210 results
Keyword azacitidine Remove keyword
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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, 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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Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008, Revision: 18, AuthorisedAuthorised 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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Orphan designation: azacitidine for: Treatment of myelodysplastic syndromes
Decision date: 06/02/2002, ExpiredLimited, 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 acute myeloid leukaemia
Decision date: 29/11/2007, ExpiredLtd, 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 nasopharyngeal carcinoma
Decision date: 11/11/2015, Withdrawnopinion 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: Pevonedistat for: Treatment of myelodysplastic syndromes
Decision date: 14/12/2018, Positivemedicine in combination with azacitidine (a medicine for myelodysplastic … syndromes), when compared with azacitidine taken alone. This assumption … -
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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: 34, Authorised
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Human medicine European public assessment report (EPAR): Dacogen
Decitabine, Leukemia, Myeloid
Date of authorisation: 20/09/2012,
, Revision: 12, Authorised
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Human medicine European public assessment report (EPAR): Mylotarg
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,, , Revision: 3, Authorised
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Human medicine European public assessment report (EPAR): Revlimid
lenalidomide, Multiple Myeloma, Lymphoma, Mantle-Cell, Myelodysplastic Syndromes
Date of authorisation: 14/06/2007,, , Revision: 37, Authorised
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Human medicine European public assessment report (EPAR): Rydapt
Midostaurin, Leukemia, Myeloid, Acute, Mastocytosis
Date of authorisation: 18/09/2017,, , Revision: 2, Authorised
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Human medicine European public assessment report (EPAR): Imatinib medac
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dermatofibrosarcoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome
Date of authorisation: 25/09/2013,
, Revision: 5, Authorised
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Human medicine European public assessment report (EPAR): Shingrix
Varicella Zoster Virus glycoprotein E antigen, Herpes Zoster
Date of authorisation: 21/03/2018,, Authorised
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Withdrawn application: Aranesp
darbepoetin alfa, date of withdrawal: 21/02/2018, Post-authorisation -
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Withdrawn application: Qinprezo
vosaroxin, date of withdrawal: 10/05/2017, Initial authorisation -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 September 2015
CHMP, 25/09/2015Name of medicine Vidaza INN azacitidine Marketing-authorisation holder … -
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Orphan designation: 3-(4'Aminoisoindoline-1'-one)-1-piperidine-2,6-dione for: Treatment of myelodysplastic syndromes
Decision date: 08/03/2004, Positive -
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Opinion/decision on a Paediatric investigation plan (PIP): Pevonedistat
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Oncology, PIP number: EMEA-002117-PIP01-17, decision date: 02/03/2018, last updated: 19/06/2018, compliance check: Xgiven in combination with azacitidine, fludarabine and cytarabine … pevonedistat in combination with azacitidine, fludarabine and cytarabine … -
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PRAC recommendations on safety signals
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Committee for Orphan Medicinal Products (COMP): 11-13 September 2018
European Medicines Agency, London, UK, from 11/09/2018 to 13/09/2018