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C(2002) 355: Public summary of negative opinion for orphan designation of ibritumomab tiuxetan for use with 90Yttrium for the treatment of B-cell non-Hodgkin’s lymphoma (PDF/25.71 KB)

orphan designation of ibritumomab tiuxetan for use with 90Yttrium for … on orphan designation of ibritumomab tiuxetan for use with 90Yttrium in … for orphan designation of ibritumomab tiuxetan for use with 90Yttrium for …

Adopted
First published: 17/09/2009
Last updated: 17/09/2009
EMEA/COMP/73/02 Rev. 2
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Recommendation for maintenance of orphan designation at the time of marketing authorisation: Gazyvaro (obinutuzumab) for the treatment of follicular lymphoma (PDF/79.9 KB)

immunotherapy rituximab and ibritumomab tiuxetan were specifically authorised … failed. Unlike Gazyvaro, ibritumomab tiuxetan must be radiolabelled (tagged …

Adopted
First published: 19/08/2016
Last updated: 19/08/2016
EMA/COMP/370418/2016
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EU/3/18/2017: Public summary of opinion on orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor for the treatment of follicular lymphoma (PDF/126.44 KB)

cancer cells). The medicines ibritumomab tiuxetan, idelalisib, interferon alfa-2b …

First published: 24/07/2018
Last updated: 24/07/2018
EMA/262875/2018
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EU/3/18/2005: Public summary of opinion on orphan designation: Tazemetostat for the treatment of follicular lymphoma (PDF/112.46 KB)

cancer cells). The medicines ibritumomab tiuxetan, idelalisib, interferon alfa-2b …

Adopted
First published: 15/05/2018
Last updated: 15/05/2018
EMA/111729/2018
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EU/3/15/1579: Public summary of opinion on orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor for the treatment of follicular lymphoma (PDF/124.89 KB)

cancer cells). The medicines ibritumomab tiuxetan, idelalisib, interferon alfa-2b …

Adopted
First published: 06/01/2016
Last updated: 06/01/2016
EMA/COMP/696766/2015
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EU/3/15/1504: Public summary of opinion on orphan designation: Obinutuzumab for the treatment of follicular lymphoma (PDF/111.37 KB)

The medicines bendamustine, ibritumomab … EMA/COMP/346519/2015 Page 2/4 tiuxetan, interferon alfa 2b and rituximab …

Adopted
First published: 27/07/2015
Last updated: 27/07/2015
EMA/COMP/346519/2015
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EU/3/13/1212: Public summary of opinion on orphan designation: Ibrutinib for the treatment of follicular lymphoma (PDF/112.18 KB)

The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab …

Adopted
First published: 23/01/2014
Last updated: 23/01/2014
EMA/COMP/708125/2013
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EU/3/13/1159: Public summary of opinion on orphan designation: Idelalisib for the treatment of follicular lymphoma (PDF/115.02 KB)

The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab …

Adopted
First published: 22/08/2013
Last updated: 15/11/2013
EMA/COMP/400936/2013 Rev.1
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EU/3/12/1097: Public summary of opinion on orphan designation: Lenalidomide for the treatment of follicular lymphoma (PDF/112.19 KB)

The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab …

Adopted
First published: 01/03/2013
Last updated: 01/03/2013
EMA/COMP/808519/2012
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EU/3/13/1157: Public summary of opinion on orphan designation: (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one for the treatment of follicular lymphoma (PDF/121.93 KB)

The medicines bendamustine, ibritumomab *Disclaimer: For the purpose … tiuxetan, interferon alfa 2b and rituximab …

Adopted
First published: 16/08/2013
Last updated: 16/08/2013
EMA/COMP/411861/2013
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Committee for Orphan Medicinal Products (COMP): 13-15 February 2018

European Medicines Agency, London, UK, from 13/02/2018 to 15/02/2018, Last updated: 19/02/2014
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Committee for Orphan Medicinal Products (COMP): 17-19 May 2016

European Medicines Agency, London, UK, from 17/05/2016 to 19/05/2016, Last updated: 17/06/2014
List item

Minutes of the COMP meeting of 13-15 February 2018 (PDF/329.85 KB)

Adopted
First published: 30/04/2018
Last updated: 15/05/2018
EMA/COMP/40855/2018 Corr. 1
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Minutes of the COMP meeting 17-19 May 2016 (PDF/308.31 KB)

Adopted
First published: 30/06/2016
Last updated: 30/06/2016
EMA/COMP/339164/2016

14 results

C(2002) 355: Public summary of negative opinion for orphan designation of ibritumomab tiuxetan for use with 90Yttrium for the treatment of B-cell non-Hodgkin’s lymphoma (PDF/25.71 KB)

Recommendation for maintenance of orphan designation at the time of marketing authorisation: Gazyvaro (obinutuzumab) for the treatment of follicular lymphoma (PDF/79.9 KB)

EU/3/18/2017: Public summary of opinion on orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor for the treatment of follicular lymphoma (PDF/126.44 KB)

EU/3/18/2005: Public summary of opinion on orphan designation: Tazemetostat for the treatment of follicular lymphoma (PDF/112.46 KB)

EU/3/15/1579: Public summary of opinion on orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor for the treatment of follicular lymphoma (PDF/124.89 KB)

EU/3/15/1504: Public summary of opinion on orphan designation: Obinutuzumab for the treatment of follicular lymphoma (PDF/111.37 KB)

EU/3/13/1212: Public summary of opinion on orphan designation: Ibrutinib for the treatment of follicular lymphoma (PDF/112.18 KB)

EU/3/13/1159: Public summary of opinion on orphan designation: Idelalisib for the treatment of follicular lymphoma (PDF/115.02 KB)

EU/3/12/1097: Public summary of opinion on orphan designation: Lenalidomide for the treatment of follicular lymphoma (PDF/112.19 KB)

EU/3/13/1157: Public summary of opinion on orphan designation: (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one for the treatment of follicular lymphoma (PDF/121.93 KB)

Committee for Orphan Medicinal Products (COMP): 13-15 February 2018

Committee for Orphan Medicinal Products (COMP): 17-19 May 2016

Minutes of the COMP meeting of 13-15 February 2018 (PDF/329.85 KB)

Minutes of the COMP meeting 17-19 May 2016 (PDF/308.31 KB)