Epclusa

sofosbuvir / velpatasvir

Table of contents

Opinion

On 25 June 2020, 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 Epclusa. The marketing authorisation holder for this medicinal product is Gilead Sciences Ireland UC.

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

Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults patients aged 6 years and older and weighing at least 17 kg.

The CHMP also recommended the addition of a new 200/50 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
Epclusa
Agency product number
EMEA/H/C/004210
International non-proprietary name (INN) or common name
  • sofosbuvir / velpatasvir
Active substance
  • Sofosbuvir
  • velpatasvir
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
25/06/2020
Company name
Gilead Sciences Ireland UC
Status
Positive
Application type
Post-authorisation

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