MHRA-100583-PIP01-22

Key Facts

Active Substance
Active Substance:
  • SACITUZUMAB GOVITECAN
Invented Name
  • Trodelvy
  • Trodelvy
  • Trodelvy
PIP Number MHRA-100583-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of lung carcinoma (small-cell and non-small-cell carcinoma)
Route(s) of administration
Route(s) of administration:
  • Intravenous 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 GOVITECAN.pdf
Published Date 25/05/2023