TIVICAY

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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 about Dolutegravir

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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