EMEA-002665-PIP02-20-M01 - paediatric investigation plan

Loncastuximab tesirine

Key facts

• Invented name:
  Zynlonta
• Active substance:
  Loncastuximab tesirine
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0152/2024
• PIP number:
  EMEA-002665-PIP02-20-M01
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of mature B-cell neoplasms
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/05/2024
• Compliance check done:
  No

Decision

P/0152/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for loncastuximab tesirine (Zynlonta), (EMEA-002665-PIP02-20-M01)

Adopted Reference Number: EMA/148125/2024