EMEA-001858-PIP02-16-M04 - paediatric investigation plan

daunorubicin

cytarabine

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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

P/0356/2024: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for daunorubicin / cytarabine (Vyxeos), (EMEA-001858-PIP02-16-M04)

Adopted Reference Number: EMA/444603/2024