For help on how to get the results you want, see our search tips.
139 results
Medicine type
Conditional approval Remove Conditional approval filter
Exceptional circumstances Remove Exceptional circumstances filter
Additional monitoring Remove Additional monitoring filter
Medicine
Summaries of opinion Remove Summaries of opinion filter
Orphan designations Remove Orphan designations filter
Categories
Human Remove Human filter
-
List item
Summary of opinion: Xofluza
baloxavir marboxil, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022 -
List item
Summary of opinion: Kerendia
finerenone, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
List item
Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
List item
Summary of opinion: Ultomiris
ravulizumab, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
List item
Summary of opinion: Ultomiris
ravulizumab, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
List item
Summary of opinion: Neparvis
sacubitril, valsartan, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
List item
Summary of opinion: Wegovy
semaglutide, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
List item
Summary of opinion: Comirnaty
tozinameran, riltozinameran and tozinameran, famtozinameran and tozinameran, COVID-19 mRNA Vaccine (nucleoside modified), opinion date: 19/10/2022, Positive, Last updated: 19/10/2022 -
List item
Summary of opinion: Fintepla
fenfluramine, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
List item
Summary of opinion: Revestive
teduglutide, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Lytgobi
futibatinib, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Bimzelx
bimekizumab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Jaypirca
pirtobrutinib, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Bimzelx
bimekizumab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Ronapreve
casirivimab, imdevimab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Imfinzi
durvalumab, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022 -
List item
Summary of opinion: Vegzelma
bevacizumab, opinion date: 23/06/2022, Positive, Last updated: 21/06/2022 -
List item
Summary of opinion: Sogroya (new)
somapacitan, opinion date: 26/05/2023, Positive, Last updated: 26/05/2023 -
List item
Orphan designation: Ivosidenib for: Treatment of biliary tract cancer (updated)
Date of designation: 21/03/2018, Positive, Last updated: 12/05/2023 -
List item
Orphan designation: Ivosidenib for: Treatment of acute myeloid leukaemia (updated)
Date of designation: 12/12/2016, Positive, Last updated: 12/05/2023 -
List item
Orphan designation: 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one (futibatinib) for: Treatment of biliary tract cancer (updated)
Date of designation: 01/04/2019, Positive, Last updated: 08/05/2023 -
List item
Orphan designation: 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde (voxelotor) for: Treatment of sickle cell disease
Date of designation: 18/11/2016, Positive, Last updated: 04/05/2023 -
List item
Orphan designation: Fenfluramine hydrochloride for: Treatment of Lennox-Gastaut syndrome
Date of designation: 27/02/2017, Positive, Last updated: 25/04/2023 -
List item
Orphan designation: Fenfluramine hydrochloride for: Treatment of Dravet syndrome
Date of designation: 18/12/2013, Positive, Last updated: 25/04/2023 -
List item
Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for: Treatment of beta thalassaemia intermedia and major
Date of designation: 29/07/2014, Positive, Last updated: 21/03/2023