Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Emtriva 200 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Each capsule has a white opaque body with a light blue opaque cap, of dimensions 19.4 mm x 6.9 mm. Each capsule is printed with “200 mg” on the cap and “GILEAD” and [Gilead logo] on the body in black ink. |
Each hard capsule contains 200 mg of emtricitabine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Emtricitabine |
Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to HIV-1, HIV-2 and HBV. Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination. Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ. |
| List of Excipients |
|---|
|
Capsule contents: Crospovidone Capsule shell: Gelatin Printing ink containing: Black iron oxide (E172) |
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure, containing 30 hard capsules.
Blisters made of polychlorotrifluorethylene (PCTFE)/polyethylene (PE)/polyvinylchloride (PVC)/aluminium. Each blister pack contains 30 hard capsules.
Pack size: 30 hard capsules.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/03/261/001
EU/1/03/261/002
Date of first authorisation: 24 October 2003
Date of latest renewal: 22 September 2008
| Drug | Countries | |
|---|---|---|
| EMTRIVA | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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