TRIUMEQ Film-coated tablet Ref.[107695] Active ingredients: Abacavir Dolutegravir Lamivudine Lamivudine, Abacavir and Dolutegravir

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Product name and form

Triumeq 50 mg/600 mg/300 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Purple, biconvex, film-coated oval tablets, approximately 22 × 11 mm, debossed with “572 Trı” on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 50 mg dolutegravir (as sodium), 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.

For the full list of excipients see section 6.1.

Active Ingredient Description
Abacavir

Abacavir is a NRTI. It is a potent selective inhibitor of HIV-1 and HIV-2. Abacavir is metabolised intracellularly to the active moiety, carbovir 5'-triphosphate (TP). In vitro studies have demonstrated that its mechanism of action in relation to HIV is inhibition of the HIV reverse transcriptase enzyme, an event which results in chain termination and interruption of the viral replication cycle.

Dolutegravir

Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.

Lamivudine

Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Its main mode of action is as a chain terminator of viral reverse transcription.

Lamivudine, Abacavir and Dolutegravir

Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. Abacavir and lamivudine are potent selective inhibitors of HIV-1 and HIV-2.

List of Excipients

Tablet core:

Mannitol (E421)
Microcrystalline cellulose
Povidone (K29/32)
Sodium starch glycollate
Magnesium stearate

Tablet coating:

Poly(vinyl) alcohol – partially hydrolysed
Titanium dioxide
Macrogol
Talc
Iron oxide black
Iron oxide red

Pack sizes and marketing

White HDPE (high density polyethylene) bottles closed with polypropylene child-resistant closures, with a polyethylene faced induction heat seal liner.

Each bottle contains 30 film-coated tablets and a desiccant.

Multipacks containing 90 (3 packs of 30) film-coated tablets. Each pack of 30 film-coated tablets contains a desiccant.

Not all pack sizes may be marketed.

Marketing authorization holder

ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Marketing authorization dates and numbers

EU/1/14/940/001
EU/1/14/940/002

Date of first authorisation: 1st September 2014
Date of latest renewal: 20th June 2019

Drugs

Drug Countries
TRIUMEQ Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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