Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Vemlidy 25 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Yellow, round, film-coated tablets, 8 mm in diameter, debossed with “GSI” on one side of the tablet and “25” on the other side of the tablet. |
Each film-coated tablet contains tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Excipient with known effect: Each tablet contains 95 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tenofovir alafenamide |
Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir. Tenofovir alafenamide enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3. Tenofovir alafenamide is primarily hydrolysed to form tenofovir by carboxylesterase 1 in primary hepatocytes. Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate. Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination. Tenofovir has activity that is specific to HBV and HIV (HIV-1 and HIV-2). |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film-coating: Polyvinyl alcohol (E1203) |
High density polyethylene (HDPE) bottles, enclosed with a polypropylene continuous-thread, child-resistant cap, lined with an induction-activated aluminium foil liner. Each bottle contains silica gel desiccant and polyester coil.
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/1/16/1154/001
EU/1/16/1154/002
Date of first authorisation: 09 January 2017
Date of latest renewal: 16 December 2021
| Drug | Countries | |
|---|---|---|
| VEMLIDY | Austria, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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