218 results
Keyword azacitidine Remove keyword
-
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, Authorised, Last updated: 14/08/2019Azacitidine Celgene … Azacitidine Celgene Myelodysplastic … Azacitidine Celgene azacitidine azacitidine … -
List item
Human medicine European public assessment report (EPAR): Vidaza
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,
, Revision: 18, Authorised, Last updated: 11/04/2019
Authorised azacitidine Overview This is a summary … contains the active substance azacitidine. It is available as a powder … active substance in Vidaza, azacitidine, belongs to the group ‘anti‑metabolites’ … -
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, 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 … -
List item
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 … -
List item
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 … -
List item
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Date of first decision: 11/11/2015, Withdrawn, Last updated: 08/02/2017opinion on orphan designation Azacitidine for the treatment of nasopharyngeal … opinion on orphan designation Azacitidine for the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 … -
List item
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: 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 … -
List item
Orphan designation: Pevonedistat 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 … -
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: Pevonedistat 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 … -
List item
Human medicine European public assessment report (EPAR): Mylotarg (updated)
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,
, 
, Revision: 4, Authorised, Last updated: 25/10/2019
-
List item
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
-
List item
Human medicine European public assessment report (EPAR): Shingrix (updated)
Varicella Zoster Virus glycoprotein E antigen, Herpes Zoster
Date of authorisation: 21/03/2018,, Revision: 2, Authorised, Last updated: 23/10/2019
-
List item
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: 36, Authorised, Last updated: 15/10/2019