EMA/PE/0000182592 - paediatric investigation plan

human polyclonal immunoglobulin G against thymocyte (SAB-142)

Key facts

• Active substance:
  human polyclonal immunoglobulin G against thymocyte (SAB-142)
• Therapeutic area:
  Immune system disorders
• Decision number:
  EMA/PE/0000182592
• PIP number:
  EMA/PE/0000182592
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of stage 3 type 1 diabetes mellitus
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  02/07/2025
• Compliance check done:
  Nein

Decision

EMA/PE/0000182592 : EMA decision of 2 July 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human polyclonal immunoglobulin G against thymocyte (SAB-142)

Adopted Reference Number: EMADOC-1700519818-2247713