Paediatric line extension LD tablets & 12 to <18 years indication

EC Decision: 16 September 2021 

Vosevi received Paediatric Line Extension.

Extension of indication to the existing presentation of 400/100/100 mg film-coated tablets for Vosevi

• a new strength: 200/50/50 mg film-coated tablets
• the extension of indication for the treatment of chronic hepatitis C virus (HCV) infection to include paediatric use in in patients aged 12 years and older and weighing at least 30 kg.