176 results
Keyword azacitidine Remove keyword
-
List item
Human medicine European public assessment report (EPAR): Azacitidine Mylan (updated)
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,
, Revision: 4, Authorised, Last updated: 24/06/2022
Azacitidine Mylan Bone Marrow Diseases Hematologic … Authorised azacitidine Overview Azacitidine Mylan is used for the treatment … cells called myeloid cells). Azacitidine Mylan is used in patients … -
List item
Human medicine European public assessment report (EPAR): Azacitidine betapharm (updated)
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,, Revision: 4, Authorised, Last updated: 10/06/2022
Azacitidine betapharm Bone Marrow Diseases Hematologic … Authorised azacitidine Overview Azacitidine betapharm is used for the … cells called myeloid cells). Azacitidine betapharm is used in patients … -
List item
Human medicine European public assessment report (EPAR): Azacitidine Accord
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 4, Authorised, Last updated: 04/04/2022
Azacitidine Accord Cancer Neoplasms Bone … Azacitidine Accord … Pack size EU/1/19/1413/001 Azacitidine Accord 25 mg/ml Powder … -
List item
Human medicine European public assessment report (EPAR): Azacitidine Celgene
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 02/08/2019, Revision: 2, Withdrawn, Last updated: 04/08/2021Azacitidine Celgene Myelodysplastic … Azacitidine Celgene … EMEA/H/C/005300 Public statement Azacitidine Celgene Withdrawal of the … -
List item
Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,
, Revision: 25, Authorised, Last updated: 14/06/2022
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’ … -
List item
Human medicine European public assessment report (EPAR): Onureg
azacitidine, Leukemia, Myeloid, Acute
Date of authorisation: 17/06/2021, Revision: 1, Authorised, Last updated: 06/09/2021azacitidine … EMEA/H/C/004761 Onureg (azacitidine) An overview of Onureg and … contains the active substance azacitidine. How is Onureg used? Onureg … -
List item
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: Xname Vidaza Active substance azacitidine Therapeutic area Haematology-Hemostaseology … paediatric investigation plan for azacitidine (Vidaza), (EMEA-001272-PIP02-13-M01 … paediatric investigation plan for azacitidine (Vidaza), (EMEA-001272-PIP02-13-M01 … -
List item
Orphan designation: azacitidine for: Treatment of acute myeloid leukaemia
Date of designation: 29/11/2007, Expired, Last updated: 20/02/2019azacitidine Overview … azacitidine … -
List item
Orphan designation: azacitidine for: Treatment of myelodysplastic syndromes
Date of designation: 06/02/2002, Expired, Last updated: 20/02/2019azacitidine Overview … azacitidine … -
List item
Orphan designation: azacitidine for: Treatment of nasopharyngeal carcinoma
Date of designation: 11/11/2015, Withdrawn, Last updated: 08/02/2017azacitidine Overview Please note that … Limited, United Kingdom, for azacitidine for the treatment of nasopharyngeal … information to show that azacitidine might be of significant benefit … -
List item
Human medicine European public assessment report (EPAR): Venclyxto
Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 04/12/2016,
, Revision: 13, Authorised, Last updated: 22/03/2022
in combination with either azacitidine or decitabinein adults who … in combination with either azacitidine or decitabine in adults who … treated with Venclyxto plus azacitidine had no sign of the disease … -
List item
Orphan designation: Magrolimab for: Treatment of myelodysplastic syndromes
Date of designation: 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 … -
List item
Orphan designation: 2-(hydroxymethyl)-2-(methoxymethyl)-1-azabicyclo[2.2.2]octan-3-one for: Treatment of myelodysplastic syndromes
Date of designation: 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 … -
List item
National expert: Bruno Quesnel, European Medicines Agency (updated)
- Declaration of interests - 82.42 KB | PDF
- Curriculum Vitae - 59.19 KB | PDF
-
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020
CHMP, Last updated: 31/01/2020Azacitidine betapharm … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2019
CHMP, Last updated: 13/12/2019Azacitidine Accord … -
List item
National expert: Alessandra Spagnoli, Italian Medicines Agency (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 32.51 KB | PDF
-
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2019
CHMP, Last updated: 28/06/2019Azacitidine Celgene … -
List item
Orphan designation: Imetelstat sodium for: Treatment of myelodysplastic syndromes
Date of designation: 27/07/2020, Positive, Last updated: 19/11/2020myelodysplastic syndromes including azacitidine, lenalidomide and imatinib … -
List item
Orphan designation: Pevonedistat for: Treatment of myelodysplastic syndromes
Date of designation: 14/12/2018, Withdrawn, Last updated: 18/02/2022medicine in combination with azacitidine (a medicine for myelodysplastic … syndromes), when compared with azacitidine taken alone. This assumption … medicine in combination with azacitidine (a medicine for myelodysplastic … -
List item
National expert: Vasileios Papadopoulos, National Organization for Medicines (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 30.93 KB | PDF
-
List item
Orphan designation: cusatuzumab for: Treatment of acute myeloid leukaemia
Date of designation: 22/04/2020, Positive, Last updated: 11/08/2020given in combination with azacitidine (another cancer medicine … -
List item
Human medicine European public assessment report (EPAR): Xospata
gilteritinib fumarate, Leukemia, Myeloid, Acute
Date of authorisation: 24/10/2019,, 
, Revision: 3, Authorised, Last updated: 20/05/2022
-
List item
Orphan designation: Pevonedistat for: Treatment of acute myeloid leukaemia
Date of designation: 25/07/2019, Withdrawn, Last updated: 18/02/2022to another cancer medicine azacitidine could improve survival of … another cancer medicine azacitidine could improve survival of … -
List item
Human medicine European public assessment report (EPAR): Ayvakyt
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,, , Revision: 4, Authorised, Last updated: 18/05/2022