PREZISTA

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

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 about Darunavir

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
Prezista 75 mg, 150 mg, 400 mg, 600 mg film-coated tablets and Oral suspension 100mg/ml	Medicines & Healthcare Products Regulatory Agency (GB)	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
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)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 10329P, 10367P
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 514506702113315, 514506703111316, 514513020026403, 514517100034003, 514520040036907
Country: CA	Health Products and Food Branch	Identifier(s): 02324024, 02338432, 02369753, 02393050, 02416530
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 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
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 1217-MEE-0815, 29619-02-11, 29692-03-11, 362501012, 362861012
Country: EE	Ravimiamet	Identifier(s): 1268287, 1426441, 1426452, 1426463, 1426474, 1597956, 1605259, 1633632
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 06380002, 06380003, 106380006, 106380007
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 033895, 463654, 522811
Country: FR	Base de données publique des médicaments	Identifier(s): 60235768, 63216342, 63372843, 64478874, 67128815, 67875450
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 151644, 151647, 162228, 162234, 215368, 218342
Country: HK	Department of Health Drug Office	Identifier(s): 58980, 63272
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6297, 6298
Country: JP	医薬品医療機器総合機構	Identifier(s): 6250030F3020, 6250030F4026
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1030402, 1036156, 1036157, 1064251, 1064252, 1068356, 1069566, 1070791
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 076M2007
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 167320, 167339, 167347, 167355, 167363, 167371, 167398
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 12707, 13620, 13621, 13830, 13831, 15625
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100113391, 100201988, 100201994, 100212785, 100212791, 100296902, 100313262
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W53877001, W53878001, W61893001, W61894001, W61895001, W61896001
Country: SG	Health Sciences Authority	Identifier(s): 13853P, 13854P, 13855P, 13856P, 14595P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699593095290, 8699593095306
Country: US	FDA, National Drug Code	Identifier(s): 59676-562, 59676-563, 59676-564, 59676-565, 59676-566, 70518-1483
Country: ZA	Health Products Regulatory Authority	Identifier(s): 45/20.2.8/0616, 46/20.2.8/0850, 46/20.2.8/0851, 47/20.2.8/1173