EMA/PE/0000229841 - paediatric investigation plan

itepekimab

Key facts

• Active substance:
  itepekimab
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  EMA/PE/0000229841
• PIP number:
  EMA/PE/0000229841
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of nasal polyposis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/03/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000229841 : EMA decision of 21 March 2025 on the granting of a product specific waiver for itepekimab

Adopted Reference Number: EMADOC-1700519818-1980448