451 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Referrals Remove Referrals filter
Medicine type
Orphan medicine Remove Orphan medicine filter
Accelerated assessment Remove Accelerated assessment filter
Conditional approval Remove Conditional approval filter
Additional monitoring Remove Additional monitoring filter
Biosimilar Remove Biosimilar filter
Authorisation status
Authorised Remove Authorised filter
-
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
-
List item
Human medicine European public assessment report (EPAR): Rubraca
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,
, , Revision: 12, Authorised, Last updated: 24/04/2023
-
List item
Human medicine European public assessment report (EPAR): Artesunate Amivas
artesunate, Malaria
Date of authorisation: 22/11/2021,, , Revision: 1, Authorised, Last updated: 24/04/2023
-
List item
Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, Revision: 20, Authorised, Last updated: 21/04/2023
-
List item
Human medicine European public assessment report (EPAR): Uplizna
Inebilizumab, Neuromyelitis Optica
Date of authorisation: 25/04/2022,, Revision: 2, Authorised, Last updated: 21/04/2023
-
List item
Human medicine European public assessment report (EPAR): Regkirona
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 7, Authorised, Last updated: 21/04/2023
-
List item
Human medicine European public assessment report (EPAR): Lunsumio
mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022,, , , Revision: 1, Authorised, Last updated: 20/04/2023
-
List item
Human medicine European public assessment report (EPAR): Fintepla
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, , Revision: 5, Authorised, Last updated: 20/04/2023
-
List item
Human medicine European public assessment report (EPAR): Wakix
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, , Revision: 14, Authorised, Last updated: 20/04/2023
-
List item
Human medicine European public assessment report (EPAR): Pelgraz
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, 
, Revision: 9, Authorised, Last updated: 20/04/2023
-
List item
Human medicine European public assessment report (EPAR): Pluvicto
lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 09/12/2022,, Revision: 2, Authorised, Last updated: 19/04/2023
-
List item
Human medicine European public assessment report (EPAR): Tezspire
tezepelumab, Asthma
Date of authorisation: 19/09/2022,, Revision: 3, Authorised, Last updated: 19/04/2023
-
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: 19/04/2023
-
List item
Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 5, Authorised, Last updated: 18/04/2023