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 formulation
Condition(s) / indication(s)
Treatment of chronic hepatitis C
Route(s) of administration
Oral use
Contact for public enquiries

AbbVie Ltd

AbbVie Ltd
E-mail: paediatricsteam@abbvie.com
Tel: +44 7341101902

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

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)

How useful do you find this page?