Biktarvy 50 mg/200 mg/25 mg film-coated tablets.
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.
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.
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)
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.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/18/1289/001
EU/1/18/1289/002
Date of first authorisation: 21 June 2018