EMA/PE/0000290054 - paediatric investigation plan

human polyclonal immunoglobulin G against thymocyte

Key facts

• Active substance:
  human polyclonal immunoglobulin G against thymocyte
• Therapeutic area:
  Immune system disorders
• Decision number:
  EMA/PE/0000290054
• PIP number:
  EMA/PE/0000290054
• 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:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  02/01/2026
• Compliance check done:
  No

Decision

EMA/PE/0000290054 : EMA decision of 2 January 2026

Adopted Reference Number: EMADOC-1700519818-2751576