European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - cd19-directed genetically modified autologous cell-based product consisting of purified cd8+ t-cells (cd8+ cells), cd19-directed genetically modified autologous cell-based product consisting of purified cd4+ t cells (cd4+ cells) - lymphoma, large b-cell, diffuse; lymphoma, follicular; mediastinal neoplasms - antineoplastic agents - breyanzi is indicated for the treatment of adult patients with diffuse large b-cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl), primary mediastinal large b-cell lymphoma (pmbcl) and follicular lymphoma grade 3b (fl3b), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

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

gilead sciences pty ltd - brexucabtagene autoleucel, quantity: 1000000 cells/kg - injection, intravenous infusion - excipient ingredients: dimethyl sulfoxide; sodium chloride; albumin - cellular therapies - tecartus is a genetically modified autologous immunocellular therapy for the treatment of patients greater than or equal to 18 years of age with relapsed or refractory (r/r) b-cell acute lymphoblastic leukaemia (b-all).

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

novartis pharmaceuticals australia pty ltd - tisagenlecleucel, quantity: 1200000 cells - suspension - excipient ingredients: glucose; sodium; chloride; albumin; aluminium; magnesium; dimethyl sulfoxide; gluconic acid; acetate; caprylate; furfural; dimethyl sulfone; dextran 40; potassium; n-acetyltryptophan - cellular therapies - kymriah is a genetically modified autologous immunocellular therapy indicated for the treatment of paediatric and young adult patients up to 25 years of age with b-cell precursor acute lymphoblastic leukaemia (all) that is refractory, in relapse post-transplant, or in second or later relapse.

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

novartis pharmaceuticals australia pty ltd - tisagenlecleucel, quantity: 60000000 cells - suspension - excipient ingredients: n-acetyltryptophan; albumin; acetate; gluconic acid; sodium; magnesium; potassium; dimethyl sulfoxide; glucose; aluminium; caprylate; dextran 40; furfural; dimethyl sulfone; chloride - cellular therapies - kymriah is a genetically modified autologous immunocellular therapy indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) after two or more lines of systemic therapy. kymriah is not indicated for patients with primary central nervous system lymphoma.

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

gilead sciences pty ltd - axicabtagene ciloleucel, quantity: 1000000 cells/kg - injection, intravenous infusion - excipient ingredients: albumin; sodium chloride; dimethyl sulfoxide - cellular therapies - yescarta is a genetically modified autologous immunocellular therapy for the treatment of 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. yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

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

gilead sciences pty ltd - brexucabtagene autoleucel, quantity: 1000000 cells/kg - injection, intravenous infusion - excipient ingredients: albumin; dimethyl sulfoxide; sodium chloride - cellular therapies - tecartus is a genetically modified autologous immunocellular therapy for the treatment of patients with relapsed or refractory mantle cell lymphoma (mcl), who have received two or more lines of therapy, including a btk inhibitor, unless ineligible or intolerant to treatment with a btk inhibitor.

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

gilead sciences pty ltd - axicabtagene ciloleucel, quantity: 1000000 cells/kg - injection, intravenous infusion - excipient ingredients: dimethyl sulfoxide; sodium chloride; albumin - cellular therapies - yescarta is a genetically modified autologous immunocellular therapy for the treatment of:large b-cell lymphoma - patients with relapsed or refractory large b-cell lymphoma (lbcl).yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. follicular lymphoma - patients with relapsed or refractory follicular lymphoma (fl) after two 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

European Union - English - EMA (European Medicines Agency)

fondazione telethon ets - autologous cd34+ enriched cell fraction that contains cd34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ada) cdna sequence from human haematopoietic stem/progenitor (cd34+) cells - severe combined immunodeficiency - immunostimulants, - strimvelis is indicated for the treatment of patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ada-scid), for whom no suitable human leukocyte antigen (hla)-matched related stem cell donor is available (see section 4.2 and section 4.4).

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).