United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

medicals international italy - 10 procedure kit (cekit001)[ribo-ker (ofcribclx-itd005), c-eye cap (cecap001) & eye speculum (sc13)] - device - combination - n/a

New Zealand - English - Ministry for Primary Industries

zoetis new zealand limited - toceranib phosphate - toceranib phosphate 124.69 g/kg - antineoplastic agent

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

pentax medical pte ltd -

Canada - English - Health Canada

taro pharmaceuticals inc - sunitinib (sunitinib malate) - capsule - 37.5mg - sunitinib (sunitinib malate) 37.5mg

Canada - English - Health Canada

taro pharmaceuticals inc - sunitinib (sunitinib malate) - capsule - 12.5mg - sunitinib (sunitinib malate) 12.5mg

Canada - English - Health Canada

taro pharmaceuticals inc - sunitinib (sunitinib malate) - capsule - 25mg - sunitinib (sunitinib malate) 25mg

Canada - English - Health Canada

taro pharmaceuticals inc - sunitinib (sunitinib malate) - capsule - 50mg - sunitinib (sunitinib malate) 50mg

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

daiichi sankyo inc. - quizartinib dihydrochloride (unii: wk7q6ziz10) (quizartinib - unii:7la4o6q0d3) - vanflyta is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (aml) that is flt3 internal tandem duplication (itd)-positive as detected by an fda-approved test [see dosage and administration (2.1) and clinical studies (14)] . limitations of use vanflyta is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (hsct); improvement in overall survival with vanflyta in this setting has not been demonstrated [see clinical studies (14)] . vanflyta is contraindicated in patients with severe hypokalemia, severe hypomagnesemia, long qt syndrome, or in patients with a history of ventricular arrhythmias or torsades de pointes [see warnings and precautions (5.1)]. risk summary based on findings from animal studies and its mechanism of action, vanflyta can cause embryo-fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on vanflyta use in pregnant women to evaluate for a drug-associated risk. in animal reproduction studies, oral administration of quizartinib to pregnant rats during organogenesis resulted in adverse developmental outcomes including structural abnormalities and alterations to growth at maternal exposures approximately 3 times those in patients at the maximum recommended human dose (mrhd) of 53 mg/day (see data ). advise pregnant women of the potential risk to a fetus. the background risk in the u.s. general population of major birth defects is 2-4%, and of miscarriage is 15-20% of clinically recognized pregnancies. data animal data in an embryo-fetal development study in rats, pregnant animals received oral doses of quizartinib of 0, 0.6, 2, or 6 mg/kg/day during the period of organogenesis. administration of quizartinib at the dose of 6 mg/kg/day was associated with adverse developmental outcomes including structural abnormalities (anasarca and edema) and alterations to growth (lower fetal weights and effects on skeletal ossification). at this dose, the maternal systemic exposures (auc) were approximately 3 times the human exposure at the mrhd of 53 mg/day. risk summary there are no data on the presence of quizartinib or its metabolites in human milk, or the effects on the breastfed child or milk production. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with vanflyta and for one month after the last dose. vanflyta can cause embryo-fetal harm when administered to pregnant women [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential within seven days before starting treatment with vanflyta. contraception females advise female patients of reproductive potential to use effective contraception during treatment with vanflyta and for 7 months after the last dose. males based on genotoxicity findings, advise male patients with female partners of reproductive potential to use effective contraception during treatment with vanflyta and for 4 months after the last dose [see nonclinical toxicology (13.1)] . infertility females based on findings from animal studies, vanflyta may impair female fertility. these effects on fertility were reversible [see nonclinical toxicology (13.1)] . males based on findings from animal studies, vanflyta may impair male fertility. these effects on fertility were reversible [see nonclinical toxicology (13.1)]. safety and effectiveness of vanflyta have not been established in pediatric patients. there were 533 patients with newly diagnosed aml in the clinical study; of the total number of vanflyta-treated patients, 69 (26%) were 65 years of age and older, while 1 (0.4%) was 75 years of age [see clinical studies (14)] . no overall differences in safety or efficacy were observed between patients 65 years of age and older and younger adult patients. no dosage adjustment is recommended in patients with mild to moderate renal impairment (i.e., estimated creatinine clearance [clcr] by cockcroft-gault equation: clcr 30 to 89 ml/min). vanflyta has not been studied in patients with severe renal impairment (clcr <30 ml/min) [see clinical pharmacology (12.3)] . no dosage adjustment is recommended in patients with mild hepatic impairment (child-pugh class a or total bilirubin ≤ upper limit of normal [uln] and aspartate aminotransferase [ast] >uln, or total bilirubin >1 to 1.5 times uln and any value for ast) or moderate hepatic impairment (child-pugh class b or total bilirubin >1.5 to 3 times uln and any value for ast). vanflyta has not been studied in patients with severe (child-pugh class c or total bilirubin >3 times uln and any value for ast) hepatic impairment [see clinical pharmacology (12.3)] .

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

omeprazole -

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

omeprazole -