EMEA-003450-PIP01-23 - paediatric investigation plan

zanidatamab

Key facts

• Active substance:
  zanidatamab
• Therapeutic area:
  Oncology
• Decision number:
  P/0433/2023
• PIP number:
  EMEA-003450-PIP01-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of biliary tract cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/10/2023
• Compliance check done:
  No

Decision

P/0433/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for zanidatamab (EMEA-003450-PIP01-23)

Adopted Reference Number: EMA/424762/2023