EMEA-003568-PIP01-23 - paediatric investigation plan

sargramostim

Key facts

• Active substance:
  sargramostim
• Therapeutic area:
  Injury, poisoning and procedural complications
• Decision number:
  P/0089/2024
• PIP number:
  EMEA-003568-PIP01-23
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of acute radiation syndrome
• 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:
  27/03/2024
• Compliance check done:
  No

Decision

P/0089/2024 : EMA decision of 27 March 2024 on the on the agreement of a paediatric investigation plan and on the granting of a deferral for sargramostim (EMEA-003568-PIP01-23)

Adopted Reference Number: EMA/128509/2024