EMA/PE/0000245064 - paediatric investigation plan

avutometinib

defactinib

Key facts

• Active substance:
  • avutometinib
  • defactinib
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000245064
• PIP number:
  EMA/PE/0000245064
• Pharmaceutical form(s):
  • Tablet
  • Capsule
• Condition(s) / indication(s):
  Treatment of ovarian cancer
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/06/2025
• Compliance check done:
  No

Decision

EMA/PE/0000245064 : EMA decision of 13 June 2025 on the granting of a product specific waiver for avutometinib / defactinib

Adopted Reference Number: on the granting of a product specific waiver for avutometinib / defactinib