Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - fedratinib as dihydrochloride monohydrate - capsules - fedratinib as dihydrochloride monohydrate 100 mg - fedratinib - inrebic® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (mf)

European Union - English - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - antineoplastic agents - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Singapore - English - HSA (Health Sciences Authority)

bristol-myers squibb (singapore) pte. ltd. - fedratinib dihydrochloride monohydrate eqv fedratinib - capsule - fedratinib dihydrochloride monohydrate eqv fedratinib 100 mg

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

celgene corporation - fedratinib hydrochloride (unii: uh9j2hbqwj) (fedratinib - unii:6l1xp550i6) - inrebic® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (mf). none. risk summary there are no available data on inrebic use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of fedratinib to pregnant rats during organogenesis at doses considerably lower than the recommended human daily dose of 400 mg/day resulted in adverse developmental outcomes (see data) . consider the benefits and risks of inrebic for the mother and possible risks to the fetus when prescribing inrebic to a pregnant woman. the background risk of major birth defects and miscarriage for the indicated population is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. general population, the estimated background ris

Canada - English - Health Canada

bristol-myers squibb canada - fedratinib (fedratinib hydrochloride) - capsule - 100mg - fedratinib (fedratinib hydrochloride) 100mg - antineoplastic agents

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

novartis pharmaceuticals australia pty ltd - ceritinib, quantity: 150 mg - capsule, hard - excipient ingredients: gelatin; magnesium stearate; sodium starch glycollate type a; hyprolose; colloidal anhydrous silica; indigo carmine; microcrystalline cellulose; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - zykadia is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that is anaplastic lymphoma kinase (alk)-positive.

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

eisai australia pty ltd - lenvatinib mesilate, quantity: 12.25 mg (equivalent: lenvatinib, qty 10 mg) - capsule, hard - excipient ingredients: microcrystalline cellulose; iron oxide yellow; purified talc; iron oxide red; calcium carbonate; propylene glycol; hyprolose; mannitol; potassium hydroxide; titanium dioxide; hypromellose; iron oxide black; shellac - endometrial carcinoma lenvima, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation., differentiated thyroid cancer (dtc) lenvima is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine (rai) refractory differentiated thyroid cancer (dtc).,renal cell carcinoma (rcc) lenvima, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).,lenvima, in combination with everolimus, is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) whose disease has progressed following one prior vascular endothelial growth factor targeted therapy.,hepatocellular carcinoma (hcc) lenvima is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc).

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

eisai australia pty ltd - lenvatinib mesilate, quantity: 4.9 mg (equivalent: lenvatinib, qty 4 mg) - capsule, hard - excipient ingredients: iron oxide yellow; propylene glycol; potassium hydroxide; mannitol; iron oxide black; titanium dioxide; hypromellose; purified talc; iron oxide red; calcium carbonate; microcrystalline cellulose; hyprolose; shellac - endometrial carcinoma lenvima, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.,differentiated thyroid cancer (dtc) lenvima is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine (rai) refractory differentiated thyroid cancer (dtc).,renal cell carcinoma (rcc) lenvima, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).,lenvima, in combination with everolimus, is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) whose disease has progressed following one prior vascular endothelial growth factor targeted therapy.,hepatocellular carcinoma (hcc) lenvima is indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc).

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

zuellig pharma sdn bhd - neratinib maleate -

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

novartis pharmaceuticals corporation - ceritinib (unii: k418kg2get) (ceritinib - unii:k418kg2get) - ceritinib 150 mg - zykadia® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk)-positive as detected by an fda-approved test [see dosage and administration (2.1)] . none. risk summary based on animal studies and its mechanism of action [see clinical pharmacology (12.1)] , zykadia can cause fetal harm when administered to a pregnant woman. the limited available data on the use of zykadia in pregnant women are insufficient to inform a risk. administration of ceritinib to rats and rabbits during the period of organogenesis at maternal plasma exposures below the recommended human dose caused increases in skeletal anomalies in rats and rabbits (see data ). advise a pregnant woman of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. data animal data in an embryo-fetal development study in which pregnant rats were administered daily doses of ceritinib during organogenesis, dose-related skeletal anomalies were observed at doses as low as 50 mg/kg (less than 0.5-fold the human exposure by auc at the recommended dose). findings included delayed ossifications and skeletal variations. in pregnant rabbits administered ceritinib daily during organogenesis, dose-related skeletal anomalies, including incomplete ossification, were observed at doses equal to or > 2 mg/kg/day (approximately 0.015-fold the human exposure by auc at the recommended dose). a low incidence of visceral anomalies, including absent or malpositioned gallbladder and retroesophageal subclavian cardiac artery, was observed at doses equal to or > 10 mg/kg/day (approximately 0.13-fold the human exposure by auc at the recommended dose). maternal toxicity and abortion occurred in rabbits at doses of 35 mg/kg or greater. in addition, embryolethality was observed in rabbits at a dose of 50 mg/kg. risk summary there are no data regarding the presence of ceritinib or its metabolites in human milk, the effects of ceritinib on the breastfed child or its effects on milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with zykadia and for 2 weeks following completion of therapy. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating zykadia [see use in specific populations (8.1)] . contraception zykadia can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . females advise females of reproductive potential to use effective contraception during treatment with zykadia and for 6 months following completion of therapy. males based on the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with zykadia and for 3 months following completion of therapy [see nonclinical toxicology (13.1)] . the safety and effectiveness of zykadia in pediatric patients have not been established. of the 925 patients in clinical studies of zykadia, 18% were 65 years or older, while 5% were 75 years or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. for patients with severe hepatic impairment (child-pugh c), reduce the dose of zykadia [see dosage and administration (2.5)] . no dose adjustment is recommended for patients with mild (child-pugh a) or moderate (child-pugh b) hepatic impairment.