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

Key Facts

PIPS 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
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Remibrutinib.pdf
Published Date 24/06/2024