REZOLSTA

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

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