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, Nigeria, 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
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

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
Switch country to NG in order to find specific presentations of TIVICAY
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

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