EMEA-001929-PIP01-16 - paediatric investigation plan

brazikumab

Key facts

• Active substance:
  brazikumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0397/2017
• PIP number:
  EMEA-001929-PIP01-16
• Pharmaceutical form(s):
  • Solution for injection
  • Solution for infusion
• Condition(s) / indication(s):
  • Treatment of Crohn's disease
  • Treatment of ulcerative colitis
• Route(s) of administration:
  • Subcutaneous use
  • Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  19/12/2017
• Compliance check done:
  No

Decision

P/0397/2017: EMA decision of 19 December 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for brazikumab (EMEA-001929-PIP01-16)

Adopted Reference Number: EMA/771133/2017