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)
Date: 2017-09-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2017328EN.01000101.xml










29.9.2017   


EN


Official Journal of the European Union


C 328/1





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 (1))
(2017/C 328/01)






—



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

















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




17.8.2017


VEPURED



E. coli verotoxoid vaccine (inactivated recombinant)


Laboratorios Hipra, S.A.
Avda. La Selva, 135, 17170 Amer (Girona), España


EU/2/17/214


Suspension for injection


QI09AB02


21.8.2017




18.8.2017


Exzolt


fluralaner


Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland


EU/2/17/212


Solution for use in drinking water


QP53BE02


22.8.2017




22.8.2017


Innovax-ND-IBD


Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant)


Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland


EU/2/17/213


Suspension and solvent for suspension for injection


QI01AD


24.8.2017




24.8.2017


Suvaxyn PRRS MLV


Porcine respiratory and reproductive syndrome virus vaccine (live)


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/17/215


Lyophilisate and solvent for suspension for injection


QI09AD03


28.8.2017










—



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






(1)  OJ L 136, 30.4.2004, p. 1.