EMA/PE/0000221213 - paediatric investigation plan

blinatumomab

Key facts

• Invented name:
  Blincyto
• Active substance:
  blinatumomab
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  EMA/PE/0000221213
• PIP number:
  EMA/PE/0000221213
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of B-lymphoblastic leukaemia/lymphoma
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000221213 : EMA decision of 3 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for blinatumomab (Blincyto)

Adopted Reference Number: EMADOC-1700519818-1809719