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Wijziging van een vergunning voor het in de handel brengen (artikel 13 van Verordening (EG) nr. 726/2004 van het Europees Parlement en de Raad): Goedgekeurd Datum van het besluit Naam van het geneesmiddel Houder van de vergunning voor het in de handel brengen Nr. in het communautair geneesmiddelenregister Datum van kennisgeving 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