MHRA-101058-PIP01-23

Key Facts

Active Substance
Active Substance:
  • SIROLIMUS
Invented Name
Pascomer
PIP Number MHRA-101058-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Cream
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Treatment of Tuberous Sclerosis
Route(s) of administration
Route(s) of administration:
  • Topical 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
Yes
Compliance Check Decision Date
Compliance opinion date
09/11/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-101058-PIP01-23-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):SIROLIMUS.pdf
Published Date 30/01/2024