EMEA-003422-PIP01-23 - paediatric investigation plan

fuzuloparib

Key facts

• Active substance:
  fuzuloparib
• Therapeutic area:
  Oncology
• Decision number:
  P/0262/2023
• PIP number:
  EMEA-003422-PIP01-23
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of prostate cancer
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/07/2023
• Compliance check done:
  No

Decision

P/0262/2023 : EMA decision of 14 July 2023 on the granting of a product specific waiver for fuzuloparib (EMEA-003422-PIP01-23)

Reference Number: EMA/284110/2023