EMEA-002536-PIP02-24 - paediatric investigation plan

Lebrikizumab

Key facts

• Invented name:
  Ebglyss
• Active substance:
  Lebrikizumab
• Therapeutic area:
  Respiratory, thoracic and mediastinal disorders
• Decision number:
  P/0212/2024
• PIP number:
  EMEA-002536-PIP02-24
• 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:
  14/06/2024
• Compliance check done:
  Non

Decision

P/0212/2024 : EMA decision of 14 June 2024 on the granting of a product specific waiver for lebrikizumab (Ebglyss), (EMEA-002536-PIP02-24)

Adopted Reference Number: EMA/267179/2024