Sovaldi

sofosbuvir

Table of contents

Opinion

On 30 April 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 Sovaldi. The marketing authorisation holder for this medicinal product is Gilead Sciences Ireland UC. 

The CHMP adopted an extension to the indication for Sovaldi as follows1:

Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients in adolescents aged 312 to <18 years and above

The CHMP also recommended the addition of a new 200 mg strength for the film-coated tablets and the introduction of a new pharmaceutical form, coated granules, which will be available in 150 mg and 200 mg strengths.  

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. 


1New text in bold, removed text as strikethrough.

Key facts

Name
Sovaldi
Agency product number
EMEA/H/C/002798
International non-proprietary name (INN) or common name
  • sofosbuvir
Active substance
  • Sofosbuvir
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
30/04/2020
Company name
Gilead Sciences Ireland UC
Status
Positive
Application type
Post-authorisation

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