For help on how to get the results you want, see our search tips.
348 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Withdrawn applications Remove Withdrawn applications filter
Orphan designations Remove Orphan designations filter
Summaries of opinion Remove Summaries of opinion filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Exceptional circumstances Remove Exceptional circumstances filter
Generic Remove Generic filter
Conditional approval Remove Conditional approval filter
Categories
Human Remove Human filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka) (updated)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,
, Revision: 14, Authorised, Last updated: 07/03/2023
-
List item
Human medicine European public assessment report (EPAR): Hemlibra (updated)
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,
, Revision: 13, Authorised, Last updated: 06/03/2023
-
List item
Human medicine European public assessment report (EPAR): Empliciti (updated)
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,, Revision: 11, Authorised, Last updated: 06/03/2023
-
List item
Human medicine European public assessment report (EPAR): Efavirenz Teva (updated)
efavirenz, HIV Infections
Date of authorisation: 09/01/2012,, Revision: 12, Authorised, Last updated: 03/03/2023
-
List item
Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,
, 
, 
, Revision: 5, Authorised, Last updated: 02/03/2023
-
List item
Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, Revision: 21, Authorised, Last updated: 02/03/2023
-
List item
Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , 
, Revision: 25, Authorised, Last updated: 02/03/2023
-
List item
Human medicine European public assessment report (EPAR): Lenvima (updated)
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, , Revision: 17, Authorised, Last updated: 28/02/2023
-
List item
Human medicine European public assessment report (EPAR): Onpattro (updated)
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,, , , Revision: 10, Authorised, Last updated: 28/02/2023
-
List item
Human medicine European public assessment report (EPAR): Hemgenix (updated)
etranacogene dezaparvovec, Hemophilia B
Date of authorisation: 20/02/2023,, , , Authorised, Last updated: 28/02/2023
-
List item
Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK) (updated)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , , Revision: 7, Authorised, Last updated: 24/02/2023
-
List item
Human medicine European public assessment report (EPAR): Telmisartan Actavis (updated)
telmisartan, Hypertension
Date of authorisation: 29/09/2010,, Revision: 11, Authorised, Last updated: 24/02/2023
-
List item
Human medicine European public assessment report (EPAR): Fulvestrant Mylan (updated)
fulvestrant, Breast Neoplasms
Date of authorisation: 08/01/2018,, Revision: 5, Authorised, Last updated: 24/02/2023
-
List item
Human medicine European public assessment report (EPAR): Vizarsin (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009,, Revision: 19, Authorised, Last updated: 24/02/2023
-
List item
Human medicine European public assessment report (EPAR): Rasagiline Mylan (updated)
rasagiline tartrate, Parkinson Disease
Date of authorisation: 04/04/2016,, Revision: 7, Authorised, Last updated: 23/02/2023
-
List item
Human medicine European public assessment report (EPAR): Anagrelide Mylan (updated)
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,, Revision: 7, Authorised, Last updated: 23/02/2023
-
List item
Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,, , , Revision: 13, Authorised, Last updated: 22/02/2023
-
List item
Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 5, Authorised, Last updated: 22/02/2023
-
List item
Human medicine European public assessment report (EPAR): Zalasta
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 27/09/2007,, Revision: 20, Authorised, Last updated: 22/02/2023
-
List item
Human medicine European public assessment report (EPAR): Pemetrexed Krka
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 6, Authorised, Last updated: 22/02/2023
-
List item
Human medicine European public assessment report (EPAR): Lamzede
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,, , , Revision: 6, Authorised, Last updated: 22/02/2023
-
List item
Human medicine European public assessment report (EPAR): Natpar
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 14, Authorised, Last updated: 22/02/2023
-
List item
Human medicine European public assessment report (EPAR): Nimvastid
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/05/2009,, Revision: 10, Authorised, Last updated: 22/02/2023
-
List item
Human medicine European public assessment report (EPAR): Tolura
telmisartan, Hypertension
Date of authorisation: 04/06/2010,, Revision: 11, Authorised, Last updated: 22/02/2023
-
List item
Human medicine European public assessment report (EPAR): Yargesa
miglustat, Gaucher Disease
Date of authorisation: 22/03/2017,, Revision: 5, Authorised, Last updated: 22/02/2023