CHMP Positive Opinion Received: Epclusa EU Paediatric Line Extension

The CHMP have adopted a positive opinion for the Epclusa paediatric line extension application. The opinion was adopted on 11 November 2021 by the CHMP.

The CHMP recommends by consensus the granting of an extension of the marketing authorisation for Epclusa as follows:

• a new pharmaceutical form in two strengths - 150 mg/ 37.5 mg coated granules and 200 mg/ 50 mg coated granules
• an indication for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 3 years and older