EMEA-003389-PIP01-23 - paediatric investigation plan

Dordaviprone

Key facts

• Active Substance:
  Dordaviprone
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0015/2024
• PIP number:
  EMEA-003389-PIP01-23
• Pharmaceutical form(s):
  • Capsule, hard
  • Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of glioma
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2024

Decision

P/0015/2024 : EMA decision of 31 January 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for dordaviprone (EMEA-003389-PIP01-23)

AdoptedReference Number: EMA/15344/2024