Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2020 to 29 February 2020 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2020-03-27
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2020101EN.01000101.xml










27.3.2020   


EN


Official Journal of the European Union


C 101/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2020 to 29 February 2020
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) (1)

(2020/C 101/01)
—   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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




13.2.2020


Amsparity


adalimumab


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


EU/1/19/1415


Solution for injection


L04AB04


17.2.2020




13.2.2020


Azacitidine Accord


Azacitidine


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


EU/1/19/1413


Powder for suspension for injection


L01BC07


17.2.2020




13.2.2020


Beovu


brolucizumab


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


EU/1/19/1417


Solution for injection


S01LA06


17.2.2020




13.2.2020


Dexmedetomidine Accord


dexmedetomidine


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


EU/1/19/1418


Concentrate for solution for infusion


N05CM18


17.2.2020




13.2.2020


Recarbrio


imipenem/cilastatin/relebactam


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


EU/1/19/1420


Powder for solution for infusion


J01DH56


17.2.2020




—   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 authorization


Number of the entry in the Community Register


Date of notification




4.2.2020


Ceprotin


Takeda Manufacturing Austria AG
Industriestraße 67, 1221 Wien, Österreich


EU/1/01/190


6.2.2020




4.2.2020


CONTROLOC Control


Takeda GmbH
Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland


EU/1/09/515


6.2.2020




4.2.2020


ellaOne


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


EU/1/09/522


6.2.2020




4.2.2020


Ivabradine Accord


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


EU/1/17/1190


6.2.2020




4.2.2020


Lacosamide Accord


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


EU/1/17/1230


6.2.2020




4.2.2020


LIFMIOR


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


EU/1/16/1165


6.2.2020




4.2.2020


Mekinist


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


EU/1/14/931


6.2.2020




4.2.2020


PANTOZOL Control


Takeda GmbH
Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland


EU/1/09/517


6.2.2020




4.2.2020


Suboxone


Indivior Europe Limited
27 Windsor Place, Dublin 2, Ireland


EU/1/06/359


6.2.2020




4.2.2020


Ucedane


Eurocept International B.V.
Trapgans 5, 1244 RL Ankeveen, Nederland


EU/1/17/1202


6.2.2020




4.2.2020


Ziagen


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


EU/1/99/112


6.2.2020




4.2.2020


Zoely


Theramex Ireland Limited
3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland


EU/1/11/690


6.2.2020




6.2.2020


Aranesp


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


EU/1/01/185


10.2.2020




6.2.2020


Bronchitol


Pharmaxis Europe Limited
108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland


EU/1/12/760


10.2.2020




6.2.2020


Fasenra


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/17/1252


10.2.2020




6.2.2020


Granpidam


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


EU/1/16/1137


10.2.2020




6.2.2020


Jardiance


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


EU/1/14/930


10.2.2020




6.2.2020


Neuraceq


Life Radiopharma Berlin GmbH
Max-Planck-Straße 4, 12489 Berlin, Deutschland


EU/1/13/906


10.2.2020




6.2.2020


SOMAC Control


Takeda GmbH
Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland


EU/1/09/516


10.2.2020




6.2.2020


Vokanamet


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


EU/1/14/918


10.2.2020




10.2.2020


Inhixa


Techdow Pharma Netherlands B.V.
Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland


EU/1/16/1132


12.2.2020




11.2.2020


Alimta


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


EU/1/04/290


13.2.2020




11.2.2020


ALPROLIX


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


EU/1/16/1098


13.2.2020




11.2.2020


Entecavir Accord


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


EU/1/17/1211


13.2.2020




11.2.2020


OCALIVA


Intercept Pharma International Limited
Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland


EU/1/16/1139


13.2.2020




11.2.2020


Orkambi


Vertex Pharmaceuticals (Ireland) Limited
28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland


EU/1/15/1059


13.2.2020




11.2.2020


Pemetrexed Fresenius Kabi


Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland


EU/1/16/1115


13.2.2020




11.2.2020


Rebetol


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


EU/1/99/107


13.2.2020




11.2.2020


Symkevi


Vertex Pharmaceuticals (Ireland) Limited
28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland


EU/1/18/1306


13.2.2020




11.2.2020


Zeffix


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


EU/1/99/114


13.2.2020




11.2.2020


Zevalin


Ceft Biopharma s.r.o
Trtinova 260/1 Cakovice, 196 00 Praha 9, Česká republika


EU/1/03/264


13.2.2020




12.2.2020


Zoledronic acid Hospira


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


EU/1/12/800


14.2.2020




13.2.2020


Aimovig


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


EU/1/18/1293


17.2.2020




13.2.2020


Bosulif


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


EU/1/13/818


17.2.2020




13.2.2020


Brineura


BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, Ireland


EU/1/17/1192


17.2.2020




13.2.2020


Dificlir


Astellas Pharma Europe B.V.
Sylviusweg 62, 2333 BE Leiden, Nederland


EU/1/11/733


17.2.2020




13.2.2020


Duloxetine Mylan


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


EU/1/15/1010


17.2.2020




13.2.2020


Ebixa


H. Lundbeck A/S
Ottiliavej 9, 2500 Valby, Danmark


EU/1/02/219


17.2.2020




13.2.2020


IBRANCE


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


EU/1/16/1147


17.2.2020




13.2.2020


Mvasi


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


EU/1/17/1246


17.2.2020




13.2.2020


Quinsair


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


EU/1/14/973


17.2.2020




13.2.2020


Sprycel


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


EU/1/06/363


17.2.2020




13.2.2020


Tamiflu


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


EU/1/02/222


17.2.2020




13.2.2020


Ventavis


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/03/255


17.2.2020




17.2.2020


Adempas


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/13/907


19.2.2020




17.2.2020


Atripla


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


EU/1/07/430


19.2.2020




17.2.2020


Eliquis


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


EU/1/11/691


19.2.2020




17.2.2020


Sifrol


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


EU/1/97/050


19.2.2020




17.2.2020


Suliqua


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


EU/1/16/1157


19.2.2020




17.2.2020


Tacforius


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


EU/1/17/1244


2.3.2020




17.2.2020


Vyndaqel


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


EU/1/11/717


19.2.2020




18.2.2020


Zypadhera


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


EU/1/08/479


20.2.2020




21.2.2020


Cholib


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


EU/1/13/866


25.2.2020




21.2.2020


Cometriq


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


EU/1/13/890


25.2.2020




21.2.2020


Docetaxel Accord


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


EU/1/12/769


25.2.2020




21.2.2020


Eptifibatide Accord


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


EU/1/15/1065


25.2.2020




21.2.2020


Holoclar


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


EU/1/14/987


25.2.2020




21.2.2020


Imfinzi


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/18/1322


18.2.2020




21.2.2020


Lyrica


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


EU/1/04/279


25.2.2020




21.2.2020


Mirapexin


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


EU/1/97/051


25.2.2020




21.2.2020


Resolor


Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland


EU/1/09/581


25.2.2020




21.2.2020


Trelegy Ellipta


GlaxoSmithKline Trading Services Limited
Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland


EU/1/17/1236


25.2.2020




21.2.2020


Voriconazole Accord


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


EU/1/13/835


25.2.2020




21.2.2020


Zalasta


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


EU/1/07/415


25.2.2020




21.2.2020


Zyprexa


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


EU/1/96/022


25.2.2020




21.2.2020


Zyprexa Velotab


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


EU/1/99/125


25.2.2020




24.2.2020


Docetaxel Kabi


Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland


EU/1/12/770


26.2.2020




24.2.2020


Lixiana


Daiichi Sankyo Europe GmbH
Zielstattstraße 48, 81379 München, Deutschland


EU/1/15/993


26.2.2020




24.2.2020


Slenyto


RAD Neurim Pharmaceuticals EEC SARL
4 rue de Marivaux, 75002 Paris, France


EU/1/18/1318


26.2.2020




25.2.2020


Aripiprazole Mylan Pharma


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


EU/1/15/1005


27.2.2020




28.2.2020


Advagraf


Astellas Pharma Europe B.V.
Sylviusweg 62, 2333 BE Leiden, Nederland


EU/1/07/387


3.3.2020




28.2.2020


Bexsero


GlaxoSmithKline Vaccines S.r.l.
Via Fiorentina, 1, 53100 Siena, Italia


EU/1/12/812


3.3.2020




28.2.2020


Cegfila


Mundipharma Corporation (Ireland) Limited
Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland


EU/1/19/1409


3.3.2020




28.2.2020


Cuprymina


A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.
Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia


EU/1/12/784


3.3.2020




28.2.2020


Hetlioz


Vanda Pharmaceuticals Germany GmbH
Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland


EU/1/15/1008


3.3.2020




28.2.2020


Januvia


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


EU/1/07/383


3.3.2020




28.2.2020


Ledaga


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


EU/1/16/1171


3.3.2020




28.2.2020


Modigraf


Astellas Pharma Europe B.V.
Sylviusweg 62, 2333 BE Leiden, Nederland


EU/1/09/523


3.3.2020




28.2.2020


Pemetrexed Accord


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


EU/1/15/1071


3.3.2020




28.2.2020


Pemetrexed Lilly


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


EU/1/15/1034


3.3.2020




28.2.2020


Simponi


Janssen Biologics B.V.
Einsteinweg 101, 2333 CB Leiden, Nederland


EU/1/09/546


3.3.2020




28.2.2020


Voncento


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


EU/1/13/857


3.3.2020




28.2.2020


Xerava


Tetraphase Pharmaceuticals Ireland Limited
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland


EU/1/18/1312


3.3.2020




28.2.2020


Xeristar


Esteve Pharmaceuticals S.A.
Passeig de la Zona Franca, 109, 08038 Barcelona, España


EU/1/04/297


3.3.2020




28.2.2020


Xolair


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


EU/1/05/319


3.3.2020




28.2.2020


Zoledronic acid Accord


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


EU/1/13/834


3.3.2020




28.2.2020


Zydelig


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


EU/1/14/938


3.3.2020




—   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 authorization


Number of the entry in the Community Register


Date of notification




11.2.2020


Picato


LEO Laboratories Ltd
285 Cashel Road, Crumlin, Dublin 12, Ireland


EU/1/12/796


13.2.2020




—   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 authorization


Number of the entry in the Community Register


Date of notification




4.2.2020


Clevor


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/2/17/222


6.2.2020




11.2.2020


Halagon


Emdoka bvba
J. Lijsenstraat 16, 2321 Hoogstraten, België


EU/2/16/201


13.2.2020




11.2.2020


Meloxidyl


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


EU/2/06/070


13.2.2020




11.2.2020


Oxyglobin


OPK Biotech Netherlands BV
Teleportboulevard 140, 1043 EJ Amsterdam, Nederland


EU/2/99/015


14.2.2020




11.2.2020


Palladia


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


EU/2/09/100


13.2.2020




17.2.2020


Zulvac 1 Bovis


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


EU/2/11/130


19.2.2020




17.2.2020


Zulvac 1 Ovis


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


EU/2/11/131


19.2.2020




18.2.2020


Emdocam


Emdoka bvba
J. Lijsenstraat 16, 2321 Hoogstraten, België


EU/2/11/128


20.2.2020




18.2.2020


Zycortal


Dechra Regulatory B.V.
Handelsweg 25, 5531 AE Bladel, Nederland


EU/2/15/189


20.2.2020




26.2.2020


Porcilis ColiClos


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


EU/2/12/141


28.2.2020




—   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




18.2.2020


Zulvac 1 Bovis


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


EU/2/11/130


20.2.2020




18.2.2020


Zulvac 1 Ovis


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


EU/2/11/131


20.2.2020




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




NETHERLANDS






(1)  OJ L 136, 30.4.2004, p. 1.