Active ingredients: Emtricitabine, Tenofovir alafenamide and Bictegravir
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.
Titanium dioxide (E171)
Iron oxide red (E172)
Iron oxide black (E172)
The following pack configurations are available:
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.
Blister packs consisting of polyvinyl chloride/polyethylene/polychlorotrifluoroethylene (PVC/PE/PCTFE) film, sealed to aluminium foil lidding material fitted with a molecular sieve desiccant within each blister cavity.
Not all pack sizes may be marketed.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Date of first authorisation: 21 June 2018