BIKTARVY Film-coated tablet

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.

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

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

Marketing authorization dates and numbers

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

Date of first authorisation: 21 June 2018

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Cyprus, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, United States