MHRA-100959-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • DOSTARLIMAB
Invented Name
  • Jemperli
  • Jemperli
  • Jemperli
PIP Number MHRA-100959-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).
Route(s) of administration
Route(s) of administration:
  • intravenous
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
11/04/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100959-PIP01-23-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DOSTARLIMAB.pdf
Published Date 30/06/2023