MHRA-100395-PIP01-21

Key Facts

Active Substance
Active Substance:
  • TALAZOPARIB TOSYLATE
Invented Name
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
PIP Number MHRA-100395-PIP01-21
Pharmaceutical form(s)
  • Capsules, hard
  • Capsules, soft
Therapeutic area
  • Psychiatry
  • Oncology
Conditions / Indications
  • Treatment of breast malignant neoplasms
  • Treatment of prostate malignant neoplasms
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):TALAZOPARIB TOSYLATE.pdf
Published Date 07/12/2022