EMEA-001858-PIP02-16-M04 - paediatric investigation plan
daunorubicin
cytarabine
PIPHuman
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Key facts
- Invented name
- Vyxeos liposomal (previously Vyxeos)
- Active substance
- daunorubicin
- cytarabine
- Therapeutic area
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Decision number
- P/0356/2024
- PIP number
- EMEA-001858-PIP02-16-M04
- Pharmaceutical form(s)
- Powder for concentrate for infusion
- Condition(s) / indication(s)
- Treatment of acute myeloid leukaemia
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
Jazz Pharmaceuticals Ireland Limited
E-mail: ukregulatory@jazzpharma.com
Tel: +1 6504963777- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- No