Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Vosevi 400 mg/100 mg/100 mg film-coated tablets.
Vosevi 200 mg/50 mg/50 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Vosevi 400 mg/100 mg/100 mg film-coated tablets: Beige, capsule-shaped, film-coated tablet of dimensions 10 mm x 20 mm, debossed with “GSI” on one side and “3” on the other side. Vosevi 200 mg/50 mg/50 mg film-coated tablets: Beige, oval-shaped, film-coated tablet of dimensions 8 mm x 15 mm, debossed with “GSI” on one side and “SVV” on the other side. |
Each film-coated tablet contains 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir.
Excipients with known effect: Each film-coated tablet contains 111 mg of lactose (as monohydrate).
Each film-coated tablet contains 200 mg sofosbuvir, 50 mg velpatasvir and 50 mg voxilaprevir.
Excipients with known effect: Each film-coated tablet contains 55 mg of lactose (as monohydrate).
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, Velpatasvir and Voxilaprevir |
Sofosbuvir/velpatasvir/voxilaprevir combination is indicated for the treatment of chronic hepatitis C virus (HCV) infection. Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication. Velpatasvir is a pan-genotypic HCV inhibitor targeting the HCV NS5A protein, which is required for viral replication. Voxilaprevir is a pan-genotypic inhibitor of the HCV NS3/4A protease. Voxilaprevir acts as a noncovalent, reversible inhibitor of the NS3/4A protease. |
|
| 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. |
|
| Voxilaprevir |
Voxilaprevir is a pan-genotypic inhibitor of the HCV NS3/4A protease. Voxilaprevir acts as a noncovalent, reversible inhibitor of the NS3/4A protease. |
| List of Excipients |
|---|
|
Tablet core: Colloidal anhydrous silica Film-coating: Iron oxide black (E172) |
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 28 film-coated tablets with polyester coil and a silica gel desiccant.
Pack size: outer carton containing 1 bottle of 28 film-coated tablets.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/17/1223/001
EU/1/17/1223/002
Date of first authorisation: 26 July 2017
Date of latest renewal: 29 April 2022
| Drug | Countries | |
|---|---|---|
| VOSEVI | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
