Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Epclusa 200 mg/50 mg coated granules in sachet.
Epclusa 150 mg/37.5 mg coated granules in sachet.
| Pharmaceutical Form |
|---|
|
Coated granules. Epclusa 200 mg/50 mg oral granules, unit-dose sachet (each sachet contains 100 oral granules of 2.0/0.5 mg/granule): White to off-white, coated granules 2 mm diameter in sachet. Epclusa 150 mg/37.5 mg oral granules, unit-dose sachet (each sachet contains 75 oral granules of 2.0/0.5 mg/granule): White to off-white, coated granules 2 mm diameter in sachet. |
Each sachet contains 200 mg sofosbuvir and 50 mg velpatasvir.
Excipient with known effect: Each sachet contains 304 mg of lactose (as monohydrate).
Each sachet contains 150 mg sofosbuvir and 37.5 mg velpatasvir.
Excipient with known effect: Each sachet contains 228 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
|---|
|
Granules core: Copovidone (E1208) Film-coating: Hypromellose (E464) |
Polyester/aluminium/polyethylene film sachets in cartons. Each carton contains 28 sachets.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/16/1116/004
EU/1/16/1116/003
Date of first authorisation: 06 July 2016
Date of latest renewal: 22 March 2021
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