MHRA-102346-PIP01-26

Key Facts

Active Substance
Active Substance:
  • Sonrotoclax
Invented Name
Not yet available
PIP Number MHRA-102346-PIP01-26
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical forms
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of mantle cell lymphoma (MCL)
  • Treatment of chronic lymphocytic leukaemia (CLL) / small lymphocytic lymphoma (SLL)
Route(s) of administration
Route(s) of administration:
  • All routes of administration
PIP applicant
  • BeOne Medicines UK, Limited.
  • Country United Kingdom
  • Tel 02081528660
  • 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):Sonrotoclax.pdf
Published Date 18/09/2026