Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2018 to 30 April 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2018-06-01
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2018188EN.01000101.xml










1.6.2018   


EN


Official Journal of the European Union


C 188/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2018 to 30 April 2018
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2018/C 188/01)






—



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




13.4.2018


Alpivab


peramivir


BioCryst UK Ltd
c/o Morgan Lewis & Bockius, Condor House, 5-10 St. Paul’s Churchyard, London EC4M 8AL, United Kingdom


EU/1/18/1269


Concentrate for solution for infusion


J05AH03


17.4.2018




19.4.2018


Mylotarg


gemtuzumab ozogamicin


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/18/1277


Powder for concentrate for solution for infusion


L01XC05


23.4.2018




23.4.2018


Riarify


beclometasone/formoterol/glycopyrronium bromide


Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/18/1275


Pressurised inhalation, solution


R03AL


26.4.2018




26.4.2018


Trydonis


beclometasone/formoterol/glycopyrronium bromide


Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/18/1274


Pressurised inhalation, solution


R03AL


2.5.2018










—



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




6.4.2018


EnCyzix


Renable Pharma Limited
20-22 Bedford Row, London WC1R 4JS, United Kingdom


—


23.4.2018










—



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




4.4.2018


Bondronat


Atnahs Pharma UK Limited
Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom


EU/1/96/012


6.4.2018




4.4.2018


Bonviva


Atnahs Pharma UK Limited
Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom


EU/1/03/265


6.4.2018




4.4.2018


Esbriet


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/11/667


6.4.2018




4.4.2018


Kinzalmono


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/98/091


6.4.2018




4.4.2018


Lacosamide Accord


Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom


EU/1/17/1230


6.4.2018




4.4.2018


Lumark


IDB Holland B.V.
Weverstraat 17, 5111 PV Baarle-Nassau, Nederland


EU/1/15/1013


6.4.2018




4.4.2018


Marixino


KRKA, d.d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/13/820


6.4.2018




4.4.2018


Pandemic influenza vaccine H5N1 AstraZeneca


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/16/1089


6.4.2018




4.4.2018


Tecentriq


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/17/1220


6.4.2018




6.4.2018


Fuzeon


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/03/252


10.4.2018




6.4.2018


Gazyvaro


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/14/937


10.4.2018




6.4.2018


Herceptin


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/00/145


10.4.2018




6.4.2018


Kineret


Swedish Orphan Biovitrum AB (publ)
112 76 Stockholm, Sverige


EU/1/02/203


10.4.2018




6.4.2018


Revolade


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/10/612


10.4.2018




6.4.2018


RoActemra


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/08/492


10.4.2018




6.4.2018


Tamiflu


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/02/222


10.4.2018




6.4.2018


Tarceva


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/05/311


10.4.2018




6.4.2018


Zelboraf


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/12/751


10.4.2018




12.4.2018


Actraphane


Novo Nordisk A/S
Novo Allé, 2880 Bagsværd, Danmark


EU/1/02/229


16.4.2018




12.4.2018


Actrapid


Novo Nordisk A/S
Novo Allé, 2880 Bagsværd, Danmark


EU/1/02/230


16.4.2018




12.4.2018


Azopt


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/00/129


16.4.2018




12.4.2018


Extavia


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/08/454


16.4.2018




12.4.2018


Farydak


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/15/1023


16.4.2018




12.4.2018


Ferriprox


Apotex Europe B.V.
Darwinweg 20, 2333 CR Leiden, Nederland


EU/1/99/108


16.4.2018




12.4.2018


Fiasp


Novo Nordisk A/S
Novo Allé, 2880 Bagsværd, Danmark


EU/1/16/1160


16.4.2018




12.4.2018


Forxiga


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/12/795


16.4.2018




12.4.2018


Galafold


Amicus Therapeutics UK Ltd
Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom


EU/1/15/1082


16.4.2018




12.4.2018


Icandra


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/08/484


16.4.2018




12.4.2018


Kinzalkomb


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/02/214


16.4.2018




12.4.2018


Kisqali


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/17/1221


16.4.2018




12.4.2018


Lumigan


Allergan Pharmaceuticals Ireland
Castlebar Road, Westport, County Mayo, Ireland


EU/1/02/205


16.4.2018




12.4.2018


Mekinist


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/14/931


16.4.2018




12.4.2018


Neparvis


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/16/1103


16.4.2018




12.4.2018


Pemetrexed Lilly


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/15/1034


16.4.2018




12.4.2018


Ravicti


Horizon Pharma Ireland Limited
Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland


EU/1/15/1062


16.4.2018




12.4.2018


RoActemra


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/08/492


16.4.2018




12.4.2018


Sebivo


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/07/388


16.4.2018




12.4.2018


Sialanar


Proveca Limited
Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom


EU/1/16/1135


17.4.2018




12.4.2018


Signifor


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/12/753


16.4.2018




12.4.2018


Simulect


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/98/084


16.4.2018




12.4.2018


Sylvant


Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België


EU/1/14/928


16.4.2018




12.4.2018


Tadalafil Mylan


Generics [UK] Limited
Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom


EU/1/14/961


16.4.2018




12.4.2018


Vidaza


Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom


EU/1/08/488


16.4.2018




12.4.2018


Zomarist


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/08/483


16.4.2018




13.4.2018


Bretaris Genuair


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/12/781


17.4.2018




13.4.2018


Eklira Genuair


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/12/778


17.4.2018




13.4.2018


Memantine ratiopharm


ratiopharm GmbH
Graf-Arco-Straße 3, 89079 Ulm, Deutschland


EU/1/13/836


17.4.2018




13.4.2018


Pritor


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/98/089


17.4.2018




13.4.2018


PritorPlus


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/02/215


17.4.2018




13.4.2018


Sialanar


Proveca Limited
Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom


EU/1/16/1135


17.4.2018




13.4.2018


Travatan


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/01/199


17.4.2018




19.4.2018


Aclasta


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/05/308


23.4.2018




19.4.2018


Azarga


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/08/482


23.4.2018




19.4.2018


Blincyto


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/15/1047


23.4.2018




19.4.2018


Comtan


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/98/081


23.4.2018




19.4.2018


Deltyba


Otsuka Novel Products GmbH
Erika-Mann-Straße 21, 80636 München, Deutschland


EU/1/13/875


23.4.2018




19.4.2018


Descovy


Gilead Sciences International Limited
Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom


EU/1/16/1099


23.4.2018




19.4.2018


Exjade


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/06/356


23.4.2018




19.4.2018


Imatinib Accord


Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom


EU/1/13/845


23.4.2018




19.4.2018


Imatinib Medac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6, 22880 Wedel, Deutschland


EU/1/13/876


23.4.2018




19.4.2018


Kyprolis


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/15/1060


23.4.2018




19.4.2018


Movymia


STADA Arzneimittel AG
Stadastraße 2-18, 61118 Bad Vilbel, Deutschland


EU/1/16/1161


23.4.2018




19.4.2018


Natpar


Shire Pharmaceuticals Ireland Limited
5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/15/1078


23.4.2018




19.4.2018


Opatanol


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/02/217


23.4.2018




19.4.2018


Peyona


Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/09/528


23.4.2018




19.4.2018


Repatha


Amgen Europe B.V.
Minervum 7061, 4817 ZK Breda, Nederland


EU/1/15/1016


23.4.2018




19.4.2018


Simbrinza


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/14/933


23.4.2018




19.4.2018


Stribild


Gilead Sciences International Limited
Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom


EU/1/13/830


23.4.2018




19.4.2018


Suliqua


Sanofi-Aventis groupe
54 rue La Boétie, 75008 Paris, France


EU/1/16/1157


23.4.2018




19.4.2018


Sutent


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/06/347


23.4.2018




19.4.2018


Volibris


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/08/451


23.4.2018




19.4.2018


Xadago


Zambon S.p.A.
Via Lillo del Duca 10, 20 091 Bresso (MI), Italia


EU/1/14/984


23.4.2018




19.4.2018


Yargesa


JensonR+ Limited
Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom


EU/1/17/1176


23.4.2018




23.4.2018


Aerinaze


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/07/399


25.4.2018




23.4.2018


Bosulif


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/13/818


25.4.2018




23.4.2018


Daxas


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/10/636


25.4.2018




23.4.2018


Desloratadine Actavis


Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland


EU/1/11/745


25.4.2018




23.4.2018


Duloxetine Zentiva


Zentiva, k.s.
U Kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/15/1028


25.4.2018




23.4.2018


Emadine


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/98/095


25.4.2018




23.4.2018


Entresto


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/15/1058


25.4.2018




23.4.2018


Eucreas


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/07/425


25.4.2018




23.4.2018


Exelon


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/98/066


25.4.2018




23.4.2018


Fycompa


Eisai Europe Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom


EU/1/12/776


25.4.2018




23.4.2018


GILENYA


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/11/677


25.4.2018




23.4.2018


Humira


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/03/256


25.4.2018




23.4.2018


Hycamtin


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/96/027


25.4.2018




23.4.2018


Imnovid


Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom


EU/1/13/850


25.4.2018




23.4.2018


Imvanex


Bavarian Nordic A/S
Hejreskovvej 10a, 3490 Kvistgaard, Danmark


EU/1/13/855


25.4.2018




23.4.2018


Lojuxta


Aegerion Pharmaceuticals Limited
Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom


EU/1/13/851


25.4.2018




23.4.2018


NeuroBloc


Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom


EU/1/00/166


25.4.2018




23.4.2018


Nevanac


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/07/433


25.4.2018




23.4.2018


Onbrez Breezhaler


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/09/593


25.4.2018




23.4.2018


Opdivo


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/15/1014


25.4.2018




23.4.2018


Pregabalin Zentiva


Zentiva, k.s.
U Kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/15/1021


25.4.2018




23.4.2018


Spedra


Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg


EU/1/13/841


25.4.2018




23.4.2018


TOBI Podhaler


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/10/652


25.4.2018




23.4.2018


Viread


Gilead Sciences International Limited
Cambridge CB21 6GT United Kingdom


EU/1/01/200


25.4.2018




23.4.2018


Zydelig


Gilead Sciences International Limited
Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom


EU/1/14/938


25.4.2018




23.4.2018


Zykadia


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/15/999


25.4.2018




26.4.2018


Aloxi


Helsinn Birex Pharmaceuticals Ltd
Damastown, Mulhuddart, Dublin 15, Ireland


EU/1/04/306


30.4.2018




26.4.2018


Avonex


Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom


EU/1/97/033


30.4.2018




26.4.2018


Cosentyx


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/14/980


30.4.2018




26.4.2018


Elonva


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/09/609


30.4.2018




26.4.2018


Firazyr


Shire Orphan Therapies GmbH
Friedrichstraße 149, 10117 Berlin, Deutschland


EU/1/08/461


30.4.2018




26.4.2018


Galvus


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/07/414


30.4.2018




26.4.2018


Jalra


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/08/485


30.4.2018




26.4.2018


Lucentis


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/06/374


30.4.2018




26.4.2018


Maviret


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/17/1213


30.4.2018




26.4.2018


Tasigna


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/07/422


30.4.2018




26.4.2018


Truxima


Celltrion Healthcare Hungary Kft.
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország


EU/1/16/1167


2.5.2018




26.4.2018


Voncento


CSL Behring GmbH
Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland


EU/1/13/857


30.4.2018




26.4.2018


Xiliarx


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/08/486


30.4.2018




26.4.2018


Xolair


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/05/319


30.4.2018




26.4.2018


Zometa


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/01/176


30.4.2018




30.4.2018


Avamys


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/07/434


3.5.2018




30.4.2018


Clopidogrel Zentiva


Zentiva, k.s.
U Kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/08/465


3.5.2018




30.4.2018


Entresto


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/15/1058


3.5.2018




30.4.2018


Hemlibra


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/18/1271


3.5.2018




30.4.2018


Perjeta


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/13/813


3.5.2018




30.4.2018


Pramipexole Teva


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/08/490


3.5.2018




30.4.2018


Remsima


Celltrion Healthcare Hungary Kft.
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország


EU/1/13/853


3.5.2018




30.4.2018


Rydapt


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/17/1218


3.5.2018










—



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




13.4.2018


Clevor


Ropinirole


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/2/17/222


Eye drops, solution


QN04BC04


17.4.2018










—



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




4.4.2018


Convenia


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


EU/2/06/059


6.4.2018




4.4.2018


Stronghold


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


EU/2/99/014


6.4.2018




4.4.2018


Zulvac 1 Bovis


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


EU/2/11/130


6.4.2018




4.4.2018


Zulvac 1 Ovis


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


EU/2/11/131


6.4.2018




4.4.2018


Zulvac 8 Bovis


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


EU/2/09/105


6.4.2018




6.4.2018


Apoquel


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


EU/2/13/154


10.4.2018




6.4.2018


Stronghold Plus


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


EU/2/16/204


10.4.2018




11.4.2018


Zulvac 8 Ovis


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


EU/2/09/104


13.4.2018




13.4.2018


Equip WNV


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


EU/2/08/086


17.4.2018




13.4.2018


ProZinc


Boehringer Ingelheim Vetmedica GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland


EU/2/13/152


17.4.2018




16.4.2018


BTVPUR


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/10/113


18.4.2018




16.4.2018


Equilis West Nile


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


EU/2/13/151


18.4.2018




20.4.2018


Meloxidolor


Le Vet Beheer B.V.
Wilgenweg 7, 3421 TV Oudewater, Nederland


EU/2/13/148


24.4.2018




26.4.2018


Naxcel


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


EU/2/05/053


30.4.2018




26.4.2018


Onsior


Elanco Europe Ltd
Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom


EU/2/08/089


30.4.2018










—



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




26.4.2018


CERTIFECT


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/11/125


30.4.2018




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.