Sovaldi

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Questions & Answers

On 20 July 2017, 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 Sovaldi. The marketing authorisation holder for this medicinal product is Gilead Sciences International Ltd.

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

“Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and in adolescents aged 12 to <18 years (see sections 4.2, 4.4 and 5.1).

For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.”

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

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Sovaldi (English only) 2017-07-21  

Key facts

Product details for Sovaldi
NameSovaldi
INN or common name

sofosbuvir

Therapeutic area Hepatitis C, Chronic
Active substance

sofosbuvir

Date opinion adopted20/07/2017
Company name

Gilead Sciences International Ltd

StatusPositive
Application typePost authorisation