Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2021 to 31 December 2021

(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 50/01)

— 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 9.12.2021 Cibinqo abrocitinib Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/21/1593 Film-coated tablet D11AH 10.12.2021 9.12.2021 Rybrevant amivantamab Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/21/1594 Concentrate for solution for infusion L01FX18 10.12.2021 9.12.2021 Sitagliptin SUN sitagliptin fumarate Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/21/1598 Film-coated tablet A10BH01 15.12.2021 13.12.2021 ASPAVELI pegcetacoplan Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/21/1595 Solution for infusion L04AA54 14.12.2021 13.12.2021 Vaxneuvance Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed) Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/21/1591 Suspension for injection J07AL 14.12.2021 17.12.2021 Xevudy sotrovimab GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/21/1562 Concentrate for solution for infusion Pending 17.12.2021 20.12.2021 Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) Novavax CZ, a.s. Bohumil 138, 281 63 Jevany, Česká republika EU/1/21/1618 dispersion for injection J07BX03 20.12.2021

— 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 2.12.2021 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 3.12.2021 2.12.2021 Ebilfumin Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/14/915 7.12.2021 2.12.2021 Ivozall ORPHELIA Pharma SAS 85 boulevard Saint-Michel, 75005 Paris, France EU/1/19/1396 7.12.2021 2.12.2021 Kaletra AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/01/172 3.12.2021 2.12.2021 Revinty Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/929 3.12.2021 3.12.2021 Kiovig Baxter AG Industriestraße 67, 1221 Wien, Österreich EU/1/05/329 6.12.2021 3.12.2021 Lojuxta Amryt Pharmaceuticals DAC 45 Mespil Road, Dublin 4, Ireland EU/1/13/851 15.12.2021 3.12.2021 Naglazyme BioMarin International Limited Shanbally, Ringaskiddy, County Cork P43 R298, Ireland EU/1/05/324 11.1.2022 3.12.2021 Ocrevus Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1231 6.12.2021 3.12.2021 Polivy Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/19/1388 7.12.2021 3.12.2021 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 6.12.2021 6.12.2021 RoActemra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/08/492 7.12.2021 7.12.2021 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 7.12.2021 8.12.2021 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle Monte Esquinza 30, 28010 Madrid, España EU/1/20/1507 8.12.2021 9.12.2021 ADCETRIS Takeda Pharma A/S Delta Park 45, 2665 Vallensbæk Strand, Danmark EU/1/12/794 14.12.2021 9.12.2021 AMGEVITA Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/16/1164 13.12.2021 9.12.2021 Amyvid Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/12/805 13.12.2021 9.12.2021 Apealea Inceptua AB Gustavslundsv. 143, 16751 Bromma, Sverige EU/1/18/1292 10.12.2021 9.12.2021 Chenodeoxycholic acid Leadiant Leadiant GmbH Liebherrstr. 22, 80538 Munich, Deutschland EU/1/16/1110 10.12.2021 9.12.2021 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 10.12.2021 9.12.2021 Dengvaxia Sanofi Pasteur 14 Espace Henry Vallée, 69007 Lyon, France EU/1/18/1338 13.12.2021 9.12.2021 Erleada Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/18/1342 10.12.2021 9.12.2021 Esbriet Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/11/667 10.12.2021 9.12.2021 Exelon Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/98/066 10.12.2021 9.12.2021 Holoclar Holostem Terapie Avanzate S.r.l. Via Glauco Gottardi 100, Modena, MO 41125, Italia EU/1/14/987 13.12.2021 9.12.2021 JETREA Inceptua AB Gustavslundsv. 143, 16751 Bromma, Sverige EU/1/13/819 10.12.2021 9.12.2021 Leganto UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/11/695 10.12.2021 9.12.2021 Livogiva Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland EU/1/20/1462 13.12.2021 9.12.2021 Ogluo Tetris Pharma B.V Element Offices, Bargelaan 180-200, 2333 CW, Leiden, Nederland EU/1/20/1523 13.12.2021 9.12.2021 Pioglitazone Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/11/722 10.12.2021 9.12.2021 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/08/442 14.12.2021 9.12.2021 Roteas Berlin-Chemie AG Glienicker Weg 125, 12489 Berlin, Deutschland EU/1/16/1152 15.12.2021 9.12.2021 Stalevo Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/03/260 10.12.2021 9.12.2021 Thalidomide BMS Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/08/443 10.12.2021 9.12.2021 Xospata Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/19/1399 10.12.2021 9.12.2021 ZALTRAP Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/12/814 10.12.2021 9.12.2021 Zyprexa Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/96/022 13.12.2021 9.12.2021 Zyprexa Velotab Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/99/125 13.12.2021 13.12.2021 ADCETRIS Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark EU/1/12/794 14.12.2021 13.12.2021 Conbriza Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/09/511 14.12.2021 13.12.2021 Giotrif Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/13/879 14.12.2021 13.12.2021 Invanz Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/02/216 14.12.2021 13.12.2021 Kanuma Alexion Europe SAS 103-105 rue Anatole France, 92300 Levallois-Perret, France EU/1/15/1033 14.12.2021 13.12.2021 Kinzalmono Bayer AG D-51368 Leverkusen, Deutschland EU/1/98/091 14.12.2021 13.12.2021 Mycophenolate mofetil Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/439 14.12.2021 13.12.2021 Neulasta Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/02/227 15.12.2021 13.12.2021 Neuraceq Life Radiopharma Berlin GmbH Max-Planck-Straße 4, 12489 Berlin, Deutschland EU/1/13/906 15.12.2021 13.12.2021 NULOJIX Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/11/694 14.12.2021 13.12.2021 Pramipexole Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/11/728 16.12.2021 13.12.2021 Pramipexole Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/490 17.12.2021 13.12.2021 Rapiscan GE Healthcare AS Nycoveien 1, 0485, Oslo, Norge EU/1/10/643 15.12.2021 13.12.2021 Rebif Merck Europe B.V. Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland EU/1/98/063 17.12.2021 13.12.2021 Rivastigmine Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/09/599 15.12.2021 13.12.2021 Thalidomide BMS Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/08/443 14.12.2021 13.12.2021 Xofigo Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/873 15.12.2021 16.12.2021 Ceprotin Baxter AG Industriestraße 67, 1221 Wien, Österreich EU/1/01/190 17.12.2021 16.12.2021 Cinacalcet Accordpharma Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/20/1429 17.12.2021 16.12.2021 Clopidogrel Krka d.d. KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/562 20.12.2021 16.12.2021 Clopidogrel Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/08/465 23.12.2021 16.12.2021 COVID-19 Vaccine Janssen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1525 16.12.2021 16.12.2021 Dexdor Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/11/718 19.12.2021 16.12.2021 Grepid Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/09/535 17.12.2021 16.12.2021 Herzuma Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1257 20.12.2021 16.12.2021 Humira AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/03/256 17.12.2021 16.12.2021 Jyseleca Galapagos NV Generaal De Wittelaan L11 A3, 2800 Mechelen Antwerp, België EU/1/20/1480 17.12.2021 16.12.2021 KANJINTI Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/18/1281 20.12.2021 16.12.2021 Retsevmo Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/20/1527 20.12.2021 16.12.2021 Revestive Shire Pharmaceuticals Ireland Limited Blocks 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/12/787 23.12.2021 16.12.2021 Rinvoq AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/19/1404 17.12.2021 16.12.2021 Sarclisa Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/20/1435 17.12.2021 16.12.2021 Siklos Addmedica 37 rue de Caumartin, 75009 Paris, France EU/1/07/397 17.12.2021 16.12.2021 Vemlidy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1154 17.12.2021 16.12.2021 Vocabria ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/20/1481 17.12.2021 16.12.2021 Zoely Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland EU/1/11/690 21.12.2021 16.12.2021 Zoely Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland EU/1/11/690 21.12.2021 17.12.2021 Kineret Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/02/203 17.12.2021 20.12.2021 Intuniv Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/15/1040 21.12.2021 20.12.2021 Nitisinone MDK MendeliKABS Europe Limited Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland EU/1/17/1217 21.12.2021 20.12.2021 PANTOLOC Control Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/09/519 21.12.2021 20.12.2021 Raloxifene Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/627 23.12.2021 20.12.2021 Selincro H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/12/815 21.12.2021 20.12.2021 Veklury Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1459 20.12.2021 20.12.2021 Voriconazole Hikma Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal EU/1/15/1004 4.1.2022

— 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 13.12.2021 Leganto UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/11/695 4.1.2022 20.12.2021 PANTOLOC Control Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/09/519 21.12.2021 20.12.2021 Rasilez HCT Noden Pharma DAC D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland EU/1/08/491 22.12.2021 20.12.2021 Ytracis CIS bio international Boite Postale 32, 91192 Gif-sur-Yvette, France EU/1/03/250 22.12.2021

— 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 7.12.2021 Imoxat imidacloprid/moxidectin Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/21/280 Spot-on solution QP54AB52 9.12.2021 7.12.2021 Suiseng Diff/A Clostridioides difficile and Clostridium perfringens vaccine, inactivated Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/21/278 Suspension for injection QI09AB12 9.12.2021 15.12.2021 Zenalpha medetomidine hydrochloride/vatinoxan hydrochloride Vetcare Oy P.O. Box 99, 24101 Salo, Suomi EU/2/21/279 Solution for injection QN05CM99 16.12.2021

— 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 7.12.2021 Circovac CEVA-Phylaxia Co. Ltd Szállás u. 5, 1107 Budapest, Magyarország EU/2/07/075 9.12.2021 7.12.2021 Stronghold Plus Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/16/204 13.12.2021 13.12.2021 Apoquel Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/13/154 15.12.2021 15.12.2021 Bravecto Plus Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/18/224 16.12.2021 15.12.2021 Cardalis Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/12/142 16.12.2021 15.12.2021 Osurnia Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/14/170 16.12.2021 15.12.2021 Rabitec Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/17/219 16.12.2021

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.