For help on how to get the results you want, see our search tips.
382 results
Medicine type
Exceptional circumstances Remove Exceptional circumstances filter
Orphan medicine Remove Orphan medicine filter
Medicine
Direct healthcare professional communication Remove Direct healthcare professional communication filter
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Orphan designations Remove Orphan designations filter
Categories
Human Remove Human filter
-
List item
Human medicine European public assessment report (EPAR): Coagadex (updated)
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,
, 
, 
, Revision: 7, Authorised, Last updated: 09/04/2021
-
List item
Human medicine European public assessment report (EPAR): Opsumit (updated)
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,, Revision: 17, Authorised, Last updated: 09/04/2021
-
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: 3, Authorised, Last updated: 09/04/2021
-
List item
Human medicine European public assessment report (EPAR): Brineura (updated)
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,, , , 
, Revision: 5, Authorised, Last updated: 08/04/2021
-
List item
Human medicine European public assessment report (EPAR): Kymriah (updated)
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,, , Revision: 4, Authorised, Last updated: 07/04/2021
-
List item
Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 10, Authorised, Last updated: 06/04/2021
-
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: 12, Authorised, Last updated: 31/03/2021
-
List item
Human medicine European public assessment report (EPAR): Amglidia (updated)
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,, Revision: 4, Authorised, Last updated: 31/03/2021
-
List item
Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, , , Revision: 21, Authorised, Last updated: 29/03/2021
-
List item
Human medicine European public assessment report (EPAR): Strensiq (updated)
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, , , Revision: 14, Authorised, Last updated: 25/03/2021
-
List item
Human medicine European public assessment report (EPAR): Gamifant (updated)
Emapalumab, Immune System Diseases
Date of refusal: 07/01/2021,, Refused, Last updated: 23/03/2021
-
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: 15, Authorised, Last updated: 23/03/2021
-
List item
Human medicine European public assessment report (EPAR): Trepulmix (updated)
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,, Revision: 1, Authorised, Last updated: 22/03/2021
-
List item
Human medicine European public assessment report (EPAR): Givlaari
Givosiran, Porphyrias, Hepatic
Date of authorisation: 02/03/2020,, , Revision: 1, Authorised, Last updated: 18/03/2021
-
List item
Human medicine European public assessment report (EPAR): Cerdelga
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,, , Revision: 12, Authorised, Last updated: 18/03/2021
-
List item
Human medicine European public assessment report (EPAR): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 2, Authorised, Last updated: 17/03/2021
-
List item
Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Revision: 2, Authorised, Last updated: 17/03/2021
-
List item
Human medicine European public assessment report (EPAR): Naglazyme
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,, , Revision: 18, Authorised, Last updated: 17/03/2021
-
List item
Human medicine European public assessment report (EPAR): Alprolix
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,, , Revision: 7, Authorised, Last updated: 17/03/2021
-
List item
Human medicine European public assessment report (EPAR): Wakix
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, , Revision: 10, Authorised, Last updated: 11/03/2021
-
List item
Human medicine European public assessment report (EPAR): Ledaga
Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017,, Revision: 6, Authorised, Last updated: 10/03/2021
-
List item
Human medicine European public assessment report (EPAR): Foclivia
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009,, Revision: 11, Authorised, Last updated: 10/03/2021
-
List item
Human medicine European public assessment report (EPAR): Libmeldy
autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, , Revision: 1, Authorised, Last updated: 09/03/2021
-
List item
Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,, Revision: 5, Authorised, Last updated: 08/03/2021
-
List item
Human medicine European public assessment report (EPAR): Ninlaro
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 9, Authorised, Last updated: 03/03/2021