MHRA-100312-PIP01-21

Key Facts

Active Substance
Active Substance:
  • Ritlectinib
Invented Name
Not yet available
PIP Number MHRA-100312-PIP01-21
Pharmaceutical form(s)
  • Capsule, hard
  • Age-appropriate oral dosage form
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Treatment of alopecia areata
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
01/07/2022
Compliance Check Procedure Number
Compliance procedure number
MHRA-100312-PIP01-21-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Ritlectinib.pdf
Published Date 29/07/2022