MHRA-100679-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Talazoparib
Invented Name
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
  • Talzenna
PIP Number MHRA-100679-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsule, hard
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of Ewing Sarcoma
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(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.pdf
Published Date 03/10/2023