100 results
Keyword azacitidine Remove keyword
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Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,
, Revision: 1, Authorised, Last updated: 16/09/2020
Azacitidine Mylan Myelodysplastic Syndromes Leukemia … Azacitidine Mylan … Azacitidine Mylan azacitidine azacitidine … -
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Human medicine European public assessment report (EPAR): Azacitidine Accord
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Authorised, Last updated: 21/02/2020
Azacitidine Accord Myelodysplastic Syndromes Leukemia … Azacitidine Accord … Azacitidine Accord azacitidine azacitidine … -
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Human medicine European public assessment report (EPAR): Azacitidine Celgene
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 02/08/2019, Authorised, Last updated: 14/08/2019Azacitidine Celgene Myelodysplastic … Azacitidine Celgene … Azacitidine Celgene azacitidine azacitidine … -
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Human medicine European public assessment report (EPAR): Azacitidine betapharm
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,, Revision: 1, Authorised, Last updated: 20/11/2020
Azacitidine betapharm Myelodysplastic … Azacitidine betapharm … Azacitidine betapharm azacitidine azacitidine … -
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Human medicine European public assessment report (EPAR): Vidaza
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,
, Revision: 19, Authorised, Last updated: 15/09/2020
Authorised azacitidine Overview This is a summary … medicine. active substance azacitidine. It is available as a powder … active substance in Vidaza, azacitidine, belongs to the group ‘anti‑metabolites’ … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vidaza, azacitidine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001272-PIP02-13-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Powder for suspension for injection, Powder for solution for infusion
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: azacitidine 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: azacitidine 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: azacitidine 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: Magrolimab for: Treatment of myelodysplastic syndromes
Date of first decision: 26/06/2020, Positive, Last updated: 16/10/2020myelodysplastic syndromes, including azacitidine, decitabine and lenalidomide … magrolimab in combination with azacitidine may lead to a long-lasting … and be more effective than azacitidine taken alone. This assumption … -
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Orphan designation: 2-(hydroxymethyl)-2-(methoxymethyl)-1-azabicyclo[2.2.2]octan-3-one for: Treatment of myelodysplastic syndromes
Date of first decision: 25/07/2019, Positive, Last updated: 13/10/2020myelodysplastic 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) 27-30 January 2020
CHMP, Last updated: 31/01/2020Azacitidine betapharm … -
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National expert: Gerrit (Gert) Ossenkoppele, European Medicines Agency (updated)
- Declaration of interests - 81.85 KB | PDF
- Curriculum Vitae - 18.24 KB | PDF
06/2017-(current) BMS/Celgene Azacitidine,CC-486,Enasidini b AML 04/2018-08/2020 … -
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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 - 81.27 KB | PDF
- Curriculum Vitae - 105.62 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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National expert: Daniela Cianci, Medicines Evaluation Board (updated)
- Declaration of interests - 81.1 KB | PDF
- Curriculum Vitae - 69.73 KB | PDF
Ingelheim AMoRe2017 Azacitidine Celgene Beacon … Azacitidine Celgene ZUMA-4 … -
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Orphan designation: Pevonedistat for: Treatment of myelodysplastic syndromes
Date of first decision: 14/12/2018, Positive, Last updated: 26/08/2020medicine in combination with azacitidine (a medicine for myelodysplastic … syndromes), when compared with azacitidine taken alone. This assumption … -
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Orphan designation: Imetelstat sodium for: Treatment of myelodysplastic syndromes
Date of first decision: 27/07/2020, Positive, Last updated: 19/11/2020myelodysplastic syndromes including azacitidine, lenalidomide and imatinib … -
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National expert: Pau Montesinos, European Medicines Agency (updated)
- Declaration of interests - 81.29 KB | PDF
- Curriculum Vitae - 48.87 KB | PDF
experience with frontline azacitidine in a large series of older … -
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Human medicine European public assessment report (EPAR): Mylotarg
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,
, 
, Revision: 5, Authorised, Last updated: 10/06/2020
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Human medicine European public assessment report (EPAR): Glivec (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001,, Revision: 39, Authorised, Last updated: 13/11/2020
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Human medicine European public assessment report (EPAR): Shingrix
Recombinant varicella zoster virus glycoprotein E, Herpes Zoster
Date of authorisation: 21/03/2018,, Revision: 5, Authorised, Last updated: 28/09/2020
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Orphan designation: Pevonedistat for: Treatment of acute myeloid leukaemia
Date of first decision: 25/07/2019, Positive, Last updated: 26/08/2020to another cancer medicine azacitidine could improve survival of … -
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Human medicine European public assessment report (EPAR): Dacogen
Decitabine, Leukemia, Myeloid
Date of authorisation: 20/09/2012,, Revision: 13, Authorised, Last updated: 13/05/2019