For help on how to get the results you want, see our search tips.
164 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Summaries of opinion Remove Summaries of opinion filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Orphan medicine Remove Orphan medicine filter
Categories
Human Remove Human filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Imcivree
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,
, 
, Revision: 5, Authorised, Last updated: 22/11/2022
-
List item
Human medicine European public assessment report (EPAR): Enjaymo
sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune
Date of authorisation: 15/11/2022,, , 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): Vyxeos liposomal (previously known as Vyxeos)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,, Revision: 8, 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): Crysvita
Burosumab, Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant; Osteomalacia
Date of authorisation: 19/02/2018,, , Revision: 10, Authorised, Last updated: 08/11/2022
-
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): Kymriah
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,, , Revision: 13, Authorised, Last updated: 07/11/2022
-
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
-
List item
Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,, , , Revision: 8, Authorised, Last updated: 27/10/2022
-
List item
Human medicine European public assessment report (EPAR): Lamzede
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,, , , Revision: 5, Authorised, Last updated: 27/10/2022
-
List item
Human medicine European public assessment report (EPAR): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,, , , Revision: 7, Authorised, Last updated: 27/10/2022
-
List item
Human medicine European public assessment report (EPAR): Cometriq
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, Revision: 26, Authorised, Last updated: 25/10/2022
-
List item
Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, Revision: 8, Authorised, Last updated: 25/10/2022
-
List item
Human medicine European public assessment report (EPAR): SomaKit TOC
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,, Revision: 12, Authorised, Last updated: 25/10/2022
-
List item
Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,, Revision: 34, Authorised, Last updated: 21/10/2022
-
List item
Human medicine European public assessment report (EPAR): Iclusig
ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,, , Revision: 24, Authorised, Last updated: 21/10/2022
-
List item
Human medicine European public assessment report (EPAR): Vpriv
velaglucerase alfa, Gaucher Disease
Date of authorisation: 26/08/2010,, Revision: 19, Authorised, Last updated: 20/10/2022
-
List item
Human medicine European public assessment report (EPAR): Isentress
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 42, Authorised, Last updated: 20/10/2022
-
List item
Human medicine European public assessment report (EPAR): Ravicti
glycerol phenylbutyrate, Urea Cycle Disorders, Inborn
Date of authorisation: 26/11/2015,, Revision: 15, Authorised, Last updated: 20/10/2022
-
List item
Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 22, Authorised, Last updated: 18/10/2022
-
List item
Human medicine European public assessment report (EPAR): Oxlumo
Lumasiran sodium, Hyperoxaluria, Primary
Date of authorisation: 19/11/2020,, , Revision: 3, Authorised, Last updated: 13/10/2022