106 results
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Human medicine European public assessment report (EPAR): Zevalin
ibritumomab tiuxetan, Lymphoma, Follicular
Date of authorisation: 16/01/2004, Revision: 21, Authorisedfor the public Zevalin ibritumomabtiuxetan This is a summary of the … of the active substance ibritumomabtiuxetan. What is Zevalin used for … Authorised ibritumomabtiuxetan Overview This is a summary … -
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Orphan designation: Ibritumomab tiuxetan for use with 90Yttrium for: Treatment of B-cell non-Hodgkin`s lymphoma
Decision date: 01/02/2002, Negativeorphan designation of ibritumomabtiuxetan for use with 90Yttrium for … on orphan designation of ibritumomabtiuxetan for use with 90Yttrium in … on orphan designation of ibritumomabtiuxetan for use with 90Yttrium in … -
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Orphan designation: Tazemetostat for: Treatment of follicular lymphoma
Decision date: 21/03/2018, Positivecancer cells). The medicines ibritumomabtiuxetan, idelalisib, interferon alfa-2b … cancer cells). The medicines ibritumomabtiuxetan, idelalisib, interferon alfa-2b … -
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Orphan designation: Glucopyranosyl lipid A for: Treatment of follicular lymphoma
Decision date: 16/10/2017, Positivecancer cells). The medicines ibritumomabtiuxetan, idelalisib, interferon alfa-2b … cancer cells). The medicines ibritumomabtiuxetan, idelalisib, interferon alfa-2b … -
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Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor for: Treatment of follicular lymphoma
Decision date: 25/05/2018, Positivecancer cells). The medicines ibritumomabtiuxetan, idelalisib, interferon alfa-2b … cancer cells). The medicines ibritumomabtiuxetan, idelalisib, interferon alfa-2b … -
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Orphan designation: lenalidomide for: Treatment of follicular lymphoma
Decision date: 24/01/2013, PositiveThe medicines bendamustine, ibritumomabtiuxetan, interferon alfa 2b and rituximab … The medicines bendamustine, ibritumomabtiuxetan, interferon alfa 2b and rituximab … -
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Orphan designation: Obinutuzumab for: Treatment of follicular lymphoma
Decision date: 19/06/2015, PositiveThe medicines bendamustine, ibritumomab … EMA/COMP/346519/2015 Page 2/4 tiuxetan, interferon alfa 2b and rituximab … The medicines bendamustine, ibritumomabtiuxetan, interferon alfa 2b and rituximab … -
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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
Decision date: 11/11/2015, Positivecancer cells). The medicines ibritumomabtiuxetan, idelalisib, interferon alfa-2b … cancer cells). The medicines ibritumomabtiuxetan, idelalisib, interferon alfa-2b … -
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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
Decision date: 17/07/2013, PositiveThe medicines bendamustine, ibritumomab *Disclaimer: For the purpose … tiuxetan, interferon alfa 2b and rituximab … The medicines bendamustine, ibritumomabtiuxetan, interferon alfa 2b and rituximab … -
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Orphan designation: 177Lu-tetraxetan-tetulomab for: Treatment of follicular lymphoma
Decision date: 04/06/2014, PositiveThe medicines bendamustine, ibritumomabtiuxetan, interferon alfa 2b and rituximab … -
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Orphan designation: Ibrutinib for: Treatment of follicular lymphoma
Decision date: 16/01/2014, PositiveThe medicines bendamustine, ibritumomabtiuxetan, interferon alfa 2b and rituximab … The medicines bendamustine, ibritumomabtiuxetan, interferon alfa 2b and rituximab … -
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Orphan designation: Idelalisib for: Treatment of follicular lymphoma
Decision date: 17/07/2013, WithdrawnThe medicines bendamustine, ibritumomabtiuxetan, interferon alfa 2b and rituximab … The medicines bendamustine, ibritumomabtiuxetan, interferon alfa 2b and rituximab … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,17-19 March 2008
CHMP, 20/03/200818 years of age. Zevalin (ibritumomabtiuxetan), from Schering AG, to extend … -
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Human medicine European public assessment report (EPAR): Gazyvaro
Obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 22/07/2014,
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, Revision: 7, Authorised
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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: 1, Authorised
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Human medicine European public assessment report (EPAR): Lympreva
dasiprotimut-t, Lymphoma, Non-Hodgkin
Date of refusal: 03/07/2015,, Refused
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Human medicine European public assessment report (EPAR): Yttriga
yttrium [90Y] chloride, Radionuclide Imaging
Date of authorisation: 19/01/2006, Revision: 9, AuthorisedHodgin’s lymphoma ([90Y] ibritumomabtiuxetan, Zevalin). Radio-immunoconjugates … -
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Withdrawn application: Velcade
bortezomib, date of withdrawal: 02/07/2012, Post-authorisation -
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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, -
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CHMP: Agendas, minutes and highlights
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Class waivers
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Annual reports and work programmes
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Pharmacovigilance Risk Assessment Committee (PRAC): 25-29 September 2017
European Medicines Agency, London, UK, from 25/09/2017 to 29/09/2017 -
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Adaptive pathways workshop
European Medicines Agency, UK, 08/12/2016