EMEA-001434-PIP01-13-M03 - paediatric investigation plan

Etrolizumab

Key facts

• Active substance:
  Etrolizumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0168/2020
• PIP number:
  EMEA-001434-PIP01-13-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of Crohn's disease
  • Treatment of ulcerative colitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/04/2020
• Compliance check done:
  No

Decision

P/0168/2020: EMA decision of 30 April 2020 on the acceptance of a modification of an agreed paediatric investigation plan for etrolizumab (EMEA-001434-PIP01-13-M03)

Adopted Reference Number: EMA/173220/2020