EMEA-001521-PIP01-13-M06 - paediatric investigation plan

Luspatercept

Key facts

• Invented name:
  Reblozyl
• Active substance:
  Luspatercept
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0155/2022
• PIP number:
  EMEA-001521-PIP01-13-M06
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  • Treatment of beta-thalassaemia
  • Treatment of myelodysplastic syndromes
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/05/2022
• Compliance check done:
  Ne

Decision

P/0155/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for luspatercept (Reblozyl), (EMEA-001521-PIP01-13-M06)

Adopted Reference Number: EMA/206730/2022