Ribavirin - paediatric investigation plan

ribavirin

Key facts

• Invented name:
  • Rebetol
  • Rebetol
• Active substance:
  ribavirin
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/63/2008
• PIP number:
  Ribavirin
• Pharmaceutical form(s):
  • Oral solution
  • Capsule, hard
• 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:
  15/08/2008
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000070-PIP01-07
• Compliance opinion date:
  17/10/2008
• Compliance outcome:
  Positive

Decision

P/63/2008: European medicines agency decision of 15 August 2008 on the application for agreement of a Paediatric Investigation Plan for ribavirin, Rebetol (EMEA-000070-PIP01-07) in accordance with Regulation (EC) No 1901...

Adopted Reference Number: EMEA/424601/2008