Union européenne - anglais - 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.,

Union européenne - anglais - 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.

Union européenne - anglais - 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.

Royaume-Uni - anglais - VMD (Veterinary Medicines Directorate)

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

Royaume-Uni - anglais - VMD (Veterinary Medicines Directorate)

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

Australie - anglais - 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.

Australie - anglais - 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.

Australie - anglais - 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.

Union européenne - anglais - 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).

États-Unis - anglais - NLM (National Library of Medicine)

juno therapeutics, inc. - lisocabtagene maraleucel (unii: 7k2yoj14x0) (lisocabtagene maraleucel - unii:7k2yoj14x0) - breyanzi is a cd19-directed genetically modified autologous t cell immunotherapy indicated for the treatment of adult patients with large b-cell lymphoma (lbcl), including diffuse large b-cell lymphoma (dlbcl) not otherwise specified (including dlbcl arising from indolent lymphoma), high-grade b-cell lymphoma, primary mediastinal large b-cell lymphoma, and follicular lymphoma grade 3b who have: limitations of use : breyanzi is not indicated for the treatment of patients with primary central nervous system (cns) lymphoma [see clinical studies (14)]. none. risk summary there are no available data with breyanzi use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with breyanzi to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known if breyanzi 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 and hypogammaglobulinemia. therefore, breyanzi is not recommended for women who are pregnant, and pregnancy after breyanzi 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% to 4% and 15% to 20%, respectively. risk summary there is no information regarding the presence of breyanzi 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 breyanzi and any potential adverse effects on the breastfed infant from breyanzi 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 breyanzi. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with breyanzi. infertility there are no data on the effects of breyanzi on fertility. the safety and efficacy of breyanzi have not been established in pediatric patients. in clinical trials of breyanzi, 111 (41%) of 268 patients with two or more prior lines of therapy for lbcl, and 89 (59%) of 150 patients with one prior line of therapy for lbcl, were 65 years of age or older; 27 (10%) and 28 (19%) were 75 years of age or older, respectively. no clinically important differences in safety or effectiveness of breyanzi were observed between patients aged ≥ 65 and younger patients.