EMEA-000384-PIP01-08 - paediatric investigation plan

peginterferon alfa-2b

Key facts

• Invented name:
  • ViraferonPeg
  • ViraferonPeg
• Active substance:
  peginterferon alfa-2b
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/92/2008
• PIP number:
  EMEA-000384-PIP01-08
• Pharmaceutical form(s):
  Powder and solvent for solution for injection in vial and in pre-filled pen
• Condition(s) / indication(s):
  Treatment of chronic viral hepatitis C
• 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:
  14/10/2008
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000384-PIP01-08
• Compliance opinion date:
  17/10/2008
• Compliance outcome:
  Positive

Decision

P/92/2008: European medicines agency decision of 14 October 2008 on the application for agreement of a Paediatric Investigation Plan for peginterferon alfa-2b (ViraferonPeg) (EMEA-000384-PIP01-08) in accordance with Regu...

Adopted Reference Number: EMEA/527764/2008