EMEA-001389-PIP01-12 - paediatric investigation plan

Deleobuvir

Key facts

• Active substance:
  Deleobuvir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0240/2013
• PIP number:
  EMEA-001389-PIP01-12
• Pharmaceutical form(s):
  • Film-coated tablet
  • Oral solution
• Condition(s) / indication(s):
  Treatment of chronic viral hepatitis C
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  24/09/2013
• Compliance check done:
  No

Decision

P/0240/2013: EMA decision of 24 September 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for deleobuvir (EMEA-001389-PIP01-12)

Adopted Reference Number: EMA/564979/2013