Vosevi

sofosbuvir / velpatasvir / voxilaprevi

Table of contents

Opinion

On 22 July 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Vosevi. The marketing authorisation holder for this medicinal product is Gilead Sciences Ireland UC.

The CHMP adopted an extension to the indication for Vosevi as follows:1

Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults patients aged 12 years and older and weighing at least 30 kg.

The CHMP also recommended the addition of a new 200/50/50 mg strength for the film-coated tablets.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold, removed text as strikethrough.

Key facts

Name
Vosevi
Agency product number
EMEA/H/C/004350
International non-proprietary name (INN) or common name
  • sofosbuvir
  • velpatasvir
  • voxilaprevi
Active substance
  • Sofosbuvir
  • velpatasvir
  • voxilaprevi
Therapeutic area
Hepatitis C, Chronic
Accelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Date opinion adopted
22/07/2021
Company name
Gilead Sciences Ireland UC
Status
Positive
Application type
Post-authorisation

How useful was this page?

Add your rating