223 results
Keyword azacitidine Remove keyword
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Summary of opinion: Azacitidine Accord
azacitidine, opinion date: 12/12/2019, Positive, Last updated: 13/12/2019Azacitidine Accord: Pending EC decision … Azacitidine Accord Azacitidine Accord azacitidine azacitidine … -
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Human medicine European public assessment report (EPAR): Azacitidine Celgene
Date of authorisation: 02/08/2019, Authorised, Last updated: 14/08/2019Azacitidine Celgene … Azacitidine Celgene Myelodysplastic … Azacitidine Celgene azacitidine azacitidine … -
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Human medicine European public assessment report (EPAR): Vidaza
Date of authorisation: 17/12/2008,
, Revision: 18, Authorised, Last updated: 11/04/2019
azacitidine … Vidaza azacitidine azacitidine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vidaza,
Decision type: PM: decision on the application for modification of an agreed PIP, PIP number: EMEA-001272-PIP02-13-M01, decision date: 02/10/2015, Last updated: 23/11/2015, compliance check: Xpaediatric investigation plan for azacitidine (Vidaza), (EMEA-001272-PIP02-13-M01 … paediatric investigation plan for azacitidine (Vidaza), (EMEA-001272-PIP02-13-M01 … paediatric investigation plan for azacitidine (Vidaza), (EMEA-001272-PIP02-13-M01 … -
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Orphan designation: for: Treatment of acute myeloid leukaemia
Date of first decision: 29/11/2007, Expired, Last updated: 20/02/2019Ltd, United Kingdom, for azacitidine for the treatment of acute … Kingdom, in October 2008. Azacitidine in treatment of acute myeloid … orphan drug designation. Azacitidine could be of potential significant … -
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Orphan designation: for: Treatment of myelodysplastic syndromes
Date of first decision: 06/02/2002, Expired, Last updated: 20/02/2019Limited, United Kingdom, for azacitidine for the treatment of myelodysplastic … Kingdom, in October 2008. Azacitidine in treatment of myelodysplastic … medicine expected to work? Azacitidine is an analogue of cytidine … -
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Orphan designation: for: Treatment of nasopharyngeal carcinoma
Date of first decision: 11/11/2015, Withdrawn, Last updated: 08/02/2017opinion on orphan designation Azacitidine for the treatment of nasopharyngeal … opinion on orphan designation Azacitidine for the treatment of nasopharyngeal … Limited, United Kingdom, for azacitidine for the treatment of nasopharyngeal … -
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Orphan designation: for: Treatment of myelodysplastic syndromes
Date of first decision: 25/07/2019, Positive, Last updated: 24/09/2019myelodysplastic syndromes including azacitidine, lenalidomide and imatinib … can be more effective than azacitidine at slowing down the growth … medicine in combination with azacitidine may be more effective than … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2019
CHMP, Last updated: 13/12/2019Azacitidine Accord … -
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National expert: David Bowen, European Medicines Agency (updated)
- Declaration of interests - 81.26 KB | PDF
- Curriculum Vitae - 105.6 KB | PDF
06/2016-(current) Celgene Azacitidine, Durvalumab MDS, AML 2.7 … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2019
CHMP, Last updated: 28/06/2019Azacitidine Celgene … -
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Orphan designation: for: Treatment of myelodysplastic syndromes
Date of first decision: 14/12/2018, Positive, Last updated: 12/03/2019medicine in combination with azacitidine (a medicine for myelodysplastic … syndromes), when compared with azacitidine taken alone. This assumption … -
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Orphan designation: for: Treatment of acute myeloid leukaemia
Date of first decision: 25/07/2019, Positive, Last updated: 24/09/2019to another cancer medicine azacitidine could improve survival of …