MHRA-101236-PIP01-23

Key Facts

Active Substance
Active Substance:
  • Rilzabrutinib
Invented Name
Not yet available
PIP Number MHRA-101236-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of autoimmune haemolytic anaemia.
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Rilzabrutinib.pdf
Published Date 03/10/2024