# C_2006217EN.01000501.xml

| 8.9.2006 | EN | Official Journal of the European Union | C 217/5 |
| -------- | -- | -------------------------------------- | ------- |

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.7.2006 to 31.7.2006

(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 217/03)

—   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 |
| ----------------------------------------------------------- | ----------------------------- | ----------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------- | ---------------------------- | ------------------------------------------------ | -------------------- |
| 19.7.2006 | SUTENT | sunitinib | Pfizer Ltd. Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom | Pfizer Ltd. | Ramsgate Road | Sandwich | Kent CT 13 9NJ |
| Pfizer Ltd. | | | | | | | |
| Ramsgate Road | | | | | | | |
| Sandwich | | | | | | | |
| Kent CT 13 9NJ | | | | | | | |
| United Kingdom | | | | | | | |
| 19.7.2006 | Nexavar | Sorafenib | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen | EU/1/06/342/001 | Film-coated tablet |
| Bayer HealthCare AG | | | | | | | |
| D-51368 Leverkusen | | | | | | | |
| 28.7.2006 | ATryn | antithrombin alfa | 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 | | | | | | | |
| 28.7.2006 | Livensa | testosterone | Procter & Gamble Pharmaceuticals — Germany GmbH Dr. Otto-Röhm-Strasse 2-4 D-64331 Weiterstadt | Procter & Gamble Pharmaceuticals — Germany GmbH | Dr. Otto-Röhm-Strasse 2-4 | D-64331 Weiterstadt | EU/1/06/351/001-003 |
| Procter & Gamble Pharmaceuticals — Germany GmbH | | | | | | | |
| Dr. Otto-Röhm-Strasse 2-4 | | | | | | | |
| D-64331 Weiterstadt | | | | | | | |
| 28.7.2006 | Savene | Dexrazoxane | TopoTarget A/S Fruebjergvej 3 DK-Denmark | TopoTarget A/S | Fruebjergvej 3 | DK-Denmark | EU/1/06/350/001 |
| TopoTarget A/S | | | | | | | |
| Fruebjergvej 3 | | | | | | | |
| DK-Denmark | | | | | | | |
| 28.7.2006 | Intrinsa | testosterone | Procter & Gamble Pharmaceuticals UK Rusham Park Technical Centre Whitehall Lane Egham Surrey TW20 9NW United Kingdom | Procter & Gamble Pharmaceuticals UK | Rusham Park Technical Centre | Whitehall Lane | Egham |
| Procter & Gamble Pharmaceuticals UK | | | | | | | |
| Rusham Park Technical Centre | | | | | | | |
| Whitehall Lane | | | | | | | |
| Egham | | | | | | | |
| Surrey TW20 9NW | | | | | | | |
| United Kingdom | | | | | | | |
| 28.7.2006 | Competact | Pioglitazone/metformin | Takeda Global Research and Development Centre (Europe) Ltd. Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd. | Arundel Great Court | 2 Arundel Street | London WC2R 3DA |
| Takeda Global Research and Development Centre (Europe) Ltd. | | | | | | | |
| Arundel Great Court | | | | | | | |
| 2 Arundel Street | | | | | | | |
| London WC2R 3DA | | | | | | | |
| 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 |
| ----------------------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------- | ------------------------- |
| 4.7.2006 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |
| 4.7.2006 | Avastin | 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 | | | | |
| 4.7.2006 | Taxotere | Aventis Pharma S.A. 20 avenue Raymond Aron F-92165 Antony Cedex | Aventis Pharma S.A. | 20 avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron | | | | |
| F-92165 Antony Cedex | | | | |
| 4.7.2006 | Zeffix | Glaxo Group Ltd. Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd. | Greenford |
| Glaxo Group Ltd. | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 4.7.2006 | Dynastat | 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 | | | | |
| 4.7.2006 | 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 | | | | |
| 6.7.2006 | 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 | | | | |
| 6.7.2006 | REYATAZ | 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 | | | | |
| 6.7.2006 | Arava | 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 | | | | |
| 6.7.2006 | 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 | | | | |
| 11.7.2006 | Comtess | Orion Corporation Orionintie 1 FIN-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| 11.7.2006 | Fareston | Orion Corporation Orionintie 1 FIN-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| 11.7.2006 | Stalevo | Orion Corporation Orionintie 1 FIN-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| 11.7.2006 | 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 | | | | |
| 12.7.2006 | 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 | | | | |
| 13.7.2006 | Starlix | 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 | | | | |
| 13.7.2006 | Trazec | 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 | | | | |
| 13.7.2006 | 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 | | | | |
| 13.7.2006 | 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 | | | | |
| 14.7.2006 | Revasc | Canyon Pharmaceuticals Ltd. 20-22 Bedford Row WC1R 4JS London United Kingdom | Canyon Pharmaceuticals Ltd. | 20-22 Bedford Row |
| Canyon Pharmaceuticals Ltd. | | | | |
| 20-22 Bedford Row | | | | |
| WC1R 4JS | | | | |
| London | | | | |
| United Kingdom | | | | |
| 19.7.2006 | PegIntron | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| 19.7.2006 | Viraferon | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| 19.7.2006 | IntronA | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| 19.7.2006 | ViraferonPeg | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| 20.7.2006 | 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 | | | | |
| 20.7.2006 | 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 | | | | |
| 20.7.2006 | Actos | Takeda Global Research and Development Centre (Europe) Ltd. Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd. | Arundel Great Court |
| Takeda Global Research and Development Centre (Europe) Ltd. | | | | |
| Arundel Great Court | | | | |
| 2 Arundel Street | | | | |
| London | | | | |
| WC2R 3DA | | | | |
| United Kingdom | | | | |
| 20.7.2006 | Glustin | Takeda Global Research and Development Centre (Europe) Ltd. Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd. | Arundel Great Court |
| Takeda Global Research and Development Centre (Europe) Ltd. | | | | |
| Arundel Great Court | | | | |
| 2 Arundel Street | | | | |
| London | | | | |
| WC2R 3DA | | | | |
| United Kingdom | | | | |
| 20.7.2006 | Tractocile | Ferring AB Soldattorpsvägen 5 Box 30 047 S-20061 Limhamn | Ferring AB | Soldattorpsvägen 5 |
| Ferring AB | | | | |
| Soldattorpsvägen 5 | | | | |
| Box 30 047 | | | | |
| S-20061 Limhamn | | | | |
| 20.7.2006 | 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 | | | | |
| 20.7.2006 | 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 | | | | |
| 20.7.2006 | Fuzeon | 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 | | | | |
| 25.7.2006 | Keppra | UCB S.A. Allée de la recherche, 60 B-1070 Bruxelles | UCB S.A. | Allée de la recherche, 60 |
| UCB S.A. | | | | |
| Allée de la recherche, 60 | | | | |
| B-1070 Bruxelles | | | | |
| 25.7.2006 | Synagis | Abbott laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd. | Queenborough |
| Abbott laboratories Ltd. | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 25.7.2006 | Rebetol | Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles | Schering Plough Europe | Rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| 25.7.2006 | Nonafact | Sanquin Plesmanlaan 125 1066 CX Amsterdam Nederland | Sanquin | Plesmanlaan 125 |
| Sanquin | | | | |
| Plesmanlaan 125 | | | | |
| 1066 CX Amsterdam | | | | |
| Nederland | | | | |
| 25.7.2006 | CUBICIN | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom Chiron Corporation Ltd. Symphony House 7 Cowley Business Park High Street Cowley Uxbridge UB8 2AD United Kingdom | Novartis Europharm Limited | Wimblehurst Road |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road | | | | |
| Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| United Kingdom | | | | |
| Chiron Corporation Ltd. | | | | |
| Symphony House | | | | |
| 7 Cowley Business Park | | | | |
| High Street | | | | |
| Cowley | | | | |
| Uxbridge | | | | |
| UB8 2AD | | | | |
| United Kingdom | | | | |
| 28.7.2006 | Replagal | TKT Europe AB Rinkebyvägen 11B S-182 36 Danderyd | TKT Europe AB | Rinkebyvägen 11B |
| TKT Europe AB | | | | |
| Rinkebyvägen 11B | | | | |
| S-182 36 Danderyd | | | | |
| 28.7.2006 | Myocet | Zeneus Pharma Limited The Magdalen Centre Oxford Science Park Oxford OX4 4GA United Kingdom Elan Pharma International Ltd. WIL House Shannon Business Park Shannon County Clare Ireland | Zeneus Pharma Limited | The Magdalen Centre |
| Zeneus Pharma Limited | | | | |
| The Magdalen Centre | | | | |
| Oxford Science Park | | | | |
| Oxford | | | | |
| OX4 4GA | | | | |
| United Kingdom | | | | |
| Elan Pharma International Ltd. | | | | |
| WIL House | | | | |
| Shannon Business Park | | | | |
| Shannon | | | | |
| County Clare | | | | |
| Ireland | | | | |
| 28.7.2006 | INOmax | INO Therapeutics AB S-181 81 Lidingö | INO Therapeutics AB | S-181 81 Lidingö |
| INO Therapeutics AB | | | | |
| S-181 81 Lidingö | | | | |
| 28.7.2006 | Rilutek | Aventis Pharma S.A. 20, Avenue Raymond Aron F-92165 Antony Cedex | Aventis Pharma S.A. | 20, Avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20, Avenue Raymond Aron | | | | |
| F-92165 Antony Cedex | | | | |
| 28.7.2006 | Epivir | 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 | | | | |
| 28.7.2006 | Fabrazyme | 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 | | | | |
| 28.7.2006 | DaTSCAN | GE Healthcare Limited Little Chalfont Bucks HP7 9NA United Kingdom | GE Healthcare Limited | Little Chalfont |
| GE Healthcare Limited | | | | |
| Little Chalfont | | | | |
| Bucks HP7 9NA | | | | |
| United Kingdom | | | | |
| 28.7.2006 | Velcade | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 28.7.2006 | REYATAZ | 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 | | | | |
| 28.7.2006 | 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 | | | | |
| 28.7.2006 | Procomvax | Sanofi Pasteur MSD S.N.C. 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD S.N.C. | 8, rue Jonas Salk |
| Sanofi Pasteur MSD S.N.C. | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |
| 28.7.2006 | MabCampath | 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 | | | | |
| 28.7.2006 | Tritanrix HepB | 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 | | | | |
| 28.7.2006 | Ceprotin | Baxter AG Industriesstrasse 67 A-1220 Vienna | Baxter AG | Industriesstrasse 67 |
| Baxter AG | | | | |
| Industriesstrasse 67 | | | | |
| A-1220 Vienna | | | | |
| 28.7.2006 | Myozyme | Genzyme Europe B.V. Gooimeer 10 NL-1411 DD Naarden Nederland | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| NL-1411 DD Naarden | | | | |
| Nederland | | | | |
| 28.7.2006 | 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 | | | | |
| 28.7.2006 | 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 | | | | |
| 28.7.2006 | 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 | | | | |
| 28.7.2006 | 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 | | | | |
| 28.7.2006 | 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 | | | | |
| 28.7.2006 | Norvir | Abbott laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd. | Queenborough |
| Abbott laboratories Ltd. | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 28.7.2006 | Vivanza | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 28.7.2006 | Levitra | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |

—   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 |
| -------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------- |
| 11.7.2006 | Dexdomitor | Orion Corporation Orionintie 1 FIN-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| 14.7.2006 | Vaxxitek HVT+ IBD | Merial 29, avenue Tony Garnier F-69007 Lyon | Merial | 29, avenue Tony Garnier |
| Merial | | | | |
| 29, avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 20.7.2006 | Porcilis Porcoli | Intervet International B.V. (NL) Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International B.V. (NL) | Wim de Körverstraat 35 |
| Intervet International B.V. (NL) | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |
| 20.7.2006 | Rabigen SAG2 | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. F-06516 Carros | VIRBAC S.A. | 1ère Avenue 2065 m L.I.D. |
| VIRBAC S.A. | | | | |
| 1ère Avenue 2065 m L.I.D. | | | | |
| F-06516 Carros | | | | |

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 April 2004, p. 1.

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