MHRA-101289-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Remibrutinib
Invented Name
Not yet available
PIP Number MHRA-101289-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral solid dosage form.
Therapeutic area
Therapeutic area:
  • Dermatology
Conditions / Indications
Conditions / Indications:
  • Treatment of chronic spontaneous urticaria.
Route(s) of administration
Route(s) of administration:
  • Oral 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
30/07/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-101289-PIP01-23-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Remibrutinib.pdf
Published Date 16/07/2026