For help on how to get the results you want, see our search tips.
329 results
Categories
Human Remove Human filter
-
List item
Summary of opinion: Nexviadyme
Avalglucosidase alfa, opinion date: 23/07/2021, Positive, Last updated: 02/08/2021 -
List item
Summary of opinion: Flynpovi
eflornithine, sulindac, opinion date: 24/06/2021, Negative, Last updated: 23/07/2021 -
List item
Summary of opinion: Abiraterone Krka
abiraterone acetate, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
List item
Summary of opinion: Deltyba
delamanid, opinion date: 22/07/2021, Positive, Last updated: 23/07/2021 -
List item
Summary of opinion: Brukinsa
zanubrutinib, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
List item
Summary of opinion: Adempas
riociguat, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
List item
Summary of opinion: Rivaroxaban Mylan
rivaroxaban, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
List item
Summary of opinion: Sugammadex Mylan
sugammadex, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
List item
Summary of opinion: Sitagliptin SUN (new)
sitagliptin fumarate, opinion date: 14/10/2021, Positive, Last updated: 15/10/2021 -
List item
Summary of opinion: Rybrevant (new)
amivantamab, opinion date: 14/10/2021, Positive, Last updated: 15/10/2021 -
List item
Orphan designation: 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4 d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one (ibrutinib) for: Treatment of chronic lymphocytic leukaemia (updated)
Date of designation: 26/04/2012, Withdrawn, Last updated: 21/10/2021 -
List item
Orphan designation: 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea for: Treatment of gastrointestinal stromal tumours (updated)
Date of designation: 08/11/2017, Positive, Last updated: 18/10/2021 -
List item
Orphan designation: N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine for: Diagnosis of positive folate-receptor status in ovarian cancer (updated)
Date of designation: 10/09/2012, Positive, Last updated: 13/10/2021 -
List item
Orphan designation: Setmelanotide for: Treatment of leptin receptor deficiency (updated)
Date of designation: 19/11/2018, Positive, Last updated: 12/10/2021 -
List item
Orphan designation: Setmelanotide for: Treatment of pro-opiomelanocortin deficiency (updated)
Date of designation: 14/07/2016, Positive, Last updated: 12/10/2021 -
List item
Orphan designation: velaglucerase alfa for: Treatment of Gaucher disease (updated)
Date of designation: 06/06/2010, Positive, Last updated: 24/09/2021 -
List item
Orphan designation: Recombinant human parathyroid hormone for: Treatment of hypoparathyroidism (updated)
Date of designation: 16/01/2014, Positive, Last updated: 24/09/2021 -
List item
Orphan designation: Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein (lanadelumab) for: Treatment of hereditary angioedema
Date of designation: 09/10/2015, Positive, Last updated: 20/09/2021 -
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 designation: 26/11/2010, Positive, Last updated: 17/09/2021 -
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 designation: 26/11/2010, Positive, Last updated: 17/09/2021 -
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 primary myelofibrosis
Date of designation: 01/10/2010, Positive, Last updated: 17/09/2021 -
List item
Orphan designation: Adenovirus-mediated herpes-simplex-virus thymidine-kinase (HKSV-tk) gene for: Treatment of high-grade glioma with subsequent use of ganciclovir sodium
Date of designation: 06/02/2002, Positive, Last updated: 16/09/2021 -
List item
Orphan designation: autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) for: Treatment of mantle cell lymphoma
Date of designation: 13/11/2019, Positive, Last updated: 15/09/2021 -
List item
Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel) for: Treatment of primary mediastinal large B-cell lymphoma
Date of designation: 09/10/2015, Positive, Last updated: 15/09/2021 -
List item
Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor (axicabtagene ciloleucel) for: Treatment of diffuse large B-cell lymphoma
Date of designation: 16/12/2014, Positive, Last updated: 15/09/2021