EMEA-001521-PIP03-22 - paediatric investigation plan

Luspatercept

Key facts

• Invented name:
  Reblozyl
• Active substance:
  Luspatercept
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0441/2023
• PIP number:
  EMEA-001521-PIP03-22
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of alpha-thalassaemia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  27/10/2023
• Compliance check done:
  Níl

Decision

P/0441/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for luspatercept (Reblozyl), (EMEA-001521-PIP03-22)

Adopted Reference Number: EMA/401553/2023