EMEA-001276-PIP01-12-M02 - paediatric investigation plan

sofosbuvir

Key facts

• Invented name:
  • Sovaldi
  • Sovaldi
• Active substance:
  sofosbuvir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0172/2018
• PIP number:
  EMEA-001276-PIP01-12-M02
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
  • Other
• 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:
  15/06/2018
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001276-PIP01-12-M02
• Compliance opinion date:
  26/04/2019
• Compliance outcome:
  Positive

Decision

P/0172/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir (Sovaldi), (EMEA-001276-PIP01-12-M02)

Adopted Reference Number: EMA/366015/2018