MHRA-102181-PIP01-25

Key Facts

Active Substance
Active Substance:
  • Tinlarebant
Invented Name
Not yet available
PIP Number MHRA-102181-PIP01-25
Pharmaceutical form(s)
  • Tablet
  • Capsule, hard
Therapeutic area
Therapeutic area:
  • Ophthamology
Conditions / Indications
Conditions / Indications:
  • Treatment of Stargardt disease
Route(s) of administration
Route(s) of administration:
  • Oral 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
30/06/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-102181-PIP01-25-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Tinlarebant.pdf
Published Date 03/07/2026