European Union - English - EMA (European Medicines Agency)

novartis europharm limited - tisagenlecleucel - precursor b-cell lymphoblastic leukemia-lymphoma; lymphoma, large b-cell, diffuse - other antineoplastic agents - kymriah is indicated for the treatment of:• paediatric and young adult patients up to and including 25 years of age with b cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post transplant or in second or later relapse.• adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl) after two or more lines of systemic therapy.• 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)

novartis pharmaceuticals corporation - tisagenlecleucel (unii: q6c9whr03o) (tisagenlecleucel - unii:q6c9whr03o) - tisagenlecleucel 2000000 - kymriah is a cd19-directed genetically modified autologous t cell immunotherapy indicated for the treatment of: patients up to 25 years of age with b-cell precursor acute lymphoblastic leukemia (all) that is refractory or in second or later relapse. adult patients with relapsed or refractory (r/r) large b-cell lymphoma after two or more lines of systemic therapy including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, high grade b-cell lymphoma and dlbcl arising from follicular lymphoma. limitation of use: kymriah is not indicated for treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory (r/r) follicular lymphoma (fl) after two or more lines of systemic therapy. this indication is approved under accelerated approval based on response rate and duration of response [see clinical studies (14.3)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. r

Israel - English - Ministry of Health

novartis israel ltd - tisagenlecleucel - dispersion for infusion - tisagenlecleucel - kymriah is indicated for the treatment of: - paediatric and young adult patients up to and including 25 years of age with cd19+ b-cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post-transplant or in second or later relapse. - adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) after two or more lines of systemic therapy. limitation of use: kymriah is not indicated for treatment of patients with primary or secondary central nervous system lymphoma- adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy

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

novartis pharmaceuticals australia pty ltd - tisagenlecleucel -

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

novartis pharmaceuticals australia pty ltd - tisagenlecleucel -

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.

Canada - English - Health Canada

novartis pharmaceuticals canada inc - tisagenlecleucel - suspension - 600000000cells - tisagenlecleucel 600000000cells - antineoplastic agents

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

international animal health products pty ltd - duddingtonia flagrans (iah 1297) - unknown - duddingtonia flagrans (iah 1297) biological active 0.0 - active constituent