MHRA-101159-PIP02-25

Key Facts

Active Substance
Active Substance:
  • Sacituzumab Tirumotecan
Invented Name
sac-TMT (佳泰莱®)
PIP Number MHRA-101159-PIP02-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical forms
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of urothelial carcinoma
Route(s) of administration
  • intravenous
  • INTRAVESICAL 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):Sacituzumab Tirumotecan .pdf
Published Date 13/08/2025