EMA/PE/0000239082 - paediatric investigation plan

human (scfv)2-fab fusion protein against cd40l

Key facts

• Active substance:
  human (scfv)2-fab fusion protein against cd40l
• Therapeutic area:
  Eye disorders
• Decision number:
  EMA/PE/0000239082
• PIP number:
  EMA/PE/0000239082
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of thyroid eye disease
• 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:
  16/05/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000239082 : EMA decision of 16 May 2025 on the granting of a product specific waiver for human (scFv)2-Fab fusion protein against CD40L

Adopted Reference Number: EMADOC-1700519818-2114066