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64 results
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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,
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, Revision: 24, Authorised, Last updated: 13/03/2019
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Human medicine European public assessment report (EPAR): Bavencio
avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017,, , Revision: 5, Authorised, Last updated: 04/11/2019
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Veterinary medicine European public assessment report (EPAR): Bluevac BTV8
bluetongue virus vaccine, serotype 8 (inactivated), Sheep, Cattle
Date of authorisation: 14/04/2011,
, Revision: 6, Authorised, Last updated: 06/03/2018
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Human medicine European public assessment report (EPAR): Bosulif
bosutinib (as monohydrate), Leukemia, Myeloid
Date of authorisation: 26/03/2013,, , Revision: 19, Authorised, Last updated: 09/12/2019
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Human medicine European public assessment report (EPAR): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,, , , 
, Revision: 3, Authorised, Last updated: 19/02/2020
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Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib s-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016,, , Revision: 7, Authorised, Last updated: 13/02/2020
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Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, , Revision: 17, Authorised, Last updated: 24/01/2020
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Human medicine European public assessment report (EPAR): Coagadex
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,, , , Revision: 5, Authorised, Last updated: 21/04/2020
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Human medicine European public assessment report (EPAR): Cometriq
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , , Revision: 17, Authorised, Last updated: 10/03/2020
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Human medicine European public assessment report (EPAR): Crysvita
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 5, Authorised, Last updated: 06/03/2020
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, , , Revision: 11, Authorised, Last updated: 23/01/2020
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Human medicine European public assessment report (EPAR): Deltyba (updated)
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 13, Authorised, Last updated: 11/05/2020
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Human medicine European public assessment report (EPAR): Empliciti
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,, , Revision: 6, Authorised, Last updated: 14/11/2019
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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, , Revision: 12, Authorised, Last updated: 31/03/2020
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Human medicine European public assessment report (EPAR): Ervebo
recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola
Date of authorisation: 11/11/2019,, , Authorised, Last updated: 12/12/2019
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, , Revision: 17, Authorised, Last updated: 14/11/2019
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Human medicine European public assessment report (EPAR): Harvoni (updated)
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, , Revision: 20, Authorised, Last updated: 19/05/2020
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Human medicine European public assessment report (EPAR): Hemlibra
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, , Revision: 5, Authorised, Last updated: 05/06/2019
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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,, , , Revision: 5, Authorised, Last updated: 12/04/2019
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Human medicine European public assessment report (EPAR): Iclusig
ponatinib, Leukemia, Myeloid, Leukemia, Lymphoid
Date of authorisation: 01/07/2013,, , , Revision: 20, Authorised, Last updated: 29/10/2019
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Human medicine European public assessment report (EPAR): Isentress
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 36, Authorised, Last updated: 25/06/2019
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Human medicine European public assessment report (EPAR): Jorveza
budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,, , Revision: 1, Authorised, Last updated: 16/07/2019
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Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 22/07/2012,, , Revision: 21, Authorised, Last updated: 03/02/2020
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Human medicine European public assessment report (EPAR): Kanuma (updated)
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,, , , Revision: 4, Authorised, Last updated: 04/05/2020
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Human medicine European public assessment report (EPAR): Ketoconazole HRA
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 10, Authorised, Last updated: 10/01/2020