EMEA-002594-PIP01-19 - paediatric investigation plan

Infigratinib

Key facts

• Active substance:
  Infigratinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0301/2019
• PIP number:
  EMEA-002594-PIP01-19
• Pharmaceutical form(s):
  Capsule, hard
• 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:
  10/09/2020
• Compliance check done:
  Nej

Decision

P/0301/2019: EMA decision of 10 September 2019 on the granting of a product specific waiver for infigratinib (EMEA-002594-PIP01-19)

Adopted Reference Number: EMA/467512/2019