EMEA-000583-PIP01-09-M08 - paediatric investigation plan

Boceprevir

Key facts

• Invented name:
  Victrelis
• Active Substance:
  Boceprevir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0156/2020
• PIP number:
  EMEA-000583-PIP01-09-M08
• Pharmaceutical form(s):
  • Granules
  • Capsule (hard)
• Condition(s) / indication(s):
  Treatment of chronic hepatitis C
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe) Inc.

  Tel.: [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/04/2020

Decision

P/0156/2020: EMA decision of 17 April 2020 on the acceptance of a modification of an agreed paediatric investigation plan for boceprevir (Victrelis), (EMEA-000583-PIP01-09-M08)

Reference Number: EMA/175407/2020