EMEA-002066-PIP02-20 - paediatric investigation plan

talazoparib

Key facts

• Invented name:
  Talzenna
• Active substance:
  talazoparib
• Therapeutic area:
  Oncology
• Decision number:
  P/130/2021
• PIP number:
  EMEA-002066-PIP02-20
• Pharmaceutical form(s):
  • Capsule, hard
  • Capsule, soft
• Condition(s) / indication(s):
  • Treatment of breast malignant neoplasms
  • Treatment of prostate malignant neoplasms
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/04/2021
• Compliance check done:
  No

Decision

P/0130/2021: EMA decision of 14 April 2021 on the granting of a product specific waiver for talazoparib (Talzenna), (EMEA-002066-PIP02-20)

Adopted Reference Number: EMA/151819/2021