JULUCA

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

Active ingredients

The drug JULUCA 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 about Dolutegravir
2 Rilpivirine
UNII 212WAX8KDD - RILPIVIRINE HYDROCHLORIDE

Rilpivirine is a diarylpyrimidine NNRTI of HIV-1. Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ.

Read about Rilpivirine

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
JULUCA 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
J05AR21 Dolutegravir and rilpivirine 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 J05AR21

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): 11540J
Country: CA Health Products and Food Branch Identifier(s): 02475774
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 5769-MEE-1220
Country: EE Ravimiamet Identifier(s): 1772973, 1772984
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 1181282001
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 495928
Country: FR Base de données publique des médicaments Identifier(s): 63504750
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 355310
Country: HK Department of Health Drug Office Identifier(s): 66018
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 8302
Country: JP 医薬品医療機器総合機構 Identifier(s): 6250115F1020
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1085607, 1085608
Country: NL Z-Index G-Standaard, PRK Identifier(s): 151246
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 20512
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100404728
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W66116001
Country: SG Health Sciences Authority Identifier(s): 15649P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699522099504, 8699522099511
Country: US FDA, National Drug Code Identifier(s): 49702-242

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