EMEA-002066-PIP01-20 - paediatric investigation plan

talazoparib

Key facts

• Invented name:
  Talzenna
• Active substance:
  talazoparib
• Therapeutic area:
  Oncology
• Decision number:
  P/0224/2021
• PIP number:
  EMEA-002066-PIP01-20
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of Ewing sarcoma
• 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:
  09/06/2021
• Compliance check done:
  Ei

Decision

P/0224/2021 : EMA decision of 9 June 2021 on the agreement of a paediatric investigation plan and on the granting of a waiver for talazoparib (Talzenna) (EMEA-002066-PIP01-20)

Adopted Reference Number: EMA/245845/2021