EMEA-000724-PIP02-11 - paediatric investigation plan

Alisporivir

Key facts

• Active Substance:
  Alisporivir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0124/2012
• PIP number:
  EMEA-000724-PIP02-11
• Pharmaceutical form(s):
  Capsule (soft)
• Condition(s) / indication(s):
  Treatment of chronic hepatitis C
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Debiopharm International SA

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/07/2012

Decision

P/0124/2012: EMA decision of 4 July 2012 on the granting of a product specific waiver for alisporivir, (EMEA-000724-PIP02-11)

AdoptedReference Number: EMA/416052/2012