For help on how to get the results you want, see our search tips.
342 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Medicine type
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): 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): Lemtrada (updated)
alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013,, Revision: 18, Authorised, Last updated: 08/06/2022
-
List item
Human medicine European public assessment report (EPAR): Rinvoq (updated)
upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,, Revision: 10, Authorised, Last updated: 08/06/2022
-
List item
Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,, 
, , Revision: 10, Authorised, Last updated: 08/06/2022
-
List item
Human medicine European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) (updated)
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: 11, Authorised, Last updated: 08/06/2022
-
List item
Human medicine European public assessment report (EPAR): Polivy (updated)
polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020,, , , Revision: 4, Authorised, Last updated: 08/06/2022
-
List item
Human medicine European public assessment report (EPAR): Quviviq (updated)
daridorexant hydrochloride, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/04/2022,, Revision: 1, Authorised, Last updated: 08/06/2022
-
List item
Human medicine European public assessment report (EPAR): Deltyba (updated)
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 20, Authorised, Last updated: 07/06/2022
-
List item
Human medicine European public assessment report (EPAR): Daxas (updated)
roflumilast, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 05/07/2010,, Revision: 18, Authorised, Last updated: 07/06/2022
-
List item
Human medicine European public assessment report (EPAR): Vydura (updated)
Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022,, Revision: 1, Authorised, Last updated: 07/06/2022
-
List item
Human medicine European public assessment report (EPAR): Symkevi (updated)
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,, , Revision: 10, Authorised, Last updated: 07/06/2022
-
List item
Human medicine European public assessment report (EPAR): Ajovy (updated)
fremanezumab, Migraine Disorders
Date of authorisation: 28/03/2019,, Revision: 8, Authorised, Last updated: 07/06/2022
-
List item
Human medicine European public assessment report (EPAR): Mulpleo (previously Lusutrombopag Shionogi) (updated)
Lusutrombopag, Thrombocytopenia
Date of authorisation: 18/02/2019,, Revision: 7, Authorised, Last updated: 07/06/2022
-
List item
Human medicine European public assessment report (EPAR): Xevudy (updated)
Sotrovimab, COVID-19 virus infection
Date of authorisation: 17/12/2021,, Revision: 2, Authorised, Last updated: 01/06/2022
-
List item
Human medicine European public assessment report (EPAR): Ponvory (updated)
ponesimod, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 19/05/2021,, Revision: 2, Authorised, Last updated: 31/05/2022
-
List item
Human medicine European public assessment report (EPAR): Vaxchora (updated)
vibrio cholerae, strain cvd 103-hgr, live, Cholera
Date of authorisation: 01/04/2020,, Revision: 5, Authorised, Last updated: 31/05/2022
-
List item
Human medicine European public assessment report (EPAR): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,, , , Revision: 1, Authorised, Last updated: 31/05/2022