BIKTARVY Film-coated tablet

Active ingredients: Emtricitabine, Tenofovir alafenamide and Bictegravir

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.

Active Ingredient
Description
Emtricitabine, Tenofovir alafenamide and Bictegravir
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

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.

  • Outer carton containing 1 bottle of 30 film-coated tablets
  • Outer carton containing 90 (3 bottles of 30) film-coated tablets.

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.

  • Outer carton containing 30 film-coated tablets (4 x blister strips containing 7 film-coated tablets and 1 x blister strip containing 2 film-coated tablets).
  • Outer carton containing 90 (3 blister packs 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
EU/1/18/1289/003
EU/1/18/1289/004

Date of first authorisation: 21 June 2018

Drugs

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