Israel - English - Ministry of Health

neopharm (israel) 1996 ltd - maralixibat chloride - solution (oral) - maralixibat chloride 10 mg/ml - maralixibat chloride - livamrli ® is an ileal bile acid transporter (ibat) inhibitor indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 1 year of age and older.

European Union - English - EMA (European Medicines Agency)

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

Canada - English - Health Canada

mirum pharmaceuticals, inc. - maralixibat (maralixibat chloride) - solution - 9.5mg - maralixibat (maralixibat chloride) 9.5mg

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

mirum pharmaceuticals inc. - maralixibat chloride (unii: v78m04f0xc) (maralixibat - unii:uyb6uof69l) - livmarli® is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 3 months of age and older. none. risk summary maternal use at the recommended clinical dose of livmarli is not expected to result in measurable fetal exposure because systemic absorption following oral administration is low [see clinical pharmacology (12.3)]. maralixibat may inhibit the absorption of fat-soluble vitamins [see warnings and precautions (5.3) and clinical considerations] . in animal reproduction studies, no developmental effects were observed (see data) . the estimated background risk of major birth defects for the indicated population is higher than the general population because alagille syndrome is an autosomal dominant condition. the estimated background risk of miscarriage for the indicated population is unknown. 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%, respec

United States - English - 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.

India - English - Central Drugs Standard Control Organization

talent lab. - magaldrate,simethicone - syr - 400,20;mg/5ml - 170ml

Philippines - English - FDA (Food And Drug Administration)

magarao airproducts, inc. - medical grade oxygen - gas - none

Nigeria - English - NAFDAC (National Agency for Food and Drugs Administration and Control)

water - 96%salt - 3%polysterene - 1%proteins

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sri kottakkal arya vaidya sala sdn. bhd. - honey; rhizoma picrorrhiza kurrooa; rhizoma zingiber officinale; radix plumbago rosea; fructus ziziphus jujuba; folium mentha piperita; cortex clitoria ternatea -

Canada - English - Health Canada

celgene inc - lisocabtagene maraleucel - suspension - 120000000cells - lisocabtagene maraleucel 120000000cells