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)

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 - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: monobasic sodium phosphate monohydrate; dibasic sodium phosphate dihydrate; sucrose - azacitidine-teva 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 percent-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

Ireland - English - HPRA (Health Products Regulatory Authority)

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

New Zealand - English - Medsafe (Medicines Safety Authority)

dr reddy's new zealand limited - azacitidine 100mg - powder for injection - 100 mg - active: azacitidine 100mg excipient: 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 leukaemia (cmmol [10-29 percent marrow blasts without myeloproliferative disorder]), and acute myeloid leukaemia (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.

Ireland - English - HPRA (Health Products Regulatory Authority)

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

Malta - English - Medicines Authority

onkovis gmbh grube 45, 82377 penzberg , germany - azacitidine - powder for suspension for injection - azacitidine 25 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

onkovis gmbh grube 45, 82377 penzberg , germany - azacitidine - powder for suspension for injection - azacitidine 25 mg/ml - antineoplastic agents

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)

seacross pharma (europe) limited - azacitidine - powder for suspension for injection - 25 milligram(s)/millilitre - azacitidine