EMA/PE/0000232759 - paediatric investigation plan

telitacicept

Key facts

• Active substance:
  telitacicept
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000232759
• PIP number:
  EMA/PE/0000232759
• Pharmaceutical form(s):
  • Powder for solution for injection
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of myasthenia gravis
• 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:
  21/03/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000232759 : EMA decision of 21 March 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for telitacicept

Adopted Reference Number: EMADOC-1700519818-1978219