MHRA-102164-PIP01-25

Key Facts

Active Substance
Active Substance:
  • ZANUBRUTINIB
Invented Name
Brukinsa
PIP Number MHRA-102164-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablets
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of lymphoplasmacytic lymphoma
  • Treatment of mature B-Cell neoplasms (excluding lymphoplasmacytic lymphoma)
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • BEONE MEDICINES UK, LTD.
  • Country United Kingdom
  • Tel 07979959723
  • Email RegUK@beonemed.com
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):ZANUBRUTINIB.pdf
Published Date 18/12/2025