EMEA-000780-PIP01-09-M07 - paediatric investigation plan

Midostaurin

Key facts

• Invented name:
  • Rydapt
  • Rydapt
• Active Substance:
  Midostaurin
• Therapeutic area:
  • Neoplasms benign, malignant and unspecified (incl cysts and polyps)
  • Oncology
• Decision number:
  P/0068/2024
• PIP number:
  EMEA-000780-PIP01-09-M07
• 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:
  08/03/2024

Decision

P/0068/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for midostaurin (Rydapt), (EMEA-000780-PIP01-09-M07)

AdoptedReference Number: EMA/76785/2024