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
The drug JULUCA contains a combination of these active pharmaceutical ingredients (APIs):
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1
Dolutegravir
UNII 1Q1V9V5WYQ - DOLUTEGRAVIR SODIUM
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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. |
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2
Rilpivirine
UNII 212WAX8KDD - RILPIVIRINE HYDROCHLORIDE
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| JULUCA Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
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 |
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: IT | Agenzia del Farmaco | Identifier(s): 046638019, 046638021 |
| 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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