For help on how to get the results you want, see our search tips.
411 results
Medicine
Periodic safety update report single assessments Remove Periodic safety update report single assessments filter
Summaries of opinion Remove Summaries of opinion filter
Orphan designations Remove Orphan designations filter
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Orphan medicine Remove Orphan medicine filter
Exceptional circumstances Remove Exceptional circumstances filter
Additional monitoring Remove Additional monitoring filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,
, 
, Revision: 17, Authorised, Last updated: 08/05/2023
-
List item
Human medicine European public assessment report (EPAR): Lojuxta (updated)
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,, 
, Revision: 16, Authorised, Last updated: 08/05/2023
-
List item
Human medicine European public assessment report (EPAR): Idelvion (updated)
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,, Revision: 11, Authorised, Last updated: 04/05/2023
-
List item
Human medicine European public assessment report (EPAR): Luxturna (updated)
voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa
Date of authorisation: 22/11/2018,, , Revision: 6, Authorised, Last updated: 04/05/2023
-
List item
Human medicine European public assessment report (EPAR): Calquence (updated)
Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020,, Revision: 5, Authorised, Last updated: 03/05/2023
-
List item
Human medicine European public assessment report (EPAR): Rybelsus (updated)
semaglutide, Diabetes Mellitus, Type 2
Date of authorisation: 03/04/2020,, Revision: 5, Authorised, Last updated: 03/05/2023
-
List item
Human medicine European public assessment report (EPAR): Ozempic (updated)
semaglutide, Diabetes Mellitus
Date of authorisation: 08/02/2018,, Revision: 10, Authorised, Last updated: 03/05/2023
-
List item
Human medicine European public assessment report (EPAR): Xenpozyme (updated)
Olipudase alfa, Acid sphingomyelinase deficiency (ASMD) type A/B or type B
Date of authorisation: 24/06/2022,, , Revision: 1, Authorised, Last updated: 03/05/2023
-
List item
Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,
, , Revision: 14, Authorised, Last updated: 02/05/2023
-
List item
Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , 
, Revision: 16, Authorised, Last updated: 02/05/2023
-
List item
Human medicine European public assessment report (EPAR): Zynlonta (updated)
loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022,, , Revision: 2, Authorised, Last updated: 02/05/2023
-
List item
Human medicine European public assessment report (EPAR): Yselty (updated)
linzagolix choline, Leiomyoma
Date of authorisation: 14/06/2022,, Revision: 3, Authorised, Last updated: 02/05/2023
-
List item
Human medicine European public assessment report (EPAR): Imfinzi
durvalumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/09/2018,, Revision: 16, Authorised, Last updated: 02/05/2023
-
List item
Human medicine European public assessment report (EPAR): Zejula
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 20, Authorised, Last updated: 28/04/2023
-
List item
Human medicine European public assessment report (EPAR): Palynziq
Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019,, , Revision: 7, Authorised, Last updated: 28/04/2023
-
List item
Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, Revision: 35, Authorised, Last updated: 28/04/2023
-
List item
Human medicine European public assessment report (EPAR): Beyfortus
nirsevimab,
Date of authorisation: 31/10/2022,, Revision: 2, Authorised, Last updated: 28/04/2023
-
List item
Human medicine European public assessment report (EPAR): Ronapreve
casirivimab, imdevimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 4, Authorised, Last updated: 28/04/2023
-
List item
Human medicine European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane)
Para-aminosalicylic acid, Tuberculosis
Date of authorisation: 07/04/2014,, Revision: 11, Authorised, Last updated: 26/04/2023
-
List item
Human medicine European public assessment report (EPAR): Ravicti
glycerol phenylbutyrate, Urea Cycle Disorders, Inborn
Date of authorisation: 26/11/2015,, Revision: 16, Authorised, Last updated: 26/04/2023
-
List item
Human medicine European public assessment report (EPAR): NexoBrid
proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012,, Revision: 15, Authorised, Last updated: 26/04/2023
-
List item
Human medicine European public assessment report (EPAR): Lyumjev (previously Liumjev)
insulin lispro, Diabetes Mellitus
Date of authorisation: 24/03/2020,, Revision: 5, Authorised, Last updated: 25/04/2023
-
List item
Human medicine European public assessment report (EPAR): Verkazia
ciclosporin, Conjunctivitis; Keratitis
Date of authorisation: 06/07/2018,, , Revision: 7, Authorised, Last updated: 25/04/2023
-
List item
Human medicine European public assessment report (EPAR): Translarna
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 22, Authorised, Last updated: 25/04/2023
-
List item
Human medicine European public assessment report (EPAR): Sarclisa
Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020,, Revision: 7, Authorised, Last updated: 25/04/2023