For help on how to get the results you want, see our search tips.
128 results
Medicine type
Conditional approval Remove Conditional approval filter
Biosimilar Remove Biosimilar filter
Additional monitoring Remove Additional monitoring filter
Exceptional circumstances Remove Exceptional circumstances filter
Categories
Human Remove Human filter
-
List item
Summary of opinion: Sirturo
bedaquiline, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
List item
Summary of opinion: Abevmy
bevacizumab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
List item
Summary of opinion: Lextemy
bevacizumab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
List item
Summary of opinion: Trelegy Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
List item
Summary of opinion: Temybric Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
List item
Summary of opinion: Elebrato Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
List item
Summary of opinion: Evkeeza
evinacumab, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
List item
Summary of opinion: Tagrisso
osimertinib, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
List item
Summary of opinion: Koselugo
selumetinib, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
List item
Summary of opinion: Maviret
glecaprevir, pibrentasvir, opinion date: 22/04/2021, Positive, Last updated: 26/04/2021 -
List item
Summary of opinion: Libtayo (new)
cemiplimab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
List item
Summary of opinion: Darzalex (new)
daratumumab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
List item
Summary of opinion: Blincyto (new)
blinatumomab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
List item
Summary of opinion: Spherox (new)
spheroids of human autologous matrix-associated chondrocytes, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
List item
Summary of opinion: Bylvay (new)
odevixibat, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
List item
Summary of opinion: Tecentriq
atezolizumab, opinion date: 25/03/2021, Positive, Last updated: 26/03/2021 -
List item
Summary of opinion: Keytruda (new)
pembrolizumab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
List item
Summary of opinion: Benlysta
belimumab, opinion date: 25/03/2021, Positive, Last updated: 26/03/2021 -
List item
Summary of opinion: Venclyxto
venetoclax, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
List item
Orphan designation: Pomalidomide for: Treatment of multiple myeloma (updated)
Date of first decision: 08/10/2009, Positive, Last updated: 10/06/2021 -
List item
Orphan designation: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor for: Treatment of cystic fibrosis
Date of first decision: 14/12/2018, Positive, Last updated: 06/05/2021 -
List item
Orphan designation: pemigatinib for: Treatment of biliary tract cancer
Date of first decision: 24/08/2018, Positive, Last updated: 04/05/2021 -
List item
Orphan designation: Murine anti-CD22 antibody variable region fused to truncated Pseudomonas exotoxin 38 ( Moxetumomab pasudotox) for: Treatment of hairy cell leukaemia
Date of first decision: 05/12/2008, Positive, Last updated: 09/03/2021 -
List item
Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of post-polycythaemia vera myelofibrosis
Date of first decision: 26/11/2010, Positive, Last updated: 03/03/2021 -
List item
Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of post-essential thrombocythaemia myelofibrosis
Date of first decision: 26/11/2010, Positive, Last updated: 03/03/2021