Internetowa baza tekstów prawnych OpenLEX (2024)

Data wydania decyzjiNazwa produktu leczniczegoPosiadacz pozwolenia na dopuszczenie do obrotuNumer pozycji w rejestrze wspólnotowymData notyfikac6.5.2024ASPAVELISwedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/21/15957.5.20246.5.2024CircadinRAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

EU/1/07/3927.5.20246.5.2024EliquisBristol-Myers Squibb/Pfizer EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, IrelandEU/1/11/6918.5.20246.5.2024EpclusaGilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, IrelandEU/1/16/11167.5.20246.5.2024FendrixGlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, BelgiqueEU/1/04/2998.5.20246.5.2024KanumaAlexion Europe SAS 103-105 rue Anatole France, 92300 Levallois-Perret, FranceEU/1/15/10337.5.20246.5.2024KisplyxEisai GmbH

Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland

EU/1/16/11287.5.20246.5.2024OrphacolTHERAVIA

16 Rue Montrosier, 92200 Neuilly- sur-Seine, France

EU/1/13/87014.5.20246.5.2024VEGZELMACelltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, MagyarországEU/1/22/16677.5.20246.5.2024XenicalCHEPLAPHARM Arzneimittel

GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/98/0718.5.202410.5.2024ArmisarteActavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjöröur, Iceland

EU/1/15/106313.5.202410.5.2024Darunavir MylanMylan Pharmaceuticals Limited Damastown Industrial Park, Mul- huddart, Dublin 15, DUBLIN, IrelandEU/1/16/114013.5.202410.5.2024Fingolimod AccordAccord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6^a planta, 08039 Barcelona, España

EU/1/20/145013.5.202410.5.2024LojuxtaAmryt Pharmaceuticals DAC 45 Mespil Road, Dublin 4, IrelandEU/1/13/85115.5.202410.5.2024NilemdoDaiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, DeutschlandEU/1/20/142513.5.202410.5.2024NustendiDaiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, DeutschlandEU/1/20/142414.5.202410.5.2024PreHevbriVBI Vaccines B.V.

Delflandlaan 1, Queen's Tower Office Number 714, 1062 EA Amsterdam, Nederland

EU/1/22/164115.5.202410.5.2024QUVIVIQIdorsia Pharmaceuticals Deutschland GmbH

Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland

EU/1/22/163814.5.202410.5.2024RevoladeNovartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, IrelandEU/1/10/61213.5.202410.5.2024Thalidomide Lipo- medLipomed GmbH Hegenheimer Straße 2, 79576 Weil/Rhein, DeutschlandEU/1/22/167613.5.202410.5.2024ThyrogenSanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/99/12214.5.202410.5.2024TrevictaJanssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, BelgiëEU/1/14/97114.5.202410.5.2024TyverbNovartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, IrelandEU/1/07/44014.5.202415.5.2024ComirnatyBioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, DeutschlandEU/1/20/152816.5.202416.5.2024AMGEVITAAmgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/116417.5.202416.5.2024BondronatAtnahs Pharma Netherlands B.V. Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, DanmarkEU/1/96/01217.5.202416.5.2024CufenceUnivar Solutions B.V. Schouwburgplein 30, Rotterdam, 3012 CL, NederlandEU/1/19/136521.5.202416.5.2024GiaprezaPAION Deutschland GmbH Heussstraße 25, 52078 Aachen, DeutschlandEU/1/19/138417.5.202416.5.2024IBRANCEPfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, BelgiëEU/1/16/114717.5.202416.5.2024ImvanexBavarian Nordic A/S

Philip Heymans Allé 3, DK-2900

Hellerup, Danmark

EU/1/13/85530.5.202416.5.2024LumykrasAmgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/21/160317.5.202416.5.2024NUBEQABayer AG

D-51368 Leverkusen, Deutschland

EU/1/20/143217.5.202416.5.2024PecFentGrünenthal GmbH Zieglerstraße 6, 52078, Aachen, DeutschlandEU/1/10/64422.5.202416.5.2024RinvoqAbbVie Deutschland GmbH & Co.

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/140417.5.202416.5.2024RozlytrekRoche Registration GmbH Emil-Barell-Strasse 1, 79639 Gren- zach-Wyhlen, DeutschlandEU/1/20/146017.5.202416.5.2024RybrevantJanssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, BelgiëEU/1/21/159417.5.202416.5.2024SaphneloAstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/162317.5.202416.5.2024VipidiaTakeda Pharma A/S

Delta Park 45, 2665 Vallensbaek Strand, Danmark

EU/1/13/84421.5.202416.5.2024XromiNova Laboratories Ireland Limited 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, IrelandEU/1/19/136620.5.202417.5.2024GrasustekJuta Pharma GmbH Gutenbergstr. 13, 24941, Flensburg, DeutschlandEU/1/19/137523.5.202417.5.2024Levetiracetam ActavisActavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjöröur, Iceland

EU/1/11/71321.5.202417.5.2024Methylthioninium chloride ProveblueProvepharm S.A.S.

22 rue Marc Donadille, 13013 Marseille, France

EU/1/11/68222.5.202417.5.2024NUCEIVAEvolus Pharma B.V.

Apollolaan 151, 1077 AR Amsterdam, Nederland

EU/1/19/136421.5.202417.5.2024OxbrytaPfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, BelgiëEU/1/21/162221.5.202417.5.2024QdengaTakeda GmbH

Byk-Gulden-StraEe 2, 78467 Konstanz, Deutschland

EU/1/22/169921.5.202417.5.2024TRISENOXTeva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/02/20422.5.202421.5.2024Rivaroxaban AccordAccord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/20/148822.5.202422.5.2024BEKEMVAmgen Technology (Ireland) UC Pottery Road, Dun Laoghaire, Co. Dublin, IrelandEU/1/23/172724.5.202422.5.2024BiResp SpiromaxTeva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/92128.5.202422.5.2024BosulifPfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, BelgiëEU/1/13/81823.5.202422.5.2024BuccolamNeuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España

EU/1/11/70924.5.202422.5.2024DuoResp SpiromaxTeva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/92028.5.202422.5.2024EbilfuminActavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjöröur, Iceland

EU/1/14/91523.5.202422.5.2024Eptifibatide AccordAccord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/15/106523.5.202422.5.2024EVOTAZBristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, IrelandEU/1/15/102523.5.202422.5.2024KarvezideSanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, FranceEU/1/98/08524.5.202422.5.2024KomboglyzeAstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/73124.5.202422.5.2024LytgobiTaiho Pharma Netherlands B.V.

Barbara Strozzilaan 201, 1083 HN Amsterdam, Noord-Holland, Nederland

EU/1/23/174129.5.202422.5.2024MenveoGSK Vaccines S.r.l.

Via Fiorentina 1, 53100 Siena, Italia

EU/1/10/61427.5.202422.5.2024OpzeluraIncyte Biosciences Distribution B.V. Paasheuvelweg 25, 1105 BP Amsterdam, NederlandEU/1/23/172623.5.202422.5.2024ProcysbiChiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/13/86129.5.202422.5.2024Ratiograstimratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, DeutschlandEU/1/08/4443.6.202422.5.2024SialanarProveca Pharma Limited

2 Dublin Landings, North Wall Quay, Dublin 1, Ireland

EU/1/16/113523.5.202423.5.2024EvrenzoAstellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, NederlandEU/1/21/157423.5.202423.5.2024Levetiracetam ratiopharmratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, DeutschlandEU/1/11/70228.5.202423.5.2024Levetiracetam TevaTeva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/70123.5.202423.5.2024OPDIVOBristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, IrelandEU/1/15/101423.5.202427.5.2024AimovigNovartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, IrelandEU/1/18/129328.5.202427.5.2024CamceviAccord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6^a planta, 08039 Barcelona, España

EU/1/22/164728.5.202427.5.2024ColumviRoche Registration GmbH Emil-Barell-Strasse 1, 79639 Gren- zach-Wyhlen, DeutschlandEU/1/23/174228.5.202427.5.2024ImfinziAstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/132228.5.202427.5.2024IMJUDOAstraZeneca AB

151 85 Södertälje, Sverige

EU/1/22/171328.5.202427.5.2024ReyatazBristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, IrelandEU/1/03/26728.5.202427.5.2024TriumeqViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/14/94028.5.202429.5.2024BLINCYTOAmgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/104726.4.202429.5.2024BLINCYTOAmgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/104730.5.202429.5.2024CerdelgaSanofi B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/14/97431.5.202429.5.2024Desloratadine ActavisActavis Group PTC ehf.

Dalshraun 1, 220 Hafnarfjöröur, Iceland

EU/1/11/7451.6.202429.5.2024Efavirenz/Emtrici- tabine/Tenofovir disoproxil ZentivaZentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/17/121030.5.202429.5.2024Emtricitabine/ Tenofovir disoproxil KrkaKRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, SlovenijaEU/1/16/115130.5.202429.5.2024Emtricitabine /Tenofovir disoproxil Krka d.d.KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, SlovenijaEU/1/17/11826.6.202429.5.2024Myocet liposomalCHEPLAPHARM Arzneimittel

GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/00/1413.6.202429.5.2024OmidriaRayner Surgical (Ireland) Limited The Mill Enterprise Hub, Newtown Link Road, Drogheda, A92 CD3D, Co. Louth, IrelandEU/1/15/10184.6.202429.5.2024Pregabalin SandozSandoz GmbH Biochemiestrasse 10, 6250 Kundl, ÖsterreichEU/1/15/10116.6.2024

Internetowa baza tekstów prawnych OpenLEX (2024)

References