105 results
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Human medicine European public assessment report (EPAR): Zevalin
Date of authorisation: 16/01/2004, Revision: 21, Authorised, Last updated: 12/12/2017for the public Zevalin ibritumomab tiuxetan This is a summary of the … of the active substance ibritumomab tiuxetan. What is Zevalin used for … ibritumomab tiuxetan … -
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Orphan designation: for: Treatment of B-cell non-Hodgkin`s lymphoma
Date of first decision: 01/02/2002, Negative, Last updated: 17/09/2009orphan designation of ibritumomab tiuxetan for use with 90Yttrium for … on orphan designation of ibritumomab tiuxetan for use with 90Yttrium in … Ibritumomab tiuxetan for use with 90Yttrium … -
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Orphan designation: for: Treatment of follicular lymphoma
Date of first decision: 17/07/2013, Positive, Last updated: 25/11/2019The medicines bendamustine, ibritumomab *Disclaimer: For the purpose … tiuxetan, interferon alfa 2b and rituximab … The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab … -
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Orphan designation: 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Date of first decision: 16/10/2017, Withdrawn, Last updated: 15/10/2019cancer cells).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: 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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Orphan designation: for: Treatment of follicular lymphoma
Date of first decision: 25/05/2018, Positive, Last updated: 22/02/2019cancer 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: 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: 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: 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: 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: for: Treatment of follicular lymphoma
Date of first decision: 19/06/2015, Positive, Last updated: 21/02/2018The medicines bendamustine, ibritumomab … EMA/COMP/346519/2015 Page 2/4 tiuxetan, interferon alfa 2b and rituximab … The medicines bendamustine, ibritumomab tiuxetan, interferon alfa 2b and rituximab … -
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Orphan designation: for: Treatment of follicular lymphoma (updated)
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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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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National expert: Daniele Focosi, European Medicines Agency (updated)
- Declaration of interests - 78.91 KB | PDF
- Curriculum Vitae - 201.79 KB | PDF
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Human medicine European public assessment report (EPAR): Yttriga
Date of authorisation: 19/01/2006, Revision: 9, Authorised, Last updated: 14/08/2014 -
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Human medicine European public assessment report (EPAR): Carmustine Obvius (updated)
Date of authorisation: 18/07/2018,
, Revision: 3, Authorised, Last updated: 30/01/2020
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National expert: Pieternella Lugtenburg, European Medicines Agency (updated)
- Declaration of interests - 82.53 KB | PDF
- Curriculum Vitae - 88.79 KB | PDF
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Human medicine European public assessment report (EPAR): Lympreva
Date of refusal: 03/07/2015,
, Refused, Last updated: 17/07/2015
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Human medicine European public assessment report (EPAR): Gazyvaro
Date of authorisation: 22/07/2014,
, , Revision: 8, Authorised, Last updated: 28/08/2019
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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, -
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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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Pharmacovigilance Risk Assessment Committee (PRAC): 25-29 September 2017
European Medicines Agency, London, UK, from 25/09/2017 to 29/09/2017, Last updated: 06/09/2017 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 April 2018
European Medicines Agency, London, UK, from 09/04/2018 to 12/04/2018, Last updated: 13/03/2014