EMEA-000780-PIP01-09-M08 - paediatric investigation plan

Midostaurin

Key facts

• Invented name:
  Rydapt
• Active Substance:
  Midostaurin
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0305/2024
• PIP number:
  EMEA-000780-PIP01-09-M08
• Pharmaceutical form(s):
  • Oral solution
  • Capsule, soft
• Condition(s) / indication(s):
  • Treatment of acute myeloid leukaemia
  • Treatment of malignant mastocytosis
  • Treatment of mast cell leukaemia
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/08/2024

Decision

P/0305/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for midostaurin (Rydapt), (EMEA-000780-PIP01-09-M08)

AdoptedReference Number: EMA/320725/2024