Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 a 30 de junho 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)]

(2022/C 289/01)

— Concessão de uma autorização de introdução no mercado [artigo 13.o 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 3.6.2022 Lunsumio mosunetuzumab Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/22/1649 Concentrado para solução para perfusão L01XC 7.6.2022 14.6.2022 Yselty linzagolix colina ObsEva Ireland Ltd. Penthouse Floor, 5 Lapps Quay, Cork, T12 RW7D, Ireland EU/1/21/1606 Comprimido revestido por película Pending 17.6.2022 20.6.2022 Pirfenidone AET pirfenidona Alfred E. Tiefenbacher (GmbH & Co. KG) Van der Smissen Strasse 1, 22767 Hamburg, Deutschland EU/1/22/1655 Comprimido revestido por película L04AX05 27.6.2022 20.6.2022 Tabrecta capmatinib Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/22/1650 Comprimido revestido por película L01EX17 21.6.2022 21.6.2022 Filsuvez extrato de casca de bétula Amryt Pharmaceuticals DAC 45 Mespil Road, Dublin 4, Ireland EU/1/22/1652 Gele D03AX13 23.6.2022 24.6.2022 Nexviadyme avalglucosidase alfa Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/21/1579 Pó para concentrado para solução para perfusão Pending 27.6.2022 24.6.2022 Xenpozyme olipudase alfa Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/22/1659 Pó para concentrado para solução para perfusão A16AB25 27.6.2022

— Alteração de uma autorização de introdução no mercado [artigo 13.o 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 2.6.2022 Abraxane Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/07/428 8.6.2022 2.6.2022 Anoro Ellipta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/14/898 5.6.2022 2.6.2022 Comtan Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/98/081 3.6.2022 2.6.2022 Cufence Univar Solutions B.V. Schouwburgplein 30, Rotterdam, 3012 CL, Nederland EU/1/19/1365 7.6.2022 2.6.2022 Exviera AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/983 3.6.2022 2.6.2022 HALAVEN Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland EU/1/11/678 3.6.2022 2.6.2022 Imcivree Rhythm Pharmaceuticals Netherlands B.V. Radarweg 29, 1043 NX Amsterdam, Nederland EU/1/21/1564 7.6.2022 2.6.2022 Instanyl Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark EU/1/09/531 14.6.2022 2.6.2022 Ketoconazole HRA HRA Pharma Rare Diseases 200 avenue de Paris, 92320 Chatillon, France EU/1/14/965 14.6.2022 2.6.2022 Kigabeq ORPHELIA Pharma SAS 85 boulevard Saint-Michel, 75005 Paris, France EU/1/18/1302 10.6.2022 2.6.2022 Posaconazole Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/19/1379 7.6.2022 2.6.2022 Slenyto RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux, 75002 Paris, France EU/1/18/1318 7.6.2022 2.6.2022 Sugamadex Mylan Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/21/1583 21.6.2022 2.6.2022 Trulicity Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/956 7.6.2022 2.6.2022 TUKYSA Seagen B.V. Evert van de Beekstraat 1-104, 1118CL Schiphol, Nederland EU/1/20/1526 7.6.2022 2.6.2022 Viekirax AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/982 3.6.2022 2.6.2022 Vyxeos liposomal Jazz Pharmaceuticals Ireland Ltd 5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland EU/1/18/1308 7.6.2022 2.6.2022 Zepatier Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/16/1119 14.6.2022 7.6.2022 Benlysta GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/11/700 13.6.2022 7.6.2022 Constella AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/12/801 13.6.2022 7.6.2022 CONTROLOC Control Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/09/515 9.6.2022 7.6.2022 Ifirmacombi KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/673 9.6.2022 7.6.2022 Ilaris Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/564 8.6.2022 7.6.2022 Irbesartan HCT Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/06/377 9.6.2022 7.6.2022 Mozobil Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/09/537 8.6.2022 7.6.2022 Ondexxya AstraZeneca AB 151 85 Södertälje, Sverige EU/1/18/1345 20.6.2022 7.6.2022 PANTOZOL Control Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/09/517 9.6.2022 7.6.2022 Perjeta Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/13/813 8.6.2022 7.6.2022 Rebetol Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/99/107 14.6.2022 7.6.2022 Rivastigmine Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/11/693 8.6.2022 7.6.2022 SOMAC Control Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/09/516 9.6.2022 7.6.2022 Stayveer Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/832 8.6.2022 7.6.2022 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 8.6.2022 7.6.2022 Truvada Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/04/305 8.6.2022 7.6.2022 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/04/274 8.6.2022 7.6.2022 Xeplion Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/11/672 8.6.2022 13.6.2022 Afinitor Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/538 15.6.2022 13.6.2022 Aimovig Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1293 14.6.2022 13.6.2022 Descovy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1099 14.6.2022 13.6.2022 Enurev Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/789 14.6.2022 13.6.2022 Feraccru Norgine B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland EU/1/15/1075 21.6.2022 13.6.2022 Fintepla Zogenix ROI Limited Trinity House, Charleston Road, Ranelagh, Dublin 6, D06 C8X4, Ireland EU/1/20/1491 14.6.2022 13.6.2022 Imfinzi AstraZeneca AB 151 85 Södertälje, Sverige EU/1/18/1322 15.6.2022 13.6.2022 Leqvio Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1494 15.6.2022 13.6.2022 Nyvepria Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/20/1486 14.6.2022 13.6.2022 Ozurdex AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/10/638 14.6.2022 13.6.2022 Pelgraz Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/18/1313 15.6.2022 13.6.2022 Pregabalina Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/15/1027 15.6.2022 13.6.2022 Xydalba AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/986 14.6.2022 14.6.2022 Lacosamida UCB UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/19/1383 20.6.2022 14.6.2022 Odefsey Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1112 15.6.2022 14.6.2022 Xermelo Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/17/1224 29.6.2022 20.6.2022 Cosentyx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/980 21.6.2022 20.6.2022 Ilumetri Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/18/1323 21.6.2022 20.6.2022 OBIZUR Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/15/1035 21.6.2022 20.6.2022 Olumiant Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/16/1170 21.6.2022 20.6.2022 Translarna PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland EU/1/13/902 21.6.2022 21.6.2022 Cresemba Basilea Pharmaceutica Deutschland GmbH Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland EU/1/15/1036 22.6.2022 21.6.2022 Cuprymina A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L. Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia EU/1/12/784 22.6.2022 21.6.2022 Elonva N.V. Organon P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland EU/1/09/609 23.6.2022 21.6.2022 Entecavir Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/17/1227 22.6.2022 21.6.2022 Hepcludex Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1446 27.6.2022 21.6.2022 Hycamtin Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/96/027 22.6.2022 21.6.2022 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 29.6.2022 21.6.2022 Lemtrada Sanofi Belgium Leonardo Da Vincilaan 19, B-1831 Diegem, België EU/1/13/869 22.6.2022 21.6.2022 Mektovi Pierre Fabre Médicament Les Cauquillous, 81500 Lavaur, France EU/1/18/1315 22.6.2022 21.6.2022 Mysimba Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/14/988 23.6.2022 21.6.2022 NexoBrid MediWound Germany GmbH Hans-Sachs-Strasse 100, 65428 Rüsselsheim, Deutschland EU/1/12/803 27.6.2022 21.6.2022 Pemetrexed Fresenius Kabi Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/16/1115 27.6.2022 21.6.2022 Retsevmo Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/20/1527 22.6.2022 21.6.2022 TOOKAD Steba Biotech S.A 7 Place du Théâtre, 2613 Luxembourg, Luxembourg EU/1/17/1228 23.6.2022 21.6.2022 Vocabria ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland EU/1/20/1481 22.6.2022 21.6.2022 Votubia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/11/710 23.6.2022 21.6.2022 XALKORI Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/12/793 22.6.2022 21.6.2022 Xaluprine Nova Laboratories Ireland Limited 3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland EU/1/11/727 27.6.2022 21.6.2022 Yescarta Kite Pharma EU B.V. Tufsteen 1, 2132 NT Hoofddorp, Nederland EU/1/18/1299 23.6.2022 22.6.2022 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 27.6.2022 24.6.2022 Abecma Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/21/1539 27.6.2022 24.6.2022 Azopt Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/00/129 27.6.2022 24.6.2022 Bretaris Genuair AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/781 27.6.2022 24.6.2022 Brimica Genuair AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/963 27.6.2022 24.6.2022 Deferasirox Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/19/1412 27.6.2022 24.6.2022 Defitelio Gentium S.r.I. Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia EU/1/13/878 28.6.2022 24.6.2022 Defitelio Gentium S.r.I. Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia EU/1/13/878 28.6.2022 24.6.2022 Dificlir Tillotts Pharma GmbH Warmbacher Strasse 80, 79618 Rheinfelden, Deutschland EU/1/11/733 30.6.2022 24.6.2022 Duaklir Genuair AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/964 27.6.2022 24.6.2022 Eklira Genuair AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/778 27.6.2022 24.6.2022 Norvir AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/96/016 27.6.2022 24.6.2022 Ocaliva Intercept Pharma International Limited Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland EU/1/16/1139 28.6.2022 24.6.2022 Onbevzi Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/20/1499 29.6.2022 24.6.2022 Oncaspar Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/15/1070 27.6.2022 24.6.2022 Spravato Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/19/1410 27.6.2022 24.6.2022 Temodal Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/98/096 28.6.2022 24.6.2022 TRIXEO AEROSPHERE AstraZeneca AB 151 85 Södertälje, Sverige EU/1/20/1498 27.6.2022 24.6.2022 Xeljanz Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/17/1178 28.6.2022 24.6.2022 Zometa Phoenix Labs Unlimited Company Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, Ireland EU/1/01/176 30.6.2022 29.6.2022 Alymsys Mabxience Research SL C/ Manuel Pombo Angulo 28 — 3a y 4a Planta, 28050 Madrid, España EU/1/20/1509 4.7.2022 29.6.2022 Apixaban Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/20/1458 30.6.2022 29.6.2022 BLENREP GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/20/1474 30.6.2022 29.6.2022 Cerezyme Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/97/053 30.6.2022 29.6.2022 Dacogen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/12/792 30.6.2022 29.6.2022 Epidyolex GW Pharma (International) B.V. Databankweg 26, 3821AL Amersfoort, Nederland EU/1/19/1389 30.6.2022 29.6.2022 Isentress Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/436 30.6.2022 29.6.2022 LIBTAYO Regeneron Ireland Designated Activity Company (DAC) One Warrington Place, Dublin 2, D02 HH27 Ireland EU/1/19/1376 30.6.2022 29.6.2022 Optruma Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/98/074 1.7.2022 29.6.2022 PritorPlus Bayer AG D-51368 Leverkusen, Deutschland EU/1/02/215 1.7.2022 29.6.2022 Respreeza CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/15/1006 1.7.2022 29.6.2022 Vizamyl GE Healthcare AS Nycoveien 1, 0485, Oslo, Norge EU/1/14/941 30.6.2022 29.6.2022 Vizimpro Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/19/1354 30.6.2022 29.6.2022 Xerava PAION Deutschland GmbH Heussstraße 25, 52078 Aachen, Deutschland EU/1/18/1312 30.6.2022 30.6.2022 Enspryng Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/21/1559 4.7.2022

— Retirada de uma autorização de introdução no mercado [artigo 13.o 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 7.6.2022 Episalvan Amryt GMBH Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland EU/1/15/1069 8.6.2022 24.6.2022 Senstend Plethora Pharma Solutions Ltd. 32 Merrion Street Upper, Dublin 2, Ireland EU/1/19/1387 28.6.2022

— Alteração de uma autorização de introdução no mercado [artigo 38.o 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 3.6.2022 Reconcile FORTE Healthcare Ltd Cougar Lane, Naul, Co. Dublin, Ireland EU/2/08/080 8.6.2022 3.6.2022 Syvazul BTV LABORATORIOS SYVA, S.A.U. Av. Párroco Pablo Diez 49-57, 24010 León, España EU/2/18/231 30.6.2022 13.6.2022 Increxxa Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/20/258 14.6.2022 13.6.2022 Purevax RCP Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/052 20.6.2022 14.6.2022 Purevax RC Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/051 20.6.2022 14.6.2022 Purevax RCPCh FeLV Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/047 20.6.2022 14.6.2022 Suprelorin VIRBAC S.A. 1ère Avenue — 2065 m — L.I.D., 06516 Carros CEDEX, France EU/2/07/072 16.6.2022 20.6.2022 Prevomax Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/17/211 29.6.2022 20.6.2022 REXXOLIDE Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/20/263 27.6.2022 24.6.2022 Apoquel Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/13/154 28.6.2022 24.6.2022 Emdocam Emdoka bvba J. Lijsenstraat 16, 2321 Hoogstraten, België EU/2/11/128 30.6.2022 24.6.2022 Enteroporc Coli AC Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/20/262 27.6.2022 24.6.2022 Innovax-ND-IBD Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/17/213 28.6.2022 24.6.2022 Lydaxx VETOQUINOL S.A. Magny-Vernois, 70200 Lure, France EU/2/20/253 30.6.2022 24.6.2022 Neptra Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/19/246 30.6.2022 24.6.2022 Purevax RC Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/051 27.6.2022 24.6.2022 Purevax RCP Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/052 28.6.2022 24.6.2022 Purevax RCPCh Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/050 28.6.2022 24.6.2022 Purevax RCPCh Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/050 27.6.2022 24.6.2022 Purevax RCPCh FeLV Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/047 27.6.2022 24.6.2022 Purevax RCP FeLV Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/048 27.6.2022 24.6.2022 Purevax RCP FeLV Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/048 27.6.2022 24.6.2022 Sileo Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/2/15/181 28.6.2022 24.6.2022 Vectormune ND CEVA-Phylaxia Co. Ltd Szállás u. 5, 1107 Budapest, Magyarország EU/2/15/188 3.7.2022 24.6.2022 Zenalpha Vetcare Oy P.O. Box 99, 24101 Salo, Suomi EU/2/21/279 27.6.2022 28.6.2022 CLYNAV Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/16/197 29.6.2022 29.6.2022 Porcilis PCV Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/08/091 1.7.2022

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.