EMA/PE/0000181050 - paediatric investigation plan

lonigutamab

Key facts

• Active substance:
  lonigutamab
• Therapeutic area:
  Eye disorders
• Decision number:
  EMA/PE/0000181050
• PIP number:
  EMA/PE/0000181050
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of thyroid eye disease
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000181050 : EMA decision of 28 January 2025 on the granting of a product specific waiver for lonigutamab

Adopted Reference Number: EMADOC-1700519818-1851948