ISENTRESS

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

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 more about Raltegravir

Medication package inserts

Below package inserts are available for further reading:

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