# C_2006259EN.01000601.xml

| 27.10.2006 | EN | Official Journal of the European Union | C 259/6 |
| ---------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2006 to 30 September 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 259/04)

—   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 |
| --------------------------- | ----------------------------- | -------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------ | ------------------------------------------------ | -------------------- |
| 20.9.2006 | Gardasil | Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk | F-69007 Lyon | EU/1/06/357/001-017 |
| Sanofi Pasteur MSD, SNC | | | | | | | |
| 8, rue Jonas Salk | | | | | | | |
| F-69007 Lyon | | | | | | | |
| 20.9.2006 | Silgard | Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon | Hertfordshire EN11 9BU | United Kingdom |
| Merck Sharp & Dohme Ltd | | | | | | | |
| Hertford Road, Hoddesdon | | | | | | | |
| Hertfordshire EN11 9BU | | | | | | | |
| United Kingdom | | | | | | | |
| 20.9.2006 | Luminity | Perflutren | Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe 185 B-1170 Brussels | Bristol-Myers Squibb Pharma | Belgium Sprl | Chaussée de la Hulpe 185 | B-1170 Brussels |
| Bristol-Myers Squibb Pharma | | | | | | | |
| Belgium Sprl | | | | | | | |
| Chaussée de la Hulpe 185 | | | | | | | |
| B-1170 Brussels | | | | | | | |
| 26.9.2006 | Suboxone | buprenorphine/ naloxone | Schering Plough Europ Rue de Stalle, 73 B-1180 Bruxelles/ Stallestraat, 73 B-180 Brussel | Schering Plough Europ | Rue de Stalle, 73 | B-1180 Bruxelles/ | Stallestraat, 73 |
| Schering Plough Europ | | | | | | | |
| Rue de Stalle, 73 | | | | | | | |
| B-1180 Bruxelles/ | | | | | | | |
| Stallestraat, 73 | | | | | | | |
| B-180 Brussel | | | | | | | |
| 26.9.2006 | Champix | varenicline tartrate | 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 | | | | | | | |

—   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 |
| -------------------- | ----------------------------- | --------------------------------------------------- | --------------------------------------------- | -------------------- |
| 5.9.2006 | Alpheon | BioPartners GmbH Eisenstrasse 3 D-65428 Rüsselsheim | BioPartners GmbH | Eisenstrasse 3 |
| BioPartners GmbH | | | | |
| Eisenstrasse 3 | | | | |
| D-65428 Rüsselsheim | | | | |

—   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 |
| -------------------------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------- |
| 1.9.2006 | Aldara | Laboratoires 3M Santé Boulevard de l'Oise F-95029 Cergy Pontoise Cedex | Laboratoires 3M Santé | Boulevard de l'Oise |
| Laboratoires 3M Santé | | | | |
| Boulevard de l'Oise | | | | |
| F-95029 Cergy Pontoise Cedex | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | Fasturtec | Sanofi-Aventis 174, avenue de France F-75013 Paris | Sanofi-Aventis | 174, avenue de France |
| Sanofi-Aventis | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | Replagal | TKT Europe AB Rinkebyvägen 11B S-182 36 Danderyd | TKT Europe AB | Rinkebyvägen 11B |
| TKT Europe AB | | | | |
| Rinkebyvägen 11B | | | | |
| S-182 36 Danderyd | | | | |
| 1.9.2006 | Liprolog | 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 | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | Sustiva | 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 | | | | |
| 1.9.2006 | Betaferon | Schering Aktiengesellschaft D-13342 Berlin | Schering Aktiengesellschaft | D-13342 Berlin |
| Schering Aktiengesellschaft | | | | |
| D-13342 Berlin | | | | |
| 1.9.2006 | Viread | 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 | | | | |
| 1.9.2006 | Stocrin | 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 | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | Humalog | 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 | | | | |
| 1.9.2006 | Apidra | Sanofi-Aventis Deutschland GmbH Brueningstrasse 50 D-65926 Frankfurt am Main | Sanofi-Aventis Deutschland GmbH | Brueningstrasse 50 |
| Sanofi-Aventis Deutschland GmbH | | | | |
| Brueningstrasse 50 | | | | |
| D-65926 Frankfurt am Main | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | IntronA | 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 | | | | |
| 1.9.2006 | Viraferon | 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 | | | | |
| 1.9.2006 | 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 | | | | |
| 1.9.2006 | Invanz | 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 | | | | |
| 7.9.2006 | 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 | | | | |
| 7.9.2006 | 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 | | | | |
| 7.9.2006 | 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 | | | | |
| 7.9.2006 | Avonex | Biogen Idec Ltd 5 Roxborough Way Foundation Park, Maidenhead Berkshire SL6 3UD United Kindgom | Biogen Idec Ltd | 5 Roxborough Way |
| Biogen Idec Ltd | | | | |
| 5 Roxborough Way | | | | |
| Foundation Park, Maidenhead | | | | |
| Berkshire SL6 3UD | | | | |
| United Kindgom | | | | |
| 7.9.2006 | 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 | | | | |
| 7.9.2006 | 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 | | | | |
| 7.9.2006 | Zonegran | Eisai Limited 3, Shortlands London W6 8EE United Kingdom | Eisai Limited | 3, Shortlands |
| Eisai Limited | | | | |
| 3, Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 12.9.2006 | Arixtra | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 12.9.2006 | ProQuad | 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 | | | | |
| 12.9.2006 | 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 | | | | |
| 12.9.2006 | Quixidar | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 12.9.2006 | 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 | | | | |
| 12.9.2006 | Zyprexa | 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 | | | | |
| 13.9.2006 | 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 | | | | |
| 13.9.2006 | Zyprexa | 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 | | | | |
| 14.9.2006 | 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 | | | | |
| 14.9.2006 | 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 | | | | |
| Eisai Limited 3, Shortlands London W6 8EE United Kingdom | Eisai Limited | 3, Shortlands | London W6 8EE | United Kingdom |
| Eisai Limited | | | | |
| 3, Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 18.9.2006 | 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 | | | | |
| 21.9.2006 | 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 | | | | |
| 21.9.2006 | 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 | | | | |
| 26.9.2006 | Aclasta | 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 | | | | |
| 26.9.2006 | 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 | | | | |
| 29.9.2006 | 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 | | | | |

—   Issuing 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 | 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 |
| ---------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- | ------------------------------------------------ | -------------------- |
| 1.9.2006 | Poulvac FluFend H5N3 RG | Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04) 256 — 4046 HA Units | Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH United Kingdom | Fort Dodge Animal Health Ltd | Flanders Road | Hedge End | Southampton SO30 4QH |
| Fort Dodge Animal Health Ltd | | | | | | | |
| Flanders Road | | | | | | | |
| Hedge End | | | | | | | |
| Southampton SO30 4QH | | | | | | | |
| United Kingdom | | | | | | | |
| 1.9.2006 | Nobilis Influenza H5N2 | Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test. | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International B.V. | Wim de Körverstraat 35 | 5831 AN Boxmeer | Nederland |
| Intervet International B.V. | | | | | | | |
| Wim de Körverstraat 35 | | | | | | | |
| 5831 AN Boxmeer | | | | | | | |
| Nederland | | | | | | | |
| 29.9.2006 | Cerenia | Maropitant | 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 | | | | | | | |
| EU/2/06/062/005 | Solution for injection | | | | | | |

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 April 2004, page 1.

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