MHRA-100471-PIP01-22-M03 (update)

Key Facts

Active Substance
Active Substance:
  • SETMELANOTIDE
Invented Name
IMCIVREE
PIP Number MHRA-100471-PIP01-22-M03 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of appetite and general nutrition disorders
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
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
04/12/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100471-PIP01-22-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):SETMELANOTIDE.pdf
Published Date 18/12/2025