MHRA-101079-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • ZANUBRUTINIB
Invented Name
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
  • Brukinsa
PIP Number MHRA-101079-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Capsule, hard
  • Age appropriate oral solid dosage form.
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
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 19/12/2023