For help on how to get the results you want, see our search tips.
157 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Orphan designations Remove Orphan designations filter
Withdrawn applications Remove Withdrawn applications filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Orphan medicine Remove Orphan medicine filter
Exceptional circumstances Remove Exceptional circumstances filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,
, 
, 
, Revision: 9, Authorised, Last updated: 03/03/2021
-
List item
Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, 
, Revision: 11, Authorised, Last updated: 03/03/2021
-
List item
Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , 
, Revision: 18, Authorised, Last updated: 02/03/2021
-
List item
Human medicine European public assessment report (EPAR): Epidyolex (updated)
Cannabidiol, Lennox Gastaut Syndrome, Epilepsies, Myoclonic
Date of authorisation: 19/09/2019,, Revision: 5, Authorised, Last updated: 01/03/2021
-
List item
Human medicine European public assessment report (EPAR): Imbruvica (updated)
Ibrutinib, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 21/10/2014,, Revision: 21, Authorised, Last updated: 26/02/2021
-
List item
Human medicine European public assessment report (EPAR): Vpriv (updated)
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, , Revision: 14, Authorised, Last updated: 26/02/2021
-
List item
Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012,, Revision: 11, Authorised, Last updated: 25/02/2021
-
List item
Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 20/07/2011,, Revision: 17, Authorised, Last updated: 24/02/2021
-
List item
Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,, , Revision: 11, Authorised, Last updated: 23/02/2021
-
List item
Human medicine European public assessment report (EPAR): Idelvion (updated)
albutrepenonacog alfa, Hemophilia B
Date of authorisation: 11/05/2016,, , Revision: 9, Authorised, Last updated: 23/02/2021
-
List item
Human medicine European public assessment report (EPAR): Spinraza (updated)
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,, , , Revision: 11, Authorised, Last updated: 22/02/2021
-
List item
Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , , Revision: 20, Authorised, Last updated: 22/02/2021
-
List item
Human medicine European public assessment report (EPAR): Crysvita (updated)
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 7, Authorised, Last updated: 18/02/2021
-
List item
Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 20, Authorised, Last updated: 16/02/2021
-
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: 1, Authorised, Last updated: 09/02/2021
-
List item
Human medicine European public assessment report (EPAR): Praxbind (updated)
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,, Revision: 9, Authorised, Last updated: 08/02/2021
-
List item
Human medicine European public assessment report (EPAR): Empliciti (updated)
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,, , Revision: 8, Authorised, Last updated: 02/02/2021
-
List item
Human medicine European public assessment report (EPAR): Prevymis
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, , Revision: 8, Authorised, Last updated: 01/02/2021
-
List item
Human medicine European public assessment report (EPAR): Rydapt
Midostaurin, Leukemia, Myeloid, Acute, Mastocytosis
Date of authorisation: 18/09/2017,, , Revision: 4, Authorised, Last updated: 01/02/2021
-
List item
Human medicine European public assessment report (EPAR): Gazyvaro
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,, , Revision: 11, Authorised, Last updated: 29/01/2021
-
List item
Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Revision: 1, Authorised, Last updated: 29/01/2021
-
List item
Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , , Revision: 13, Authorised, Last updated: 28/01/2021
-
List item
Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, , , , Revision: 3, Authorised, Last updated: 28/01/2021
-
List item
Human medicine European public assessment report (EPAR): Strimvelis
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016,, , Revision: 5, Authorised, Last updated: 28/01/2021
-
List item
Human medicine European public assessment report (EPAR): Kyprolis
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 18, Authorised, Last updated: 28/01/2021