EVIPLERA Film-coated tablet Ref.[107676] Active ingredients: Emtricitabine Emtricitabine, Tenofovir disoproxil and Rilpivirine Rilpivirine Tenofovir disoproxil

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Product name and form

Eviplera 200 mg/25 mg/245 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Purplish-pink, capsule-shaped, film-coated tablet of dimensions 19 mm x 8.5 mm, debossed on one side with “GSI” and plain on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate).

Excipients with known effect: Each film-coated tablet contains 277 mg lactose monohydrate and 4 micrograms sunset yellow aluminium lake (E110).

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.

Emtricitabine, Tenofovir disoproxil and Rilpivirine

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 HIV-1, HIV-2 and, HBV. Rilpivirine is a diarylpyrimidine NNRTI of HIV-1. Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).

Rilpivirine

Rilpivirine is a diarylpyrimidine NNRTI of HIV-1. Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Rilpivirine does not inhibit the human cellular DNA polymerases α, β and 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.

List of Excipients

Tablet core:

Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Polysorbate 20
Povidone
Pregelatinised maize starch

Film-coating:

Hypromellose
Indigo carmine aluminium lake
Lactose monohydrate
Polyethylene glycol
Red iron oxide
Sunset yellow aluminium lake (E110)
Titanium dioxide
Triacetin

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 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/1/11/737/001
EU/1/11/737/002

Date of first authorisation: 28 November 2011
Date of latest renewal: 22 July 2016

Drugs

Drug Countries
EVIPLERA Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Netherlands, Poland, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.