Malta - English - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - powder for suspension for injection - azacitidine 25 mg/ml - antineoplastic agents

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

bluepoint laboratories - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg - azacitidine for injection is indicated for treatment of patients with the following french-american-british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmml). azacitidine for injection is contraindicated in patients with - advanced malignant hepatic tumors [see warnings and precautions ( 5.2)] . - a known hypersensitivity to azacitidine [see adverse reactions ( 6.3)] . risk summary based on its mechanism of action and findings in animals, azacitidine for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. there are no data on the use of azacitidine in pregnant women. azacitidin

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

dr. reddy's laboratories inc. - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg - azacitidine for injection is indicated for treatment of adult patients with the following french-american- british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol). pediatric use information is approved for celgene corporation's vidaza (azacitidine for injection). however, due to celgene corporation's marketing exclusivity rights, this drug product is not labeled with that information. azacitidine for injection is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.3)]. azacitidine for injection is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. risk summary based on its mechanism of action and findings in animals, azacitidine for injec

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

dr. reddy's laboratories inc. - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg - azacitidine for injection is indicated for treatment of patients with the following french-american-british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol). azacitidine is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.2) ]. azacitidine is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. risk summary based on its mechanism of action and findings in animals, azacitidine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. there are no data on the use of azacitidine in pregnant women. azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended

Israel - English - Ministry of Health

abic marketing ltd, israel - azacitidine - lyophilized powder for suspension for sc injection / solution for infusion - azacitidine 100 mg/vial - azacitidine - azacitidine teva is indicated for treatment of patients with the following french-american- british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol).

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

fresenius kabi usa, llc - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg in 30 ml - azacitidine for injection is indicated for treatment of patients with the following french-american-british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol). azacitidine is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.2)] . azacitidine is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. risk summary based on its mechanism of action and findings in animals, azacitidine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no data on the use of azacitidine in pregnant women. azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended

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

mylan institutional llc - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg - azacitidine for injection is indicated for treatment of patients with the following french-american-british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol). azacitidine for injection is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.2)] . azacitidine for injection is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. based on its mechanism of action and findings in animals, azacitidine for injection can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no data on the use of azacitidine in pregnant women. azacitidine was teratogenic and caused embryo-fetal lethality in animals at dos

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

shilpa medicare limited - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg - azacitidine for injection is indicated for treatment of patients with the following french-american-british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol). azacitidine is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.2) ]. azacitidine is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. risk summary based on its mechanism of action and findings in animals, azacitidine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ]. there are no data on the use of azacitidine in pregnant women. azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended

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

wockhardt usa llc. - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg - azacitidine for injection is indicated for treatment of patients with the following french-american-british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol). azacitidine is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.2) ]. azacitidine is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. risk summary based on its mechanism of action and findings in animals, azacitidine can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ]. there are no data on the use of azacitidine in pregnant women. azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended

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

breckenridge pharmaceutical, inc. - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - azacitidine 100 mg in 50 ml - azacitidine for injection is indicated for treatment of adult patients with the following french-american- british (fab) myelodysplastic syndrome subtypes: refractory anemia (ra) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (raeb), refractory anemia with excess blasts in transformation (raeb-t), and chronic myelomonocytic leukemia (cmmol). pediatric use information is approved for celgene corporation's vidaza (azacitidine for injection). however, due to celgene corporation's marketing exclusivity rights, this drug product is not labeled with that information. azacitidine for injection is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions (5.3)] . azacitidine for injection is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol. risk summary based on its mechanism of action and findings in animals, azacitidine can caus