# C_2007174EN.01000301.xml

| 27.7.2007 | EN | Official Journal of the European Union | C 174/3 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2007 to 30 June 2007

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

(2007/C 174/04)

—   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 |
| ----------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------ | ----------------------------------------------- | -------------------------- | ------------------------------------------------ | -------------------- |
| 1.6.2007 | Optaflu | Influenza vaccine (surface antigen, inactivated, prepared in cell culture) | Novartis Vaccines and Diagnostics GmbH & Co. KG Emil-von-Behring-Straße 76 D-35041 Marburg | Novartis Vaccines and Diagnostics GmbH & Co. KG | Emil-von-Behring-Straße 76 | D-35041 Marburg | EU/1/07/394/001-006 |
| Novartis Vaccines and Diagnostics GmbH & Co. KG | | | | | | | |
| Emil-von-Behring-Straße 76 | | | | | | | |
| D-35041 Marburg | | | | | | | |
| 14.6.2007 | Revlimid | Lenalidomide | Celgene Europe Limited 8 The Square Stockley Park Uxbridge UB11 1FW Middlesex United Kingdom | Celgene Europe Limited | 8 The Square | Stockley Park | Uxbridge UB11 1FW |
| Celgene Europe Limited | | | | | | | |
| 8 The Square | | | | | | | |
| Stockley Park | | | | | | | |
| Uxbridge UB11 1FW | | | | | | | |
| Middlesex | | | | | | | |
| United Kingdom | | | | | | | |
| 20.6.2007 | Soliris | Eculizumab | Alexion Europe SAS 54-56, Avenue Hoche F-75008 Paris | Alexion Europe SAS | 54-56, Avenue Hoche | F-75008 Paris | EU/1/07/393/001 |
| Alexion Europe SAS | | | | | | | |
| 54-56, Avenue Hoche | | | | | | | |
| F-75008 Paris | | | | | | | |
| 25.6.2007 | Invega | Paliperidone | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 | B-2340 Beerse | EU/1/07/395/001-064 |
| Janssen-Cilag International NV | | | | | | | |
| Turnhoutseweg, 30 | | | | | | | |
| B-2340 Beerse | | | | | | | |
| 25.6.2007 | Pergoveris | Follitropin alfa/lutropin alfa | Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom | Serono Europe Limited | 56, Marsh Wall | London E14 9TP | United Kingdom |
| Serono Europe Limited | | | | | | | |
| 56, Marsh Wall | | | | | | | |
| London E14 9TP | | | | | | | |
| United Kingdom | | | | | | | |
| 29.6.2007 | Circadin | Melatonin | Neurim Pharmaceuticals EEC Limited 6 Fortuna Court Calleva Park Aldermaston Berkshire RG7 8UB United Kingdom | Neurim Pharmaceuticals EEC Limited | 6 Fortuna Court | Calleva Park | Aldermaston |
| Neurim Pharmaceuticals EEC Limited | | | | | | | |
| 6 Fortuna Court | | | | | | | |
| Calleva Park | | | | | | | |
| Aldermaston | | | | | | | |
| Berkshire RG7 8UB | | | | | | | |
| United Kingdom | | | | | | | |
| 29.6.2007 | Siklos | Hydroxycarbamide | Addmedica 84, rue d'Amsterdam F-75009 Paris | Addmedica | 84, rue d'Amsterdam | F-75009 Paris | EU/1/07/397/001 |
| Addmedica | | | | | | | |
| 84, rue d'Amsterdam | | | | | | | |
| F-75009 Paris | | | | | | | |

—   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 |
| --------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------ |
| 1.6.2007 | Renagel | 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 | | | | |
| 1.6.2007 | Rebetol | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat, 73 | | | | |
| B-1180 Brussel | | | | |
| 4.6.2007 | Myocet | Zeneus Pharma Limited The Magdalen Centre Oxford Science Park Oxford OX4 4GA United Kingdom | Zeneus Pharma Limited | The Magdalen Centre |
| Zeneus Pharma Limited | | | | |
| The Magdalen Centre | | | | |
| Oxford Science Park | | | | |
| Oxford OX4 4GA | | | | |
| United Kingdom | | | | |
| Cephalon Europe 5, Rue Charles Martigny F-94700 Maisons Alfort | Cephalon Europe | 5, Rue Charles Martigny | F-94700 Maisons Alfort | 6.6.2007 |
| Cephalon Europe | | | | |
| 5, Rue Charles Martigny | | | | |
| F-94700 Maisons Alfort | | | | |
| 4.6.2007 | Vasovist | Bayer Schering Pharma AG Müllerstraße 170-178 D-13342 Berlin | Bayer Schering Pharma AG | Müllerstraße 170-178 |
| Bayer Schering Pharma AG | | | | |
| Müllerstraße 170-178 | | | | |
| D-13342 Berlin | | | | |
| 4.6.2007 | 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 | | | | |
| 4.6.2007 | Humira | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 4.6.2007 | Trudexa | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 4.6.2007 | Orgalutran | N.V. Organon P.O. Box 20 Kloosterstraat 6 5340 BH Oss Nederland | N.V. Organon | P.O. Box 20 |
| N.V. Organon | | | | |
| P.O. Box 20 | | | | |
| Kloosterstraat 6 | | | | |
| 5340 BH Oss | | | | |
| Nederland | | | | |
| 4.6.2007 | TRIZIVIR | 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 | | | | |
| 4.6.2007 | Zometa | 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 | | | | |
| 4.6.2007 | 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 | | | | |
| 5.6.2007 | Azomyr | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat, 73 | | | | |
| B-1180 Brussel | | | | |
| 5.6.2007 | Aerius | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat, 73 | | | | |
| B-1180 Brussel | | | | |
| 5.6.2007 | Neoclarityn | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat, 73 | | | | |
| B-1180 Brussel | | | | |
| 5.6.2007 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom | Otsuka Pharmaceutical Europe Ltd | Hunton House |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House | | | | |
| Highbridge Business Park | | | | |
| Oxford Road | | | | |
| Uxbridge | | | | |
| Middlesex UB8 1HU | | | | |
| United Kingdom | | | | |
| 5.6.2007 | Trisenox | Cephalon UK Ltd 20 Alan Turing Road Surrey Research Park Guildford Surrey GU2 7YF United Kingdom | Cephalon UK Ltd | 20 Alan Turing Road |
| Cephalon UK Ltd | | | | |
| 20 Alan Turing Road | | | | |
| Surrey Research Park | | | | |
| Guildford | | | | |
| Surrey GU2 7YF | | | | |
| United Kingdom | | | | |
| Cephalon Europe 5, Rue Charles Martigny F-94700 Maisons Alfort, Cedex | Cephalon Europe | 5, Rue Charles Martigny | F-94700 Maisons Alfort, Cedex | 7.6.2007 |
| Cephalon Europe | | | | |
| 5, Rue Charles Martigny | | | | |
| F-94700 Maisons Alfort, Cedex | | | | |
| 5.6.2007 | Visudyne | 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 | | | | |
| 7.6.2007 | Tracleer | 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 | | | | |
| 8.6.2007 | Levemir | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 8.6.2007 | Vistide | Pfizer Enterprises SARL 51, Avenue Kennedy-Rond Point du Kirchberg L-1855 Luxembourg | Pfizer Enterprises SARL | 51, Avenue Kennedy-Rond Point du Kirchberg |
| Pfizer Enterprises SARL | | | | |
| 51, Avenue Kennedy-Rond Point du Kirchberg | | | | |
| L-1855 Luxembourg | | | | |
| 13.6.2007 | ViraferonPeg | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat, 73 | | | | |
| B-1180 Brussel | | | | |
| 13.6.2007 | Azopt | Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom | Alcon Laboratories (UK) Ltd | Pentagon Park |
| Alcon Laboratories (UK) Ltd | | | | |
| Pentagon Park | | | | |
| Boundary Way | | | | |
| Hemel Hempstead | | | | |
| Herts HP2 7UD | | | | |
| United Kingdom | | | | |
| 13.6.2007 | Tracleer | 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 | | | | |
| 13.6.2007 | Gardasil | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |
| 13.6.2007 | 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 | | | | |
| 13.6.2007 | PegIntron | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat, 73 | | | | |
| B-1180 Brussel | | | | |
| 13.6.2007 | Silgard | 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 | | | | |
| 14.6.2007 | Rapilysin | 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 | | | | |
| 19.6.2007 | 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 | | | | |
| 20.6.2007 | 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 | | | | |
| 20.6.2007 | Cialis | Lilly ICOS Limited St Bride's House 10 Salisbury Square London EC4Y 8EH United Kingdom | Lilly ICOS Limited | St Bride's House |
| Lilly ICOS Limited | | | | |
| St Bride's House | | | | |
| 10 Salisbury Square | | | | |
| London EC4Y 8EH | | | | |
| United Kingdom | | | | |
| 21.6.2007 | Levemir | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 21.6.2007 | 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 | | | | |
| 21.6.2007 | Hycamtin | 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 | | | | |
| 21.6.2007 | Iscover | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge UD8 1DH | | | | |
| United Kingdom | | | | |
| 21.6.2007 | Synagis | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 21.6.2007 | 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 | | | | |
| 21.6.2007 | Revasc | Canyon Pharmaceuticals Ltd 20-22 Bedford Row London WC1R 4JS United Kingdom | Canyon Pharmaceuticals Ltd | 20-22 Bedford Row |
| Canyon Pharmaceuticals Ltd | | | | |
| 20-22 Bedford Row | | | | |
| London WC1R 4JS | | | | |
| United Kingdom | | | | |
| 21.6.2007 | Cystagon | Orphan Europe S.à r.l. Immeuble «Le Guillaumet» F-92046 Paris La Défense | Orphan Europe S.à r.l. | Immeuble «Le Guillaumet» |
| Orphan Europe S.à r.l. | | | | |
| Immeuble «Le Guillaumet» | | | | |
| F-92046 Paris La Défense | | | | |
| 21.6.2007 | 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 | | | | |
| 22.6.2007 | Plavix | 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 | | | | |
| 25.6.2007 | M-M-RVAXPRO | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |
| 25.6.2007 | NeoRecormon | 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 | | | | |
| 27.6.2007 | Vaniqa | 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 | | | | |
| 29.6.2007 | Tamiflu | 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 | | | | |
| 29.6.2007 | Ferriprox | Apotex Europe Ltd Rowan House 41 London Street Reading Berkshire RG1 4PS United Kingdom | Apotex Europe Ltd | Rowan House |
| Apotex Europe Ltd | | | | |
| Rowan House | | | | |
| 41 London Street | | | | |
| Reading | | | | |
| Berkshire RG1 4PS | | | | |
| United Kingdom | | | | |
| Apotex Europe B.V. Darwingweg 20 2333 CR Leiden Nederland | Apotex Europe B.V. | Darwingweg 20 | 2333 CR Leiden | Nederland |
| Apotex Europe B.V. | | | | |
| Darwingweg 20 | | | | |
| 2333 CR Leiden | | | | |
| Nederland | | | | |
| 29.6.2007 | Humira | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 29.6.2007 | 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 | | | | |
| 29.6.2007 | Trudexa | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 29.6.2007 | 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 | | | | |
| 29.6.2007 | 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 | | | | |
| 29.6.2007 | Tygacil | 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 | | | | |
| 29.6.2007 | 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 | | | | |

—   Issuing of a marketing authorization (Article 38 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 |
| ----------------------- | ----------------------------- | ----------------------------------------- | ------------------------------------------------------- | --------------------------------------------- | ----------------------- | ------------------------------------------------ | -------------------- |
| 20.6.2007 | PRILACTONE | Spironolactone | CEVA SANTE ANIMALE Z.I. la Ballastière F-33500 Libourne | CEVA SANTE ANIMALE | Z.I. la Ballastière | F-33500 Libourne | EU/2/07/074/001-006 |
| CEVA SANTE ANIMALE | | | | | | | |
| Z.I. la Ballastière | | | | | | | |
| F-33500 Libourne | | | | | | | |
| 21.6.2007 | Circovac | Inactivated porcine circovirus type 2 | MERIAL 29, avenue Tony Garnier F-69007 Lyon | MERIAL | 29, avenue Tony Garnier | F-69007 Lyon | EU/2/07/075/001-004 |
| MERIAL | | | | | | | |
| 29, avenue Tony Garnier | | | | | | | |
| F-69007 Lyon | | | | | | | |

—   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 |
| ----------------------- | ----------------------------- | ------------------------------------------- | --------------------------------------------- | ----------------------- |
| 14.6.2007 | Vaxxitek HVT+ IBD | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |

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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