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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: 5, Authorised, Last updated: 21/12/2022
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Human medicine European public assessment report (EPAR): Adakveo (updated)
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,,
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, Revision: 3, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Arepanrix
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 23/03/2010,, Revision: 1, Withdrawn, Last updated: 25/10/2011
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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: 4, Authorised, Last updated: 18/05/2022
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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: 4, Authorised, Last updated: 12/10/2022
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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: 2, Authorised, Last updated: 05/10/2022
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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: 15, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,,
, Revision: 22, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Carvykti (updated)
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,,
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, Revision: 1, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Coagadex (updated)
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,,
, Revision: 9, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Daklinza
daclatasvir dihydrochloride, Hepatitis C, Chronic
Date of authorisation: 22/08/2014,, Revision: 15, Withdrawn, Last updated: 30/08/2019
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,,
, Revision: 19, Authorised, Last updated: 11/07/2022
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Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,,
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, Revision: 22, Authorised, Last updated: 18/10/2022
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,,
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, Revision: 6, Authorised, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Empliciti
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,, Revision: 9, Authorised, Last updated: 16/02/2022
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Human medicine European public assessment report (EPAR): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,,
, Revision: 9, Authorised, Last updated: 17/11/2022
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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, Revision: 18, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Evrysdi
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,,
, Revision: 2, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 25, Authorised, Last updated: 12/08/2022
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Human medicine European public assessment report (EPAR): Gavreto
pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021,,
, Revision: 3, Authorised, Last updated: 10/06/2022
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, Revision: 26, Authorised, Last updated: 10/11/2022
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Human medicine European public assessment report (EPAR): Hemlibra
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,,
, Revision: 12, Authorised, Last updated: 27/09/2022
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,,
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, Revision: 8, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Holoclar
ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation; Corneal Diseases
Date of authorisation: 17/02/2015,,
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, Revision: 8, Authorised, Last updated: 06/01/2022