For help on how to get the results you want, see our search tips.
71 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Orphan designations Remove Orphan designations filter
Categories
Human Remove Human filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Exceptional circumstances Remove Exceptional circumstances filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) (updated)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,,
,
, Revision: 6, Authorised, Last updated: 18/09/2023
-
List item
Human medicine European public assessment report (EPAR): Abrysvo (updated)
Respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B, Respiratory Syncytial Virus Infections
Date of authorisation: 23/08/2023,,
, Authorised, Last updated: 15/09/2023
-
List item
Human medicine European public assessment report (EPAR): Mepsevii (updated)
vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018,,
,
, Revision: 7, Authorised, Last updated: 14/09/2023
-
List item
Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,, Revision: 4, Authorised, Last updated: 12/09/2023
-
List item
Human medicine European public assessment report (EPAR): Kanuma (updated)
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,,
,
, Revision: 10, Authorised, Last updated: 25/08/2023
-
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): 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): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, Revision: 21, Authorised, Last updated: 14/08/2023
-
List item
Human medicine European public assessment report (EPAR): Zabdeno
Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,,
, Revision: 4, Authorised, Last updated: 14/08/2023
-
List item
Human medicine European public assessment report (EPAR): Mvabea
Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,,
, Revision: 3, Authorised, Last updated: 14/08/2023
-
List item
Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, Revision: 18, Authorised, Last updated: 11/08/2023
-
List item
Human medicine European public assessment report (EPAR): Vyndaqel
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,,
,
, Revision: 25, Authorised, Last updated: 09/08/2023
-
List item
Human medicine European public assessment report (EPAR): Vpriv
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, Revision: 20, Authorised, Last updated: 08/08/2023
-
List item
Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,, Revision: 24, Authorised, Last updated: 01/08/2023
-
List item
Human medicine European public assessment report (EPAR): Kisplyx
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, Revision: 20, Authorised, Last updated: 25/07/2023
-
List item
Human medicine European public assessment report (EPAR): Lenvima
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,,
, Revision: 19, Authorised, Last updated: 25/07/2023
-
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: 15, Authorised, Last updated: 18/07/2023
-
List item
Human medicine European public assessment report (EPAR): Sylvant
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,,
, Revision: 13, Authorised, Last updated: 17/07/2023
-
List item
Human medicine European public assessment report (EPAR): Praxbind
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,, Revision: 12, Authorised, Last updated: 11/07/2023
-
List item
Human medicine European public assessment report (EPAR): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,,
,
, Revision: 3, Authorised, Last updated: 05/07/2023
-
List item
Human medicine European public assessment report (EPAR): Livmarli
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,,
,
, Revision: 2, Authorised, Last updated: 05/07/2023
-
List item
Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, Revision: 36, Authorised, Last updated: 30/06/2023
-
List item
Human medicine European public assessment report (EPAR): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,,
,
, Revision: 8, Authorised, Last updated: 29/06/2023
-
List item
Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,, Revision: 17, Authorised, Last updated: 23/06/2023
-
List item
Human medicine European public assessment report (EPAR): Vidaza
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 26, Authorised, Last updated: 15/06/2023