Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2017 to 31 August 2017 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) 2017/C 328/01

Version 2017-07-01

Grade B

mapped from publisher markup. A grade says how a document's structure was obtained, not how reliable the law is.

Not the law itself: Notice

Ask Gelex about this law

Address https://gelex.eu/eli/EU/notice/oj/C/2017/328/01@2017-07-01/en

Contents

Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Issuing of a marketing authorisation (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 authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 6.7.2017 OXERVATE cenegermin Dompé farmaceutici S.p.A. Via Santa Lucia 6, 20122 Milano, Italia EU/1/17/1197 Eye drops, solution Pending 10.7.2017 10.7.2017 Spherox spheroids of human autologous matrix-associated chondrocytes CO.DON AG Warthestraße 21, 14513 Teltow, Deutschland EU/1/17/1181 Implantation suspension M09AX02 12.7.2017 13.7.2017 Blitzima rituximab Celltrion Healthcare Hungary Kft. 1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország EU/1/17/1205 Concentrate for solution for infusion L01XC02 17.7.2017 13.7.2017 Reagila cariprazine Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország EU/1/17/1209 Capsule, hard N05AX15 17.7.2017 13.7.2017 Ritemvia rituximab Celltrion Healthcare Hungary Kft. 1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország EU/1/17/1207 Concentrate for solution for infusion L01XC02 17.7.2017 13.7.2017 Tuxella rituximab Celltrion Healthcare Hungary Kft. 1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország EU/1/17/1206 Concentrate for solution for infusion L01XC02 17.7.2017 17.7.2017 Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva efavirenz/emtricitabine/tenofovir disoproxil Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/17/1210 Film-coated tablet J05AR06 19.7.2017 17.7.2017 Kyntheum brodalumab Leo Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark EU/1/16/1155 Solution for injection L04AC12 19.7.2017 17.7.2017 Trimbow beclometasone/formoterol/glycopyrronium bromide Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/17/1208 Pressurised inhalation, solution R03AL09 19.7.2017 19.7.2017 Insulin lispro Sanofi insulin lispro Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/17/1203 Solution for injection A10AB04 21.7.2017 19.7.2017 Veltassa patiromer Vifor Fresenius Medical Care Renal Pharma France 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France EU/1/17/1179 Powder for oral suspension V03AE09 21.7.2017 26.7.2017 Maviret glecaprevir/pibrentasvir AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/17/1213 Film-coated tablet J05AX 28.7.2017 26.7.2017 Vosevi sofosbuvir/velpatasvir/voxilaprevir Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/17/1223 Film-coated tablet Pending 28.7.2017 26.7.2017 Zykadia ceritinib Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/999 Capsule, hard L01XE28 28.7.2017 22.8.2017 Kisqali ribociclib Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/17/1221 Film-coated tablet L01XE42 24.8.2017 22.8.2017 MAVENCLAD cladribine Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/17/1212 Tablet L01BB04 24.8.2017 24.8.2017 Fotivda tivozanib EUSA Pharma (UK) Limited Breakspear Park, Breakspear Way, HP2 4TZ, Hemel Hempstead, United Kingdom EU/1/17/1215 Capsule, hard L01XE34 29.8.2017 24.8.2017 Imraldi adalimumab Samsung Bioepis UK Limited 5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom EU/1/17/1216 Solution for injection L04AB04 29.8.2017 24.8.2017 Nitisinone MendeliKABS nitisinone MendeliKABS Europe Limited Office 7, Gateway 1000, Whittle Way, Stevenage, Hertfordshire, SG1 2FP, United Kingdom EU/1/17/1217 Capsule, hard A16AX04 29.8.2017

Modification of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 6.7.2017 Celsentri ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/07/418 10.7.2017 6.7.2017 Clopidogrel Krka d.d. Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/562 10.7.2017 6.7.2017 Imlygic Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/1064 10.7.2017 6.7.2017 Kivexa ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/04/298 10.7.2017 6.7.2017 Nexavar Bayer AG D-51368 Leverkusen, Deutschland EU/1/06/342 10.7.2017 6.7.2017 Toviaz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/386 10.7.2017 10.7.2017 Memantine Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/880 12.7.2017 10.7.2017 Myozyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/333 12.7.2017 10.7.2017 Xeloda Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/00/163 12.7.2017 13.7.2017 Edistride AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/15/1052 17.7.2017 13.7.2017 Enurev Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/789 17.7.2017 13.7.2017 Eylea Bayer AG D-51368 Leverkusen, Deutschland EU/1/12/797 17.7.2017 13.7.2017 Incruse Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/922 17.7.2017 13.7.2017 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436 17.7.2017 13.7.2017 Kuvan BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland EU/1/08/481 17.7.2017 13.7.2017 Latuda Sunovion Pharmaceuticals Europe Ltd First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom EU/1/14/913 17.7.2017 13.7.2017 Lixiana Daiichi Sankyo Europe GmbH Zielstattstrasse 48, D-81379 München, Deutschland EU/1/15/993 17.7.2017 13.7.2017 Memantine Merz Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland EU/1/12/799 17.7.2017 13.7.2017 Picato LEO Laboratories Ltd. 285 Cashel Road, Crumlin, Dublin 12, Ireland EU/1/12/796 17.7.2017 13.7.2017 Praxbind Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/15/1056 17.7.2017 13.7.2017 Torisel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/424 17.7.2017 13.7.2017 Xaluprine Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom EU/1/11/727 17.7.2017 13.7.2017 Xultophy Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/14/947 17.7.2017 13.7.2017 Zalmoxis MolMed S.p.A. Via Olgettina 58, I-20132 Milano, Italia EU/1/16/1121 17.7.2017 13.7.2017 Zoledronic acid Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/834 17.7.2017 14.7.2017 Zinbryta Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/16/1107 18.7.2017 17.7.2017 Dinutuximab beta Apeiron EUSA Pharma (UK) Limited Breakspear Park, Breakspear Way, HP2 4TZ, Hemel Hempstead, United Kingdom EU/1/17/1191 19.7.2017 17.7.2017 Inhixa Techdow Europe AB Kåbovägen 32, 75236 Uppsala, Sverige EU/1/16/1132 20.7.2017 17.7.2017 Opsumit Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/13/893 19.7.2017 17.7.2017 Rivastigmine Sandoz Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/09/599 19.7.2017 17.7.2017 Thorinane Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Nederland EU/1/16/1131 19.7.2017 17.7.2017 Zinforo Pfizer Ireland Pharmaceuticals Operations Services Group, Ringaskiddy, County Cork, Ireland EU/1/12/785 19.7.2017 19.7.2017 Clopidogrel BGR Laboratoires BIOGARAN 15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France EU/1/09/558 21.7.2017 19.7.2017 Clopidogrel Krka Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/556 21.7.2017 19.7.2017 Clopidogrel TAD TAD Pharma GmbH Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland EU/1/09/555 21.7.2017 19.7.2017 Cuprymina SPARKLE S.r.l. Località Cavallino, 62010 Montecosaro (MC), Italia EU/1/12/784 24.7.2017 19.7.2017 Forxiga AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/795 24.7.2017 19.7.2017 Grepid Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/09/535 21.7.2017 19.7.2017 Harvoni Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/958 24.7.2017 19.7.2017 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/930 21.7.2017 19.7.2017 Ofev Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/979 21.7.2017 19.7.2017 Qtern AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/16/1108 24.7.2017 19.7.2017 Raxone Santhera Pharmaceuticals (Deutschland) GmbH Marie-Curie Strasse 8, D-79539 Lörrach, Deutschland EU/1/15/1020 24.7.2017 19.7.2017 Revolade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/612 21.7.2017 19.7.2017 Seebri Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/788 21.7.2017 19.7.2017 Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/15/1003 21.7.2017 19.7.2017 Tracleer Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220 21.7.2017 19.7.2017 Zavesca Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/238 21.7.2017 19.7.2017 Zavicefta Pfizer Ireland Pharmaceuticals Operations Services Group, Ringaskiddy, County Cork, Ireland EU/1/16/1109 24.7.2017 25.7.2017 Faslodex AstraZeneca UK Limited Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom EU/1/03/269 27.7.2017 25.7.2017 Granupas Lucane Pharma 172 rue de Charonne, 75011 Paris, France EU/1/13/896 27.7.2017 25.7.2017 Olanzapine Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/08/475 31.7.2017 25.7.2017 Orencia Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/07/389 27.7.2017 25.7.2017 Rivastigmine 1 A Pharma 1 A Pharma GmbH Keltenring 1 + 3, D-82041 Oberhaching, Deutschland EU/1/09/585 28.7.2017 25.7.2017 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529 27.7.2017 25.7.2017 Voncento CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/13/857 28.7.2017 26.7.2017 Aripiprazole Mylan Pharma Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/15/1005 28.7.2017 26.7.2017 Bridion Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/466 28.7.2017 26.7.2017 Kaletra AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/01/172 28.7.2017 26.7.2017 Oprymea Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/469 28.7.2017 26.7.2017 Tovanor Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/790 28.7.2017 26.7.2017 Velphoro Vifor Fresenius Medical Care Renal Pharma France 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France EU/1/14/943 28.7.2017 26.7.2017 Votubia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/710 28.7.2017 26.7.2017 Yellox PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika EU/1/11/692 28.7.2017 2.8.2017 Stivarga Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/858 4.8.2017 2.8.2017 Zyllt Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/553 4.8.2017 3.8.2017 Abilify Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/04/276 17.8.2017 3.8.2017 Apidra Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/04/285 7.8.2017 7.8.2017 Colobreathe Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/747 9.8.2017 7.8.2017 Nordimet Nordic Group B.V. Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland EU/1/16/1124 9.8.2017 7.8.2017 Stivarga Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/858 9.8.2017 14.8.2017 Exjade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/356 17.8.2017 14.8.2017 Mekinist Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/14/931 18.8.2017 14.8.2017 Soliris Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France EU/1/07/393 17.8.2017 14.8.2017 Vargatef Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/954 17.8.2017 14.8.2017 Xofigo Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/873 17.8.2017 22.8.2017 CoAprovel Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France EU/1/98/086 24.8.2017 22.8.2017 Ketoconazole HRA Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/14/965 24.8.2017 22.8.2017 Rasilez Noden Pharma DAC D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland EU/1/07/405 24.8.2017 22.8.2017 SonoVue Bracco International B.V. Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland EU/1/01/177 24.8.2017 22.8.2017 Xarelto Bayer AG D-51368 Leverkusen, Deutschland EU/1/08/472 24.8.2017 24.8.2017 Aranesp Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/01/185 28.8.2017 24.8.2017 BYDUREON AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/696 28.8.2017 24.8.2017 Dacogen Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/12/792 28.8.2017 24.8.2017 EDURANT Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/736 28.8.2017 24.8.2017 Fluenz Tetra AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/13/887 28.8.2017 24.8.2017 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/945 28.8.2017 24.8.2017 Invega Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/07/395 28.8.2017 24.8.2017 Kaletra AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/01/172 29.8.2017 24.8.2017 Karvezide Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/98/085 28.8.2017 24.8.2017 KEYTRUDA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1024 29.8.2017 24.8.2017 Norvir AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/96/016 29.8.2017 24.8.2017 Orkambi Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/15/1059 29.8.2017 24.8.2017 Ruconest Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland EU/1/10/641 28.8.2017 24.8.2017 Zoledronic acid Hospira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/12/800 29.8.2017 28.8.2017 Constella Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland EU/1/12/801 30.8.2017 28.8.2017 Ecalta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/416 30.8.2017 28.8.2017 Forxiga AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/795 30.8.2017 28.8.2017 Irbesartan HCT Zentiva Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/06/377 30.8.2017 28.8.2017 Mimpara Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/04/292 30.8.2017 28.8.2017 Rasilez HCT Noden Pharma DAC D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland EU/1/08/491 30.8.2017

Withdrawal of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 19.7.2017 Enzepi Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland EU/1/16/1113 21.7.2017 19.7.2017 Repso Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/674 21.7.2017

Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Modification of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 10.7.2017 Onsior Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/08/089 12.7.2017 14.7.2017 Nobilis IB Primo QX Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/14/174 18.7.2017 14.7.2017 Zolvix Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/09/101 18.7.2017 19.7.2017 Aivlosin ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom EU/2/04/044 21.7.2017 28.7.2017 Loxicom Norbrook Laboratories Ltd Station Works, Newry, Co. Down, BT35 6JP, United Kindgom EU/2/08/090 1.8.2017 28.7.2017 Vaxxitek HVT + IBD Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/02/032 1.8.2017 3.8.2017 BLUEVAC BTV8 CZ Veterinaria, S.A. La Relva s/n, 36400 Porriño, España EU/2/11/122 7.8.2017 10.8.2017 Canigen L4 Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/15/183 14.8.2017 Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact: European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

Versions

2017-07-01