Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

accord healthcare sdn.bhd. - azacitidine -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

mega lifesciences sdn. bhd. - azacitidine -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dr. reddy`s laboratories malaysia sdn. bhd. - azacitidine -

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

dr reddyÆs laboratories (pty) ltd - powder - 100,0 mg - each vial contains azacitidine 100,0 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

celgene limited, a bristol myers squibb company - azacitidine 100mg;   - powder for injection - 100 mg - active: azacitidine 100mg   excipient: mannitol - · intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss) in whom allogenic stem cell transplantation is not indicated.

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastic agents - vidaza 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.vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for hsct with aml with >30% marrow blasts according to the who classification.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - azacitidine - film coated tablets - azacitidine 200 mg - azacitidine - onureg is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (cr) or complete remission with incomplete blood count recovery (cri) following intensive induction chemotherapy and are not able to complete intensive curative therapy

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - azacitidine - film coated tablets - azacitidine 300 mg - azacitidine - onureg is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (cr) or complete remission with incomplete blood count recovery (cri) following intensive induction chemotherapy and are not able to complete intensive curative therapy

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

celgene corporation - azacitidine (unii: m801h13nru) (azacitidine - unii:m801h13nru) - onureg is indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (cr) or complete remission with incomplete blood count recovery (cri) following intensive induction chemotherapy and are not able to complete intensive curative therapy. onureg is contraindicated in patients with known severe hypersensitivity to azacitidine or its components [see adverse reactions (6.2), description (11)] . risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings in animals, onureg can cause fetal harm when administered to a pregnant woman. there are no available data on onureg use in pregnant women to evaluate for a drug-associated risk. azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses less than the recommended human daily dose of oral azacitidine on a mg/m2 basis (see data) . advise pregnant women of the potential risk to the fetus. the estimated background of major birth defects and miscarriag

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

cipla australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacip 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% percent blasts and multi-lineage dysplasia, according to world health organisation classification (who) in whom allogenic stem cell transplantation is not indicated