Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - lopinavir, ritonavir - film-coated tablet - lopinavir 200 mg ritonavir 50 mg - antivirals for systemic use

European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - lopinavir/ritonavir - hiv infections - antivirals for systemic use, - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - lopinavir, quantity: 100 mg; ritonavir, quantity: 25 mg - tablet, film coated - excipient ingredients: titanium dioxide; polyvinyl alcohol; macrogol 3350; purified talc; colloidal anhydrous silica; iron oxide yellow; copovidone; sorbitan monolaurate; sodium stearylfumarate - kaletra is indicated for the treatment of hiv-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older. this indication is based on the analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled clinical studies (see clinical trials).

Australia - English - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - lopinavir, quantity: 200 mg; ritonavir, quantity: 50 mg - tablet, film coated - excipient ingredients: sodium stearylfumarate; macrogol 3350; hyprolose; macrogol 400; colloidal anhydrous silica; polysorbate 80; purified talc; copovidone; titanium dioxide; iron oxide yellow; hypromellose; sorbitan monolaurate - kaletra is indicated for the treatment of hiv-1 infection, in combination with other antiretroviral agents in adults and children aged 2 years and older. this indication is based on the analyses of plasma hiv-1 rna levels and cd4 cell counts from controlled clinical studies (see clinical trials).

Australia - English - 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).

United States - English - NLM (National Library of Medicine)

mylan specialty lp - pretomanid (unii: 2xoi31yc4n) (pretomanid - unii:2xoi31yc4n) - limited population: pretomanid tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (xdr) or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). approval of this indication is based on limited clinical safety and efficacy data. this drug is indicated for use in a limited and specific population of patients. limitations of use: - pretomanid tablets are not indicated in patients with the following conditions: drug-sensitive (ds) tuberculosis latent infection due to mycobacterium tuberculosis. extra-pulmonary infection due to mycobacterium tuberculosis. mdr-tb that is not treatment-intolerant or nonresponsive to standard therapy. - drug-sensitive (ds) tuberculosis - latent infection due to mycobacterium tuberculosis. - extra-pulmonary infection due to mycobacterium tuberculosis. - mdr-tb that is not treatment-intolerant or nonresponsive to stan

United States - English - NLM (National Library of Medicine)

mylan specialty l.p. - pretomanid (unii: 2xoi31yc4n) (pretomanid - unii:2xoi31yc4n) - limited population: pretomanid tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary tuberculosis (tb) resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug or adults with pulmonary tb resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy. approval of this indication is based on limited clinical safety and efficacy data. this drug is indicated for use in a limited and specific population of patients. limitations of use: pretomanid tablets used in the combination regimen with bedaquiline and linezolid are contraindicated in patients for whom bedaquiline and/or linezolid are contraindicated. refer to the bedaquiline and linezolid prescribing information. there are no studies or available data on pretomanid use in pregnant women to inform any drug-associated risks. there are risks associated with active tuberculosis during pregnancy (see cl

Australia - English - Department of Health (Therapeutic Goods Administration)

abbvie pty ltd - ritonavir -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

cipla malaysia sdn bhd - ritonavir; lopinavir -

Singapore - English - HSA (Health Sciences Authority)

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