For help on how to get the results you want, see our search tips.
12 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Orphan designations Remove Orphan designations filter
Categories
Human Remove Human 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): Olumiant (updated)
Baricitinib, Arthritis, Rheumatoid
Date of authorisation: 13/02/2017,, Revision: 16, Authorised, Last updated: 21/09/2023
-
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
-
List item
Human medicine European public assessment report (EPAR): Xeljanz
Tofacitinib, Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,
Date of refusal: 25/04/2013,, Revision: 27, Authorised, Last updated: 12/06/2023
-
List item
Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,,
,
, Revision: 5, Withdrawn, Last updated: 30/11/2022
-
List item
Human medicine European public assessment report (EPAR): Ulipristal Acetate Gedeon Richter
ulipristal acetate, Leiomyoma
Date of authorisation: 27/08/2018, Revision: 1, Withdrawn, Last updated: 09/07/2021 -
List item
Human medicine European public assessment report (EPAR): Esmya
ulipristal acetate, Leiomyoma
Date of authorisation: 22/02/2012, Revision: 16, Authorised, Last updated: 03/02/2021 -
List item
Human medicine European public assessment report (EPAR): Picato
Ingenol mebutate, Keratosis, Actinic
Date of authorisation: 15/11/2012,, Revision: 10, Withdrawn, Last updated: 31/07/2020