EMEA-001190-PIP01-11 - paediatric investigation plan

asunaprevir

Key facts

• Active Substance:
  asunaprevir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0165/2012
• PIP number:
  EMEA-001190-PIP01-11
• Pharmaceutical form(s):
  • Capsule (soft)
  • Chewable tablet
• Condition(s) / indication(s):
  Treatment of chronic hepatitis C
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Bristol-Myers Squibb International Corporation

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  26/08/2012

Decision

P/0165/2012: EMA decision of 26 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for asunaprevir (EMEA-001190-PIP01-11)

AdoptedReference Number: EMA/476808/2012