59 results
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Human medicine European public assessment report (EPAR): Zevalin
ibritumomab tiuxetan, Lymphoma, Follicular
Date of authorisation: 16/01/2004, Revision: 22, Authorised, Last updated: 09/03/2020Authorised ibritumomab tiuxetan Overview This is a summary … vein) of the active substance ibritumomab tiuxetan. What is Zevalin used for … active substance in Zevalin, ibritumomab, is a monoclonal antibody … -
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Orphan designation: ibritumomab tiuxetan for: Treatment of B-cell non-Hodgkin`s lymphoma
Date of first decision: 01/02/2002, Negative, Last updated: 17/09/2009Ibritumomab tiuxetan for use with 90Yttrium … on orphan designation of ibritumomab tiuxetan for use with 90Yttrium in … for orphan designation of ibritumomab tiuxetan for use with 90Yttrium for … -
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Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor (lisocabtagene maraleucel) for: Treatment of follicular lymphoma
Date of first decision: 25/05/2018, Positive, Last updated: 09/02/2021cancer cells). The medicines ibritumomab tiuxetan, idelalisib, interferon alfa-2b … cancer cells). The medicines ibritumomab tiuxetan, idelalisib, interferon alfa-2b … -
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Orphan designation: lenalidomide for: Treatment of follicular lymphoma
Date of first decision: 24/01/2013, Withdrawn, Last updated: 11/02/2020The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab … -
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Orphan designation: (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one for: Treatment of follicular lymphoma
Date of first decision: 17/07/2013, Positive, Last updated: 25/11/2019The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab … The medicines bendamustine, ibritumomab *Disclaimer: For the purpose … tiuxetan, interferon alfa 2b and rituximab … -
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Orphan designation: Glucopyranosyl lipid A for: Treatment of follicular lymphoma
Date of first decision: 16/10/2017, Withdrawn, Last updated: 15/10/2019cancer cells). The medicines ibritumomab tiuxetan, idelalisib, interferon alfa-2b … -
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Orphan designation: Tazemetostat for: Treatment of follicular lymphoma
Date of first decision: 21/03/2018, Positive, Last updated: 25/06/2019cancer cells). The medicines ibritumomab tiuxetan, idelalisib, interferon alfa-2b … cancer cells). The medicines ibritumomab tiuxetan, idelalisib, interferon alfa-2b … -
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National expert: Christian Gisselbrecht, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 80.91 KB | PDF
- Curriculum Vitae - 34.18 KB | PDF
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Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor for: Treatment of follicular lymphoma
Date of first decision: 11/11/2015, Positive, Last updated: 25/04/2017cancer cells). The medicines ibritumomab tiuxetan, idelalisib, interferon alfa-2b … cancer cells). The medicines ibritumomab tiuxetan, idelalisib, interferon alfa-2b … -
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Orphan designation: Ibrutinib for: Treatment of follicular lymphoma
Date of first decision: 16/01/2014, Positive, Last updated: 23/01/2014The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab … The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab … -
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Orphan designation: Idelalisib for: Treatment of follicular lymphoma
Date of first decision: 17/07/2013, Withdrawn, Last updated: 15/11/2013The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab … The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab … -
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Orphan designation: 177Lu-tetraxetan-tetulomab for: Treatment of follicular lymphoma
Date of first decision: 04/06/2014, Positive, Last updated: 10/07/2014The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab … -
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Orphan designation: Obinutuzumab for: Treatment of follicular lymphoma
Date of first decision: 19/06/2015, Positive, Last updated: 21/02/2018The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab … The medicines bendamustine, ibritumomab … EMA/COMP/346519/2015 Page 2/4 tiuxetan, interferon alfa 2b and rituximab … -
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National expert: Daniele Focosi, European Medicines Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 84.8 KB | PDF
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,17-19 March 2008
CHMP, Last updated: 20/03/200818 years of age. Zevalin (ibritumomab tiuxetan), from Schering AG, to extend … -
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Human medicine European public assessment report (EPAR): Yttriga
yttrium (90Y) chloride, Radionuclide Imaging
Date of authorisation: 19/01/2006, Revision: 10, Authorised, Last updated: 29/01/2021 -
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National expert: Pieternella Lugtenburg, European Medicines Agency (updated)
- Declaration of interests - 82.89 KB | PDF
- Curriculum Vitae - 25.35 KB | PDF
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Human medicine European public assessment report (EPAR): Carmustine Obvius
carmustine, Hodgkin Disease, Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,
, Revision: 5, Authorised, Last updated: 21/10/2020
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Human medicine European public assessment report (EPAR): Lympreva
dasiprotimut-t, Lymphoma, Non-Hodgkin
Date of refusal: 03/07/2015,
, Refused, Last updated: 17/07/2015
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Human medicine European public assessment report (EPAR): Gazyvaro
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,
, , Revision: 11, Authorised, Last updated: 29/01/2021
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Withdrawn application: Velcade
bortezomib, date of withdrawal: 02/07/2012, Post-authorisation, Last updated: 30/08/2012 -
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Referral: Levact
bendamustine, associated names: Ribomustin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 07/07/2010, Last updated: 08/09/2011 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 October 2014
European Medicines Agency, London, UK, from 06/10/2014 to 09/10/2014, Last updated: 13/08/2013 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2021 to 22/04/2021, Last updated: 19/04/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 September-1 October 2020
Virtual meeting, from 28/09/2020 to 01/10/2020, Last updated: 29/09/2020