JULUCA

This brand name is authorized in Austria, Australia, 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

Active ingredients

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

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
2
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 more about Rilpivirine

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 JULUCA 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
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)
AU Pharmaceutical Benefits Scheme 11540J
CA Health Products and Food Branch 02475774
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 5769-MEE-1220
EE Ravimiamet 1772973, 1772984
ES Centro de información online de medicamentos de la AEMPS 1181282001
FI Lääkealan turvallisuus- ja kehittämiskeskus 495928
FR Base de données publique des médicaments 63504750
GB Medicines & Healthcare Products Regulatory Agency 355310
HK Department of Health Drug Office 66018
IL מִשְׂרַד הַבְּרִיאוּת 8302
IT Agenzia del Farmaco 046638019, 046638021
JP 医薬品医療機器総合機構 6250115F1020
LT Valstybinė vaistų kontrolės tarnyba 1085607, 1085608
NL Z-Index G-Standaard, PRK 151246
NZ Medicines and Medical Devices Safety Authority 20512
PL Rejestru Produktów Leczniczych 100404728
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W66116001
SG Health Sciences Authority 15649P
TR İlaç ve Tıbbi Cihaz Kurumu 8699522099504, 8699522099511
US FDA, National Drug Code 49702-242

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.