For help on how to get the results you want, see our search tips.
407 results
Medicine
Periodic safety update report single assessments Remove Periodic safety update report single assessments filter
Summaries of opinion Remove Summaries of opinion filter
Orphan designations Remove Orphan designations filter
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Orphan medicine Remove Orphan medicine filter
Exceptional circumstances Remove Exceptional circumstances filter
Additional monitoring Remove Additional monitoring filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,
, 
, Revision: 18, Authorised, Last updated: 24/11/2023
-
List item
Human medicine European public assessment report (EPAR): Symkevi (updated)
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,, Revision: 12, Authorised, Last updated: 24/11/2023
-
List item
Human medicine European public assessment report (EPAR): Talvey (updated)
talquetamab, Multiple Myeloma
Date of authorisation: 21/08/2023,, , 
, Revision: 1, Authorised, Last updated: 24/11/2023
-
List item
Human medicine European public assessment report (EPAR): Voxzogo (updated)
Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021,, , Revision: 4, Authorised, Last updated: 24/11/2023
-
List item
Human medicine European public assessment report (EPAR): Herwenda (updated)
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 15/11/2023,, 
, Authorised, Last updated: 23/11/2023
-
List item
Human medicine European public assessment report (EPAR): Takhzyro (updated)
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,
, , Revision: 12, Authorised, Last updated: 22/11/2023
-
List item
Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
Single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 06/01/2021,
, , Revision: 41, Authorised, Last updated: 21/11/2023
-
List item
Human medicine European public assessment report (EPAR): Gavreto (updated)
pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021,, , Revision: 6, Authorised, Last updated: 21/11/2023
-
List item
Human medicine European public assessment report (EPAR): Fetcroja (updated)
cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections
Date of authorisation: 23/04/2020,, Revision: 7, Authorised, Last updated: 21/11/2023
-
List item
Human medicine European public assessment report (EPAR): Respreeza (updated)
Human alpha1-proteinase inhibitor, Genetic Diseases, Inborn; Lung Diseases
Date of authorisation: 20/08/2015,, Revision: 12, Authorised, Last updated: 21/11/2023
-
List item
Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, Revision: 17, Authorised, Last updated: 21/11/2023
-
List item
Human medicine European public assessment report (EPAR): Vanflyta (updated)
Quizartinib dihydrochloride, Leukemia, Myeloid
Date of authorisation: 06/11/2023,, Authorised, Last updated: 21/11/2023
-
List item
Human medicine European public assessment report (EPAR): Exjade (updated)
deferasirox, beta-Thalassemia; Iron Overload
Date of authorisation: 28/08/2006,, Revision: 52, Authorised, Last updated: 20/11/2023
-
List item
Human medicine European public assessment report (EPAR): Esperoct (updated)
Turoctocog alfa pegol, Hemophilia A
Date of authorisation: 20/06/2019,, Revision: 6, Authorised, Last updated: 20/11/2023
-
List item
Human medicine European public assessment report (EPAR): Tepmetko (updated)
Tepotinib hydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2022,, Revision: 2, Authorised, Last updated: 20/11/2023
-
List item
Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos) (updated)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,, Revision: 9, Authorised, Last updated: 20/11/2023
-
List item
Human medicine European public assessment report (EPAR): Obizur (updated)
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,, 
, Revision: 11, Authorised, Last updated: 20/11/2023
-
List item
Human medicine European public assessment report (EPAR): Vimizim (updated)
recombinant human n-acetylgalactosamine-6-sulfatase, Mucopolysaccharidosis IV
Date of authorisation: 27/04/2014,, , Revision: 13, Authorised, Last updated: 20/11/2023
-
List item
Human medicine European public assessment report (EPAR): Tagrisso (updated)
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, Revision: 19, Authorised, Last updated: 20/11/2023
-
List item
Human medicine European public assessment report (EPAR): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, , Revision: 21, Authorised, Last updated: 20/11/2023
-
List item
Human medicine European public assessment report (EPAR): Ajovy (updated)
fremanezumab, Migraine Disorders
Date of authorisation: 28/03/2019,, Revision: 10, Authorised, Last updated: 20/11/2023
-
List item
Human medicine European public assessment report (EPAR): Jaypirca (updated)
pirtobrutinib, Lymphoma, Mantle-Cell
Date of authorisation: 30/10/2023,, , Authorised, Last updated: 20/11/2023
-
List item
Human medicine European public assessment report (EPAR): Leqvio (updated)
inclisiran, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 09/12/2020,, Revision: 5, Authorised, Last updated: 20/11/2023
-
List item
Human medicine European public assessment report (EPAR): Wakix (updated)
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, , Revision: 15, Authorised, Last updated: 20/11/2023
-
List item
Human medicine European public assessment report (EPAR): Gazyvaro (updated)
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,, , Revision: 16, Authorised, Last updated: 20/11/2023