This is a summary of the European public assessment report (EPAR) for Dacogen. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dacogen.
Therapeutic Indication
### Therapeutic indication Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy.
Therapeutic Area (MeSH)
ATC Code
L01BC08
ATC Item
decitabine
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| decitabine | N/A | 地西他滨 |
EMA Name
Dacogen
Medicine Name
Dacogen
Aliases
N/ANo risk management plan link.
