This brand name is authorized in Australia, Canada, Hong Kong, Japan, United States
The drug PREZCOBIX contains a combination of these active pharmaceutical ingredients (APIs):
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1
Darunavir
UNII 33O78XF0BW - DARUNAVIR ETHANOLATE
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Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 × 10-12 M). It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles. |
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2
Cobicistat
UNII LW2E03M5PG - COBICISTAT
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Cobicistat is a mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily. Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as darunavir, where bioavailability is limited and half-life is shortened due to CYP3A-dependent metabolism. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| PREZCOBIX Film-coated tablet | FDA, National Drug Code (US) | MPI, US: SPL/PLR |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| J05AR14 | Darunavir and cobicistat | 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): 10903W |
| Country: CA | Health Products and Food Branch | Identifier(s): 02426501 |
| Country: HK | Department of Health Drug Office | Identifier(s): 64960 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 6250110F1028 |
| Country: US | FDA, National Drug Code | Identifier(s): 59676-575 |
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