Izraelis - anglų - 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.

Europos Sąjunga - anglų - 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.

Kanada - anglų - Health Canada

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

Jungtinės Valstijos - anglų - 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 3 months of age and older with alagille syndrome (algs). livmarli is indicated for the treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis (pfic). limitations of use: livmarli is not recommended in a subgroup of pfic type 2 patients with specific abcb11 variants resulting in non-functional or complete absence of bile salt export pump (bsep) protein [see clinical studies (14.2)] . livmarli is contraindicated in patients with prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy) [see warnings and precautions (5.1)] . 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 algs is higher than the general population because algs is an autosomal dominant condition. the background risk of miscarriage for algs is unknown. the background risk of birth defects and miscarriage for pfic 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%, respectively. clinical considerations fetal/neonatal adverse reactions maralixibat may inhibit the absorption of fat-soluble vitamins (fsv). monitor for fsv deficiency and supplement as needed. increased supplementation of fsvs may be needed during pregnancy [see warnings and precautions (5.3)] . data animal data no effects on embryo-fetal development were observed in pregnant rats treated orally with up to 1000 mg/kg/day (approximately 3300 to 12000 times the maximum recommended dose based on auc [area under the plasma concentration-time curve]) or in pregnant rabbits treated orally with up to 250 mg/kg/day (approximately 1200 to 4700 times the maximum recommended dose based on auc) during the period of organogenesis. no effects on postnatal development were observed in a pre- and postnatal development study, in which female rats were treated orally with up to 750 mg/kg/day during organogenesis through lactation. maternal systemic exposure to maralixibat at the maximum dose tested was approximately 2500 to 9400 times the maximum recommended dose based on auc. risk summary livmarli has low absorption following oral administration, and breastfeeding is not expected to result in exposure of the infant to livmarli at the recommended dose [see clinical pharmacology (12.3)] . there are no data on the presence of livmarli in human milk, the effects on the breastfed infant, or the effects on milk production. patients with algs or pfic can have fsv deficiency as part of their disease. maralixibat may reduce absorption of fat-soluble vitamins [see warnings and precautions (5.3)] . monitor fsv levels and supplement fsv intake, if fsv deficiency is observed during lactation. the developmental and health benefits of breastfeeding should be considered along with the mother's need for livmarli and any potential adverse effects on the breastfed child from livmarli or from the underlying maternal condition. algs the safety and effectiveness of livmarli for the treatment of cholestatic pruritus in alagille syndrome have been established in pediatric patients aged 3 months of age and older. use of livmarli in this population is supported by evidence from a study of patients 1 to 15 years of age (n=31) that included 18 weeks of open-label treatment followed by a 4 week placebo-controlled randomized withdrawal period and a subsequent 26-week open-label treatment period. additional safety information was obtained from four studies in patients up to 21 years of age (n=55) [see adverse reactions (6) and clinical studies (14.1)] . use of livmarli in patients 3 to <12 months of age is supported by an open-label, multicenter study of livmarli which showed a similar safety, tolerability and pharmacokinetic profile to patients with algs ≥12 months of age. the safety and effectiveness of livmarli have not been established in patients with algs less than 3 months of age. pfic the safety and effectiveness of livmarli for the treatment of cholestatic pruritus in pfic have been established in pediatric patients aged 5 years of age and older. use of livmarli in this population is supported by evidence from trial 2 in patients 1 to <18 years of age that included 26 weeks of placebo-controlled safety and efficacy data [see adverse reactions (6) and clinical studies (14.2)] . the safety and effectiveness of livmarli have not been established in patients with pfic younger than 12 months of age. the safety and effectiveness of livmarli for the treatment of pruritus in algs or pfic in adult patients, 65 years of age and older, have not been established. clinical studies of livmarli included algs or pfic patients with impaired hepatic function at baseline. the efficacy and safety in algs or pfic patients with clinically significant portal hypertension and in patients with decompensated cirrhosis have not been established. livmarli is contraindicated in patients with prior or active hepatic decompensation events [see dosage and administration (2.5), contraindications (4), warnings and precautions (5.1), and clinical studies (14)] . - before you give livmarli for the first time, talk to your healthcare provider or pharmacist about how to correctly measure your prescribed dose. - you may be given 1 or more dosing dispensers of different sizes as shown in table 1 below. always use the correct dosing dispenser size provided with livmarli based on your current prescribed dose. - your prescribed dose may change over time. use the table above to choose the correct dosing dispenser size for your prescribed dose. - if you do not have the correct dosing dispenser size for your prescribed dose, contact your healthcare provider or pharmacist. - the dosing dispenser may be used for 100 days if cleaned correctly (see section c). after 100 days, replace the dosing dispenser with a new one. a new replacement dosing dispenser may be used within the 100 days if necessary. - do not use a household teaspoon or any other dosing device to measure the dose. - do not open more than 1 bottle at a time. - do not give more than the prescribed dose. - do not use livmarli after 100 days of first opening the bottle or after the throw away (discard) date listed on the pharmacy label (see section d). - when you start a new bottle of livmarli, use a new dosing dispenser. - store unopened livmarli at room temperature, between 68°f and 77°f (20°c and 25°c). - after opening the livmarli bottle, store below 86°f (30°c). - store the dosing dispenser in a clean, dry place when not in use. livmarli (9.5 mg/ml):                                          figure a                                          figure b                                                  figure c figure d figure e - make sure you use the correct dosing dispenser size for your prescribed dose (see table 1). - after 100 days, replace with a new dosing dispenser provided. a new replacement dosing dispenser may be used within the 100 days if necessary. - check the dosing dispenser for any damage to the barrel, plunger or tip (see figure g). if you cannot see the dosage marking or if it becomes hard to move the plunger, replace with a new dosing dispenser. figure f figure g figure h figure i figure j figure k figure l figure m figure n figure o figure p figure q figure r section c: cleaning instructions for the dosing dispenser figure s figure t figure u figure v figure w figure x before you give the next dose, put the dosing dispenser back together by pushing the plunger into the barrel (see figure y). figure y section d: disposal - throw away (dispose of) the bottle of livmarli following the steps below 100 days after first opened or after the throw away (discard) date listed on the pharmacy label, even if there is still medicine in it. mix medicine with a substance such as dirt, cat litter, or used coffee grounds. place the mixture in a container such as a sealed plastic bag. delete all personal information on the prescription label of the empty medicine bottle, then throw away (dispose of) in the household trash or recycle the empty bottle. - mix medicine with a substance such as dirt, cat litter, or used coffee grounds. - place the mixture in a container such as a sealed plastic bag. - delete all personal information on the prescription label of the empty medicine bottle, then throw away (dispose of) in the household trash or recycle the empty bottle. - throw away (dispose of) used dosing dispensers in the household trash.

Jungtinės Valstijos - anglų - 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.

Indija - anglų - Central Drugs Standard Control Organization

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

Filipinai - anglų - FDA (Food And Drug Administration)

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

Nigerija - anglų - NAFDAC (National Agency for Food and Drugs Administration and Control)

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

Malaizija - anglų - 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 -

Kanada - anglų - Health Canada

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