TIVICAY

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, South Africa, Spain, Turkey, UK, United States.

Active ingredients

The drug TIVICAY contains one active pharmaceutical ingredient (API):

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

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
B4-5134	Tablet	Tivicay 50mg Tablets TAB 50 mg 1 X 30	90 RNW-PP-121333 Tivicay 50mg Tablets DOLUTEGRAVIR (AS DOLUTEGRAVIR SODIUM) 50MG Dolutegravir sodium - 52.6mg) (Excipients - D-mannitol {E421} - q.s. {to 145.4}mg, Microcrystalline Cellulose {E460} - 60.0mg, Povidone K29/32 {E1201} - 15.0mg, Sodium starch Glycolate - 21.0mg, Sodium stearyl Fumarate {E365} - 6.0mg, Opadry II Yellow 85F92461 - 9.0mg, Purified water - q.s.) B4-5134 Drugs Imported Products 130 Prescription Only Medicine (POM) 3/24/2020 GLAXOSMITHKLINE PHARMACEUTICAL NIGERIA LIMITED, 1, Industrial Avenue, Ilupeju 12711000 regulatorypharma-ng@gsk.com Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street Ware Hertfordshire SG12 0DJ UK, United Kingdom	06/07/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TIVICAY 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
J05AJ03		J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AJ Integrase inhibitors
Discover more medicines within J05AJ03

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	10283F
BR	Câmara de Regulação do Mercado de Medicamentos	510614080052502, 510618050059602, 510618050059702
CA	Health Products and Food Branch	02414945, 02461218, 02461226
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	344-MEE-0614, 4653-MEE-0419, 4655-MEE-0419, 7557-MEE-1022
EE	Ravimiamet	1637940, 1637951, 1741351, 1741362, 1741373, 1741384, 1836402
ES	Centro de información online de medicamentos de la AEMPS	113892001, 113892003, 113892005
FI	Lääkealan turvallisuus- ja kehittämiskeskus	044177, 450211, 513851, 563600
FR	Base de données publique des médicaments	62685155, 63679504, 64510425
GB	Medicines & Healthcare Products Regulatory Agency	239064, 341788, 341791, 393909
HK	Department of Health Drug Office	63516
IL	מִשְׂרַד הַבְּרִיאוּת	7419, 8156, 8157, 9408
IT	Agenzia del Farmaco	043195015, 043195027, 043195039, 043195041, 043195054, 043195066, 043195078
JP	医薬品医療機器総合機構	6250038F1023
LT	Valstybinė vaistų kontrolės tarnyba	1072629, 1072630, 1082486, 1082487, 1082488, 1082489, 1091754
NG	Registered Drug Product Database	B4-5134
NL	Z-Index G-Standaard, PRK	116467, 142565, 142573
NZ	Medicines and Medical Devices Safety Authority	16341
PL	Rejestru Produktów Leczniczych	100306799, 100382145, 100382151, 100443591
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64581001, W64581002, W64582001, W64582002, W64583001, W67357001
SG	Health Sciences Authority	14579P, 15532P, 15533P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699522097296, 8699522097302, 8699522097319, 8699522097357, 8699522097708
US	FDA, National Drug Code	49702-226, 49702-227, 49702-228, 49702-255, 53808-1130, 67296-1818, 70518-1487
ZA	Health Products Regulatory Authority	48/20.2.8/0403, 56/20.2.8/0131