EMEA-001411-PIP01-12-M04 - paediatric investigation plan

sofosbuvir

ledipasvir

Key facts

• Invented name:
  • Harvoni
  • Harvoni
• Active substance:
  • sofosbuvir
  • ledipasvir
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0063/2017
• PIP number:
  EMEA-001411-PIP01-12-M04
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
  • Age appropriate 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:
  16/03/2017
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001411-PIP01-12-M04
• Compliance opinion date:
  26/04/2019
• Compliance outcome:
  Positive

Decision

P/0063/2017: EMA decision of 17 March 2017 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir / ledipasvir (Harvoni), (EMEA-001411-PIP01-12-M04)

Adopted Reference Number: EMA/114829/2017