For help on how to get the results you want, see our search tips.
135 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Withdrawn applications Remove Withdrawn applications filter
Medicine type
Exceptional circumstances Remove Exceptional circumstances filter
Orphan medicine Remove Orphan medicine filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,
, 
, 
, Revision: 8, Authorised, Last updated: 25/01/2021
-
List item
Human medicine European public assessment report (EPAR): Blincyto
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 11, Authorised, Last updated: 22/01/2021
-
List item
Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, , Revision: 27, Authorised, Last updated: 22/01/2021
-
List item
Human medicine European public assessment report (EPAR): Symkevi
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,, , Revision: 7, Authorised, Last updated: 22/01/2021
-
List item
Human medicine European public assessment report (EPAR): Wakix
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, , Revision: 9, Authorised, Last updated: 21/01/2021
-
List item
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: 7, Authorised, Last updated: 14/01/2021
-
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): Daurismo
Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020,, , Revision: 1, Authorised, Last updated: 08/01/2021
-
List item
Human medicine European public assessment report (EPAR): Ninlaro
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 8, Authorised, Last updated: 08/01/2021
-
List item
Human medicine European public assessment report (EPAR): Luxturna
voretigene neparvovec, Leber Congenital Amaurosis, Retinitis Pigmentosa
Date of authorisation: 22/11/2018,, , Revision: 3, Authorised, Last updated: 05/01/2021
-
List item
Human medicine European public assessment report (EPAR): Alofisel
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,, , Revision: 6, Authorised, Last updated: 04/01/2021
-
List item
Human medicine European public assessment report (EPAR): Mylotarg
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,, , Revision: 7, Authorised, Last updated: 21/12/2020
-
List item
Human medicine European public assessment report (EPAR): Adcetris
Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012,, , , Revision: 28, Authorised, Last updated: 18/12/2020
-
List item
Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene)
Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013,, , Revision: 17, Authorised, Last updated: 18/12/2020
-
List item
Human medicine European public assessment report (EPAR): Isturisa
Osilodrostat phosphate, Cushing Syndrome
Date of authorisation: 09/01/2020,, , Revision: 3, Authorised, Last updated: 17/12/2020
-
List item
Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 14, Authorised, Last updated: 17/12/2020
-
List item
Human medicine European public assessment report (EPAR): Ledaga
Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017,, Revision: 5, Authorised, Last updated: 16/12/2020
-
List item
Human medicine European public assessment report (EPAR): Polivy
polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020,, , , Revision: 2, Authorised, Last updated: 15/12/2020
-
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): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,, , , Revision: 5, Authorised, Last updated: 10/12/2020
-
List item
Human medicine European public assessment report (EPAR): Kanuma
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,, , , Revision: 6, Authorised, Last updated: 10/12/2020
-
List item
Human medicine European public assessment report (EPAR): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 1, Authorised, Last updated: 09/12/2020
-
List item
Human medicine European public assessment report (EPAR): Onpattro
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,, , , Revision: 8, Authorised, Last updated: 04/12/2020
-
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): Esbriet
Pirfenidone, Idiopathic Pulmonary Fibrosis
Date of authorisation: 27/02/2011,, Revision: 26, Authorised, Last updated: 03/12/2020