EMA/PE/0000245423 - paediatric investigation plan

human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein

Key facts

• Active substance:
  human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  EMA/PE/0000245423
• PIP number:
  EMA/PE/0000245423
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  X-linked hypohidrotic ectodermal dysplasia (XLHED)
• Route(s) of administration:
  Intraamniotic use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/06/2025
• Compliance check done:
  Не

Decision

EMA/PE/0000245423 : EMA decision of 13 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for human immunoglobulin G1 constant region – human ectodysplasin-A1 receptor-binding domain fusion protein (ER004)

Adopted Reference Number: EMADOC-1700519818-2154845