Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2021 to 30 November 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 527/01)

— 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 12.11.2021 Libmyris adalimumab STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland EU/1/21/1590 Solution for injection L04AB04 16.11.2021 12.11.2021 Rivaroxaban Mylan rivaroxaban Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/21/1588 Tablet B01AF01 3.12.2021 15.11.2021 Hukyndra adalimumab STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland EU/1/21/1589 Solution for injection L04AB04 16.11.2021 15.11.2021 Sugammadex Mylan sugammadex Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/21/1583 Solution for injection V03AB35 3.12.2021 15.11.2021 Vumerity diroximel fumarate Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/21/1585 Gastro-resistant capsule, hard L04AX09 16.11.2021 18.11.2021 GAVRETO pralsetinib Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/21/1555 Capsule, hard L01EX23 22.11.2021 18.11.2021 QINLOCK ripretinib Deciphera Pharmaceuticals (Netherlands) B.V. Atrium Building Floor 4th, Strawinskylaan 3051, Amsterdam, Noord-Holland, 1077 ZX, Nederland EU/1/21/1569 Tablet L01EX19 24.11.2021 22.11.2021 Artesunate Amivas artesunate Amivas Ireland Limited Durands Court 7, Parnell Street, Waterford, Ireland EU/1/21/1582 Powder and solvent for solution for injection P01BE03 24.11.2021 22.11.2021 Brukinsa zanubrutinib BeiGene Ireland Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Co. Dublin, Ireland EU/1/21/1576 Capsule, hard L01EL03 23.11.2021 22.11.2021 Trodelvy sacituzumab govitecan Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/21/1592 Powder for concentrate for solution for infusion L01FX17 23.11.2021

— 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 15.11.2021 Raylumis Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België — 17.11.2021

— 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 3.11.2021 Besponsa Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/17/1200 4.11.2021 3.11.2021 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 3.11.2021 3.11.2021 Extavia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/454 8.11.2021 3.11.2021 Fulvestrant Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/17/1253 4.11.2021 3.11.2021 Lamzede Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/17/1258 5.11.2021 3.11.2021 Pregabalin Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/15/997 4.11.2021 3.11.2021 Pregabalin Mylan Pharma Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/998 5.11.2021 3.11.2021 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle Monte Esquinza 30, 28010 Madrid, España EU/1/20/1507 4.11.2021 9.11.2021 Clopidogrel Viatris Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/09/568 30.11.2021 9.11.2021 Enyglid KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/580 1.12.2021 9.11.2021 Luxturna Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1331 10.11.2021 9.11.2021 Sutent Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/06/347 10.11.2021 9.11.2021 Talmanco Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/16/1153 1.12.2021 9.11.2021 Tegsedi Akcea Therapeutics Ireland Ltd Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland EU/1/18/1296 30.11.2021 9.11.2021 Vaxzevria AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1529 10.11.2021 11.11.2021 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle Monte Esquinza 30, 28010 Madrid, España EU/1/20/1507 12.11.2021 12.11.2021 Akynzeo Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland EU/1/15/1001 19.11.2021 12.11.2021 Atriance Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/403 15.11.2021 12.11.2021 Atripla Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/07/430 15.11.2021 12.11.2021 Daptomycin Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/17/1175 16.11.2021 12.11.2021 Dzuveo Laboratoire Aguettant 1 Rue Alexander Fleming, 69007 Lyon, France EU/1/18/1284 16.11.2021 12.11.2021 Edistride AstraZeneca AB 151 85 Södertälje, Sverige EU/1/15/1052 15.11.2021 12.11.2021 Enhertu Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/20/1508 2.12.2021 12.11.2021 Evoltra Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/06/334 16.11.2021 12.11.2021 Iasibon Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/10/659 16.11.2021 12.11.2021 Jyseleca Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1480 15.11.2021 12.11.2021 Lacosamide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/17/1230 15.11.2021 12.11.2021 Lyrica Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/04/279 3.12.2021 12.11.2021 Ninlaro Takeda Pharma A/S Delta Park 45, 2665 Vallensbæk Strand, Danmark EU/1/16/1094 1.12.2021 12.11.2021 Nucala GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/15/1043 15.11.2021 12.11.2021 Olanzapine Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/08/475 15.11.2021 12.11.2021 Olumiant Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/16/1170 16.11.2021 12.11.2021 Sevelamer carbonate Winthrop Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/14/952 7.12.2021 12.11.2021 SomaKit TOC Advanced Accelerator Applications 20 rue Diesel, 01630 Saint-Genis-Pouilly, France EU/1/16/1141 16.11.2021 12.11.2021 Steglujan Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1266 15.11.2021 12.11.2021 Stelara Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/08/494 15.11.2021 12.11.2021 Suliqua Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/16/1157 15.11.2021 12.11.2021 Tadalafil Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/17/1177 15.11.2021 12.11.2021 Tivicay ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/13/892 17.11.2021 12.11.2021 Viagra Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/98/077 3.12.2021 12.11.2021 Xermelo Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/17/1224 8.12.2021 15.11.2021 Aldurazyme Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/03/253 7.12.2021 15.11.2021 Brilique AstraZeneca AB 151 85 Södertälje, Sverige EU/1/10/655 17.11.2021 15.11.2021 Clopidogrel Taw Pharma Taw Pharma (Ireland) Limited 104 Lower Baggot Street, Dublin 2, Ireland EU/1/09/559 25.11.2021 15.11.2021 Dovato ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/19/1370 17.11.2021 15.11.2021 Emtricitabine/Tenofovir disoproxil Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/16/1133 16.11.2021 15.11.2021 Fasturtec Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/00/170 16.11.2021 15.11.2021 Forxiga AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/795 17.11.2021 15.11.2021 Gardasil MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/357 17.11.2021 15.11.2021 Hizentra CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/11/687 18.11.2021 15.11.2021 Hulio Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/18/1319 17.11.2021 15.11.2021 Invokana Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/884 16.11.2021 15.11.2021 Jorveza Dr Falk Pharma GmbH Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland EU/1/17/1254 16.11.2021 15.11.2021 Kevzara Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1196 16.11.2021 15.11.2021 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 20.11.2021 15.11.2021 Myalepta Amryt Pharmaceuticals DAC 45 Mespil Road, Dublin 4, Ireland EU/1/18/1276 18.11.2021 15.11.2021 Praluent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/15/1031 16.11.2021 15.11.2021 Remicade Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/99/116 19.11.2021 15.11.2021 Rilutek Sanofi Mature IP 54 rue La Boétie, 75008, Paris, France EU/1/96/010 18.11.2021 15.11.2021 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/901 16.11.2021 15.11.2021 Skyrizi AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/19/1361 16.11.2021 15.11.2021 Thyrogen Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/99/122 17.11.2021 15.11.2021 Triumeq ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/14/940 17.11.2021 15.11.2021 Truxima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/16/1167 16.11.2021 15.11.2021 Xeljanz Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/17/1178 17.11.2021 15.11.2021 Yellox Bausch Health Ireland Limited 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland EU/1/11/692 2.12.2021 15.11.2021 Zercepac Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/20/1456 16.11.2021 15.11.2021 Zercepac Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/20/1456 16.11.2021 15.11.2021 Zoledronic acid Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/12/786 16.11.2021 15.11.2021 Zonisamide Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/16/1093 16.11.2021 18.11.2021 Abecma Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/21/1539 21.11.2021 18.11.2021 Aripiprazole Mylan Pharma Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/15/1005 19.11.2021 18.11.2021 Axumin Blue Earth Diagnostics Ireland Ltd 6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland EU/1/17/1186 23.11.2021 18.11.2021 Aybintio Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/20/1454 22.11.2021 18.11.2021 Beovu Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/19/1417 26.11.2021 18.11.2021 Champix Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/06/360 19.11.2021 18.11.2021 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 18.11.2021 18.11.2021 Marixino KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/13/820 22.11.2021 18.11.2021 Ogivri Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/18/1341 22.11.2021 18.11.2021 Opatanol Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/02/217 19.11.2021 18.11.2021 Pemetrexed Krka KRKA, d.d. Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/18/1283 22.11.2021 18.11.2021 Prometax Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/98/092 19.11.2021 18.11.2021 Ritonavir Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/17/1242 19.11.2021 18.11.2021 Steglujan Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1266 20.11.2021 18.11.2021 Tecartus Kite Pharma EU B.V. Tufsteen 1, 2132 NT Hoofddorp, Nederland EU/1/20/1492 19.11.2021 18.11.2021 Xagrid Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland EU/1/04/295 19.11.2021 18.11.2021 Xoterna Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/863 19.11.2021 18.11.2021 Zeffix GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/99/114 19.11.2021 18.11.2021 Zeposia Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/20/1442 21.11.2021 19.11.2021 Aripiprazole Mylan Pharma Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/15/1005 22.11.2021 22.11.2021 Briviact UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/15/1073 1.12.2021 22.11.2021 BYANNLI Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1453 23.11.2021 22.11.2021 Foclivia Seqirus S.r.l., Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italia EU/1/09/577 23.11.2021 22.11.2021 Lacosamide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/17/1230 23.11.2021 22.11.2021 Pregabalin Zentiva k.s Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1166 23.11.2021 22.11.2021 Saxenda Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/15/992 23.11.2021 22.11.2021 Suliqua Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/16/1157 23.11.2021 22.11.2021 Talmanco Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/16/1153 23.11.2021 22.11.2021 TOBI Podhaler Mylan IRE Healthcare Ltd Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/10/652 23.11.2021 22.11.2021 Zypadhera Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/08/479 23.11.2021 23.11.2021 Vaxzevria AstraZeneca AB 151 85 Södertälje, Sverige EU/1/21/1529 23.11.2021 26.11.2021 Clopidogrel Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/540 30.11.2021 26.11.2021 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 26.11.2021 26.11.2021 Corbilta Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/13/859 30.11.2021 26.11.2021 Kisplyx Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/16/1128 29.11.2021 26.11.2021 Lenvima Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/15/1002 29.11.2021 26.11.2021 Lyxumia Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/12/811 29.11.2021 26.11.2021 NeoRecormon Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/97/031 1.12.2021 26.11.2021 Pritor Bayer AG D-51368 Leverkusen, Deutschland EU/1/98/089 30.11.2021 26.11.2021 Relvar Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/13/886 29.11.2021 26.11.2021 Repatha Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1016 29.11.2021 26.11.2021 Replagal Shire Human Genetic Therapies AB Lindhagensgatan 120, 112 51, Stockholm, Sverige EU/1/01/189 6.12.2021 26.11.2021 Rivaroxaban Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/20/1488 24.10.2021 26.11.2021 Rivaroxaban Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/20/1488 30.11.2021 26.11.2021 Uptravi Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/15/1083 29.12.2021 29.11.2021 Carmustine Obvius Obvius Investment B.V. De Cuserstraat 93, 1081 CN Amsterdam, Nederland EU/1/18/1278 1.12.2021 29.11.2021 Hirobriz Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/594 30.11.2021 29.11.2021 IntronA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/99/127 1.12.2021 29.11.2021 Simulect Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/98/084 30.11.2021

— 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 3.11.2021 Pregabalin Mylan Pharma Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/998 5.11.2021 15.11.2021 Atripla Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/07/430 16.11.2021 18.11.2021 Skysona bluebird bio (Netherlands) B.V. Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland EU/1/21/1563 19.11.2021 30.11.2021 IntronA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/99/127 1.12.2021

— 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 11.11.2021 Felpreva tigolaner/emodepside/praziquantel Vetoquinol S.A. Magny-Vernois, 70200 Lure, France EU/2/21/277 Spot-on solution QP52AA51 12.11.2021

— 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 3.11.2021 Chanhold Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/19/236 5.11.2021 3.11.2021 Equilis Prequenza Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/056 5.11.2021 3.11.2021 Equilis Prequenza Te Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/057 5.11.2021 3.11.2021 Kexxtone Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/12/145 4.11.2021 11.11.2021 Cepedex CP Pharma Handelsgesellschaft mbH Ostlandring 13, 31303 Burgdorf, Deutschland EU/2/16/200 25.11.2021 11.11.2021 Coliprotec F4/F18 Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/16/202 15.11.2021 12.11.2021 Aivlosin ECO Animal Health Europe Limited 6th Floor, South Bank House, Barrow Street, Dublin 4, D04 TR29, Ireland EU/2/04/044 16.11.2021 12.11.2021 Simparica Trio Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/19/243 16.11.2021 26.11.2021 PREVEXXION RN Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/20/254 3.12.2021 29.11.2021 NexGard Combo Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/20/267 30.11.2021

— Withdrawal of a marketing authorisation (Article 38 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 15.11.2021 Coliprotec F4 Prevtec Microbia GmbH Geyerspergerstr 27, 80689 München, Deutschland EU/2/14/180 7.12.2021

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.