herne |
| Unigene UK Limited | | | | |
| 191 Sparrows Herne | | | | |
| Bushey Heath | | | | |
| Hertfordshire WD23 1AJ | | | | |
| United Kingdom | | | | |
| 16.5.2006 | 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 | | | | |
| 19.5.2006 | Caelyx | 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 | | | | |
| 19.5.2006 | 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 | | | | |
| 19.5.2006 | 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 | | | | |
| 19.5.2006 | 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 | | | | |
| 19.5.2006 | 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 | | | | |
| 19.5.2006 | 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 | | | | |
| 19.5.2006 | PegIntron | 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 | | | | |
| 19.5.2006 | 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 | | | | |
| 19.5.2006 | ViraferonPeg | 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 | | | | |
| 22.5.2006 | Prandin | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 22.5.2006 | Herceptin | 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 | | | | |
| 29.5.2006 | NovoNorm | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 29.5.2006 | Puregon | Organon N.V P.O. Box 20 5340 BH Oss Nederland | Organon N.V | P.O. Box 20 |
| Organon N.V | | | | |
| P.O. Box 20 | | | | |
| 5340 BH Oss | | | | |
| Nederland | | | | |
| 29.5.2006 | PEGASYS | 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 | | | | |
| 29.5.2006 | Emend | 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 | | | | |
| 29.5.2006 | Emend | 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 | | | | |
| 31.5.2006 | 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 | | | | |
| 31.5.2006 | 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 | | | | |
| 31.5.2006 | 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 | | | | |
| 31.5.2006 | 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 | | | | |
| 31.5.2006 | 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 | | | | |
| 31.5.2006 | Trudexa | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 31.5.2006 | 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 | | | | |
| 31.5.2006 | Xenical | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City Hertfordshire AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| Hertfordshire AL7 1TW | | | | |
| United Kingdom | | | | |
| 31.5.2006 | AVANDIA | 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 | | | | |
| 31.5.2006 | Rebif | Serono Europe Ltd. 56, Marsh Wall London E14 9TP United Kingdom | Serono Europe Ltd. | 56, Marsh Wall |
| Serono Europe Ltd. | | | | |
| 56, Marsh Wall | | | | |
| London E14 9TP | | | | |
| United Kingdom | | | | |
| 31.5.2006 | 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 | | | | |
| 31.5.2006 | Enbrel | Abbott Laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd. | Queenborough |
| Abbott Laboratories Ltd. | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 31.5.2006 | Abilify | Otsuka Pharmaceutical Europe Ltd Commonwealth House 2 Chalkhill Road Hammersmith London W6 8DW United Kingdom | Otsuka Pharmaceutical Europe Ltd | Commonwealth House |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Commonwealth House | | | | |
| 2 Chalkhill Road | | | | |
| Hammersmith | | | | |
| London W6 8DW | | | | |
| United Kingdom | | | | |
| 31.5.2006 | Vfend | Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Sandwich |
| Pfizer Limited | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 31.5.2006 | 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 | | | | |
| 31.5.2006 | 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 | | | | |
| 31.5.2006 | Aprovel -77 | 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 | | | | |
| 31.5.2006 | Cymbalta | 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 authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| 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 |
| -------------------------- | ----------------------------- | ----------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 5.5.2006 | Infergen | Astellas Pharma Europe B.V Elisabethhof 19 2353 EW Leiderdorp Nederland | Astellas Pharma Europe B.V | Elisabethhof 19 |
| Astellas Pharma Europe B.V | | | | |
| Elisabethhof 19 | | | | |
| 2353 EW Leiderdorp | | | | |
| Nederland | | | | |

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) — 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 |
| --------------------- | ----------------------------- | ----------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 22.5.2006 | Aivlosin W 04-W 05 | ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | ECO Animal Health Ltd | 78 Coombe Road |
| ECO Animal Health Ltd | | | | |
| 78 Coombe Road | | | | |
| New Malden | | | | |
| Surrey KT3 4QS | | | | |
| United Kingdom | | | | |

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 of 30.4.2004, p. 1.

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