Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2018 to 31 August 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2018-09-28
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2018349EN.01000101.xml










28.9.2018   


EN


Official Journal of the European Union


C 349/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2018 to 31 August 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 349/01)






—



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




23.8.2018


Duzallo


allopurinol/lesinurad


Grünenthal GmbH
Zieglerstraße 6, 52078, Aachen, Deutschland


EU/1/18/1300


Film-coated tablet


M04AA51


27.8.2018




23.8.2018


Kymriah


tisagenlecleucel


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


EU/1/18/1297


Dispersion for infusion


Pending


27.8.2018




23.8.2018


Mepsevii


vestronidase alfa


Ultragenyx Germany GmbH
Friedrichstraße 191, 10117 Berlin, Deutschland


EU/1/18/1301


Concentrate for solution for infusion


A16AB18


27.8.2018




23.8.2018


Vyxeos


daunorubicin/cytarabine


Jazz Pharmaceuticals Ireland Ltd
5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland


EU/1/18/1308


Powder for concentrate for solution for infusion


L01XY01


27.8.2018




23.8.2018


Yescarta


axicabtagene ciloleucel


Kite Pharma EU B.V.
Science Park 408, 1098 XH Amsterdam, Nederland


EU/1/18/1299


Dispersion for infusion


L01X


27.8.2018




27.8.2018


Onpattro


patisiran


Alnylam Netherlands B.V.
Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland


EU/1/18/1320


Concentrate for solution for infusion


Pending


29.8.2018




27.8.2018


Ulipristal Acetate Gedeon Richter


Ulipristal Acetate


Gedeon Richter Plc.
Gyömrői út 19-21., 1103 Budapest, Magyarország


EU/1/18/1309


Tablet


G03XB02


29.8.2018




31.8.2018


Cablivi


caplacizumab


Ablynx N.V.
Technologiepark 21, 9052 Zwijnaarde, België


EU/1/18/1305


Powder and solvent for solution for injection


B01AX07


4.9.2018




31.8.2018


Nerlynx


neratinib


Puma Biotechnology, Ltd
11th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, United Kingdom


EU/1/18/1311


Film-coated tablet


L01XE45


4.9.2018




31.8.2018


VEYVONDI


vonicog alfa


Baxalta Innovations GmbH
Industriestraße 67, 1221 Wien, Österreich


EU/1/18/1298


Powder and solvent for solution for injection


B02BD10


4.9.2018










—



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




2.8.2018


Avonex


Biogen Netherlands B.V.
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland


EU/1/97/033


6.8.2018




2.8.2018


Bosulif


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/13/818


6.8.2018




2.8.2018


Cetrotide


Merck Europe B.V.
Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland


EU/1/99/100


6.8.2018




2.8.2018


Conbriza


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/09/511


6.8.2018




2.8.2018


Dexdor


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/1/11/718


6.8.2018




2.8.2018


DUAVIVE


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/14/960


6.8.2018




2.8.2018


Fampyra


Biogen Netherlands B.V.
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland


EU/1/11/699


6.8.2018




2.8.2018


Insulin lispro Sanofi


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


EU/1/17/1203


6.8.2018




2.8.2018


KEYTRUDA


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/15/1024


6.8.2018




2.8.2018


Kyntheum


Leo Pharma A/S
Industriparken 55, 2750 Ballerup, Danmark


EU/1/16/1155


6.8.2018




2.8.2018


Onglyza


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/09/545


6.8.2018




2.8.2018


Otezla


Celgene Europe B.V.
Winthontlaan 6 N, 3526 KV Utrecht, Nederland


EU/1/14/981


6.8.2018




2.8.2018


Rapamune


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


EU/1/01/171


6.8.2018




2.8.2018


ReFacto AF


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/99/103


6.8.2018




2.8.2018


Siklos


Addmedica
37 rue de Caumartin, 75009 Paris, France


EU/1/07/397


6.8.2018




2.8.2018


Temomedac


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


EU/1/09/605


6.8.2018




2.8.2018


Tepadina


ADIENNE S.r.l.
Via Galileo Galilei 19, 20867 Caponago (MB), Italia


EU/1/10/622


6.8.2018




2.8.2018


Tysabri


Biogen Netherlands B.V.
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland


EU/1/06/346


6.8.2018




2.8.2018


Zoledronic acid Accord


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


EU/1/13/834


6.8.2018




3.8.2018


Accofil


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


EU/1/14/946


7.8.2018




3.8.2018


Brimica Genuair


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/14/963


7.8.2018




3.8.2018


Crixivan


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/96/024


7.8.2018




3.8.2018


Duaklir Genuair


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/14/964


7.8.2018




3.8.2018


Duloxetine Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/15/1010


7.8.2018




3.8.2018


Inlyta


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/12/777


7.8.2018




3.8.2018


Inovelon


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


EU/1/06/378


7.8.2018




3.8.2018


Memantine Accord


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


EU/1/13/880


7.8.2018




3.8.2018


Numient


Amneal Pharma Europe Ltd
70 Sir John Rogerson’s Quay, Dublin 2, Ireland


EU/1/15/1044


7.8.2018




3.8.2018


Ribavirin Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/10/634


7.8.2018




3.8.2018


Tadalafil Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/14/961


7.8.2018




3.8.2018


Vyndaqel


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/11/717


7.8.2018




6.8.2018


GONAL-f


Merck Europe B.V.
Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland


EU/1/95/001


8.8.2018




8.8.2018


Bortezomib Hospira


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/16/1114


10.8.2018




8.8.2018


Brinavess


Correvio
15 rue du Bicentenaire, 92800 Puteaux, France


EU/1/10/645


10.8.2018




8.8.2018


CANCIDAS


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/01/196


10.8.2018




8.8.2018


Cubicin


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/05/328


10.8.2018




8.8.2018


Januvia


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/07/383


10.8.2018




8.8.2018


Lymphoseek


Norgine B.V.
Hogehilweg 7, 1101 CA Amsterdam, Nederland


EU/1/14/955


10.8.2018




8.8.2018


Sivextro


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/15/991


10.8.2018




8.8.2018


Tesavel


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/07/435


10.8.2018




8.8.2018


Thalidomide Celgene


Celgene Europe B.V.
Winthontlaan 6 N, 3526 KV Utrecht, Nederland


EU/1/08/443


10.8.2018




8.8.2018


Torisel


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/07/424


10.8.2018




13.8.2018


Ivabradine Zentiva


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


EU/1/16/1144


15.8.2018




13.8.2018


Komboglyze


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/11/731


15.8.2018




13.8.2018


Orbactiv


Rempex London Ltd
115L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom


EU/1/15/989


15.8.2018




13.8.2018


Xyrem


UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België


EU/1/05/312


15.8.2018




20.8.2018


Cholib


Mylan IRE Healthcare Ltd
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland


EU/1/13/866


22.8.2018




20.8.2018


Lenvima


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


EU/1/15/1002


22.8.2018




20.8.2018


Luveris


Merck Europe B.V.
Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland


EU/1/00/155


22.8.2018




20.8.2018


Pergoveris


Merck Europe B.V.
Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland


EU/1/07/396


22.8.2018




20.8.2018


Xelevia


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/07/382


22.8.2018




23.8.2018


Abilify


Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292, 1101 CT, Amsterdam, Nederland


EU/1/04/276


28.8.2018




23.8.2018


Aranesp


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


EU/1/01/185


27.8.2018




23.8.2018


Arixtra


Aspen Pharma Trading Limited
3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland


EU/1/02/206


27.8.2018




23.8.2018


Beromun


BELPHARMA s.a.
2, Rue Albert 1er, L-1117, Luxembourg, Luxembourg


EU/1/99/097


27.8.2018




23.8.2018


Biktarvy


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/18/1289


27.8.2018




23.8.2018


Blincyto


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


EU/1/15/1047


27.8.2018




23.8.2018


CABOMETYX


Ipsen Pharma
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France


EU/1/16/1136


27.8.2018




23.8.2018


Entyvio


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/14/923


27.8.2018




23.8.2018


Evicel


Omrix Biopharmaceuticals N.V.
Leonardo Da Vincilaan 15, 1831 Diegem, België


EU/1/08/473


27.8.2018




23.8.2018


Firazyr


Shire Pharmaceuticals Ireland Limited
Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland


EU/1/08/461


27.8.2018




23.8.2018


IMBRUVICA


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


EU/1/14/945


27.8.2018




23.8.2018


Intelence


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


EU/1/08/468


27.8.2018




23.8.2018


Kalydeco


Vertex Pharmaceuticals (Europe) Limited
2 Kingdom Street, London W2 6BD, United Kingdom


EU/1/12/782


28.8.2018




23.8.2018


Lemtrada


Sanofi Belgium
Leonardo Da Vincilaan 19, B-1831 Diegem, België


EU/1/13/869


28.8.2018




23.8.2018


LIFMIOR


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/16/1165


28.8.2018




23.8.2018


Nivestim


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/10/631


27.8.2018




23.8.2018


Opsumit


Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom


EU/1/13/893


27.8.2018




23.8.2018


Orkambi


Vertex Pharmaceuticals (Europe) Limited
2 Kingdom Street, London W2 6BD, United Kingdom


EU/1/15/1059


28.8.2018




23.8.2018


Parsabiv


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


EU/1/16/1142


27.8.2018




23.8.2018


Pixuvri


CTI Life Sciences Ltd
Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom


EU/1/12/764


28.8.2018




23.8.2018


Ristaben


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/10/621


28.8.2018




23.8.2018


RoActemra


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


EU/1/08/492


27.8.2018




23.8.2018


Somavert


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/02/240


27.8.2018




23.8.2018


Sovaldi


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/13/894


27.8.2018




23.8.2018


Steglujan


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/18/1266


27.8.2018




23.8.2018


Strimvelis


Orchard Therapeutics (Netherlands) B.V.
Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland


EU/1/16/1097


27.8.2018




23.8.2018


Temodal


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/98/096


28.8.2018




23.8.2018


Venclyxto


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


EU/1/16/1138


27.8.2018




23.8.2018


Xagrid


Shire Pharmaceuticals Ireland Limited
Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland


EU/1/04/295


25.8.2018




23.8.2018


Xarelto


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/08/472


27.8.2018




27.8.2018


ABILIFY MAINTENA


Otsuka Pharmaceutical Europe Ltd
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom


EU/1/13/882


29.8.2018




27.8.2018


BYDUREON


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/11/696


29.8.2018




27.8.2018


Cinryze


Shire Services BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België


EU/1/11/688


29.8.2018




27.8.2018


Coagadex


Bio Products Laboratory Ltd
Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom


EU/1/16/1087


29.8.2018




27.8.2018


Cometriq


Ipsen Pharma
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France


EU/1/13/890


29.8.2018




27.8.2018


Filgrastim Hexal


Hexal AG
Industriestraße 25, 83607 Holzkirchen, Deutschland


EU/1/08/496


29.8.2018




27.8.2018


Fulvestrant Mylan


Mylan S.A.S.
117 allée des Parcs, 69800 Saint Priest, France


EU/1/17/1253


29.8.2018




27.8.2018


Lojuxta


Amryt Pharmaceuticals DAC
90 Harcourt Street, Dublin 2, Ireland


EU/1/13/851


29.8.2018




27.8.2018


Mekinist


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


EU/1/14/931


29.8.2018




27.8.2018


Nucala


GlaxoSmithKline Trading Services Limited
Currabinny, Carrigaline, County Cork, Ireland


EU/1/15/1043


29.8.2018




27.8.2018


Rasilez HCT


Noden Pharma DAC
D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland


EU/1/08/491


29.8.2018




27.8.2018


Tafinlar


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


EU/1/13/865


29.8.2018




27.8.2018


Varuby


TESARO U.K. Limited
55 Baker Street, London W1U 7EU, United Kingdom


EU/1/17/1180


29.8.2018




27.8.2018


Victoza


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


EU/1/09/529


29.8.2018




27.8.2018


Vokanamet


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


EU/1/14/918


29.8.2018




27.8.2018


Xarelto


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/08/472


29.8.2018




27.8.2018


Zarzio


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/08/495


29.8.2018




28.8.2018


Fluenz Tetra


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/13/887


30.8.2018




28.8.2018


Steglatro


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/18/1267


30.8.2018




31.8.2018


Abseamed


Medice Arzneimittel Pütter GmbH & Co KG
Kuhloweg 37, 58638 Iserlohn, Deutschland


EU/1/07/412


4.9.2018




31.8.2018


Bavencio


Merck Europe B.V.
Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland


EU/1/17/1214


4.9.2018




31.8.2018


Binocrit


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/07/410


4.9.2018




31.8.2018


Darzalex


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


EU/1/16/1101


4.9.2018




31.8.2018


Efavirenz/Emtricitabine/Tenofovir disoproxil Krka


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


EU/1/17/1263


4.9.2018




31.8.2018


Epoetin alfa Hexal


Hexal AG
Industriestraße 25, 83607 Holzkirchen, Deutschland


EU/1/07/411


4.9.2018




31.8.2018


Spinraza


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


EU/1/17/1188


4.9.2018




31.8.2018


TAGRISSO


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/16/1086


4.9.2018




31.8.2018


Viekirax


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


EU/1/14/982


4.9.2018




31.8.2018


XALKORI


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/12/793


4.9.2018










—



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




3.8.2018


Intanza


Sanofi Pasteur Europe
2 avenue Pont Pasteur, 69007 Lyon, France


EU/1/08/505


7.8.2018










—



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




27.8.2018


Cortacare


Hydrocortisone aceponate


Ecuphar NV
Legeweg 157-i, 8020 Oostkamp, België


EU/2/18/230


Cutaneous spray, solution


QD07AC16


29.8.2018










—



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




3.8.2018


Cerenia


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


EU/2/06/062


7.8.2018




3.8.2018


LETIFEND


Laboratorios LETI, S.L.unipersonal
C/Del Sol 5, Polígono Industrial Norte, Tres Cantos, 28760 Madrid, España


EU/2/16/195


7.8.2018




3.8.2018


Novem


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/04/042


7.8.2018




3.8.2018


Onsior


Elanco GmbH
Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland


EU/2/08/089


7.8.2018




9.8.2018


Leucofeligen FeLV/RCP


Virbac
1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France


EU/2/09/097


14.8.2018




9.8.2018


Nobivac LeuFel


Virbac
1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France


EU/2/17/217


14.8.2018




20.8.2018


BTVPUR


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/10/113


22.8.2018




20.8.2018


CLYNAV


Elanco GmbH
Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland


EU/2/16/197


22.8.2018




20.8.2018


Leucogen


Virbac
1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France


EU/2/09/096


22.8.2018




27.8.2018


Prac-Tic


Elanco GmbH
Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland


EU/2/06/066


29.8.2018




27.8.2018


Vectra 3D


Ceva Santé Animale
10 avenue de la Ballastière, 33500 Libourne, France


EU/2/13/156


29.8.2018










—



Withdrawal of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




20.8.2018


Gripovac 3


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/09/102


22.8.2018




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.