KALETRA

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

Active ingredients

The drug KALETRA contains a combination of these active pharmaceutical ingredients (APIs):

1 Lopinavir UNII 2494G1JF75 - LOPINAVIR

Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. Inhibition of HIV protease prevents cleavage of the gag-pol polyprotein resulting in the production of immature, non-infectious virus. Read about Lopinavir

2 Ritonavir UNII O3J8G9O825 - RITONAVIR

Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1 and HIV-2 aspartyl proteases. Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to the production of HIV particles with immature morphology that are unable to initiate new rounds of infection. Ritonavir has selective affinity for the HIV protease and has little inhibitory activity against human aspartyl proteases. Pharmacokinetic enhancement by ritonavir is based on ritonavir’s activity as a potent inhibitor of CYP3A-mediated metabolism. Read about Ritonavir

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
KALETRA Oral solution	European Medicines Agency (EU)	MPI, EU: SmPC
KALETRA Film-coated 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
J05AR10		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 J05AR10

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): 10272P, 10285H, 10327M
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 543715110002017, 543715110002117, 543715110002217, 543715110002317
Country: CA	Health Products and Food Branch	Identifier(s): 02243644, 02285533, 02312301
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 562-MEE-1214
Country: EE	Ravimiamet	Identifier(s): 1082472, 1284320, 1367030, 1462766, 1750902
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 01172003, 01172006, 01172008
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 003974, 053043, 114019
Country: FR	Base de données publique des médicaments	Identifier(s): 64629002, 67969992, 69474926
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 106255, 136315, 350552, 382345, 46902
Country: HK	Department of Health Drug Office	Identifier(s): 48165, 55200, 58310
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 4789, 6647, 6648
Country: JP	医薬品医療機器総合機構	Identifier(s): 6250101F1037, 6250101S1035
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1010318, 1028883, 1028884, 1031776, 1064026, 1064027, 1084285
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 219M2006, 556M2000
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 59439, 81094, 86142
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 12243, 13159, 9848
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100108438, 100162395, 100192663
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64677001, W64677002, W64678001
Country: SG	Health Sciences Authority	Identifier(s): 11492P, 13250P, 13713P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 4683021H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8680656080094, 8680656080100
Country: US	FDA, National Drug Code	Identifier(s): 0074-0522, 0074-1575, 0074-2605, 0074-3956, 0074-6799, 55289-947, 70518-0091
Country: ZA	Health Products Regulatory Authority	Identifier(s): 35/20.2.8/0255