EN Official Journal of the European Union C 250/30

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2013 to 31 July 2013

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

2013/C 250/02

— 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 13.6.2013 Memantine ratiopharm memantine ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/13/836 Film-coated tablet N06DX01 17.6.2013 14.6.2013 Votrient Pazopanib hydrochloride Glaxo Group Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/10/628 Film-coated tablet L01XE11 18.6.2013 21.6.2013 Capecitabine SUN Capecitabine Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/13/831 Film-coated tablet L01BC06 25.6.2013 21.6.2013 Spedra avanafil VIVUS B.V. Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland EU/1/13/841 Tablet G04BE 25.6.2013 21.6.2013 Xtandi enzalutamide Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/13/846 Capsule, soft Pending 25.6.2013 24.6.2013 Nuedexta Dextromethorphan/quinidine Jenson Pharmaceutical Services Ltd Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom EU/1/13/833 Capsule, hard N07XX 26.6.2013 24.6.2013 Stayveer bosentan Marklas Nederland B.V. Beneluxlaan 2b, NL-3446 GR Woerden, Nederland EU/1/13/832 Film-coated tablet C02KX01 25.6.2013 27.6.2013 MACI Matrix applied characterised autologous cultured chondrocytes Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/13/847 Implantation matrix M09AX02 1.7.2013 1.7.2013 Iclusig ponatinib ARIAD Pharma Ltd 2 Temple Back East, Temple Quay, Bristol, BS1 6EG, United Kingdom EU/1/13/839 Film-coated tablet L01XE24 3.7.2013 1.7.2013 Imatinib Accord Imatinib Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom EU/1/13/845 Film-coated tablet L01XE01 3.7.2013 12.7.2013 Erivedge vismodegib Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/848 Capsule, hard L01XX43 17.7.2013 25.7.2013 Lonquex lipegfilgrastim Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/13/856 Solution for injection L03AA14 29.7.2013 31.7.2013 Atosiban SUN atosiban Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/13/852 Concentrate for solution for infusion Solution for injection G02CX01 2.8.2013 31.7.2013 Imvanex modified vaccinia ankara virus Bavarian Nordic A/S Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark EU/1/13/855 Suspension for injection J07BX 5.8.2013 31.7.2013 Lojuxta Lomitapide Aegerion Pharmaceuticals 37/39 avenue Ledru Rollin, F-75012 Paris, France EU/1/13/851 Capsule, hard C10AX12 5.8.2013 31.7.2013 PHEBURANE Sodium Phenylbutyrate Lucane Pharma 172 rue de Charonne, 75011 Paris, France EU/1/13/822/ Granules A16AX03 5.8.2013





— 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 11.6.2013 IOA Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland EU/1/11/689 13.6.2013 11.6.2013 Rienso Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark EU/1/12/774 13.6.2013 11.6.2013 Zoely Theramex S.r.l. Via Messina 38, 20154 Milano, Italia EU/1/11/690 18.6.2013 13.6.2013 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom. EU/1/04/276 17.6.2013 13.6.2013 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430 17.6.2013 13.6.2013 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/07/391 17.6.2013 13.6.2013 Tysabri Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/06/346 17.6.2013 21.6.2013 Bridion Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland EU/1/08/466 25.6.2013 21.6.2013 Brinavess Cardiome UK Limited Sherborne House, 119-121 Cannon Street, 3rd Floor, London EC4N 5AT, United Kingdom EU/1/10/645 25.6.2013 21.6.2013 EDURANT Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/736 25.6.2013 21.6.2013 Eviplera Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/11/737 25.6.2013 21.6.2013 Intelence Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/468 25.6.2013 21.6.2013 Javlor Pierre Fabre Médicament 45, place Abel Gance, F-92100 Boulogne, France EU/1/09/550 25.6.2013 21.6.2013 Osseor Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/04/287 25.6.2013 21.6.2013 Protelos Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France EU/1/04/288 25.6.2013 21.6.2013 Reyataz Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/03/267 25.6.2013 21.6.2013 Xenical Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/071 25.6.2013 21.6.2013 Zerit Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/96/009 25.6.2013 27.6.2013 Glivec Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/01/198 1.7.2013 27.6.2013 Levodopa/Carbidopa/Entacapone Orion Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/706 1.7.2013 27.6.2013 Rasilamlo Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/686 1.7.2013 27.6.2013 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405 1.7.2013 27.6.2013 Vivanza Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/03/249 1.7.2013 1.7.2013 Ariclaim Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/283 3.7.2013 1.7.2013 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/03/261 3.7.2013 1.7.2013 Fampyra Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/11/699 3.7.2013 1.7.2013 Intelence Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/468 3.7.2013 1.7.2013 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/06/380 3.7.2013 1.7.2013 Rasilez HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/491 3.7.2013 1.7.2013 Replagal Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige EU/1/01/189 3.7.2013 1.7.2013 Stocrin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/99/111 3.7.2013 1.7.2013 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/99/110 3.7.2013 1.7.2013 Trobalt Glaxo Group Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/11/681 3.7.2013 1.7.2013 Truvada Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/04/305 3.7.2013 1.7.2013 Viread Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/01/200 3.7.2013 1.7.2013 Votrient Glaxo Group Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/10/628 3.7.2013 1.7.2013 Yentreve Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/280 3.7.2013 4.7.2013 Cymbalta Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/296 8.7.2013 4.7.2013 Lucentis Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/374 8.7.2013 4.7.2013 Rasitrio Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/730 8.7.2013 4.7.2013 Xeristar Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland EU/1/04/297 8.7.2013 9.7.2013 Prevenar 13 Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/590 11.7.2013 9.7.2013 Tysabri Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/06/346 11.7.2013 15.7.2013 Benlysta Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom EU/1/11/700 17.7.2013 15.7.2013 Onduarp Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/11/729 17.7.2013 15.7.2013 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/08/442 17.7.2013 15.7.2013 Votubia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/710 17.7.2013 17.7.2013 Iscover Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/98/070 19.7.2013 17.7.2013 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France EU/1/98/069 19.7.2013 17.7.2013 Votubia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/710 19.7.2013 19.7.2013 Clopidogrel Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/08/465 23.7.2013 19.7.2013 DuoPlavin Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France EU/1/10/619 23.7.2013 19.7.2013 Ratiograstim ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/444 23.7.2013 19.7.2013 Tevagrastim Teva GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/445 23.7.2013 19.7.2013 Thalidomide Celgene Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/08/443 23.7.2013 25.7.2013 Aranesp Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/01/185 29.7.2013 25.7.2013 Biograstim CT Arzneimittel GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/08/450 29.7.2013 25.7.2013 Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstraße 3, D-20354 Hamburg, Deutschland EU/1/10/637 29.7.2013 25.7.2013 Remicade Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland EU/1/99/116 29.7.2013 25.7.2013 Tyverb Glaxo Group Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/440 29.7.2013 25.7.2013 Vectibix Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/07/423 29.7.2013 25.7.2013 Zytiga Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/714 29.7.2013 26.7.2013 BYDUREON Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/696 31.7.2013 26.7.2013 DuoCover Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/10/623 31.7.2013 26.7.2013 Eucreas Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/425 30.7.2013 26.7.2013 Evicel Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België EU/1/08/473 30.7.2013 26.7.2013 Iscover Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/98/070 31.7.2013 26.7.2013 Onglyza Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/09/545 30.7.2013 26.7.2013 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France EU/1/98/069 30.7.2013 26.7.2013 Rasilez Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/405 31.7.2013 26.7.2013 Rasitrio Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/11/730 30.7.2013 26.7.2013 Teysuno Nordic Group B.V. Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland EU/1/11/669 31.7.2013 31.7.2013 Aprovel Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France EU/1/97/046 5.8.2013 31.7.2013 CoAprovel Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France EU/1/98/086 5.8.2013 31.7.2013 Copalia Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/372 2.8.2013 31.7.2013 Copalia HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/575 5.8.2013 31.7.2013 Dafiro Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/371 5.8.2013 31.7.2013 Dafiro HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/574 2.8.2013 31.7.2013 Exforge Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/370 5.8.2013 31.7.2013 Exforge HCT Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/09/569 2.8.2013 31.7.2013 Galvus Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/07/414 5.8.2013 31.7.2013 Icandra Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/484 5.8.2013 31.7.2013 Imprida Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/06/373 5.8.2013 31.7.2013 Irbesartan HCT Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/06/377 2.8.2013 31.7.2013 Irbesartan Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/06/376 5.8.2013 31.7.2013 Jalra Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/485 5.8.2013 31.7.2013 Karvea Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/97/049 2.8.2013 31.7.2013 Karvezide Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/98/085 2.8.2013 31.7.2013 Leganto UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland EU/1/11/695 2.8.2013 31.7.2013 Neupro UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland EU/1/05/331 2.8.2013 31.7.2013 ProQuad Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France EU/1/05/323 2.8.2013 31.7.2013 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/04/274 5.8.2013 31.7.2013 Vimpat UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/08/470 5.8.2013 31.7.2013 Xiliarx Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/486 5.8.2013 31.7.2013 Zomarist Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom EU/1/08/483 2.8.2013





— 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 6.6.2013 Sepioglin Vaia S.A. 1, 28 Octovriou str., Ag. Varvara 123 51, Athens, Ελλάδα EU/1/12/754 10.6.2013





— Lift of suspension of a marketing authorization (Article 20 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 17.7.2013 Ribavirin Teva Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/509 19.7.2013 17.7.2013 Ribavirin Teva Pharma BV Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland EU/1/09/527 19.7.2013





— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2) ): 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 6.6.2013 Equilis West Nile Inactivated chimeric flavivirus strain YF-WN Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/13/151 Suspension for injection QI05AA10 10.6.2013 12.7.2013 ProZinc Insulin human Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/2/13/152 Suspension for injection QA10AC01 16.7.2013 15.7.2013 Aftovaxpur Doe purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/13/153 Emulsion for injection QI02AA04 17.7.2013





— 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 6.6.2013 Equioxx Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/08/083 11.6.2013 13.6.2013 Contacera Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/12/144 17.6.2013 9.7.2013 Suvaxyn Aujeszky 783 + O/W Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/98/009 11.7.2013 15.7.2013 Reconcile Eli Lilly and Company Ltd Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/08/080 19.7.2013 15.7.2013 Zactran Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/08/082 17.7.2013 26.7.2013 Zulvac 1+8 Ovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique EU/2/11/120 30.7.2013





— Withdrawal of a marketing authorization (Article 38 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 21.6.2013 Ibaflin Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/00/022 25.6.2013

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 UK-LONDON E14 4H

(1) OJ L 136, 30.4.2004, p. 1.

(2) OJ L 136, 30.4.2004, p. 1.