For help on how to get the results you want, see our search tips.
461 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Summaries of opinion Remove Summaries of opinion filter
Referrals Remove Referrals filter
Withdrawn applications Remove Withdrawn applications filter
Categories
Human Remove Human filter
-
List item
Human medicine European public assessment report (EPAR): Pirfenidone axunio (previously Pirfenidone AET)
Pirfenidone, Idiopathic Pulmonary Fibrosis
Date of authorisation: 20/06/2022,, Revision: 3, Authorised, Last updated: 25/08/2023
-
List item
Human medicine European public assessment report (EPAR): Duloxetine Mylan
duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders
Date of authorisation: 19/06/2015,, Revision: 18, Authorised, Last updated: 25/08/2023
-
List item
Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 15, Authorised, Last updated: 25/08/2023
-
List item
Human medicine European public assessment report (EPAR): Tolucombi
Telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 13/03/2013,, Revision: 11, Authorised, Last updated: 24/08/2023
-
List item
Human medicine European public assessment report (EPAR): Artesunate Amivas
artesunate, Malaria
Date of authorisation: 22/11/2021,,
, Revision: 2, Authorised, Last updated: 23/08/2023
-
List item
Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,,
,
, Revision: 5, Authorised, Last updated: 21/08/2023
-
List item
Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,,
, Revision: 36, Authorised, Last updated: 21/08/2023
-
List item
Human medicine European public assessment report (EPAR): Fingolimod Accord
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 25/06/2020,, Revision: 4, Authorised, Last updated: 18/08/2023
-
List item
Human medicine European public assessment report (EPAR): Nemdatine
memantine, Alzheimer Disease
Date of authorisation: 22/04/2013,
Date of refusal: 22/02/2013,, Revision: 13, Authorised, Last updated: 17/08/2023
-
List item
Human medicine European public assessment report (EPAR): Amlodipine / Valsartan Mylan
Amlodipine besilate, valsartan, Hypertension
Date of authorisation: 22/03/2016,, Revision: 11, Authorised, Last updated: 17/08/2023
-
List item
Human medicine European public assessment report (EPAR): Lacosamide Accord
lacosamide, Epilepsy
Date of authorisation: 18/09/2017,, Revision: 12, Authorised, Last updated: 16/08/2023
-
List item
Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, Revision: 52, Authorised, Last updated: 16/08/2023
-
List item
Human medicine European public assessment report (EPAR): Takhzyro
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,,
, Revision: 11, Authorised, Last updated: 16/08/2023
-
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: 25, Authorised, Last updated: 14/08/2023
-
List item
Human medicine European public assessment report (EPAR): Tolvaptan Accord
Tolvaptan, Inappropriate ADH Syndrome, Authorised, Last updated: 14/08/2023
-
List item
Human medicine European public assessment report (EPAR): Plerixafor Accord
Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation
Date of authorisation: 16/12/2022,,
, Revision: 1, Authorised, Last updated: 07/08/2023
-
List item
Human medicine European public assessment report (EPAR): Arikayce liposomal
Amikacin sulfate, Respiratory Tract Infections
Date of authorisation: 27/10/2020,, Revision: 2, Authorised, Last updated: 04/08/2023
-
List item
Human medicine European public assessment report (EPAR): Capecitabine Accord
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 16, Authorised, Last updated: 03/08/2023
-
List item
Human medicine European public assessment report (EPAR): Idefirix
Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020,,
,
, Revision: 4, Authorised, Last updated: 01/08/2023
-
List item
Human medicine European public assessment report (EPAR): Sogroya
Somapacitan, Growth
Date of authorisation: 31/03/2021,,
, Revision: 2, Authorised, Last updated: 31/07/2023
-
List item
Human medicine European public assessment report (EPAR): Ztalmy
Ganaxolone, Epileptic Syndromes; Spasms, Infantile
Date of authorisation: 26/07/2023,,
, Authorised, Last updated: 31/07/2023
-
List item
Human medicine European public assessment report (EPAR): Oprymea
pramipexole dihydrochloride monohydrate, Parkinson Disease
Date of authorisation: 12/09/2008,, Revision: 22, Authorised, Last updated: 31/07/2023
-
List item
Human medicine European public assessment report (EPAR): Luxturna
voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa
Date of authorisation: 22/11/2018,,
, Revision: 7, Authorised, Last updated: 28/07/2023
-
List item
Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 5, Authorised, Last updated: 27/07/2023
-
List item
Human medicine European public assessment report (EPAR): Gefitinib Mylan
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,, Revision: 6, Authorised, Last updated: 27/07/2023