PREZCOBIX

This brand name is authorized in United States. It is also authorized in Australia, Canada, Hong Kong SAR China, Japan.

Active ingredients

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

1	Darunavir UNII 33O78XF0BW - DARUNAVIR ETHANOLATE
	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.
	Read more about Darunavir
2	Cobicistat UNII LW2E03M5PG - COBICISTAT
	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.
	Read more about Cobicistat

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
PREZCOBIX Film-coated tablet	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		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
Discover more medicines within J05AR14

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	10903W
CA	Health Products and Food Branch	02426501
HK	Department of Health Drug Office	64960
JP	医薬品医療機器総合機構	6250110F1028
US	FDA, National Drug Code	59676-575