Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de dezembro de 2022 a 31 de dezembro de 2022

[Publicado nos termos do artigo 13.o ou do artigo 38.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho (1) ou do artigo 5.o do Regulamento (UE) 2019/6 do Parlamento Europeu e do Conselho (2)]

(2023/C 37/01)

— Concessão de uma autorização de introdução no mercado (Artigo 13 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho): Autorizado

Data da decisão Nome do medicamento DCI (Denominação Comum Internacional) Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Forma farmacêutica Código ATC (código anatómico-terapêutico-químico) Data de notificação 2.12.2022 Mycapssa octreotida Amryt Pharmaceuticals DAC 45 Mespil Road, Dublin 4, Ireland EU/1/22/1690 Cápsula dura gastrorresistente H01CB02 5.12.2022 5.12.2022 Qdenga vacina contra a dengue tetravalente (viva, atenuada) Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/22/1699 Pó e solvente para solução injectável J07BX04 6.12.2022 9.12.2022 Livmarli cloreto de maralixibato Mirum Pharmaceuticals International B.V. Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland EU/1/22/1704 Solução oral A05AX04 12.12.2022 9.12.2022 Locametz gozetotido Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/22/1692 Pó para solução injectável V09IX14 12.12.2022 9.12.2022 Pemetrexedo Baxter pemetrexedo Baxter Holding B.V. Kobaltweg 49, 3542 CE Utrecht, Nederland EU/1/22/1705 Pó para concentrado para solução para perfusão L01BA04 13.12.2022 9.12.2022 Pluvicto vipivotido tetraxetano de lutécio (177Lu) Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/22/1703 Solução para injecção ou perfusão V10XX05 12.12.2022 9.12.2022 Spevigo spesolimab Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/22/1688 Concentrado para solução para perfusão L04AC22 12.12.2022 12.12.2022 Dimethyl Fumarate Teva fumarato de dimetilo Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/22/1702 Cápsula dura gastrorresistente L04AX07 3.1.2023 12.12.2022 Eladynos abaloparatida Radius Health (Ireland) Ltd. 13 Classon House, Dundrum Business Park, Dundrum, Dublin D14 W9Y3, Ireland EU/1/22/1706 Solução injectável H05AA04 13.12.2022 16.12.2022 Ebvallo tabelecleucel Atara Biotherapeutics Ireland Limited Arthur Cox Building, 10 Earlsfort Terrace, Dublin 2 D02 T380, Ireland EU/1/22/1700 Dispersão injetável Pending 16.12.2022 16.12.2022 Plerixafor Accord plerixafor Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/22/1701 Solução injectável L03AX16 19.12.2022 20.12.2022 Zynlonta loncastuximab tesirina ADC Therapeutics (NL) B.V. Laarderhoogtweg 25, Amsterdam, Noord-Holland, 1101 EB, Nederland EU/1/22/1695 Pó para concentrado para solução para perfusão L01FX22 22.12.2022

— Alteração de uma autorização de introdução no mercado (Artigo 13 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho): Autorizado

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 2.12.2022 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 2.12.2022 2.12.2022 DuoPlavin Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/10/619 5.12.2022 2.12.2022 Kaftrio Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland EU/1/20/1468 5.12.2022 2.12.2022 Kalydeco Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland EU/1/12/782 5.12.2022 2.12.2022 QINLOCK Deciphera Pharmaceuticals (Netherlands) B.V. Atrium Building Floor 4th, Strawinskylaan 3051, Amsterdam, Noord-Holland, 1077 ZX, Nederland EU/1/21/1569 8.12.2022 2.12.2022 Sifrol Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/97/050 7.12.2022 2.12.2022 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España EU/1/20/1507 7.12.2022 2.12.2022 Trizivir ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/00/156 5.12.2022 2.12.2022 Trogarzo Theratechnologies Europe Limited 4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland EU/1/19/1359 14.12.2022 2.12.2022 Trydonis Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/18/1274 5.12.2022 2.12.2022 Zyclara Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/12/783 6.12.2022 5.12.2022 Shingrix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/18/1272 6.12.2022 5.12.2022 Steglujan Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1266 6.12.2022 5.12.2022 Xarelto Bayer AG D-51368 Leverkusen, Deutschland EU/1/08/472 6.12.2022 9.12.2022 Abevmy Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1515 14.12.2022 9.12.2022 Atriance Sandoz Pharmaceuticals d.d. Verovškova ulica 57, 1000 Ljubljana, Slovenija EU/1/07/403 12.12.2022 9.12.2022 Aybintio Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/20/1454 13.12.2022 9.12.2022 Bortezomib Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/15/1019 15.12.2022 9.12.2022 Deferiprone Lipomed Lipomed GmbH Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland EU/1/18/1310 12.12.2022 9.12.2022 Duaklir Genuair Covis Pharma Europe B.V. Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland EU/1/14/964 12.12.2022 9.12.2022 Eklira Genuair Covis Pharma Europe B.V. Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland EU/1/12/778 14.12.2022 9.12.2022 Erleada Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/18/1342 12.12.2022 9.12.2022 Eylea Bayer AG D-51368 Leverkusen, Deutschland EU/1/12/797 13.12.2022 9.12.2022 Herzuma Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1257 14.12.2022 9.12.2022 Insulina lispro Sanofi Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/17/1203 13.12.2022 9.12.2022 Insulin aspart Sanofi Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/20/1447 13.12.2022 9.12.2022 Onbevzi Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/20/1499 13.12.2022 9.12.2022 Oyavas STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland EU/1/20/1510 12.12.2022 9.12.2022 Qarziba EUSA Pharma (Netherlands) B.V. Beechavenue 54, 1119PW Schiphol-Rijk, Nederland EU/1/17/1191 14.12.2022 9.12.2022 Retsevmo Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/20/1527 12.12.2022 9.12.2022 Riarify Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/18/1275 12.12.2022 9.12.2022 Spravato Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/19/1410 12.12.2022 9.12.2022 Suliqua Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/16/1157 13.12.2022 9.12.2022 Vaxelis MCM Vaccine B.V. Robert Boyleweg 4, 2333 CG Leiden, Nederland EU/1/15/1079 13.12.2022 9.12.2022 Vydura Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/22/1645 12.12.2022 9.12.2022 Xydalba AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/986 12.12.2022 9.12.2022 Zirabev Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/18/1344 12.12.2022 12.12.2022 Alymsys Mabxience Research SL C/ Manuel Pombo Angulo 28 — 3a y 4a Planta, 28050 Madrid, España EU/1/20/1509 13.12.2022 12.12.2022 Cablivi Ablynx N.V. Technologiepark 21, 9052 Zwijnaarde, België EU/1/18/1305 21.12.2022 12.12.2022 Dificlir Tillotts Pharma GmbH Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland EU/1/11/733 13.12.2022 12.12.2022 DuoPlavin Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/10/619 14.12.2022 12.12.2022 Dupixent Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/17/1229 13.12.2022 12.12.2022 Enhertu Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/20/1508 13.12.2022 12.12.2022 Karvezide Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/98/085 13.12.2022 12.12.2022 Kisqali Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/17/1221 13.12.2022 12.12.2022 Refixia Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/17/1193 13.12.2022 16.12.2022 Ácido zoledrónico Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/13/834 19.12.2022 16.12.2022 Avastin Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/04/300 19.12.2022 16.12.2022 Bretaris Genuair Covis Pharma Europe B.V. Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland EU/1/12/781 3.1.2023 16.12.2022 Brilique AstraZeneca AB 151 85 Södertälje, Sverige EU/1/10/655 19.12.2022 16.12.2022 Brimica Genuair Covis Pharma Europe B.V. Gustav Mahlerplein 2, 1082MA Amsterdam, Nederland EU/1/14/963 19.12.2022 16.12.2022 Caprelsa Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/11/749 19.12.2022 16.12.2022 Ceprotin Baxter AG Industriestraße 67, 1221 Wien, Österreich EU/1/01/190 19.12.2022 16.12.2022 Combivir ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/98/058 19.12.2022 16.12.2022 Corbilta Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/13/859 20.12.2022 16.12.2022 DUAVIVE Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/14/960 20.12.2022 16.12.2022 DuoPlavin Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/10/619 19.12.2022 16.12.2022 Dupixent Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/17/1229 19.12.2022 16.12.2022 Eptifibatide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/15/1065 19.12.2022 16.12.2022 Granpidam Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/16/1137 19.12.2022 16.12.2022 Imatinib Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/13/845 19.12.2022 16.12.2022 Imfinzi AstraZeneca AB 151 85 Södertälje, Sverige EU/1/18/1322 19.12.2022 16.12.2022 Inhixa Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland EU/1/16/1132 22.12.2022 16.12.2022 Intuniv Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/15/1040 20.12.2022 16.12.2022 Iscover Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/98/070 19.12.2022 16.12.2022 Iscover Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/98/070 19.12.2022 16.12.2022 Iscover Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/98/070 19.12.2022 16.12.2022 Karvea Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/97/049 20.12.2022 16.12.2022 Levodopa/Carbidopa/Entacapona Orion Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/11/706 21.12.2022 16.12.2022 Lynparza AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/959 19.12.2022 16.12.2022 Moventig Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland EU/1/14/962 21.12.2022 16.12.2022 Mvabea Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1445 20.12.2022 16.12.2022 Myalepta Amryt Pharmaceuticals DAC 45 Mespil Road, Dublin 4, Ireland EU/1/18/1276 21.12.2022 16.12.2022 Neulasta Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/02/227 20.12.2022 16.12.2022 Ocaliva ADVANZ PHARMA Limited Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland EU/1/16/1139 19.12.2022 16.12.2022 Ozawade Bioprojet Pharma 9 rue Rameau, 75002 Paris, France EU/1/21/1546 19.12.2022 16.12.2022 Plavix Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/98/069 19.12.2022 16.12.2022 Plavix Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/98/069 19.12.2022 16.12.2022 Plavix Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/98/069 19.12.2022 16.12.2022 Resolor Takeda Pharmaceuticals International AG Ireland Branch Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland EU/1/09/581 20.12.2022 16.12.2022 Rybelsus Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/20/1430 20.12.2022 16.12.2022 Sarclisa Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/20/1435 19.12.2022 16.12.2022 Saxenda Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/15/992 19.12.2022 16.12.2022 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España EU/1/20/1507 19.12.2022 16.12.2022 Trajenta Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/11/707 19.12.2022 16.12.2022 Tresiba Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/12/807 20.12.2022 16.12.2022 Truvelog Mix 30 Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/22/1639 19.12.2022 16.12.2022 Twynsta Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/10/648 3.1.2023 19.12.2022 Inrebic Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/20/1514 20.12.2022 20.12.2022 Ácido Ibandrónico Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/12/798 22.12.2022 20.12.2022 Mvasi Amgen Technology (Ireland) UC Pottery Road, Dun Laoghaire, Co. Dublin, Ireland EU/1/17/1246 4.1.2023 20.12.2022 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 22.12.2022 20.12.2022 Sarclisa Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France EU/1/20/1435 21.12.2022 20.12.2022 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/901 21.12.2022 20.12.2022 Skytrofa Ascendis Pharma Endocrinology Division A/S Tuborg Boulevard 12, 2900 Hellerup, Danmark EU/1/21/1607 21.12.2022 22.12.2022 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 22.12.2022 22.12.2022 Paxlovid Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/22/1625 22.12.2022

— Retirada de uma autorização de introdução no mercado (Artigo 13 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho)

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 5.12.2022 Trogarzo Theratechnologies Europe Limited 4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland EU/1/19/1359 5.1.2023 9.12.2022 NeuroBloc Sloan Pharma S.a.r.l. 33 Rue de Puits Romain, 8070 Bertrange, Luxembourg EU/1/00/166 12.12.2022

— Concessão de uma autorização de introdução no mercado (Artigo 38 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho; Artigo 5.o do Regulamento (UE) 2019/6 do Parlamento Europeu e do Conselho): Autorizado

Data da decisão Nome do medicamento DCI (Denominação Comum Internacional) Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Forma farmacêutica Código ATC (código anatómico-terapêutico-químico) Data de notificação 20.12.2022 NEOLEISH Vacina contra a leishmaniose canina (plasmídeo de ADN recombinante) CZ Veterinaria, S.A. La Relva s/n — Torneiros, 36410 Porriño, España EU/2/22/290 Solução para pulverização nasal Pending 21.12.2022

— Alteração de uma autorização de introdução no mercado (Artigo 38 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho; Artigo 5.o do Regulamento (UE) 2019/6 do Parlamento Europeu e do Conselho): Autorizado

Data da decisão Nome do medicamento Titular da autorização de introdução no mercado Número de inscrição no Registo Comunitário Data de notificação 2.12.2022 CYTOPOINT Zoetis Belgium rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/205 5.12.2022 2.12.2022 Fevaxyn Pentofel Zoetis Belgium rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/96/002 6.12.2022 2.12.2022 Solensia Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/20/269 5.12.2022 2.12.2022 Tulissin VIRBAC 1ère avenue 2065 m LID, 06516 Carros, France EU/2/20/252 6.12.2022 2.12.2022 Zenalpha Vetcare Oy P.O. Box 99, 24101 Salo, Suomi EU/2/21/279 7.12.2022 9.12.2022 Convenia Zoetis Belgium rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/06/059 14.12.2022 9.12.2022 Zeleris Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/17/210 14.12.2022 13.12.2022 Innovax-ND-ILT Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/20/256 14.12.2022 13.12.2022 Versican Plus DHPPi/L4R Zoetis Belgium rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/163 14.12.2022 15.12.2022 Exzolt Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/17/212 20.12.2022 15.12.2022 Librela Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/20/261 21.12.2022 15.12.2022 NEXGARD SPECTRA Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/14/177 16.12.2022 15.12.2022 Porcilis PCV M Hyo Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/14/175 20.12.2022 15.12.2022 Simparica Trio Zoetis Belgium rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/19/243 20.12.2022 15.12.2022 Simparica Trio Zoetis Belgium rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/19/243 20.12.2022 15.12.2022 UBAC Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/18/227 21.12.2022 15.12.2022 Versican Plus Pi/L4R Zoetis Belgium rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/173 16.12.2022 16.12.2022 Equip WNV Zoetis Belgium rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/08/086 20.12.2022 20.12.2022 Lydaxx VETOQUINOL S.A. Magny-Vernois, 70200 Lure, France EU/2/20/253 21.12.2022 20.12.2022 Novem Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/042 22.12.2022 20.12.2022 Onsior Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/08/089 21.12.2022 20.12.2022 ProteqFlu Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/03/037 22.12.2022 20.12.2022 ProteqFlu-Te Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/03/038 22.12.2022 20.12.2022 Rabitec Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/17/219 21.12.2022 20.12.2022 RHINISENG Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/10/109 22.12.2022 20.12.2022 Suprelorin VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France EU/2/07/072 23.12.2022 20.12.2022 Tulaven Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/20/251 21.12.2022

Os interessados podem solicitar o acesso ao relatório público dos medicamentos em questão e das decisões correspondentes junto de:

European Medicines Agency Domenico Scarlattilaan 6 1083 HS Amsterdam NETHERLANDS

(1) JO L 136 de 30.4.2004, p. 1.

(2) JO L 4 de 7.1.2019, p. 43.