Canada - English - Health Canada

pharmascience inc - azacitidine - powder for suspension - 100mg - azacitidine 100mg

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

Canada - English - Health Canada

dr reddy's laboratories ltd - azacitidine - powder for suspension - 100mg - azacitidine 100mg - antineoplastic agents

Canada - English - Health Canada

natco pharma (canada) inc - azacitidine - powder for suspension - 100mg - azacitidine 100mg - antineoplastic agents

European Union - English - EMA (European Medicines Agency)

celgene europe bv - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastic agents - azacitidine celgene 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.

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).

European Union - English - EMA (European Medicines Agency)

betapharm arzneimittel gmbh - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastic agents - azacitidine betapharm 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 % to 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 % to 30 % blasts and multi-lineage dysplasia, according to world health organization (who) classification,aml with > 30 % marrow blasts according to the who classification.

European Union - English - 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.

European Union - English - 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.

Australia - English - 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.