For help on how to get the results you want, see our search tips.
127 results
Keyword Remove keyword
Medicine type
Conditional approval Remove Conditional approval filter
Additional monitoring Remove Additional monitoring filter
Exceptional circumstances Remove Exceptional circumstances filter
Medicine
Withdrawn applications Remove Withdrawn applications filter
Orphan designations Remove Orphan designations filter
Categories
Human Remove Human filter
-
List item
Withdrawn application: Rienso
ferumoxytol, date of withdrawal: 19/01/2015, Post-authorisation, Last updated: 27/02/2015 -
List item
Withdrawn application: Omontys
date of withdrawal: 28/06/2013, Initial authorisation, Last updated: 28/06/2013 -
List item
Withdrawn application: Memantine FGK
memantine, date of withdrawal: 18/12/2012, Initial authorisation, Last updated: 10/04/2013 -
List item
Orphan designation: Humanised Fc engineered monoclonal antibody against CD19 (tafasitamab) for: Treatment of diffuse large B-cell lymphoma
Date of designation: 15/01/2015, Positive, Last updated: 08/09/2021 -
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: inotuzumab ozogamicin for: Treatment of B-cell acute lymphoblastic leukaemia
Date of designation: 07/06/2013, Positive, Last updated: 25/06/2013 -
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: Brentuximab vedotin for: Treatment of cutaneous T-cell lymphoma
Date of designation: 11/01/2012, Positive, Last updated: 26/08/2020 -
List item
Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E (brentuximab vedotin) for: Treatment of Hodgkin's lymphoma
Date of designation: 15/01/2009, Positive, Last updated: 26/08/2020 -
List item
Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E for: Treatment of peripheral T-cell lymphoma
Date of designation: 21/09/2019, Positive, Last updated: 26/08/2020 -
List item
Orphan designation: Obinutuzumab for: Treatment of chronic lymphocytic leukaemia
Date of designation: 10/10/2012, Positive, Last updated: 21/02/2018 -
List item
Orphan designation: Obinutuzumab for: Treatment of follicular lymphoma
Date of designation: 19/06/2015, Positive, Last updated: 21/02/2018 -
List item
Orphan designation: Mogamulizumab for: Treatment of cutaneous T-cell lymphoma
Date of designation: 14/10/2016, Positive, Last updated: 28/01/2019 -
List item
Orphan designation: Humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F for: Treatment of multiple myeloma
Date of designation: 16/10/2017, Positive, Last updated: 17/09/2020 -
List item
Orphan designation: Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, (L)-malate salt (cabozantinib) for: Treatment of medullary thyroid carcinoma
Date of designation: 06/02/2009, Positive, Last updated: 12/05/2014 -
List item
Orphan designation: Midostaurin for: Treatment of acute myeloid leukaemia
Date of designation: 29/07/2004, Positive, Last updated: 29/05/2018 -
List item
Orphan designation: Midostaurin for: Treatment of mastocytosis
Date of designation: 04/08/2010, Positive, Last updated: 29/05/2018 -
List item
Withdrawn application: Glivec
imatinib, date of withdrawal: 18/10/2006, Post-authorisation, Last updated: 23/10/2006 -
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: 2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid for: Treatment of multiple myeloma
Date of designation: 27/09/2011, Positive, Last updated: 26/08/2020 -
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