European Union - English - EMA (European Medicines Agency)

kite pharma eu b.v. - autologous peripheral blood t cells cd4 and cd8 selected and cd3 and cd28 activated transduced with retroviral vector expressing anti-cd19 cd28/cd3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) - lymphoma, mantle-cell - antineoplastic agents - mantle cell lymphomatecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton’s tyrosine kinase (btk) inhibitor.acute lymphoblastic leukaemiatecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).

European Union - English - EMA (European Medicines Agency)

kite pharma eu b.v. - axicabtagene ciloleucel - lymphoma, follicular; lymphoma, large b-cell, diffuse - antineoplastic agents - yescarta is indicated for the treatment of adult patients with diffuse large b cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) dlbcl and primary mediastinal large b cell lymphoma (pmbcl), after two or more lines of systemic therapy.yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (fl) after three or more lines of systemic therapy.

Israel - English - Ministry of Health

gilead sciences israel ltd - anti-cd19 car t cells - dispersion for infusion - anti-cd19 car t cells - acute lymphoblastic leukaemia tecartus is indicated for the treatment of adult patients with relapsed or refractory b-cell precursor acute lymphoblastic leukaemia (all).mantle cell lymphoma tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after two or more lines of systemic therapy including a bruton's tyrosine kinase (btk) inhibitor unless ineligible to btk inhibitor •limitation of use : tecartus is not indicated for the treatment of patients with active central nervous system lymphoma

Canada - English - Health Canada

oakite canada limited - symclosene; sodium metasilicate; sodium carbonate (anhydrous) - powder for solution - 5%; 10%; 74.1% - symclosene 5%; sodium metasilicate 10%; sodium carbonate (anhydrous) 74.1% - disinfectants (for agents used on object)

Canada - English - Health Canada

oakite canada limited - calcium hypochlorite - powder for solution - 9% - calcium hypochlorite 9% - disinfectants (for agents used on object)

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

kite pharma, inc. - axicabtagene ciloleucel (unii: u2i8t43y7r) (axicabtagene ciloleucel - unii:u2i8t43y7r) - axicabtagene ciloleucel 2000000 in 68 ml - yescarta is indicated for the treatment of: - adult patients with large b-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. - adult patients with relapsed or refractory large b-cell lymphoma after two or more lines of systemic therapy, including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, primary mediastinal large b-cell lymphoma, high grade b-cell lymphoma, and dlbcl arising from follicular lymphoma. limitations of use : yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy. this indication is approved under accelerated approval based on response rate [see clinical studies (14.2)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary there are no available data with yescarta use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with yescarta to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known if yescarta has the potential to be transferred to the fetus. based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including b-cell lymphocytopenia. therefore, yescarta is not recommended for women who are pregnant, and pregnancy after yescarta infusion should be discussed with the treating physician. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively. risk summary there is no information regarding the presence of yescarta in human milk, the effect on the breastfed infant, and the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for yescarta and any potential adverse effects on the breastfed infant from yescarta or from the underlying maternal condition. pregnancy testing pregnancy status of females with reproductive potential should be verified. sexually active females of reproductive potential should have a pregnancy test prior to starting treatment with yescarta. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with yescarta. infertility there are no data on the effect of yescarta on fertility. the safety and efficacy of yescarta have not been established in pediatric patients. of the 422 patients with nhl who received yescarta in clinical trials, 127 patients (30%) were 65 years of age and older. no clinically important differences in safety or effectiveness were observed between patients aged 65 years and older and younger patients.

Israel - English - Ministry of Health

gilead sciences israel ltd - axicabtagene ciloleucel - dispersion for infusion - axicabtagene ciloleucel - yescarta is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl) and high-grade b-cell lymphoma (hgbl) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.yescarta is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) and primary mediastinal large b-cell lymphoma (pmbcl), after two or more lines of systemic therapy. limitation of use :yescarta is not indicated for the treatment of patients with primary or secondary central nervous system lymphoma.yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy

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

kite pharma, inc. - brexucabtagene autoleucel (unii: 4md2j2t8sj) (brexucabtagene autoleucel - unii:4md2j2t8sj) - tecartus is a cd19-directed genetically modified autologous t cell immunotherapy indicated for the treatment of: adult patients with relapsed or refractory mantle cell lymphoma (mcl). this indication is approved under accelerated approval based on overall 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. adult patients with relapsed or refractory b-cell precursor acute lymphoblastic leukemia (all). none. risk summary there are no available data with tecartus use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with tecartus to assess whether tecartus can cause fetal harm when administered to a pregnant woman. it is not known if tecartus has the potential to be transferred to the fetus. based on the mechanism of action of tecartus, if the transduced cells cross the placenta, they may cause fetal toxicity, including b cell lymphocytopenia. therefore, tecartus is not recommended for women who are pregnant. pregnancy after tecartus infusion should be discussed with the treating physician. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% – 4% and 15% – 20%, respectively. risk summary there is no information regarding the presence of tecartus in human milk, the effect on the breastfed infant, and the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tecartus and any potential adverse effects on the breastfed infant from tecartus or from the underlying maternal condition. pregnancy testing pregnancy status of females with reproductive potential should be verified. sexually active females of reproductive potential should have a negative pregnancy test prior to starting treatment with tecartus. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with tecartus. infertility there are no data on the effect of tecartus on fertility. the safety and efficacy of tecartus have not been established in pediatric patients. of the 82 patients treated with tecartus for mcl, 42 (51%) were 65 years of age and over. of the 78 patients treated with tecartus for all, 12 (15%) were 65 years of age and over. no overall differences in safety or effectiveness were observed between these patients and younger patients.

Canada - English - Health Canada

chemetall basf canada ltd - phosphoric acid; sodium dodecylbenzenesulfonate - liquid - 21%; 2.75% - phosphoric acid 21%; sodium dodecylbenzenesulfonate 2.75% - disinfectants (for agents used on object)

Canada - English - Health Canada

chemetall basf canada ltd - benzalkonium chloride - liquid - 20% - benzalkonium chloride 20% - disinfectants (for agents used on object)