SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| Laperto | 200,50 mg,mg | Film-coated tablet · Oral use | 120 Bottle | SAR 988.85 | Generic · Prescription | SPIMACO | Valid |
| Virtra | 200,50 mg,mg | Film-coated tablet · Oral use | 120 Tablet Container | SAR 1040.90 | NCE · Prescription | Saudi Amarox | Valid |
Indications — CHI Daman Drug Formulary
HUMAN IMMUNODEFICIENCY VIRUS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| KALETRA | 80MG/ML;20MG/ML | solution · oral | ABBVIE | Prescription | 15 Sep 2000 |
| KALETRA | 200MG;50MG; 100MG;25MG | tablet · oral | ABBVIE | Prescription | 28 Oct 2005 |
| LOPINAVIR AND RITONAVIR | 100MG;25MG; 200MG;50MG | tablet · oral | HETERO LABS LTD III | Prescription | 4 Jun 2021 |
| LOPINAVIR AND RITONAVIR | 100MG;25MG; 200MG;50MG | tablet · oral | LAURUS | Prescription | 21 Mar 2022 |
| LOPINAVIR AND RITONAVIR | 100MG;25MG; 200MG;50MG | tablet · oral | MYLAN LABS LTD | Prescription | 7 Feb 2024 |
| LOPINAVIR AND RITONAVIR | 100MG;25MG; 200MG;50MG | tablet · oral | MACLEODS PHARMS | Prescription | 25 Jul 2024 |
| LOPINAVIR AND RITONAVIR | 100MG;25MG; 200MG;50MG | tablet · oral | MICRO LABS | Prescription | 11 Dec 2025 |
| KALETRA | 133.3MG;33.3MG | capsule · oral | ABBVIE | Discontinued | 15 Sep 2000 |
| LOPINAVIR AND RITONAVIR | 80MG/ML;20MG/ML | solution · oral | LANNETT CO INC | Discontinued | 27 Dec 2016 |
EMA European Union — centrally authorised medicines
Kaletra AbbVie Deutschland GmbH & Co. KG · Authorised · authorised 19 Mar 2001 · ATC J05AR10
Therapeutic indication (EMA)
Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children aged from 14 days and older. The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.
Therapeutic indication (EMA)
Lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years. The choice of lopinavir/ritonavir to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| KALETRA | 02243644 | 400 MG / 5 ML; 100 MG / 5 ML | SOLUTION · ORAL | ABBVIE CORPORATION |
| KALETRA | 02285533 | 50 MG; 200 MG | TABLET · ORAL | ABBVIE CORPORATION |
| KALETRA | 02312301 | 100 MG; 25 MG | TABLET · ORAL | ABBVIE CORPORATION |
WHO WHO Model List of Essential Medicines (2025)
- 6.4.2.3. Antiretrovirals > Protease inhibitors · core
Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified
Oral > Solid > tablet: 100 mg + 25 mg tablet (heat-stable); 200 mg + 50 mg tablet (heat-stable) (EML) | Oral > Solid > dosage form: 40 mg + 10 mg (EMLc)
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.