Official Journal of the European Union

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.