EMEA-001511-PIP02-13 - paediatric investigation plan

simtuzumab

Key facts

• Active substance:
  simtuzumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0096/2015
• PIP number:
  EMEA-001511-PIP02-13
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  • Treatment of hepatic cirrhosis
  • Treatment of hepatic fibrosis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/05/2015
• Compliance check done:
  No

Decision

P/0096/2015: EMA decision of 8 May 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for simtuzumab (EMEA-001511-PIP02-13 )

Reference Number: EMA/281873/2015