EMA/PE/0000243095 - paediatric investigation plan

teplizumab

Key facts

• Active substance:
  teplizumab
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  EMA/PE/0000243095
• PIP number:
  EMA/PE/0000243095
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of type I diabetes mellitus
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000243095 : EMA decision of 16 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for teplizumab

Adopted Reference Number: EMADOC-1700519818-1850257