Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Epclusa 400 mg/100 mg film-coated tablets.
Epclusa 200 mg/50 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Epclusa 400 mg/100 mg film-coated tablets: Pink, diamond-shaped, film-coated tablet of dimensions 20 mm x 10 mm, debossed on one side with “GSI” and “7916” on the other side. Epclusa 200 mg/50 mg film-coated tablets: Pink, oval-shaped, film-coated tablets of dimensions 14 mm x 7 mm, debossed on one side with “GSI” and “S/V” on the other side. |
Epclusa 400 mg/100 mg film-coated tablets: Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir.
Epclusa 200 mg/50 mg film-coated tablets: Each film-coated tablet contains 200 mg sofosbuvir and 50 mg velpatasvir.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sofosbuvir |
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. |
|
| Sofosbuvir and Velpatasvir |
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Velpatasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions. |
|
| Velpatasvir |
Velpatasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions. In vitro resistance selection and cross-resistance studies indicate velpatasvir targets NS5A as its mode of action. |
| List of Excipients |
|---|
|
Tablet core: Copovidone (E1208) Film-coating: Poly(vinyl alcohol) (E1203) |
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 28 film-coated tablets with polyester coil.
Pack size of 1 bottle containing 28 film-coated tablets.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/16/1116/001
EU/1/16/1116/002
Date of first authorisation: 06 July 2016
Date of latest renewal: 22 March 2021
| Drug | Countries | |
|---|---|---|
| EPCLUSA | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States |
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