For help on how to get the results you want, see our search tips.
114 results
Categories
Human Remove Human filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Exceptional circumstances Remove Exceptional circumstances filter
Conditional approval Remove Conditional approval filter
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,,
,
, Revision: 8, Authorised, Last updated: 22/12/2022
-
List item
Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,,
,
, Revision: 5, Authorised, Last updated: 21/12/2022
-
List item
Human medicine European public assessment report (EPAR): Retsevmo
Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021,,
, Revision: 5, Authorised, Last updated: 20/12/2022
-
List item
Human medicine European public assessment report (EPAR): Jemperli
dostarlimab, Endometrial Neoplasms
Date of authorisation: 21/04/2021,,
, Revision: 6, Authorised, Last updated: 19/12/2022
-
List item
Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,,
, Revision: 25, Authorised, Last updated: 15/12/2022
-
List item
Human medicine European public assessment report (EPAR): Nyxthracis (previously Obiltoxaximab SFL)
nyxthracis, Anthrax
Date of authorisation: 18/11/2020,,
,
, Revision: 3, Authorised, Last updated: 15/12/2022
-
List item
Human medicine European public assessment report (EPAR): Livmarli
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,,
,
, Authorised, Last updated: 14/12/2022
-
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: 12, Authorised, Last updated: 14/12/2022
-
List item
Human medicine European public assessment report (EPAR): Takhzyro
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,,
,
, Revision: 10, Authorised, Last updated: 13/12/2022
-
List item
Human medicine European public assessment report (EPAR): Libtayo
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,,
, Revision: 13, Authorised, Last updated: 08/12/2022
-
List item
Human medicine European public assessment report (EPAR): Jorveza
budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,,
, Revision: 6, Authorised, Last updated: 06/12/2022
-
List item
Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,, Revision: 26, Authorised, Last updated: 06/12/2022
-
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: 15, Authorised, Last updated: 05/12/2022
-
List item
Human medicine European public assessment report (EPAR): Rozlytrek
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,,
, Revision: 5, Authorised, Last updated: 29/11/2022
-
List item
Human medicine European public assessment report (EPAR): Lumykras
sotorasib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/01/2022,,
, Revision: 1, Authorised, Last updated: 29/11/2022
-
List item
Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, Revision: 17, Authorised, Last updated: 29/11/2022
-
List item
Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,,
,
, Revision: 2, Authorised, Last updated: 23/11/2022
-
List item
Human medicine European public assessment report (EPAR): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,,
, Revision: 9, Authorised, Last updated: 17/11/2022
-
List item
Human medicine European public assessment report (EPAR): Zolgensma
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,,
,
, Revision: 8, Authorised, Last updated: 14/11/2022
-
List item
Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,,
, Revision: 33, Authorised, Last updated: 14/11/2022
-
List item
Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, Revision: 26, Authorised, Last updated: 10/11/2022
-
List item
Human medicine European public assessment report (EPAR): Roctavian
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,,
,
, Revision: 1, Authorised, Last updated: 09/11/2022
-
List item
Human medicine European public assessment report (EPAR): Waylivra
Volanesorsen sodium, Hyperlipoproteinemia Type I
Date of authorisation: 03/05/2019,,
,
, Revision: 6, Authorised, Last updated: 08/11/2022
-
List item
Human medicine European public assessment report (EPAR): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,,
,
, Revision: 12, Authorised, Last updated: 08/11/2022
-
List item
Human medicine European public assessment report (EPAR): Scenesse
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,,
,
, Revision: 9, Authorised, Last updated: 04/11/2022