For help on how to get the results you want, see our search tips.
86 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Summaries of opinion Remove Summaries of opinion filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Conditional approval Remove Conditional approval filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,
, 
, 
, Revision: 10, Authorised, Last updated: 08/06/2022
-
List item
Human medicine European public assessment report (EPAR): Polivy (updated)
polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020,, , 
, Revision: 4, Authorised, Last updated: 08/06/2022
-
List item
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: 20, Authorised, Last updated: 07/06/2022
-
List item
Human medicine European public assessment report (EPAR): Vosevi (updated)
Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, Revision: 12, Authorised, Last updated: 02/06/2022
-
List item
Human medicine European public assessment report (EPAR): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,, , 
, Revision: 1, Authorised, Last updated: 31/05/2022
-
List item
Human medicine European public assessment report (EPAR): Rubraca
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,, , Revision: 8, Authorised, Last updated: 23/05/2022
-
List item
Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,, Revision: 24, Authorised, Last updated: 13/05/2022
-
List item
Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, , Revision: 33, Authorised, Last updated: 12/05/2022
-
List item
Human medicine European public assessment report (EPAR): Iclusig
ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,, , Revision: 23, Authorised, Last updated: 11/05/2022
-
List item
Human medicine European public assessment report (EPAR): Hemlibra
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, , Revision: 11, Authorised, Last updated: 10/05/2022
-
List item
Human medicine European public assessment report (EPAR): Paxlovid
(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido) butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide [PF-07321332], ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022,, Revision: 1, Authorised, Last updated: 29/04/2022
-
List item
Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, , , Revision: 6, Authorised, Last updated: 28/04/2022
-
List item
Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 22, Authorised, Last updated: 26/04/2022
-
List item
Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, Revision: 15, Authorised, Last updated: 07/04/2022
-
List item
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,, , , Revision: 4, Authorised, Last updated: 07/04/2022
-
List item
Human medicine European public assessment report (EPAR): Lorviqua
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,, , Revision: 9, Authorised, Last updated: 07/04/2022
-
List item
Human medicine European public assessment report (EPAR): Oxervate
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,, , , Revision: 1, Authorised, Last updated: 04/04/2022
-
List item
Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Revision: 3, Authorised, Last updated: 01/04/2022
-
List item
Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, , Revision: 18, Authorised, Last updated: 01/04/2022
-
List item
Human medicine European public assessment report (EPAR): Veklury
remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020,, , Revision: 10, Authorised, Last updated: 28/03/2022
-
List item
Human medicine European public assessment report (EPAR): Retsevmo
Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021,, , Revision: 3, Authorised, Last updated: 14/03/2022
-
List item
Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , , Revision: 5, Authorised, Last updated: 23/02/2022
-
List item
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
-
List item
Human medicine European public assessment report (EPAR): Translarna
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 21, Authorised, Last updated: 10/02/2022
-
List item
Human medicine European public assessment report (EPAR): Vitrakvi
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 5, Authorised, Last updated: 09/02/2022