European Union - English - EMA (European Medicines Agency)

ceva santé animale - genetically modified recombinant shiga-toxin-2e antigen - immunologicals for suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - pigs - active immunisation of piglets from the age of four days, to reduce the mortality and clinical signs of oedema disease caused by shiga toxin 2e produced by escherichia coli (stec). onset of immunity: 21 days after vaccination. duration of immunity: 105 days after vaccination.,

European Union - English - EMA (European Medicines Agency)

molmed spa - allogeneic t cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (Δlngfr) and the herpes simplex i virus thymidine kinase (hsv-tk mut2) - hematopoietic stem cell transplantation; graft vs host disease - antineoplastic agents - zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (hsct) of adult patients with high-risk haematological malignancies.

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.

United Kingdom - English - VMD (Veterinary Medicines Directorate)

ceva animal health ltd - genetically modified recombinant stx2e antigen - suspension for injection - inactivated bacterial vaccine - pigs

United Kingdom - English - VMD (Veterinary Medicines Directorate)

laboratorios hipra sa - genetically modified recombinant stx2e antigen - suspension for injection - inactivated bacterial vaccine - pigs

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.

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).

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.