TRIUMEQ

This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Turkey, UK, United States.

Active ingredients

The drug TRIUMEQ contains a combination of these active pharmaceutical ingredients (APIs):

1	Dolutegravir UNII 1Q1V9V5WYQ - DOLUTEGRAVIR SODIUM
	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.
	Read more about Dolutegravir
2	Abacavir UNII J220T4J9Q2 - ABACAVIR SULFATE
	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.
	Read more about Abacavir
3	Lamivudine UNII 2T8Q726O95 - 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.
	Read more about Lamivudine

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
B4-8285	Tablet	TRIUMEQ TAB 50 mg; 600 mg; 300 mg 130tablets	TRIUMEQ DOLUTEGRAVIR/ABACAVIR/LAMIVUDINE 50 mg of dolutegravir as dolutegravir sodium, 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine B4-8285 Drugs Imported Products 130tablets POM 1 30/01/2023 GLAXOSMITHKLINE PHARMACEUTICAL NIGERIA LTD., INDUSTRIAL AVENUE ILUPEJU LAGOS 12711000 delphine.u.onyeaso@gsk.com GLAXO OPERATIONS UK LTD , PRIORY STREET ,WARE HERTFORDSHIRE SG12 0DJ, UNITED KINGDOM . , GLAXO OPERATIONS UK LTD , PRIORY STREET ,WARE HERTFORDSHIRE SG12 0DJ, UNITED KINGDOM . , United Kingdom	26/04/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TRIUMEQ Film-coated tablet	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
J05AR13		J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AR Antivirals for treatment of HIV infections, combinations
Discover more medicines within J05AR13

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	10345L
BR	Câmara de Regulação do Mercado de Medicamentos	510617070057105
CA	Health Products and Food Branch	02430932
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	1008-MEE-0515
EE	Ravimiamet	1663916, 1663927
ES	Centro de información online de medicamentos de la AEMPS	114940001
FI	Lääkealan turvallisuus- ja kehittämiskeskus	454381
FR	Base de données publique des médicaments	64287253
GB	Medicines & Healthcare Products Regulatory Agency	273944
HK	Department of Health Drug Office	64012
IL	מִשְׂרַד הַבְּרִיאוּת	7555
IT	Agenzia del Farmaco	043618014, 043618026, 043618038
JP	医薬品医療機器総合機構	6250106F1021
LT	Valstybinė vaistų kontrolės tarnyba	1074385, 1074386
NG	Registered Drug Product Database	B4-8285
NL	Z-Index G-Standaard, PRK	136034
NZ	Medicines and Medical Devices Safety Authority	17489
PL	Rejestru Produktów Leczniczych	100325302
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65274001, W65274002
SG	Health Sciences Authority	15100P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699522094561, 8699522094578
US	FDA, National Drug Code	49702-231