Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2019 to 31 August 2019(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2019-10-04
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_2019334EN.01000101.xml










4.10.2019   


EN


Official Journal of the European Union


C 334/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2019 to 31 August 2019

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

(2019/C 334/01)






—



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




1.7.2019


Dovato


dolutegravir/lamivudine


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/19/1370


Film-coated tablet


J05AR25


3.7.2019




1.7.2019


Xromi


hydroxycarbamide


Nova Laboratories Ireland Limited
3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland


EU/1/19/1366


Oral solution


L01XX05


3.7.2019




2.7.2019


Ultomiris


Ravulizumab


Alexion Europe SAS
103-105 Rue Anatole France, 92300 Levallois-Perret, France


EU/1/19/1371


Concentrate for solution for infusion


L04AA


5.7.2019




25.7.2019


Cufence


trientine dihydrochloride


Univar BV
Schouwburgplein 30-34, 3012 CL Rotterdam, Nederland


EU/1/19/1365


Capsule, hard


A16AX12


29.7.2019




25.7.2019


LysaKare


arginine/lysine


Advanced Accelerator Applications
20 rue Diesel, 01630 Saint-Genis-Pouilly, France


EU/1/19/1381


Solution for infusion


V03AF11


29.7.2019




25.7.2019


Posaconazole Accord


posaconazole


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona, España


EU/1/19/1379


Gastro-resistant tablet


J02AC04


30.7.2019




25.7.2019


Posaconazole AHCL


posaconazole


Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España


EU/1/19/1380


Oral suspension


J02AC04


29.7.2019




2.8.2019


Azacitidine Celgene


azacitidine


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


EU/1/19/1382


Powder for suspension for injection


L01BC07


6.8.2019




23.8.2019


Giapreza


angiotensin II acetate


La Jolla Pharmaceutical II B.V.
Herengracht 500, 1017 CB Amsterdam, Nederland


EU/1/19/1384


Concentrate for solution for infusion


C01CX09


27.8.2019




26.8.2019


Lacosamide UCB


lacosamide


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


EU/1/19/1383


Film-coated tablet Solution for infusion Syrup


N03AX18


28.8.2019










—



Issuing of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




11.7.2019


Cabazitaxel Teva


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


—


15.7.2019




8.8.2019


Doxolipad


TLC Biopharmaceuticals B.V.
J.H. Oortweg 19, 2333CH Leiden, Netherlands


—


12.8.2019










—



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




1.7.2019


Benlysta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/11/700


3.7.2019




1.7.2019


Cetrotide


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


EU/1/99/100


3.7.2019




1.7.2019


Comtan


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


EU/1/98/081


3.7.2019




1.7.2019


Eliquis


Bristol-Myers Squibb/Pfizer EEIG
Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland


EU/1/11/691


3.7.2019




1.7.2019


Eviplera


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


EU/1/11/737


3.7.2019




1.7.2019


Exviera


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


EU/1/14/983


3.7.2019




1.7.2019


Fiasp


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


EU/1/16/1160


3.7.2019




1.7.2019


Instanyl


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


EU/1/09/531


3.7.2019




1.7.2019


Mimpara


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


EU/1/04/292


3.7.2019




1.7.2019


Ravicti


Immedica Pharma AB
SE-113 29 Stockholm, Sverige


EU/1/15/1062


3.7.2019




1.7.2019


Symtuza


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


EU/1/17/1225


3.7.2019




1.7.2019


Xarelto


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/08/472


3.7.2019




4.7.2019


Dukoral


Valneva Sweden AB
105 21 Stockholm, Sverige


EU/1/03/263


8.7.2019




4.7.2019


IKERVIS


Santen Oy
Niittyhaankatu 20, 33720 Tampere, Suomi


EU/1/15/990


8.7.2019




4.7.2019


Kaletra


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


EU/1/01/172


8.7.2019




4.7.2019


Nerlynx


Pierre Fabre Médicament
45, place Abel Gance, 92100 Boulogne-Billancourt, France


EU/1/18/1311


9.7.2019




4.7.2019


Orphacol


Laboratoires CTRS
63 rue de l’Est, 92100 Boulogne-Billancourt, France


EU/1/13/870


8.7.2019




4.7.2019


Prolia


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


EU/1/10/618


8.7.2019




4.7.2019


Verkazia


Santen Oy
Niittyhaankatu 20, 33720 Tampere, Suomi


EU/1/17/1219


8.7.2019




4.7.2019


Zinforo


Pfizer Ireland Pharmaceuticals
Operations Support Group, Ringaskiddy, County Cork, Ireland


EU/1/12/785


8.7.2019




8.7.2019


Emtricitabine/Tenofovir disoproxil Krka d.d.


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


EU/1/17/1182


10.7.2019




8.7.2019


Hefiya


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/18/1287


10.7.2019




8.7.2019


Pazenir


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


EU/1/18/1317


10.7.2019




8.7.2019


Tecentriq


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


EU/1/17/1220


10.7.2019




8.7.2019


Tremfya


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


EU/1/17/1234


10.7.2019




8.7.2019


Viekirax


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


EU/1/14/982


10.7.2019




8.7.2019


Xultophy


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


EU/1/14/947


10.7.2019




9.7.2019


Elocta


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


EU/1/15/1046


11.7.2019




11.7.2019


Ammonaps


Immedica Pharma AB
SE-113 29 Stockholm, Sverige


EU/1/99/120


15.7.2019




11.7.2019


Defitelio


Gentium S.r.I.
Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia


EU/1/13/878


15.7.2019




11.7.2019


Gliolan


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


EU/1/07/413


15.7.2019




11.7.2019


Halimatoz


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/18/1288


15.7.2019




11.7.2019


Tasigna


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


EU/1/07/422


15.7.2019




18.7.2019


Jentadueto


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


EU/1/12/780


29.7.2019




18.7.2019


Myocet


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


EU/1/00/141


22.7.2019




18.7.2019


Norvir


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


EU/1/96/016


22.7.2019




18.7.2019


Xadago


Zambon S.p.A.
Via Lillo del Duca 10, 20091 Bresso (MI), Italia


EU/1/14/984


22.7.2019




18.7.2019


Xyrem


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


EU/1/05/312


22.7.2019




19.7.2019


Besponsa


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


EU/1/17/1200


23.7.2019




19.7.2019


Colobreathe


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


EU/1/11/747


23.7.2019




19.7.2019


Edistride


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/15/1052


23.7.2019




19.7.2019


Exjade


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


EU/1/06/356


23.7.2019




19.7.2019


HyQvia


Baxalta Innovations GmbH
Industriestraße 67, 1221 Wien, Österreich


EU/1/13/840


23.7.2019




19.7.2019


Incruse Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/922


23.7.2019




19.7.2019


Lartruvo


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


EU/1/16/1143


23.7.2019




19.7.2019


Truvada


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


EU/1/04/305


23.7.2019




19.7.2019


Truxima


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


EU/1/16/1167


23.7.2019




25.7.2019


Abasaglar


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


EU/1/14/944


29.7.2019




25.7.2019


Abraxane


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


EU/1/07/428


29.7.2019




25.7.2019


Anoro Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/898


29.7.2019




25.7.2019


Blitzima


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


EU/1/17/1205


29.7.2019




25.7.2019


Corbilta


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/1/13/859


29.7.2019




25.7.2019


Deltyba


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


EU/1/13/875


29.7.2019




25.7.2019


Edistride


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/15/1052


29.7.2019




25.7.2019


Forxiga


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/12/795


29.7.2019




25.7.2019


Gardasil 9


MSD VACCINS
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/15/1007


29.7.2019




25.7.2019


Genvoya


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


EU/1/15/1061


29.7.2019




25.7.2019


Hepsera


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


EU/1/03/251


29.7.2019




25.7.2019


Herceptin


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


EU/1/00/145


29.7.2019




25.7.2019


KANJINTI


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


EU/1/18/1281


29.7.2019




25.7.2019


Lixiana


Daiichi Sankyo Europe GmbH
Zielstattstraße 48, 81379 München, Deutschland


EU/1/15/993


29.7.2019




25.7.2019


Maviret


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


EU/1/17/1213


29.7.2019




25.7.2019


NexoBrid


MediWound Germany GmbH
Eisenstraße 5, 65428 Ruesselsheim, Deutschland


EU/1/12/803


29.7.2019




25.7.2019


Ofev


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


EU/1/14/979


29.7.2019




25.7.2019


Ontruzant


Samsung Bioepis NL B.V.
Olof Palmestraat 10, 2616 LR Delft, Nederland


EU/1/17/1241


29.7.2019




25.7.2019


Ritemvia


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


EU/1/17/1207


29.7.2019




25.7.2019


Rolufta Ellipta


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


EU/1/17/1174


29.7.2019




25.7.2019


Roteas


Daiichi Sankyo Europe GmbH
Zielstattstraße 48, 81379 München, Deutschland


EU/1/16/1152


29.7.2019




25.7.2019


Telmisartan Teva Pharma


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


EU/1/11/719


29.7.2019




25.7.2019


Temozolomide SUN


Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, 2132 JH Hoofddorp, Nederland


EU/1/11/697


29.7.2019




25.7.2019


Translarna


PTC Therapeutics International Limited
5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland


EU/1/13/902


29.7.2019




25.7.2019


Uptravi


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


EU/1/15/1083


29.7.2019




25.7.2019


Visudyne


CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24, 17489 Greifswald, Deutschland


EU/1/00/140


29.7.2019




25.7.2019


Vizamyl


GE Healthcare AS
Nycoveien 1, 0485, Oslo, Norge


EU/1/14/941


29.7.2019




25.7.2019


Xigduo


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/13/900


29.7.2019




25.7.2019


Zalmoxis


MolMed S.p.A.
Via Olgettina 58, 20132 Milano, Italia


EU/1/16/1121


29.7.2019




25.7.2019


Zinforo


Pfizer Ireland Pharmaceuticals
Operations Support Group, Ringaskiddy, County Cork, Ireland


EU/1/12/785


29.7.2019




25.7.2019


Zometa


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


EU/1/01/176


29.7.2019




31.7.2019


Aclasta


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


EU/1/05/308


2.8.2019




31.7.2019


Adenuric


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


EU/1/08/447


5.8.2019




31.7.2019


Adjupanrix


GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89, 1330 Rixensart, Belgique


EU/1/09/578


2.8.2019




31.7.2019


Duloxetine Lilly


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


EU/1/14/972


2.8.2019




31.7.2019


Fiasp


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


EU/1/16/1160


2.8.2019




31.7.2019


Flebogamma DIF


Instituto Grifols, S.A.
Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa


EU/1/07/404


2.8.2019




31.7.2019


Forxiga


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/12/795


2.8.2019




31.7.2019


Inovelon


Eisai GmbH
Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland


EU/1/06/378


2.8.2019




31.7.2019


Invirase


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


EU/1/96/026


2.8.2019




31.7.2019


Ketoconazole HRA


Laboratoire HRA Pharma
200 avenue de Paris, 92320 Chatillon, France


EU/1/14/965


2.8.2019




31.7.2019


Nucala


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


EU/1/15/1043


2.8.2019




31.7.2019


Rezolsta


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


EU/1/14/967


2.8.2019




31.7.2019


Stalevo


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/1/03/260


2.8.2019




31.7.2019


Tadalafil Mylan


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


EU/1/14/961


2.8.2019




31.7.2019


Thalidomide Celgene


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


EU/1/08/443


2.8.2019




31.7.2019


Trazimera


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


EU/1/18/1295


2.8.2019




31.7.2019


Vargatef


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


EU/1/14/954


2.8.2019




31.7.2019


Vimpat


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


EU/1/08/470


2.8.2019




31.7.2019


Xydalba


Allergan Pharmaceuticals International Limited
Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland


EU/1/14/986


2.8.2019




1.8.2019


Cyramza


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


EU/1/14/957


5.8.2019




1.8.2019


Dupixent


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


EU/1/17/1229


5.8.2019




1.8.2019


Ebymect


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/15/1051


5.8.2019




1.8.2019


Faslodex


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/03/269


5.8.2019




1.8.2019


Harvoni


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


EU/1/14/958


6.8.2019




1.8.2019


Herzuma


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


EU/1/17/1257


6.8.2019




1.8.2019


Hirobriz Breezhaler


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


EU/1/09/594


6.8.2019




1.8.2019


Laventair Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/899


6.8.2019




2.8.2019


Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan


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


EU/1/17/1222


6.8.2019




2.8.2019


IMBRUVICA


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


EU/1/14/945


6.8.2019




2.8.2019


JETREA


Oxurion NV
Gaston Geenslaan 1, 3001 Leuven, België


EU/1/13/819


6.8.2019




2.8.2019


Praxbind


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


EU/1/15/1056


7.8.2019




8.8.2019


InductOs


Medtronic BioPharma B.V.
Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland


EU/1/02/226


12.8.2019




8.8.2019


Levodopa/Carbidopa/Entacapone Orion


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/1/11/706


12.8.2019




8.8.2019


Stivarga


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/13/858


12.8.2019




8.8.2019


Teysuno


Nordic Group B.V.
Siriusdreef 22, 2132 WT Hoofddorp, Nederland


EU/1/11/669


12.8.2019




9.8.2019


Jivi


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/18/1324


13.8.2019




9.8.2019


Travatan


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


EU/1/01/199


13.8.2019




9.8.2019


Truberzi


Allergan Pharmaceuticals International Limited
Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland


EU/1/16/1126


13.8.2019




9.8.2019


Victoza


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


EU/1/09/529


13.8.2019




14.8.2019


Oslif Breezhaler


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


EU/1/09/586


19.8.2019




23.8.2019


Aimovig


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


EU/1/18/1293


27.8.2019




23.8.2019


Brimica Genuair


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/14/963


27.8.2019




23.8.2019


Cinacalcet Mylan


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


EU/1/15/1054


27.8.2019




23.8.2019


Cometriq


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


EU/1/13/890


27.8.2019




23.8.2019


Duaklir Genuair


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/14/964


27.8.2019




23.8.2019


Elmiron


bene-Arzneimittel GmbH
Herterichstraße 1-3, 81479 München, Deutschland


EU/1/17/1189


27.8.2019




23.8.2019


Empliciti


Bristol-Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland


EU/1/16/1088


27.8.2019




23.8.2019


Firdapse


BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland


EU/1/09/601


27.8.2019




23.8.2019


Flucelvax Tetra


Seqirus Netherlands B.V.
Paasheuvelweg 28, 1105BJ Amsterdam, Netherlands


EU/1/18/1326


27.8.2019




23.8.2019


Fluenz Tetra


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/13/887


27.8.2019




23.8.2019


Nordimet


Nordic Group B.V.
Siriusdreef 22, 2132 WT Hoofddorp, Nederland


EU/1/16/1124


27.8.2019




23.8.2019


Otezla


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


EU/1/14/981


27.8.2019




23.8.2019


Ovitrelle


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


EU/1/00/165


27.8.2019




23.8.2019


Renagel


Genzyme Europe B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland


EU/1/99/123


27.8.2019




23.8.2019


Sevelamer carbonate Winthrop


Genzyme Europe B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland


EU/1/14/952


27.8.2019




23.8.2019


Sovaldi


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


EU/1/13/894


27.8.2019




23.8.2019


Spinraza


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


EU/1/17/1188


27.8.2019




23.8.2019


Trulicity


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


EU/1/14/956


27.8.2019




23.8.2019


Zerbaxa


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


EU/1/15/1032


27.8.2019




26.8.2019


Emadine


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


EU/1/98/095


28.8.2019




26.8.2019


Imraldi


Samsung Bioepis NL B.V.
Olof Palmestraat 10, 2616 LR Delft, Nederland


EU/1/17/1216


28.8.2019




26.8.2019


Jylamvo


Therakind (Europe) Limited
3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland


EU/1/17/1172


28.8.2019




26.8.2019


KEYTRUDA


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


EU/1/15/1024


28.8.2019




26.8.2019


Levitra


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/03/248


28.8.2019




26.8.2019


Mycophenolate mofetil Teva


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


EU/1/07/439


28.8.2019




26.8.2019


Nevanac


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


EU/1/07/433


28.8.2019




26.8.2019


Onbrez Breezhaler


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


EU/1/09/593


28.8.2019




26.8.2019


Prasugrel Mylan


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


EU/1/18/1273


28.8.2019




26.8.2019


PREVYMIS


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


EU/1/17/1245


28.8.2019




26.8.2019


Renvela


Genzyme Europe B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland


EU/1/09/521


28.8.2019




26.8.2019


Soliris


Alexion Europe SAS
103-105 rue Anatole France, 92300 Levallois-Perret, France


EU/1/07/393


28.8.2019




26.8.2019


TAGRISSO


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/16/1086


28.8.2019




26.8.2019


Tasmar


Meda AB
Pipers väg 2A, 170 09 Solna, Sverige


EU/1/97/044


28.8.2019




26.8.2019


Tecentriq


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


EU/1/17/1220


28.8.2019




26.8.2019


Vargatef


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


EU/1/14/954


28.8.2019




26.8.2019


Vivanza


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/03/249


28.8.2019




31.8.2019


Kisqali


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


EU/1/17/1221


2.8.2019










—



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




19.7.2019


EVICTO


selamectin


VIRBAC
1ère avenue – 2065m – LID, 06516 Carros, France


EU/2/19/242


Spot-on solution


QP54AA05


23.7.2019




29.7.2019


NASYM


Live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56


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


EU/2/19/241


Lyophilisate and solvent for suspension for injection or nasal spray


QI02AD04


31.7.2019










—



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




1.7.2019


Osurnia


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


EU/2/14/170


3.7.2019




4.7.2019


Bravecto Plus


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


EU/2/18/224


9.7.2019




29.7.2019


Advocate


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/03/039


31.7.2019




9.8.2019


Vectormune ND


CEVA-Phylaxia Co. Ltd
Szállás u. 5, 1107 Budapest, Magyarország


EU/2/15/188


13.8.2019




19.8.2019


NexGard


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/13/159


21.8.2019




19.8.2019


NEXGARD SPECTRA


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/14/177


21.8.2019




29.8.2019


Bovilis Blue-8


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


EU/2/17/218


2.9.2019




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




Domenico Scarlattilaan 6




1083 HS Amsterdam




The Netherlands






(1)  OJ L 136, 30.4.2004, p. 1.