6 results
Categories
Human Remove Human filter
Authorisation status
Authorised Remove Authorised filter
Medicine type
Additional monitoring Remove Additional monitoring filter
Biosimilar Remove Biosimilar filter
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Patient safety
Yes Remove Yes filter
-
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: 40, Authorised, Last updated: 28/09/2023
-
List item
Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA 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: 21/12/2020,,
, Revision: 44, Authorised, Last updated: 28/09/2023
-
List item
Human medicine European public assessment report (EPAR): Rinvoq
upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,,
, Revision: 17, Authorised, Last updated: 29/08/2023
-
List item
Human medicine European public assessment report (EPAR): Jyseleca
filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020,,
, Revision: 10, Authorised, Last updated: 27/07/2023
-
List item
Human medicine European public assessment report (EPAR): Cibinqo
Abrocitinib, Dermatitis, Atopic
Date of authorisation: 09/12/2021,,
, Revision: 5, Authorised, Last updated: 30/06/2023
-
List item
Human medicine European public assessment report (EPAR): Rubraca
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,,
, Revision: 13, Authorised, Last updated: 22/06/2023