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.
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.
|Agency product number||
|International non-proprietary name (INN) or common name||
Hepatitis C, Chronic
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||