Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Viread 245 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Light blue, almond-shaped, film-coated tablets, of dimensions 16.8 mm x 10.3 mm, debossed on one side with “GILEAD” and “4331” and on the other side with “300”. |
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate).
Excipient with known effect: Each tablet contains 156 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tenofovir disoproxil |
Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination. |
| List of Excipients |
|---|
|
Tablet core: Croscarmellose sodium Film-coating: Glycerol triacetate (E1518) |
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets. Not all pack sizes may be marketed.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/01/200/001
EU/1/01/200/002
Date of first authorisation: 5 February 2002
Date of latest renewal: 14 December 2011
| Drug | Countries | |
|---|---|---|
| VIREAD | Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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