Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2022 to 31 January 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 96/02)

— 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 6.1.2022 Lumykras sotorasib Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/21/1603 Film-coated tablet L01XX73 7.1.2022 6.1.2022 Riltrava Aerosphere formoterol / glycopyrronium bromide / budesonide AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1604 Pressurised inhalation, suspension R03AL11 7.1.2022 6.1.2022 Tecovirimat SIGA tecovirimat SIGA Technologies Netherlands B.V. Prinsenhil 29, Breda 4825 AX, Nederland EU/1/21/1600 Capsule, hard J05AX24 7.1.2022 6.1.2022 Wegovy semaglutide Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/21/1608 Solution for injection A10BJ06 7.1.2022 11.1.2022 Lonapegsomatropin Ascendis Pharma Lonapegsomatropin Ascendis Pharma Endocrinology Division A/S Tuborg Boulevard 12, 2900 Hellerup, Danmark EU/1/21/1607 Powder and solvent for solution for injection Pending 17.1.2022 11.1.2022 Tavneos avacopan Vifor Fresenius Medical Care Renal Pharma France 100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France EU/1/21/1605 Capsule, hard Pending 19.1.2022 11.1.2022 Voraxaze glucarpidase SERB SAS 40 Avenue George V, 75008 Paris, France EU/1/21/1586 Powder for solution for injection V03AF09 13.1.2022 24.1.2022 Vyepti eptinezumab H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/21/1599 Concentrate for solution for infusion N02CD05 25.1.2022

— 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 6.1.2022 Nouryant Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland — 11.1.2022

— 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 3.1.2022 COVID-19 Vaccine Janssen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1525 4.1.2022 6.1.2022 ADYNOVI Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/17/1247 7.1.2022 6.1.2022 Arsenic trioxide Mylan Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1427 7.1.2022 6.1.2022 Bavencio Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/17/1214 10.1.2022 6.1.2022 Braftovi Pierre Fabre Médicament Les Cauquillous, 81500 Lavaur, France EU/1/18/1314 10.1.2022 6.1.2022 CRYSVITA Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/17/1262 12.1.2022 6.1.2022 Darzalex Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/16/1101 7.1.2022 6.1.2022 Dupixent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1229 7.1.2022 6.1.2022 Elocta Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/15/1046 10.1.2022 6.1.2022 Emtricitabine /Tenofovir disoproxil Krka d.d. KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1182 12.1.2022 6.1.2022 Ferriprox Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/99/108 3.2.2022 6.1.2022 Inhixa Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland EU/1/16/1132 18.1.2022 6.1.2022 Metalyse Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/00/169 11.1.2022 6.1.2022 Noxafil Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/05/320 10.1.2022 6.1.2022 Nuwiq Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige EU/1/14/936 10.1.2022 6.1.2022 Qarziba EUSA Pharma (Netherlands) B.V. Beechavenue 54, 1119PW Schiphol-Rijk, Nederland EU/1/17/1191 12.1.2022 6.1.2022 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/901 7.1.2022 6.1.2022 Tecfidera Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/13/837 7.1.2022 6.1.2022 Trydonis Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/18/1274 7.1.2022 6.1.2022 Vfend Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/02/212 7.1.2022 6.1.2022 Zytiga Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/11/714 7.1.2022 7.1.2022 Epclusa Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1116 10.1.2022 7.1.2022 Kaftrio Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/20/1468 10.1.2022 7.1.2022 Kalydeco Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/12/782 10.1.2022 7.1.2022 Ledaga Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15, Ireland EU/1/16/1171 10.1.2022 7.1.2022 LIBTAYO Regeneron Ireland Designated Activity Company (DAC) One Warrington Place, Dublin 2, D02 HH27 Ireland EU/1/19/1376 11.1.2022 7.1.2022 Rolufta Ellipta GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/17/1174 11.1.2022 7.1.2022 YERVOY Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/11/698 13.1.2022 11.1.2022 Caprelsa Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/11/749 13.1.2022 11.1.2022 elmiron bene-Arzneimittel GmbH Herterichstraße 1-3, 81479 München, Deutschland EU/1/17/1189 12.1.2022 11.1.2022 Ozempic Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/17/1251 12.1.2022 11.1.2022 Yargesa Piramal Critical Care B.V. Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland EU/1/17/1176 13.1.2022 12.1.2022 Multaq Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/09/591 13.1.2022 12.1.2022 Ocaliva Intercept Pharma International Limited Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland EU/1/16/1139 13.1.2022 14.1.2022 COVID-19 Vaccine Janssen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1525 14.1.2022 14.1.2022 Lonquex Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/13/856 18.1.2022 14.1.2022 Vaxzevria AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1529 14.1.2022 20.1.2022 Abecma Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/21/1539 21.1.2022 20.1.2022 Cosentyx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/980 24.1.2022 20.1.2022 Inhixa Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland EU/1/16/1132 21.1.2022 20.1.2022 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/02/205 25.1.2022 20.1.2022 Plenadren Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/11/715 24.1.2022 20.1.2022 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/08/442 24.1.2022 20.1.2022 Yescarta Kite Pharma EU B.V. Tufsteen 1, 2132 NT Hoofddorp, Nederland EU/1/18/1299 21.1.2022 24.1.2022 Bridion Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/466 25.1.2022 24.1.2022 Cinryze Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België EU/1/11/688 25.1.2022 24.1.2022 Circadin RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux, 75002 Paris, France EU/1/07/392 26.1.2022 24.1.2022 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 24.1.2022 24.1.2022 Exjade Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/356 25.1.2022 24.1.2022 Fotivda EUSA Pharma (Netherlands) B.V. Beechavenue 54, 1119PW Schiphol-Rijk, Nederland EU/1/17/1215 28.1.2022 24.1.2022 Javlor PIERRE FABRE MEDICAMENT Les Cauquillous, 81500 Lavaur, France EU/1/09/550 25.1.2022 24.1.2022 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 25.1.2022 24.1.2022 Kymriah Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1297 25.1.2022 24.1.2022 Lokelma AstraZeneca AB 151 85 Södertälje, Sverige EU/1/17/1173 25.1.2022 24.1.2022 NUCEIVA Evolus Pharma B.V. Apollolaan 151, 1077 AR Amsterdam, Nederland EU/1/19/1364 7.2.2022 24.1.2022 Oslif Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/586 25.1.2022 24.1.2022 Pregabalin Sandoz GmbH Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1012 25.1.2022 24.1.2022 Tecartus Kite Pharma EU B.V. Tufsteen 1, 2132 NT Hoofddorp, Nederland EU/1/20/1492 25.1.2022 24.1.2022 Teysuno Nordic Group B.V. Siriusdreef 41, 2132 WT Hoofddorp, Nederland EU/1/11/669 26.1.2022 24.1.2022 Ultibro Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/862 25.1.2022 24.1.2022 Vizarsin KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/551 26.1.2022 24.1.2022 Zynquista Guidehouse Germany GmbH Albrechtstrasse 10c, 10117 Berlin, Deutschland EU/1/19/1363 29.1.2022 25.1.2022 Actraphane Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/02/229 31.1.2022 25.1.2022 Actrapid Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/02/230 26.1.2022 25.1.2022 Fasenra AstraZeneca AB 151 85 Södertälje, Sverige EU/1/17/1252 27.1.2022 25.1.2022 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134 26.1.2022 25.1.2022 Prolia Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/10/618 27.1.2022 25.1.2022 Sixmo L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A Strada Statale 67, 50018 Scandicci (Firenze), Italia EU/1/19/1369 27.1.2022 27.1.2022 Arsenic trioxide medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/20/1475 31.1.2022 27.1.2022 Desloratadine ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/11/746 30.1.2022 27.1.2022 Gilenya Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/11/677 28.1.2022 27.1.2022 Libmeldy Orchard Therapeutics (Netherlands) B.V. Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland EU/1/20/1493 31.1.2022 27.1.2022 Lorviqua Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/19/1355 28.1.2022 27.1.2022 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 28.1.2022 27.1.2022 Staquis Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/19/1421 28.1.2022 27.1.2022 Telmisartan Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/719 28.1.2022 27.1.2022 Zinforo Pfizer Ireland Pharmaceuticals Operations Support Group, Ringaskiddy, County Cork, Ireland EU/1/12/785 28.1.2022 27.1.2022 Zonegran Amdipharm Limited 3 Burlington Road, Dublin 4, D04 RD68, IRELAND EU/1/04/307 28.1.2022 31.1.2022 Avastin Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/04/300 1.2.2022 31.1.2022 Benepali Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/15/1074 4.2.2022 31.1.2022 Besremi AOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, 1190 Wien, Österreich EU/1/18/1352 2.2.2022 31.1.2022 Entyvio Takeda Pharma A/S Delta Park 45, 2665 Vallensbæk Strand, Danmark EU/1/14/923 2.2.2022 31.1.2022 Ervebo Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/19/1392 2.2.2022 31.1.2022 Fareston Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/96/004 1.2.2022 31.1.2022 Juluca ViiV Healthcare B.V. Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands EU/1/18/1282 1.2.2022 31.1.2022 Luveris Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/00/155 2.2.2022 31.1.2022 Mulpleo Shionogi B.V. Kingsfordweg 151, 1043 GR Amsterdam, Nederland EU/1/18/1348 1.2.2022 31.1.2022 Pemetrexed Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/15/1057 1.2.2022 31.1.2022 Rhokiinsa Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi EU/1/19/1400 2.2.2022 31.1.2022 Spinraza Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/17/1188 1.2.2022 31.1.2022 Tivicay ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/13/892 1.2.2022

— 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 31.1.2022 Staquis Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/19/1421 1.2.2022

— 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 11.1.2022 CircoMax Porcine circovirus vaccine (inactivated, recombinant) Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/21/281 Emulsion for injection QI09AA07 12.1.2022

— 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 4.1.2022 Meloxidolor Le Vet Beheer B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/13/148 11.1.2022 4.1.2022 Sileo Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/2/15/181 5.1.2022 4.1.2022 VarroMed BeeVital GmbH Wiesenbergstrasse 19,A- 5164, Seeham, Österreich EU/2/16/203 17.1.2022 11.1.2022 Innovax-ILT Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/15/182 13.1.2022 11.1.2022 Vectormune FP ILT + AE Ceva-Phylaxia Co. Ltd. Szállás u. 5, 1107 Budapest, Magyarország EU/2/20/250 17.1.2022 20.1.2022 Improvac Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/095 21.1.2022 24.1.2022 Suvaxyn Aujeszky 783 + O/W Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/98/009 25.1.2022

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.