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decitabine (Dacogen®)

 

Following non-submission

AWMSG advice

Status: Not endorsed (Statement of Advice)

In the absence of a submission from the holder of the marketing authorisation, decitabine (Dacogen®) cannot be endorsed for use within NHS Wales for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia, according to the World Health Organisation classification, who are not candidates for standard induction chemotherapy.

 Statement of Advice (SOA): decitabine (Dacogen) 507 (PDF, 96Kb)

Medicine details

Medicine name decitabine (Dacogen®)
Formulation 50 mg powder for concentrate for solution for injection/infusion
Reference number 507
Indication

Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia, according to the World Health Organisation classification, who are not candidates for standard induction chemotherapy

Company Janssen-Cilag Ltd
BNF chapter Malignant disease & immunosuppression
Submission type Non-submission
Status Not endorsed (Statement of Advice)
Date of issue 18/03/2013
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