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

northstar rxllc - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - 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. 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 dose

Malta - English - Medicines Authority

aqvida gmbh kaiser-wilhelm-str 89, 20355 hamburg, germany - azacitidine - powder for suspension for injection - azacitidine 25 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

aqvida gmbh kaiser-wilhelm-str 89, 20355 hamburg, germany - azacitidine - powder for suspension for injection - azacitidine 25 mg/ml - antineoplastic agents

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

arrotex pharmaceuticals pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine is indicated for the treatment of patients with:,- intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), - chronic myelomonocytic leukemia (cmmol (10%-29% marrow blasts without myeloproliferative disorder)), - acute myeloid leukemia (aml) with 20-30% blasts and multi-lineage dysplasia, according to world health organisation classification (who),,in whom allogenic stem cell transplantation is not indicated.

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

dr reddys laboratories australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine juno is indicated for the treatment of patients with intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), chronic myelomonocytic leukemia (cmmol (10-29 percent marrow blasts without myeloproliferative disorder)), acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.

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

arrotex pharmaceuticals pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine is indicated for the treatment of patients with:,- intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), - chronic myelomonocytic leukemia (cmmol (10%-29% marrow blasts without myeloproliferative disorder)), - acute myeloid leukemia (aml) with 20-30% blasts and multi-lineage dysplasia, according to world health organisation classification (who),,in whom allogenic stem cell transplantation is not indicated.

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - azacitidine - powder for suspension for injection - 25 milligram(s)/millilitre - azacitidine

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - azacitidine - powder for suspension for injection - 25 milligram(s)/millilitre - azacitidine

Ireland - English - HPRA (Health Products Regulatory Authority)

ever valinject gmbh - azacitidine - powder for suspension for injection - 25 milligram(s)/millilitre - azacitidine

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - azacitidine - powder for suspension for injection - azacitidine