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BIKTARVY Film-coated tablet (2018)

Active ingredients: Bictegravir Emtricitabine Tenofovir alafenamide

Product Name and Form

Biktarvy 50 mg/200 mg/25 mg film-coated tablets.

Pharmaceutical form

Film-coated tablet (tablet).

Purplish-brown, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “9883” on the other side of the tablet. Each tablet is approximately 15 mm × 8 mm.

Qualitative and Quantitative Composition

Each film-coated tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine, and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Bictegravir

Bictegravir is a type of antiviral agent called an ‘integrase inhibitor’. It blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.

Emtricitabine

Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2) and hepatitis B virus (HBV).

Tenofovir alafenamide

Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir. The pharmacologically active metabolite 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 hepatitis B virus and human immunodeficiency virus (HIV-1 and HIV-2).

List of excipients

Tablet core:

Microcrystalline cellulose
Croscarmellose sodium
Magnesium stearate

Film-coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol
Talc
Iron oxide red (E172)
Iron oxide black (E172)

Pack sizes and Marketing

White, high density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets. 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.

Marketing authorization holder
Authorization dates

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

Date of first authorisation: 21 June 2018

Marketing authorization number:

EU/1/18/1289/001
EU/1/18/1289/002