EMEA-001646-PIP01-14-M02 - paediatric investigation plan

sofosbuvir

velpatasvir

Key facts

• Invented name:
  • Epclusa
  • Epclusa
• Active substance:
  • sofosbuvir
  • velpatasvir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0150/2018
• PIP number:
  EMEA-001646-PIP01-14-M02
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral formulation
• 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:
  18/05/2018
• Compliance check done:
  Da
• Compliance procedure number:
  EMEA-C-001646-PIP01-14-M02
• Compliance opinion date:
  26/02/2021
• Compliance outcome:
  Positive

Decision

P/0150/2018: EMA decision of 18 May 2018 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir / velpatasvir (Epclusa), (EMEA-001646-PIP01-14-M02)

Adopted Reference Number: EMA/291038/2018