PREZISTA

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

The drug PREZISTA contains one active pharmaceutical ingredient (API):

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

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
Prezista 75 mg, 150 mg, 400 mg, 600 mg film-coated tablets and Oral suspension 100mg/ml	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

ATC Group		Classification
J05AE10	Darunavir	J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AE Protease inhibitors
Discover more medicines within J05AE10

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	10329P, 10367P
BR	Câmara de Regulação do Mercado de Medicamentos	514506702113315, 514506703111316, 514513020026403, 514517100034003, 514520040036907
CA	Health Products and Food Branch	02324024, 02338432, 02369753, 02393050, 02416530
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	02918601, 02918618, 04826470, 05393702, 05515200, 06400746, 06417511, 06571413, 07523072, 09915126, 10027141, 10039434, 10118292, 10118524, 10118530, 10179230, 10179247, 10193000, 10193017, 10211028, 10533016, 10533022, 10756727, 10946273, 11077974, 11140997, 12638363, 12638386, 16353982, 16353999
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	1217-MEE-0815, 29619-02-11, 29692-03-11, 362501012, 362861012
EE	Ravimiamet	1268287, 1426441, 1426452, 1426463, 1426474, 1597956, 1605259, 1633632
ES	Centro de información online de medicamentos de la AEMPS	06380002, 06380003, 106380006, 106380007
FI	Lääkealan turvallisuus- ja kehittämiskeskus	033895, 463654, 522811
FR	Base de données publique des médicaments	60235768, 63216342, 63372843, 64478874, 67128815, 67875450
GB	Medicines & Healthcare Products Regulatory Agency	151644, 151647, 162228, 162234, 215368, 218342
HK	Department of Health Drug Office	58980, 63272
IL	מִשְׂרַד הַבְּרִיאוּת	6297, 6298
JP	医薬品医療機器総合機構	6250030F3020, 6250030F4026
LT	Valstybinė vaistų kontrolės tarnyba	1030402, 1036156, 1036157, 1064251, 1064252, 1068356, 1069566, 1070791
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	076M2007
NL	Z-Index G-Standaard, PRK	167320, 167339, 167347, 167355, 167363, 167371, 167398
NZ	Medicines and Medical Devices Safety Authority	12707, 13620, 13621, 13830, 13831, 15625
PL	Rejestru Produktów Leczniczych	100113391, 100201988, 100201994, 100212785, 100212791, 100296902, 100313262
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W53877001, W53878001, W61893001, W61894001, W61895001, W61896001
SG	Health Sciences Authority	13853P, 13854P, 13855P, 13856P, 14595P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699593095290, 8699593095306
US	FDA, National Drug Code	59676-562, 59676-563, 59676-564, 59676-565, 59676-566, 70518-1483
ZA	Health Products Regulatory Authority	45/20.2.8/0616, 46/20.2.8/0850, 46/20.2.8/0851, 47/20.2.8/1173