EMEA-003504-PIP01-23 - paediatric investigation plan

tinengotinib

Key facts

• Active substance:
  tinengotinib
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  P/0031/2024
• PIP number:
  EMEA-003504-PIP01-23
• 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:
  29/01/2024
• Compliance check done:
  Ne

Decision

P/0031/2024 : EMA decision of 29 January 2024 on the granting of a product-specific waiver for tinengotinib (EMEA-003504-PIP01-23)

Adopted Reference Number: EMA/501922/2008