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

janssen biotech, inc. - talquetamab (unii: 4w3kfi3tn3) (talquetamab - unii:4w3kfi3tn3) - talvey is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody. this indication is approved under accelerated approval based on response rate and durability of response [see clinical studies (14)]. continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none. risk summary based on the mechanism of action, talvey may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of talvey in pregnant women to evaluate for a drug associated risk. no animal reproductive or developmental toxicity studies have been conducted with talquetamab-tgvs. talquetamab-tgvs causes t-cell activation and cytokine release; immune activation may compromise pregna

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - multiple myeloma - antineoplastic agents - talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti cd38 antibody and have demonstrated disease progression on the last therapy.,

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

specialised therapeutics alim pty ltd - tafasitamab, quantity: 200 mg - injection, powder for - excipient ingredients: polysorbate 20; citric acid monohydrate; trehalose dihydrate; sodium citrate dihydrate - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).,this indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single arm trial. continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial.

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

morphosys us inc. - tafasitamab (unii: qqa9mlh692) (tafasitamab - unii:qqa9mlh692) - monjuvi, in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) not otherwise specified, including dlbcl arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (asct). this indication is approved under accelerated approval based on overall response rate [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). none. risk summary based on its mechanism of action, monjuvi may cause fetal b-cell depletion when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on monjuvi use in pregnant women to evaluate for a drug-associated risk. animal reproductive toxicity studies have not been conducted with tafasitamab-cxix. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically

European Union - English - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - tafasitamab - lymphoma, large b-cell, diffuse - antineoplastic agents - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).

Israel - English - Ministry of Health

medison pharma ltd - tafasitamab - powder for concentrate for solution for infusion - tafasitamab 200 mg - tafasitamab - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).

Canada - English - Health Canada

incyte corporation - tafasitamab - powder for solution - 200mg - tafasitamab 200mg - antineoplastic agents

European Union - English - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - efavirenz/emtricitabine/tenofovir disoproxil zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil zentiva prior to initiation of their first antiretroviral treatment regimen., the demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavir