Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2021 to 31 October 2021 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2021-11-26
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_2021478EN.01000101.xml










26.11.2021   


EN


Official Journal of the European Union


C 478/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2021 to 31 October 2021
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2021/C 478/01)
—   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




1.10.2021


COVID-19 Vaccine Janssen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


1.10.2021




4.10.2021


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


5.10.2021




4.10.2021


Docetaxel Kabi







Fresenius Kabi Deutschland GmbH




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






EU/1/12/770


6.10.2021




4.10.2021


Posaconazole Accord







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España






EU/1/19/1379


5.10.2021




4.10.2021


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle Monte Esquinza 30, 28010 Madrid, España






EU/1/20/1507


4.10.2021




5.10.2021


Comirnaty







BioNTech Manufacturing GmbH




An der Goldgrube 12, 55131 Mainz, Deutschland






EU/1/20/1528


5.10.2021




5.10.2021


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle Monte Esquinza 30, 28010 Madrid, España






EU/1/20/1507


5.10.2021




11.10.2021


Copalia







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/06/372


12.10.2021




11.10.2021


COVID-19 Vaccine Janssen







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1525


11.10.2021




11.10.2021


Dafiro







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/06/371


12.10.2021




11.10.2021


Entecavir Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/17/1227


12.10.2021




11.10.2021


Equidacent







Centus Biotherapeutics Europe Limited




6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland






EU/1/20/1472


8.11.2021




11.10.2021


Exforge







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/06/370


12.10.2021




11.10.2021


Onpattro







Alnylam Netherlands B.V.




Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland






EU/1/18/1320


13.10.2021




11.10.2021


Ovitrelle







Merck Europe B.V.




Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland






EU/1/00/165


12.10.2021




11.10.2021


ReFacto AF







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/99/103


12.10.2021




11.10.2021


Sifrol







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/97/050


14.10.2021




11.10.2021


Vargatef







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/954


27.10.2021




11.10.2021


Vyndaqel







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/11/717


12.10.2021




15.10.2021


Vaxzevria







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1529


15.10.2021




19.10.2021


Ammonaps







Immedica Pharma AB




SE-113 29 Stockholm, Sverige






EU/1/99/120


20.10.2021




19.10.2021


Busilvex







Pierre Fabre Médicament




45 place Abel Gance, 92654 Boulogne-Billancourt CEDEX, France






EU/1/03/254


20.10.2021




19.10.2021


Ceprotin







Takeda Manufacturing Austria AG




Industriestraße 67, 1221 Wien, Österreich






EU/1/01/190


20.10.2021




19.10.2021


Clopidogrel/Acetylsalicylic acid Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/19/1395


20.10.2021




19.10.2021


Duloxetine Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/15/1010


21.10.2021




19.10.2021


Ecalta







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/07/416


20.10.2021




19.10.2021


Erelzi







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/17/1195


20.10.2021




19.10.2021


Firmagon







Ferring Pharmaceuticals A/S




Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark






EU/1/08/504


25.10.2021




19.10.2021


Forsteo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/03/247


25.10.2021




19.10.2021


Gazyvaro







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/14/937


20.10.2021




19.10.2021


Gefitinib Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/18/1321


20.10.2021




19.10.2021


Hefiya







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1287


20.10.2021




19.10.2021


Imfinzi







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/18/1322


21.10.2021




19.10.2021


Inrebic







Bristol-Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland






EU/1/20/1514


21.10.2021




19.10.2021


Integrilin







GlaxoSmithKline (Ireland) Limited




12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland






EU/1/99/109


20.10.2021




19.10.2021


KEYTRUDA







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/15/1024


21.10.2021




19.10.2021


Lopinavir/Ritonavir Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/15/1067


21.10.2021




19.10.2021


Memantine LEK







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/13/826


21.10.2021




19.10.2021


Memantine Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/13/827


20.10.2021




19.10.2021


Mirapexin







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/97/051


21.10.2021




19.10.2021


Myozyme







Genzyme Europe B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/06/333


25.10.2021




19.10.2021


NovoEight







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/13/888


21.10.2021




19.10.2021


NovoMix







Novo Nordisk A/S




Novo Allé, 2880 Bagsvaerd, Danmark






EU/1/00/142


21.10.2021




19.10.2021


Noxafil







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/05/320


21.10.2021




19.10.2021


OPDIVO







Bristol-Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland






EU/1/15/1014


9.11.2021




19.10.2021


Prasugrel Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/18/1273


20.10.2021




19.10.2021


Rasagiline Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/16/1090


20.10.2021




19.10.2021


REKAMBYS







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/20/1482


20.10.2021




19.10.2021


Repaglinide Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/579


21.10.2021




19.10.2021


Semglee







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/18/1270


20.10.2021




19.10.2021


Spedra







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/13/841


21.10.2021




19.10.2021


Sunosi







Jazz Pharmaceuticals Ireland Ltd




5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland






EU/1/19/1408


21.10.2021




19.10.2021


Tasmar







Meda AB




Pipers väg 2A, 170 09 Solna, Sverige






EU/1/97/044


21.10.2021




19.10.2021


Tenofovir disoproxil Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/16/1129


20.10.2021




19.10.2021


Torisel







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/07/424


20.10.2021




19.10.2021


Vaborem







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare, 1611 Luxembourg, Luxembourg






EU/1/18/1334


20.10.2021




19.10.2021


Vfend







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/02/212


21.10.2021




19.10.2021


Vocabria







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/20/1481


20.10.2021




19.10.2021


Xydalba







Allergan Pharmaceuticals International Limited




Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland






EU/1/14/986


20.10.2021




19.10.2021


Zessly







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1280


20.10.2021




22.10.2021


Adempas







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/13/907


5.11.2021




22.10.2021


Alofisel







Takeda Pharma A/S




Delta Park 45, 2665 Vallensbaek Strand, Danmark






EU/1/17/1261


28.10.2021




22.10.2021


Betaferon







Bayer AG




D-51368 Leverkusen, Deutschland






EU/1/95/003


5.11.2021




22.10.2021


Biktarvy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/18/1289


27.10.2021




22.10.2021


Clopidogrel ratiopharm







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/14/975


26.10.2021




22.10.2021


Hyrimoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1286


25.10.2021




22.10.2021


Idacio







Fresenius Kabi Deutschland GmbH




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






EU/1/19/1356


25.10.2021




22.10.2021


Imcivree







Rhythm Pharmaceuticals Netherlands B.V.




Herengracht 280, 1016 BX Amsterdam, Nederland






EU/1/21/1564


26.10.2021




22.10.2021


Inflectra







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/13/854


25.10.2021




22.10.2021


Jardiance







Boehringer Ingelheim International GmbH




Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland






EU/1/14/930


25.10.2021




22.10.2021


Retacrit







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/07/431


25.10.2021




22.10.2021


Steglatro







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1267


25.10.2021




22.10.2021


Veltassa







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


9.11.2021




22.10.2021


Zepatier







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/16/1119


25.10.2021




25.10.2021


Clopidogrel Taw Pharma







Mylan S.A.S.




117 allée des Parcs, 69800 Saint Priest, France






EU/1/09/559


26.10.2021




25.10.2021


Clopidogrel Viatris







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/09/568


1.11.2021




25.10.2021


Firazyr







Takeda Pharmaceuticals International AG Ireland Branch




Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland






EU/1/08/461


27.10.2021




25.10.2021


Forxiga







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/12/795


26.11.2021




25.10.2021


Latuda







Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.p.A.




Viale Amelia 70, 00181 Roma, Italia






EU/1/14/913


26.10.2021




25.10.2021


Nerlynx







Pierre Fabre Médicament




45, place Abel Gance, 92100 Boulogne-Billancourt, France






EU/1/18/1311


10.11.2021




25.10.2021


Segluromet







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/18/1265


28.10.2021




25.10.2021


Zyllt







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/553


27.10.2021




28.10.2021


Clopidogrel Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/556


2.11.2021




28.10.2021


Clopidogrel TAD







TAD Pharma GmbH




Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland






EU/1/09/555


3.11.2021




28.10.2021


Darunavir Mylan







Mylan Pharmaceuticals Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland






EU/1/16/1140


5.11.2021




28.10.2021


Mysildecard







Viatris Limited




Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland






EU/1/16/1134


29.10.2021




28.10.2021


Ontozry







Angelini Pharma S.p.A




Viale Amelia 70, 00181 Rome, Italia






EU/1/21/1530


29.10.2021




28.10.2021


Tyverb







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/07/440


29.10.2021




28.10.2021


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


29.10.2021




29.10.2021


Spikevax







MODERNA BIOTECH SPAIN, S.L.




Calle Monte Esquinza 30, 28010 Madrid, España






EU/1/20/1507


29.10.2021




—   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




11.10.2021


Docetaxel Teva







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/09/611


12.10.2021




11.10.2021


Equidacent







Centus Biotherapeutics Europe Limited




6th Floor, South Bank House, Barrow Street, Dublin 4, Ireland






EU/1/20/1472


8.11.2021




—   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




18.10.2021


Oxyglobin







OPK Biotech Netherlands BV




Herikerbergweg 88, 1101CM Amsterdam, Nederland






EU/2/99/015


5.11.2021




25.10.2021


Activyl Tick Plus







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/11/137


26.10.2021




25.10.2021


Canigen L4







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/15/183


26.10.2021




25.10.2021


Nobilis IB Primo QX







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/14/174


27.10.2021




25.10.2021


Tulissin







VIRBAC




1ère avenue 2065 m LID, 06516 Carros, France






EU/2/20/252


28.10.2021




25.10.2021


Vectra 3D







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/13/156


26.10.2021




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.