MHRA-100324-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Loncastuximab tesirine
Invented Name
  • Zynlonta
  • Zynlonta
  • Zynlonta
  • Zynlonta
  • Zynlonta
PIP Number MHRA-100324-PIP01-21-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of mature B-cell neoplasms
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
  • Swedish Orphan Biovitrum AB
  • Country Sweden
  • Tel +4686972000
  • Email info@sobi.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
13/06/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100324-PIP01-21-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):LONCASTUXIMAB TESIRINE.pdf
Published Date 01/05/2026