EMEA-000625-PIP01-09-M03 - paediatric investigation plan

simeprevir

Key facts

• Invented name:
  Olysio
• Active substance:
  simeprevir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0325/2018
• PIP number:
  EMEA-000625-PIP01-09-M03
• Pharmaceutical form(s):
  • Capsule, hard
  • Age appropriate dosage form, other
• Condition(s) / indication(s):
  Treatment of chronic viral hepatitis C
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/09/2018
• Compliance check done:
  Ei

Decision

P/0325/2018: EMA decision of 12 September 2018 on the acceptance of a modification of an agreed paediatric investigation plan for simeprevir (EMEA-000625-PIP01-09-M03)

Adopted Reference Number: EMA/538893/2018