For help on how to get the results you want, see our search tips.
144 results
-
List item
Withdrawn application: Epostim
epoetin alfa, date of withdrawal: 15/03/2011, Initial authorisation, Last updated: 19/04/2011 -
List item
Withdrawn application: Kyndrisa
date of withdrawal: 31/05/2016, Initial authorisation, Last updated: 06/09/2016 -
List item
Withdrawn application: Rienso
ferumoxytol, date of withdrawal: 19/01/2015, Post-authorisation, Last updated: 27/02/2015 -
List item
Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 08/01/2016, Initial authorisation, Last updated: 29/03/2016 -
List item
Withdrawn application: Ambrisentan Zentiva
ambrisentan, date of withdrawal: 29/04/2019, Initial authorisation, Last updated: 29/05/2019 -
List item
Withdrawn application: Erlotinib Accord
erlotinib, date of withdrawal: 28/05/2020, Initial authorisation, Last updated: 29/05/2020 -
List item
Withdrawn application: Memantine FGK
memantine, date of withdrawal: 18/12/2012, Initial authorisation, Last updated: 10/04/2013 -
List item
Withdrawn application: Teriparatide Cinnagen
teriparatide, date of withdrawal: 09/09/2021, Initial authorisation, Last updated: 17/09/2021 -
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: gemtuzumab ozogamicin for: Treatment of acute myeloid leukaemia
Date of designation: 18/10/2000, Positive, Last updated: 19/06/2013 -
List item
Orphan designation: Gilteritinib for: Treatment of acute myeloid leukaemia
Date of designation: 17/01/2018, Positive, Last updated: 08/11/2019 -
List item
Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosilate monohydrate saltĀ (niraparib) for: Treatment of ovarian cancer
Date of designation: 04/08/2010, Positive, Last updated: 06/11/2020 -
List item
Withdrawn application: Zydelig
idelalisib, date of withdrawal: 30/01/2018, Post-authorisation, Last updated: 23/02/2018 -
List item
Orphan designation: Chimeric monoclonal antibody against GD2 for: Treatment of neuroblastoma
Date of designation: 08/11/2012, Positive, Last updated: 26/08/2021 -
List item
Orphan designation: polatuzumab vedotin for: Treatment of diffuse large B-cell lymphoma
Date of designation: 16/04/2018, Positive, Last updated: 27/01/2020 -
List item
Orphan designation: Glasdegib maleate for: Treatment of acute myeloid leukaemia
Date of designation: 16/10/2017, Positive, Last updated: 09/01/2018 -
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 -
List item
Withdrawn application: Evoltra
clofarabine, date of withdrawal: 18/03/2008, Post-authorisation, Last updated: 19/03/2008 -
List item
Orphan designation: Fenfluramine hydrochloride for: Treatment of Dravet syndrome
Date of designation: 18/12/2013, Positive, Last updated: 08/01/2021 -
List item
Orphan designation: defibrotide for: Treatment of hepatic veno-occlusive disease
Date of designation: 29/07/2004, Positive, Last updated: 17/08/2016 -
List item
Orphan designation: Recombinant human tripeptidyl-peptidase 1 for: Treatment of neuronal ceroid lipofuscinosis type 2
Date of designation: 12/03/2013, Positive, Last updated: 09/02/2016 -
List item
Orphan designation: Humanised monoclonal antibody against P-selectin (crizanlizumab) for: Treatment of sickle cell disease
Date of designation: 09/08/2012, Positive, Last updated: 24/11/2020 -
List item
Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against delta-aminolevulinic acid synthase 1 mRNA, covalently linked to a ligand containing three N-acetylgalactosamine residues (givosiran) for: Treatment of acute hepatic porphyria
Date of designation: 29/08/2016, Positive, Last updated: 09/03/2020 -
List item
Orphan designation: Osilodrostat for: Treatment of Cushing's syndrome
Date of designation: 15/10/2014, Positive, Last updated: 07/07/2020