EMEA-002647-PIP01-19 - paediatric investigation plan

Futibatinib

Key facts

• Active substance:
  Futibatinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0045/2020
• PIP number:
  EMEA-002647-PIP01-19
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of cholangiocarcinoma
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/01/2020
• Compliance check done:
  Ne

Decision

P/0045/2020: EMA decision of 29 January 2020 on the granting of a product specific waiver for futibatinib (EMEA-002647-PIP01-19)

Adopted Reference Number: EMA/26705/2020