For help on how to get the results you want, see our search tips.
389 results
Keyword Remove keyword
Categories
Human Remove Human filter
Medicine
Periodic safety update report single assessments Remove Periodic safety update report single assessments filter
Summaries of opinion Remove Summaries of opinion filter
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Medicine type
Orphan medicine Remove Orphan medicine filter
Additional monitoring Remove Additional monitoring filter
Authorisation status
Authorised Remove Authorised filter
-
List item
Human medicine European public assessment report (EPAR): Ayvakyt
Avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,,
,
, Revision: 6, Authorised, Last updated: 14/03/2023
-
List item
Human medicine European public assessment report (EPAR): Bavencio
avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017,, Revision: 15, Authorised, Last updated: 24/03/2023
-
List item
Human medicine European public assessment report (EPAR): Benlysta (updated)
belimumab, Lupus Erythematosus, Systemic
Date of authorisation: 13/07/2011,, Revision: 30, Authorised, Last updated: 23/05/2023
-
List item
Human medicine European public assessment report (EPAR): Beovu (updated)
brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020,, Revision: 8, Authorised, Last updated: 26/05/2023
-
List item
Human medicine European public assessment report (EPAR): Besponsa
Inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 28/06/2017,, Revision: 9, Authorised, Last updated: 16/03/2022
-
List item
Human medicine European public assessment report (EPAR): Besremi
ropeginterferon alfa-2b, Polycythemia Vera
Date of authorisation: 15/02/2019,, Revision: 4, Authorised, Last updated: 25/01/2023
-
List item
Human medicine European public assessment report (EPAR): Beyfortus
nirsevimab,
Date of authorisation: 31/10/2022,, Revision: 2, Authorised, Last updated: 28/04/2023
-
List item
Human medicine European public assessment report (EPAR): Bimervax
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains, COVID-19 virus infection
Date of authorisation: 30/03/2023,, Authorised, Last updated: 05/04/2023
-
List item
Human medicine European public assessment report (EPAR): Bimzelx
bimekizumab, Psoriasis
Date of authorisation: 20/08/2021,, Revision: 2, Authorised, Last updated: 05/12/2022
-
List item
Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,,
,
, Revision: 5, Authorised, Last updated: 31/03/2023
-
List item
Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,,
, Revision: 17, Authorised, Last updated: 08/05/2023
-
List item
Human medicine European public assessment report (EPAR): Braftovi
Encorafenib, Melanoma; Colorectal Neoplasms
Date of authorisation: 19/09/2018,, Revision: 10, Authorised, Last updated: 05/08/2022
-
List item
Human medicine European public assessment report (EPAR): Bretaris Genuair
aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 20/07/2012,, Revision: 18, Authorised, Last updated: 05/01/2023
-
List item
Human medicine European public assessment report (EPAR): Breyanzi (updated)
CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022,, Revision: 1, Authorised, Last updated: 25/05/2023
-
List item
Human medicine European public assessment report (EPAR): Brimica Genuair
formoterol fumarate dihydrate, aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014,, Revision: 13, Authorised, Last updated: 04/01/2023
-
List item
Human medicine European public assessment report (EPAR): Brineura
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,,
,
,
, Revision: 6, Authorised, Last updated: 16/08/2022
-
List item
Human medicine European public assessment report (EPAR): Brukinsa
zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021,, Revision: 5, Authorised, Last updated: 24/03/2023
-
List item
Human medicine European public assessment report (EPAR): Byfavo
remimazolam besilate, Conscious Sedation
Date of authorisation: 26/03/2021,, Revision: 5, Authorised, Last updated: 18/04/2023
-
List item
Human medicine European public assessment report (EPAR): Bylvay (updated)
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,,
,
, Revision: 2, Authorised, Last updated: 12/05/2023
-
List item
Human medicine European public assessment report (EPAR): Byooviz
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,,
, Revision: 6, Authorised, Last updated: 14/04/2023
-
List item
Human medicine European public assessment report (EPAR): Cablivi (updated)
Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018,, Revision: 8, Authorised, Last updated: 15/05/2023
-
List item
Human medicine European public assessment report (EPAR): Calquence
Acalabrutinib, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 05/11/2020,, Revision: 5, Authorised, Last updated: 03/05/2023
-
List item
Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,,
,
, Revision: 3, Authorised, Last updated: 14/04/2023
-
List item
Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,,
, Revision: 7, Authorised, Last updated: 24/02/2023
-
List item
Human medicine European public assessment report (EPAR): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,,
, Revision: 12, Authorised, Last updated: 19/04/2023