Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

mylan ireland limited - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastic agents - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

accord healthcare s.l.u. - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastic agents - azacitidine accord is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:- intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),- chronic myelomonocytic leukaemia (cmml) with 10-29 % marrow blasts without myeloproliferative disorder,- acute myeloid leukaemia (aml) with 20-30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification,- aml with >30% marrow blasts according to the who classification.

Marekani - Kiingereza - 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

Marekani - Kiingereza - 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

Marekani - Kiingereza - 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

Marekani - Kiingereza - 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

Marekani - Kiingereza - NLM (National Library of Medicine)

sandoz 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). azacitidine for injection is indicated for the treatment of pediatric patients aged one month and older with newly diagnosed jmml. azacitidine is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions ( 5.3 )]. 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 a

Marekani - Kiingereza - NLM (National Library of Medicine)

sandoz 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). azacitidine for injection is indicated for the treatment of pediatric patients aged one month and older with newly diagnosed jmml. azacitidine is contraindicated in patients with advanced malignant hepatic tumors [see warnings and precautions ( 5.3 )]. 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 a

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

juno 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 - Kiingereza - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine accord 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.