REZOLSTA

This brand name is authorized in Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom

Active ingredients

The drug REZOLSTA 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 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 about Cobicistat

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
REZOLSTA Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

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
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)
Country: EE	Ravimiamet	Identifier(s): 1669170
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 114967001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 141015
Country: FR	Base de données publique des médicaments	Identifier(s): 69967958
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 283945
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7856
Country: IT	Agenzia del Farmaco	Identifier(s): 043776018
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1075099
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 167401
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100332182
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W61899001