EMEA-001822-PIP01-15-M01 - paediatric investigation plan

sofosbuvir

velpatasvir

voxilaprevi

Key facts

• Invented name:
  Vosevi
• Active substance:
  • sofosbuvir
  • velpatasvir
  • voxilaprevi
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0006/2020
• PIP number:
  EMEA-001822-PIP01-15-M01
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of chronic hepatitis C
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/01/2020
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001822-PIP01-15-M01
• Compliance opinion date:
  16/10/2020
• Compliance outcome:
  Positive

Decision

P/0006/2020: EMA decision of 6 January 2020 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir / velpatasvir / voxilaprevir (Vosevi), (EMEA-001822-PIP01-15-M01)

Adopted Reference Number: EMA/658961/2019