Malásia - inglês - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

johnson & johnson sdn bhd - itraconazole -

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

abbvie limited - ritonavir 100mg - film coated tablet - 100 mg - active: ritonavir 100mg excipient: calcium hydrogen phosphate colloidal silicon dioxide copovidone opadry white 16b18449 sodium stearyl fumarate sorbitan laurate - norvir is indicated for use in combination with appropriate antiretroviral agents or as monotherapy if combination therapy is inappropriate, for the treatment of hiv-1 infection in adults and children aged 12 years and older. for persons with advanced hiv disease, the indication for ritonavir is based on the results for one study that showed a reduction in both mortality and aids defining clinical events for patients who received ritonavir. median duration of follow-up in this study was 6 months. the clinical benefit from ritonavir for longer periods of treatment is unknown. for persons with less advanced disease, the indication is based on changes in surrogate markers in controlled trials of up to 16 weeks duration.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - ritonavir -

Israel - inglês - Ministry of Health

abbvie biopharmaceuticals ltd, israel - lopinavir; ritonavir - solution (oral) - ritonavir 20 mg/ml; lopinavir 80 mg/ml - ritonavir - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection.

Israel - inglês - Ministry of Health

abbvie biopharmaceuticals ltd, israel - lopinavir; ritonavir - solution (oral) - ritonavir 20 mg/ml; lopinavir 80 mg/ml - ritonavir - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection.

Cingapura - inglês - HSA (Health Sciences Authority)

abbvie pte. ltd. - lopinavir; ritonavir - tablet, film coated - 100mg - lopinavir 100mg; ritonavir 25mg

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

viatris limited - lopinavir 100mg; ritonavir 25mg;   - film coated tablet - 100mg/25mg - active: lopinavir 100mg ritonavir 25mg   excipient: colloidal silicon dioxide copovidone opadry white 20c580015 sodium stearyl fumarate sorbitan laurate - lopinavir/ritonavir mylan is indicated for the treatment of hiv-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older.

Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

viatris limited - lopinavir 200mg; ritonavir 50mg;   - film coated tablet - 200mg/50mg - active: lopinavir 200mg ritonavir 50mg   excipient: colloidal silicon dioxide copovidone opadry white 20c580015 sodium stearyl fumarate sorbitan laurate - lopinavir/ritonavir mylan is indicated for the treatment of hiv-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - darunavir, quantity: 800 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; crospovidone; silicon dioxide; magnesium stearate; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - prezcobix, a fixed dose combination of darunavir and cobicistat, is indicated in combination with other antiretroviral agents for the treatment of adult patients with human immunodeficiency virus- 1 (hiv-1) infection in:,- antiretroviral treatment-naive patients,- antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma hiv-1 rna <100,000 copies/ml,- antiretroviral treatment-experienced but hiv protease inhibitor-naive patients for whom hiv-1 genotype testing is unavailable (see section 4.2 dose and method of administration)

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - ritonavir, quantity: 100 mg - tablet, film coated - excipient ingredients: macrogol 3350; macrogol 400; sodium stearylfumarate; titanium dioxide; calcium hydrogen phosphate; sorbitan monolaurate; copovidone; hyprolose; purified talc; polysorbate 80; hypromellose; colloidal anhydrous silica - norvir (ritonavir) is indicated for use in combination with appropriate antiretriviral agents or as monotherapy if combination therapy is inappropriate, for the treatment of hiv-1 infection in adults and children aged 12 years and older. for persons with advanced hiv disease, the indication for ritonavir is based on the results for one study that showed a reduction in both mortality and aids defining clinical events for patients who received ritonavir. median duration of follow-up in this study was 6 months. the clinical benefit from ritonavir for longer periods of treatment is unknown. for persons with less advanced disease, the indication is based on changes in surrogate markers in controlled trials of up to 16 weeks in duration ( see clinical trials).