KALETRA

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

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 more 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 more about Ritonavir

Medication package inserts

Below package inserts are available for further reading:

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