Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Sovaldi 400 mg film-coated tablets.
Sovaldi 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Sovaldi 400 mg film-coated tablets: Yellow, capsule-shaped, film-coated tablet of dimensions of approximately 20 mm x 9 mm, debossed on one side with “GSI” and “7977” on the other side. Sovaldi 200 mg film-coated tablets: Yellow, oval-shaped, film-coated tablet of dimensions of approximately 15 mm x 8 mm, debossed on one side with “GSI” and “200” on the other side. |
Sovaldi 400 mg film-coated tablets: Each film-coated tablet contains 400 mg of sofosbuvir.
Sovaldi 200 mg film-coated tablets: Each film-coated tablet contains 200 mg of sofosbuvir.
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. |
| List of Excipients |
|---|
|
Tablet core: Mannitol (E421) Film-coating: Polyvinyl alcohol (E1203) |
Sovaldi 400 mg tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets with a silica gel desiccant and polyester coil.
Sovaldi 200 mg tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets and a polyester coil.
The following pack sizes are available:
Not all pack sizes may be marketed.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/13/894/001
EU/1/13/894/002
EU/1/13/894/003
Date of first authorisation: 16 January 2014
Date of latest renewal: 17 September 2018
| Drug | Countries | |
|---|---|---|
| SOVALDI | Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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