Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2022 to 28 February 2022

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

(2022/C 144/01)

— 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 14.2.2022 Apexxnar pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/21/1612 Suspension for injection J07AL02 15.2.2022 14.2.2022 Ngenla somatrogon Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/21/1617 Solution for injection Pending 15.2.2022 14.2.2022 OKEDI risperidone Laboratorios Farmacéuticos Rovi, S.A. Julián Camarillo 35, 28037 Madrid, España EU/1/21/1621 Powder and solvent for prolonged-release suspension for injection N05AX08 15.2.2022 14.2.2022 Oxbryta voxelotor Global Blood Therapeutics Netherlands B.V. Strawinskylaan 3051, 1077 ZX Amsterdam, Noord-Holland, Nederland EU/1/21/1622 Film-coated tablet B06AX 15.2.2022 14.2.2022 Saphnelo anifrolumab AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1623 Concentrate for solution for infusion L04AA51 15.2.2022 16.2.2022 Kerendia finerenone Bayer AG D-51368 Leverkusen, Deutschland EU/1/21/1616 Film-coated tablet C03DA05 17.2.2022 16.2.2022 Sapropterin Dipharma sapropterin Dipharma B.V. Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland EU/1/21/1620 Powder for oral solution Soluble tablet A16AX07 17.2.2022 16.2.2022 Sitagliptin/Metformin hydrochloride Mylan sitagliptin/metformin hydrochloride Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/21/1619 Film-coated tablet A10BD07 21.2.2022 16.2.2022 Tepmetko tepotinib Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/21/1596 Film-coated tablet L01EX21 17.2.2022 21.2.2022 Ontilyv opicapone Bial — Portela & Ca, SA À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal EU/1/21/1578 Capsule, hard N04BX04 22.2.2022

— 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 2.2.2022 Vaxzevria AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1529 2.2.2022 3.2.2022 Clopidogrel Viatris Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/09/568 7.2.2022 3.2.2022 DaTSCAN GE Healthcare B.V. De Rondom 8, 5612 AP, Eindhoven, Nederland EU/1/00/135 9.2.2022 3.2.2022 Edarbi Takeda Pharma A/S Delta Park 45, 2665 Vallensbæk Strand, Danmark EU/1/11/734 8.2.2022 3.2.2022 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1263 9.2.2022 3.2.2022 Nyxoid Mundipharma Corporation (Ireland) Limited Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland EU/1/17/1238 7.2.2022 3.2.2022 Pregabalin Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1021 8.2.2022 3.2.2022 Vivanza Bayer AG D-51368 Leverkusen, Deutschland EU/1/03/249 7.2.2022 3.2.2022 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 4.2.2022 3.2.2022 Xigduo AstraZeneca AB 151 85 Södertälje, Sverige EU/1/13/900 4.2.2022 4.2.2022 Cialis Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/02/237 8.2.2022 4.2.2022 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 4.2.2022 4.2.2022 Ebixa H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/02/219 8.2.2022 4.2.2022 Ebymect AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1051 7.2.2022 4.2.2022 Entacapone Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/665 8.2.2022 4.2.2022 HyQvia Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/13/840 7.2.2022 4.2.2022 Iressa AstraZeneca AB 151 85 Södertälje, Sverige EU/1/09/526 7.2.2022 4.2.2022 Neupro UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/05/331 9.2.2022 4.2.2022 Noxafil Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/05/320 8.2.2022 4.2.2022 Plegridy Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/14/934 9.2.2022 4.2.2022 Revolade Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/10/612 7.2.2022 4.2.2022 Roclanda Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi EU/1/20/1502 10.2.2022 4.2.2022 Sivextro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/991 8.2.2022 4.2.2022 Temozolomide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/10/615 9.2.2022 4.2.2022 Vantobra PARI Pharma GmbH Moosstraße 3, 82319 Starnberg, Deutschland EU/1/18/1350 10.2.2022 4.2.2022 Yellox BAUSCH + LOMB IRELAND LIMITED 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT3, Ireland EU/1/11/692 14.2.2022 4.2.2022 Zoledronic acid Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/12/800 7.2.2022 10.2.2022 Ameluz Biofrontera Bioscience GmbH Hemmelrather Weg 201, 51377 Leverkusen, Deutschland EU/1/11/740 15.2.2022 10.2.2022 Axumin Blue Earth Diagnostics Ireland Ltd 6th Floor, 2 Grand Canal Square, Dublin 2, Ireland EU/1/17/1186 15.2.2022 10.2.2022 Cotellic Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/15/1048 14.2.2022 10.2.2022 Nityr Cycle Pharmaceuticals (Europe) Ltd 70 Sir John Rogerson’s Quay, Dublin 2, Ireland EU/1/18/1290 15.2.2022 10.2.2022 Wakix Bioprojet Pharma 9 rue Rameau, 75002 Paris, France EU/1/15/1068 3.3.2022 14.2.2022 Cubicin Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/05/328 18.2.2022 14.2.2022 Incruse Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/922 4.3.2022 14.2.2022 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 15.2.2022 14.2.2022 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle Monte Esquinza 30, 28010 Madrid, España EU/1/20/1507 16.2.2022 14.2.2022 Waylivra Akcea Therapeutics Ireland Limited Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland EU/1/19/1360 21.2.2022 14.2.2022 Xromi Nova Laboratories Ireland Limited 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland EU/1/19/1366 17.2.2022 16.2.2022 AMGLIDIA AMMTeK 55 rue de Turbigo, 75003 Paris, France EU/1/18/1279 16.2.2022 16.2.2022 Besponsa Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/17/1200 17.2.2022 16.2.2022 CellCept Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/96/005 17.2.2022 16.2.2022 Deltyba Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München, Deutschland EU/1/13/875 17.2.2022 16.2.2022 Eliquis Bristol-Myers Squibb/Pfizer EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland EU/1/11/691 17.2.2022 16.2.2022 ellaOne Laboratoire HRA Pharma 200 avenue de Paris, 92320 Chatillon, France EU/1/09/522 23.2.2022 16.2.2022 Envarsus Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/935 21.2.2022 16.2.2022 Febuxostat Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/17/1194 17.2.2022 16.2.2022 JEMPERLI GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/21/1538 17.2.2022 16.2.2022 Laventair Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/899 4.3.2022 16.2.2022 Mayzent Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/19/1414 17.2.2022 16.2.2022 Modigraf Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/09/523 17.2.2022 16.2.2022 Myclausen Passauer Pharma GmbH Eiderstedter Weg 3, 14129 Berlin, Deutschland EU/1/10/647 17.2.2022 16.2.2022 Pemazyre Incyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/21/1535 21.2.2022 16.2.2022 Pregabalin Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1011 21.2.2022 16.2.2022 Riximyo Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1184 17.2.2022 16.2.2022 Temybric Ellipta GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/19/1378 4.3.2022 16.2.2022 Yuflyma Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/20/1513 2.3.2022 16.2.2022 Zykadia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/999 17.2.2022 17.2.2022 Advagraf Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/07/387 21.2.2022 17.2.2022 Avonex Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/97/033 23.2.2022 17.2.2022 Mycophenolate mofetil Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/439 18.2.2022 17.2.2022 Myfenax Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/438 21.2.2022 17.2.2022 Nexium Control GlaxoSmithKline Dungarvan Limited Dungarvan, Co. Waterford, Ireland EU/1/13/860 24.2.2022 18.2.2022 Tarceva Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/05/311 21.2.2022 18.2.2022 Zelboraf Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/12/751 21.2.2022 21.2.2022 Clopidogrel Taw Pharma Taw Pharma (Ireland) Limited 104 Lower Baggot Street, Dublin 2, Ireland EU/1/09/559 22.2.2022 21.2.2022 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/930 25.2.2022 21.2.2022 Ogivri Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/18/1341 23.2.2022 21.2.2022 Refixia Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/17/1193 24.2.2022 21.2.2022 Skilarence Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/17/1201 23.2.2022 23.2.2022 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 25.2.2022 24.2.2022 ADVATE Takeda Manufacturing Austria AG Industriestraße 67, 1221 Wien, Österreich EU/1/03/271 28.2.2022 24.2.2022 Bortezomib Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/16/1114 25.2.2022 24.2.2022 Briviact UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/15/1073 25.2.2022 24.2.2022 Irbesartan Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/576 28.2.2022 24.2.2022 JEVTANA Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/11/676 28.2.2022 24.2.2022 Lacosamide UCB UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/19/1383 25.2.2022 24.2.2022 Rixathon Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/17/1185 25.2.2022 24.2.2022 Senshio Shionogi B.V. Kingsfordweg 151, 1043 GR Amsterdam, Nederland EU/1/14/978 25.2.2022 28.2.2022 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 28.2.2022 28.2.2022 Imfinzi AstraZeneca AB 151 85 Södertälje, Sverige EU/1/18/1322 2.3.2022 28.2.2022 Nimenrix Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/12/767 1.3.2022 28.2.2022 Retsevmo Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/20/1527 2.3.2022 28.2.2022 Xagrid Takeda Pharmaceuticals International AG Ireland Branch 50-58 Baggot Street Lower, Block 3 Miesian Plaza, Dublin 2, Co Dublin, D02 Y754, Ireland EU/1/04/295 1.3.2022

— 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 3.2.2022 Vivanza Bayer AG D-51368 Leverkusen, Deutschland EU/1/03/249 7.2.2022

— 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 1.2.2022 Bravecto Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/13/158 3.2.2022 1.2.2022 Mirataz Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/19/247 2.2.2022 8.2.2022 Exzolt Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/17/212 9.2.2022 8.2.2022 Zulvac 8 Ovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/104 9.2.2022 10.2.2022 Draxxin Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/03/041 16.2.2022 10.2.2022 Nobilis IB 4-91 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/98/006 14.2.2022 10.2.2022 Onsior Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/08/089 11.2.2022 28.2.2022 Innovax-ND-IBD Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/17/213 2.3.2022 28.2.2022 Innovax-ND-ILT Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/20/256 2.3.2022

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.