EMA/PE/0000181993 - paediatric investigation plan

mosunetuzumab

Key facts

• Invented name:
  Lunsumio
• Active substance:
  mosunetuzumab
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  EMA/PE/0000181993
• PIP number:
  EMA/PE/0000181993
• Pharmaceutical form(s):
  • Solution for infusion
  • Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of mature B-cell neoplasms
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/11/2024
• Compliance check done:
  No

Decision

EMA/PE/0000181993 : EMA decision of 8 Nov 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mosunetuzumab (Lunsumio)

Adopted Reference Number: EMADOC-1700519818-3003858 Corr.