EMEA-000071-PIP01-07 - paediatric investigation plan

peginterferon alfa-2b

Key facts

• Invented name:
  • PegIntron
  • PegIntron
• Active Substance:
  peginterferon alfa-2b
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/64/2008
• PIP number:
  EMEA-000071-PIP01-07
• 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
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe), Inc.

  The Netherlands; E-mail: [e-mail]; Tel. [phone]; Fax [phone]

• 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 procedure number:
  EMEA-C-000071-PIP01-07
• Compliance opinion date:
  17/10/2008
• Compliance outcome:
  Positive

Decision

P/64/2008: European medicines agency decision of 15 August 2008 on the application for agreement of a Paediatric Investigation Plan for peginterferon alfa-2b, PegIntron (EMEA-000071-PIP01-07) in accordance with Regulatio...

AdoptedReference Number: EMEA/424620/2008