—

Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno Datum odluke Naziv lijeka Nositelj odobrenja za stavljanje u promet Broj upisa u registar Zajednice Datum obavijesti 1.9.2022 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 1.9.2022 1.9.2022 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España EU/1/20/1507 1.9.2022 2.9.2022 Aprovel Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/97/046 5.9.2022 2.9.2022 CoAprovel Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/98/086 5.9.2022 2.9.2022 Copalia HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/575 5.9.2022 2.9.2022 Dafiro HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/574 5.9.2022 2.9.2022 Dupixent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1229 5.9.2022 2.9.2022 Imcivree Rhythm Pharmaceuticals Netherlands B.V. Radarweg 29, 1043 NX Amsterdam, Nederland EU/1/21/1564 5.9.2022 2.9.2022 Januvia Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/383 7.9.2022 2.9.2022 Retsevmo Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/20/1527 5.9.2022 2.9.2022 Tecartus Kite Pharma EU B.V. Tufsteen 1, 2132 NT Hoofddorp, Nederland EU/1/20/1492 5.9.2022 2.9.2022 Zolgensma Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1443 12.9.2022 6.9.2022 Nuvaxovid Novavax CZ, a.s. Bohumil 138, 281 63 Jevany, Česká republika EU/1/21/1618 7.9.2022 09.9.2022 Ceplene Laboratoires Delbert 49 rue Rouelle, 75015 Paris, FRANCE EU/1/08/477 12.9.2022 12.9.2022 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 12.9.2022 13.9.2022 Buvidal Camurus AB Ideon Science Park, 223 70 Lund, Sverige EU/1/18/1336 14.9.2022 13.9.2022 Exforge HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/569 14.9.2022 13.9.2022 GAVRETO Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/21/1555 15.9.2022 13.9.2022 Izba Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/905 14.9.2022 13.9.2022 JEMPERLI GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/21/1538 14.9.2022 13.9.2022 Karvea Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/97/049 14.9.2022 13.9.2022 Karvezide Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/98/085 14.9.2022 13.9.2022 Ninlaro Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark EU/1/16/1094 19.9.2022 13.9.2022 Oncaspar Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/15/1070 14.9.2022 13.9.2022 Temozolomide HEXAL Hexal AG Industriestraße 25, 83607 Holzkirchen, Deutschland EU/1/10/616 19.9.2022 13.9.2022 Temozolomide Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/10/617 16.9.2022 13.9.2022 Tigecycline Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/19/1394 14.9.2022 13.9.2022 Xeljanz Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/17/1178 14.9.2022 15.9.2022 Corlentor Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes CEDEX, France EU/1/05/317 19.9.2022 15.9.2022 Fasenra AstraZeneca AB 151 85 Södertälje, Sverige EU/1/17/1252 16.9.2022 15.9.2022 Hemlibra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/18/1271 16.9.2022 15.9.2022 Intrarosa Endoceutics S.A. Rue Belliard 40, 1040 Bruxelles, Belgique/ Belliardstraat 40, 1040 Brussel, België EU/1/17/1255 18.9.2022 15.9.2022 Kinpeygo STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland EU/1/22/1657 19.9.2022 15.9.2022 Nyxoid Mundipharma Corporation (Ireland) Limited Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland EU/1/17/1238 16.9.2022 15.9.2022 Oxlumo Alnylam Netherlands B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland EU/1/20/1496 16.9.2022 15.9.2022 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/06/380 16.9.2022 15.9.2022 Procoralan Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes CEDEX, France EU/1/05/316 19.9.2022 15.9.2022 Stribild Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/830 19.9.2022 16.9.2022 Comirnaty BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland EU/1/20/1528 19.9.2022 16.9.2022 EVUSHELD AstraZeneca AB 151 85 Södertälje, Sverige EU/1/22/1651 16.9.2022 16.9.2022 Spikevax MODERNA BIOTECH SPAIN, S.L. Calle del Principe de Vergara 132 Plt 12, 28002 Madrid, España EU/1/20/1507 19.9.2022 16.9.2022 Veklury Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/20/1459 19.9.2022 19.9.2022 Miglustat Gen.Orph Gen.Orph 185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France EU/1/17/1232 21.9.2022 19.9.2022 Reblozyl Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/20/1452 23.9.2022 19.9.2022 SomaKit TOC Advanced Accelerator Applications 20 rue Diesel, 01630 Saint-Genis-Pouilly, France EU/1/16/1141 21.9.2022 19.9.2022 TAGRISSO AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1086 20.9.2022 19.9.2022 Tarceva Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/05/311 21.9.2022 21.9.2022 Betmiga Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/12/809 26.9.2022 21.9.2022 Cervarix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/07/419 26.9.2022 21.9.2022 Dafiro Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/371 23.9.2022 21.9.2022 Daxas AstraZeneca AB 151 85 Södertälje, Sverige EU/1/10/636 23.9.2022 21.9.2022 Efficib Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/457 26.9.2022 21.9.2022 Evrysdi Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/21/1531 23.9.2022 21.9.2022 InductOs Medtronic BioPharma B.V. Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland EU/1/02/226 23.9.2022 21.9.2022 Inlyta Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/12/777 26.9.2022 21.9.2022 Lyrica Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/04/279 27.9.2022 21.9.2022 Mvasi Amgen Technology (Ireland) UC Pottery Road, Dun Laoghaire, Co. Dublin, Ireland EU/1/17/1246 26.9.2022 21.9.2022 Ocrevus Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1231 23.9.2022 21.9.2022 Ozempic Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/17/1251 23.9.2022 21.9.2022 Rubraca Clovis Oncology Ireland Limited Regus Dublin Airport, Skybridge House - Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland EU/1/17/1250 23.9.2022 21.9.2022 Tegsedi Akcea Therapeutics Ireland Ltd Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland EU/1/18/1296 23.9.2022 21.9.2022 Tesavel Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/435 26.9.2022 21.9.2022 Travatan Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/199 26.9.2022 21.9.2022 Tybost Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/872 28.9.2022 21.9.2022 Ultomiris Alexion Europe SAS 103-105 Rue Anatole France, 92300 Levallois-Perret, France EU/1/19/1371 23.9.2022 21.9.2022 Verkazia Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi EU/1/17/1219 26.9.2022 21.9.2022 Zabdeno Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/20/1444 27.9.2022 26.9.2022 Cometriq Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/13/890 27.9.2022 26.9.2022 Gencebok Gennisium Pharma Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles, France EU/1/20/1465 28.9.2022 26.9.2022 Lamivudine / Zidovudine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/663 27.9.2022 26.9.2022 Lutathera Advanced Accelerator Applications 20 rue Diesel, 01630 Saint-Genis-Pouilly, France EU/1/17/1226 28.9.2022 26.9.2022 Pirfenidone axunio axunio Pharma GmbH Van-der-Smissen-Straße 1, 22767 Hamburg, Deutschland EU/1/22/1655 27.9.2022 26.9.2022 Pregabalin Pfizer Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/14/916 27.10.2022 26.9.2022 Rybrevant Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/21/1594 27.9.2022 26.9.2022 TOOKAD Steba Biotech S.A 7 Place du Théâtre, 2613 Luxembourg, Luxembourg EU/1/17/1228 6.10.2022 27.9.2022 COVID-19 Vaccine (inactivated, adjuvanted) Valneva Valneva Austria GmbH Campus Vienna Biocenter 3, 1030 Wien, Österreich EU/1/21/1624 29.9.2022 27.9.2022 Jorveza Dr Falk Pharma GmbH Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland EU/1/17/1254 28.9.2022 29.9.2022 ABILIFY MAINTENA Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland EU/1/13/882 3.10.2022 29.9.2022 Byooviz Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/21/1572 4.10.2022 29.9.2022 CABOMETYX Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/16/1136 30.9.2022 29.9.2022 Copalia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/372 30.9.2022 29.9.2022 Dupixent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1229 30.9.2022 29.9.2022 Efient SUBSTIPHARM 24 rue Erlanger, 75016 Paris, France EU/1/08/503 30.9.2022 29.9.2022 Entresto Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/1058 3.10.2022 29.9.2022 Exforge Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/370 30.9.2022 29.9.2022 IVEMEND Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/437 3.10.2022 29.9.2022 Janumet Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/455 29.9.2022 29.9.2022 Lydisilka Estetra SRL Rue Saint Georges 5-7, 4000 Liège, Belgique EU/1/21/1548 3.10.2022 29.9.2022 Paxlovid Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/22/1625 30.9.2022 29.9.2022 PHELINUN ADIENNE S.r.l.S.U. Via Galileo Galilei 19, 20867 Caponago (MB), Italia EU/1/20/1487 30.9.2022 29.9.2022 Ristaben Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/10/621 30.9.2022 29.9.2022 Ristfor Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/10/620 29.9.2022 29.9.2022 Simbrinza Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/933 3.10.2022 29.9.2022 TAKHZYRO Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland EU/1/18/1340 3.10.2022 29.9.2022 Vaniqa Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/01/173 3.10.2022 29.9.2022 Velmetia Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/456 30.9.2022 30.9.2022 Evrenzo Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/21/1574 3.10.2022 30.9.2022 Lamivudine Teva Pharma B.V. Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/596 3.10.2022