EMEA-002536-PIP01-18-M04 - paediatric investigation plan

Lebrikizumab

Key facts

• Invented name:
  Ebglyss
• Active substance:
  Lebrikizumab
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0382/2024
• PIP number:
  EMEA-002536-PIP01-18-M04
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of atopic dermatitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/10/2024
• Compliance check done:
  Nee

Decision

P/0382/2024: EMA decision of 31 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for lebrikizumab (Ebglyss), (EMEA-002536-PIP01-18-M04)

Adopted Reference Number: EMA/480694/2024