EMEA-001439-PIP01-13-M03 - paediatric investigation plan

Dasabuvir (sodium monohydrate)

Key facts

• Invented name:
  • Exviera
  • Exviera
• Active substance:
  Dasabuvir (sodium monohydrate)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0289/2020
• PIP number:
  EMEA-001439-PIP01-13-M03
• Pharmaceutical form(s):
  • 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:
  12/08/2020
• Compliance check done:
  Níl

Decision

P/0289/2020 : EMA decision of 12 August 2020 on the acceptance of a modification of an agreed paediatric investigation plan for dasabuvir (sodium monohydrate) (Exviera) (EMEA-001439-PIP01-13-M03)

Adopted Reference Number: EMA/371374/2020