For help on how to get the results you want, see our search tips.
90 results
Keyword Remove keyword
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Medicine type
Exceptional circumstances Remove Exceptional circumstances filter
Conditional approval Remove Conditional approval filter
Categories
Human Remove Human filter
-
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): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,,
,
, Revision: 2, Authorised, Last updated: 30/08/2021
-
List item
Human medicine European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) (updated)
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
-
List item
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Date of authorisation: 23/03/2010,, Revision: 1, Withdrawn, Last updated: 25/10/2011
-
List item
Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,,
, Revision: 24, Authorised, Last updated: 04/12/2020
-
List item
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, Revision: 16, Withdrawn, Last updated: 02/07/2019
-
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): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,,
,
,
, Revision: 5, Authorised, Last updated: 08/04/2021
-
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): Caprelsa (updated)
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,,
, Revision: 22, Authorised, Last updated: 30/06/2022
-
List item
Human medicine European public assessment report (EPAR): Carvykti (updated)
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,,
,
, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,,
, Revision: 12, Authorised, Last updated: 01/08/2018
-
List item
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,,
,
, Revision: 5, Authorised, Last updated: 15/12/2021
-
List item
Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,,
,
, Revision: 25, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Crysvita
Burosumab, Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,,
,
, Revision: 9, Authorised, Last updated: 10/12/2021
-
List item
Human medicine European public assessment report (EPAR): Daronrix
Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs, Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 21/03/2007,, Withdrawn, Last updated: 02/07/2013
-
List item
Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,,
,
, Revision: 13, Authorised, Last updated: 28/01/2021
-
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): 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): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,,
, Revision: 23, Authorised, Last updated: 24/05/2022
-
List item
Human medicine European public assessment report (EPAR): Elzonris
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,,
,
, Revision: 3, Authorised, Last updated: 13/01/2022
-
List item
Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,,
, Revision: 5, Authorised, Last updated: 13/06/2022
-
List item
Human medicine European public assessment report (EPAR): Evkeeza
Evinacumab, Hypercholesterolemia
Date of authorisation: 17/06/2021,,
, Authorised, Last updated: 21/04/2021
-
List item
Human medicine European public assessment report (EPAR): Evoltra
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006,,
, Revision: 30, Authorised, Last updated: 04/05/2021
-
List item
Human medicine European public assessment report (EPAR): Firdapse (previously Zenas)
amifampridine, Lambert-Eaton Myasthenic Syndrome
Date of authorisation: 23/12/2009,,
, Revision: 21, Authorised, Last updated: 25/05/2022