ISENTRESS

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

Active ingredients

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

1 Raltegravir UNII 43Y000U234 - RALTEGRAVIR POTASSIUM

Raltegravir is an integrase strand transfer inhibitor active against the Human Immunodeficiency Virus (HIV-1). Raltegravir inhibits the catalytic activity of integrase, an HIV-encoded enzyme that is required for viral replication. Inhibition of integrase prevents the covalent insertion, or integration, of the HIV genome into the host cell genome. Read about Raltegravir

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ISENTRESS Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC
ISENTRESS Granules for oral suspension	European Medicines Agency (EU)	MPI, EU: SmPC
ISENTRESS Chewable 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
J05AJ01	Raltegravir	J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AJ Integrase inhibitors
Discover more medicines within J05AJ01

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): 10286J, 10299C, 10326L, 11248B
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 525504301117216, 525513090015705, 525513090015805
Country: CA	Health Products and Food Branch	Identifier(s): 02301881, 02392429, 02392437, 02465337
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 28441-04-08, 92-MEE-0214, 94-MEE-0214
Country: EE	Ravimiamet	Identifier(s): 1343225, 1343236, 1614473, 1614484, 1662768, 1750553, 1768080
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 07436001, 107436003, 107436004, 107436006
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 110750, 391582, 401134, 564264
Country: FR	Base de données publique des médicaments	Identifier(s): 62457041, 63586968, 63588136, 67315206, 69260153
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 131095, 222229, 222232, 296970, 347332
Country: HK	Department of Health Drug Office	Identifier(s): 56630, 65872
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6339, 8399
Country: IT	Agenzia del Farmaco	Identifier(s): 038312017, 038312029, 038312031, 038312043, 038312056, 038312068, 038312070
Country: JP	医薬品医療機器総合機構	Identifier(s): 6250032F1026, 6250032F2022
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1031795, 1031796, 1074819, 1074820, 1074821, 1083658, 1084272
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 308M2007
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 146161, 85804
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 13173, 19788
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100190782, 100311197, 100311205, 100356923, 100393516
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64644001, W64644002, W64645001, W64646001
Country: SG	Health Sciences Authority	Identifier(s): 13568P, 13936P, 14522P, 14523P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699636090220
Country: US	FDA, National Drug Code	Identifier(s): 0006-0227, 0006-0473, 0006-0477, 0006-3080, 0006-3603, 50090-1085, 61919-706, 67296-1235, 68071-2113, 70518-1621
Country: ZA	Health Products Regulatory Authority	Identifier(s): 42/20.2.8/0687, 46/20.2.8/0863, 46/20.2.8/0864