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Epclusa



Gilead Sciences Ireland UCEU/1/16/1116/004

Main Information

Trade NameEpclusa
Active SubstancesSofosbuvir
Velpatasvir
Dosage FormCoated granules
Licence HolderGilead Sciences Ireland UC
Licence NumberEU/1/16/1116/004

Group Information

ATC CodeJ05AP55 sofosbuvir and velpatasvir

Status

License statusAuthorised
Licence Issued07/01/2022
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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