For help on how to get the results you want, see our search tips.
457 results
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Exceptional circumstances Remove Exceptional circumstances filter
Biosimilar Remove Biosimilar filter
Additional monitoring Remove Additional monitoring filter
Medicine
Summaries of opinion Remove Summaries of opinion filter
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Authorisation status
Withdrawn Remove Withdrawn filter
Authorised Remove Authorised filter
Refused Remove Refused filter
Categories
Human Remove Human filter
-
List item
Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,
, 
, Revision: 12, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,
, Revision: 17, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen) (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,
, , , Revision: 20, Authorised, Last updated: 17/06/2022
-
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): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,, , , Revision: 21, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Nuvaxovid (updated)
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, , Revision: 2, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, 
, , Revision: 14, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord (updated)
metformin hydrochloride, vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 24/03/2022,, 
, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Alecensa (updated)
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,, Revision: 10, Authorised, Last updated: 15/06/2022
-
List item
Human medicine European public assessment report (EPAR): Kyprolis (updated)
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 20, Authorised, Last updated: 15/06/2022
-
List item
Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,, , , Revision: 3, Authorised, Last updated: 15/06/2022
-
List item
Human medicine European public assessment report (EPAR): Truvelog Mix 30 (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/04/2022,, Authorised, Last updated: 15/06/2022
-
List item
Human medicine European public assessment report (EPAR): Fasenra (updated)
benralizumab, Asthma
Date of authorisation: 08/01/2018,, Revision: 8, Authorised, Last updated: 14/06/2022
-
List item
Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 25, Authorised, Last updated: 14/06/2022
-
List item
Human medicine European public assessment report (EPAR): Riximyo (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017,
, Revision: 10, Authorised, Last updated: 13/06/2022
-
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): Minjuvi (updated)
Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021,, , , Revision: 3, Authorised, Last updated: 13/06/2022
-
List item
Human medicine European public assessment report (EPAR): Jemperli (updated)
dostarlimab, Endometrial Neoplasms
Date of authorisation: 21/04/2021,, , Revision: 3, Authorised, Last updated: 10/06/2022
-
List item
Human medicine European public assessment report (EPAR): Orgovyx (updated)
relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022,, Revision: 2, Authorised, Last updated: 10/06/2022
-
List item
Human medicine European public assessment report (EPAR): Nuceiva (updated)
Botulinum toxin type A, Skin Aging
Date of authorisation: 27/09/2019,, Revision: 4, Authorised, Last updated: 10/06/2022
-
List item
Human medicine European public assessment report (EPAR): Palynziq (updated)
Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019,, , Revision: 6, Authorised, Last updated: 10/06/2022
-
List item
Human medicine European public assessment report (EPAR): Nexpovio (updated)
Selinexor, Multiple Myeloma
Date of authorisation: 26/03/2021,, , Revision: 2, Authorised, Last updated: 10/06/2022
-
List item
Human medicine European public assessment report (EPAR): Gavreto (updated)
pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021,, , Revision: 3, Authorised, Last updated: 10/06/2022
-
List item
Human medicine European public assessment report (EPAR): Veltassa (updated)
patiromer sorbitex calcium, Hyperkalemia
Date of authorisation: 19/07/2017,, Revision: 5, Authorised, Last updated: 09/06/2022
-
List item
Human medicine European public assessment report (EPAR): Cabometyx (updated)
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,, Revision: 14, Authorised, Last updated: 09/06/2022