EMTRIVA Hard capsule Ref.[7240] Active ingredients: Emtricitabine

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Product name and form

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.

Qualitative and quantitative composition

Each hard capsule contains 200 mg of emtricitabine.

For the full list of excipients, see section 6.1.

Active Ingredient Description

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:

Magnesium stearate (E572)
Microcrystalline cellulose (E460)
Povidone (E1201)

Capsule shell:

Indigotine (E132)
Titanium dioxide (E171)

Printing ink containing:

Black iron oxide (E172)
Shellac (E904)

Pack sizes and marketing

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.

Marketing authorization holder

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Marketing authorization dates and numbers


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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