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Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,,
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, Revision: 6, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Abrysvo
Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein, Respiratory Syncytial Virus Infections
Date of authorisation: 23/08/2023,,
, Authorised, Last updated: 26/09/2023
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Human medicine European public assessment report (EPAR): Adcetris
Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease
Date of authorisation: 25/10/2012,, Revision: 34, Authorised, Last updated: 13/03/2023
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Human medicine European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 10/10/2009,, Revision: 11, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Alofisel
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,, Revision: 11, Authorised, Last updated: 11/10/2023
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Human medicine European public assessment report (EPAR): Alprolix
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,, Revision: 8, Authorised, Last updated: 04/11/2021
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Human medicine European public assessment report (EPAR): Amglidia
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,, Revision: 7, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Amvuttra
vutrisiran sodium, Amyloid Neuropathies, Familial
Date of authorisation: 15/09/2022,,
, Revision: 1, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Arikayce liposomal
Amikacin sulfate, Respiratory Tract Infections
Date of authorisation: 27/10/2020,, Revision: 2, Authorised, Last updated: 04/08/2023
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Human medicine European public assessment report (EPAR): Artesunate Amivas (updated)
artesunate, Malaria
Date of authorisation: 22/11/2021,,
, Revision: 4, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Aspaveli
Pegcetacoplan, Hemoglobinuria, Paroxysmal
Date of authorisation: 13/12/2021,,
, Revision: 3, Authorised, Last updated: 06/09/2022
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,,
, Revision: 26, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): ATryn
Antithrombin alfa, Antithrombin III Deficiency
Date of authorisation: 28/07/2006,,
, Revision: 16, Withdrawn, Last updated: 02/07/2019
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Human medicine European public assessment report (EPAR): Ayvakyt
Avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,,
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, Revision: 7, Authorised, Last updated: 28/06/2023
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Human medicine European public assessment report (EPAR): Besponsa
Inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 28/06/2017,, Revision: 9, Authorised, Last updated: 16/03/2022
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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,,
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, Revision: 7, Authorised, Last updated: 25/10/2023
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Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,,
, Revision: 18, Authorised, Last updated: 24/11/2023
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Human medicine European public assessment report (EPAR): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,,
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, Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,,
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, Revision: 3, Authorised, Last updated: 05/07/2023
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Human medicine European public assessment report (EPAR): Cablivi
Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018,, Revision: 8, Authorised, Last updated: 15/05/2023
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Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,, Revision: 18, Authorised, Last updated: 10/10/2023
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,,
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, Revision: 4, Authorised, Last updated: 26/07/2023
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Human medicine European public assessment report (EPAR): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,,
, Revision: 12, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Cerdelga
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,,
, Revision: 16, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,,
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, Revision: 6, Authorised, Last updated: 18/09/2023