TRUVADA Film-coated tablet Ref.[27928] Active ingredients: Emtricitabine Tenofovir disoproxil Tenofovir disoproxil and Emtricitabine

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Product name and form

Truvada 200 mg/245 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Blue, capsule-shaped, film-coated tablet, of dimensions 19 mm x 8.5 mm, debossed on one side with “GILEAD” and on the other side with “701”.

Qualitative and quantitative composition

Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir).

Excipient with known effect: Each tablet contains 91 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Emtricitabine

Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to HIV-1, HIV-2 and HBV. Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination. Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ.

Tenofovir disoproxil

Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination.

Tenofovir disoproxil and Emtricitabine

Emtricitabine is a nucleoside analogue of cytidine. Tenofovir disoproxil is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate. Both emtricitabine and tenofovir have activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2) and hepatitis B virus.

List of Excipients

Tablet core:

Croscarmellose sodium
Lactose monohydrate
Magnesium stearate (E572)
Microcrystalline cellulose (E460)
Pregelatinised starch (gluten free)

Film-coating:

Glycerol triacetate (E1518)
Hypromellose (E464)
Indigo carmine aluminium lake (E132)
Lactose monohydrate
Titanium dioxide (E171)

Pack sizes and marketing

High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.

The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 60 (2 bottles of 30) and 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/1/04/305/001
EU/1/04/305/002
EU/1/04/305/003

Date of first authorisation: 21 February 2005
Date of latest renewal: 20 January 2010

Drugs

Drug Countries
TRUVADA Austria, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States, South Africa

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