For help on how to get the results you want, see our search tips.
69 results
Medicine type
Exceptional circumstances Remove Exceptional circumstances filter
Accelerated assessment Remove Accelerated assessment filter
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Authorisation status
Authorised Remove Authorised filter
-
List item
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: 10, Authorised, Last updated: 06/11/2019
-
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
Veterinary medicine European public assessment report (EPAR): Bluevac BTV (previously known as Bluevac BTV8)
bluetongue virus vaccine serotypes 1 or 4 or 8 [inactivated], Sheep, Cattle
Date of authorisation: 14/04/2011,, Revision: 7, Authorised, Last updated: 27/10/2020
-
List item
Human medicine European public assessment report (EPAR): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,,
,
,
, Revision: 4, Authorised, Last updated: 12/06/2020
-
List item
Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016,,
, Revision: 9, Authorised, Last updated: 11/11/2020
-
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: 3, Authorised, Last updated: 24/11/2017
-
List item
Human medicine European public assessment report (EPAR): Coagadex
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,,
,
, Revision: 6, Authorised, Last updated: 27/01/2021
-
List item
Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,,
,
, Revision: 15, Authorised, Last updated: 26/01/2021
-
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): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,,
, Revision: 20, Authorised, Last updated: 24/06/2020
-
List item
Human medicine European public assessment report (EPAR): Elzonris
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,,
,
, Authorised, Last updated: 25/01/2021
-
List item
Human medicine European public assessment report (EPAR): Empliciti
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,,
, Revision: 8, Authorised, Last updated: 02/02/2021
-
List item
Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,,
, Revision: 13, Authorised, Last updated: 11/12/2020
-
List item
Human medicine European public assessment report (EPAR): Evoltra
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006,,
, Revision: 29, Authorised, Last updated: 30/11/2020
-
List item
Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,,
, Revision: 18, Authorised, Last updated: 13/10/2020
-
List item
Human medicine European public assessment report (EPAR): Firdapse (previously Zenas)
amifampridine, Lambert-Eaton Myasthenic Syndrome
Date of authorisation: 23/12/2009,,
, Revision: 20, Authorised, Last updated: 26/11/2020
-
List item
Human medicine European public assessment report (EPAR): Foclivia
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009,, Revision: 10, Authorised, Last updated: 13/01/2021
-
List item
Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,,
, Revision: 21, Authorised, Last updated: 29/07/2020
-
List item
Human medicine European public assessment report (EPAR): Hemlibra
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,,
, Revision: 7, Authorised, Last updated: 22/12/2020
-
List item
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
-
List item
Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine
Date of authorisation: 31/07/2013,,
, Revision: 18, Authorised, Last updated: 14/12/2020
-
List item
Human medicine European public assessment report (EPAR): Increlex
Mecasermin, Laron Syndrome
Date of authorisation: 02/08/2007,,
, Revision: 21, Authorised, Last updated: 20/04/2020
-
List item
Human medicine European public assessment report (EPAR): Isentress
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 37, Authorised, Last updated: 16/11/2020
-
List item
Human medicine European public assessment report (EPAR): Jorveza
budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,,
, Revision: 2, Authorised, Last updated: 04/06/2020