JULUCA

This brand name is authorized in United States. It is also authorized in Australia, Austria, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Turkey, UK.

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 more 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 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