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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - gemtuzumab ozogamicin (unii: 8gzg754x6m) (gemtuzumab ozogamicin - unii:8gzg754x6m) - gemtuzumab ozogamicin 5 mg in 5 ml - mylotarg is indicated for the treatment of newly-diagnosed cd33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older. mylotarg is indicated for the treatment of relapsed or refractory cd33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older. mylotarg is contraindicated in patients with a history of hypersensitivity to the active substance in mylotarg or any of its components or to any of the excipients. reactions have included anaphylaxis [see warnings and precautions (5.2), adverse reactions (6)] . risk summary based on its mechanism of action and findings from animal studies [see clinical pharmacology (12.1), nonclinical toxicology (13.1)] , mylotarg can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on mylotarg use in pregnant women to evaluate for a drug-associated risk. in animal reproduction studies, gemtuzumab ozogamicin caused embryo-fetal toxicity, including structural abnormalities and alteration

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

pfizer australia pty ltd - gemtuzumab ozogamicin, quantity: 5 mg - injection, powder for - excipient ingredients: sucrose; dextran 40; sodium chloride; monobasic sodium phosphate monohydrate; dibasic sodium phosphate - mylotarg is indicated for combination therapy with standard anthracycline and cytarabine (arac) for the treatment of patients age 15 years and above with previously untreated, de novo cd33-positive acute myeloid leukaemia (aml), except acute promyelocytic leukaemia (apl) (see section 4.4 special warnings and precautions for use, and section 5.1 pharmacodynamic properties).

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - gemtuzumab ozogamicin - powder for concentrate for solution for infusion - gemtuzumab ozogamicin 5 mg/vial - gemtuzumab - mylotarg is indicated for the treatment of newly-diagnosed cd33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older.mylotarg is indicated for the treatment of relapsed or refractory cd33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older…….

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - gemtuzumab ozogamicin - leukemia, myeloid, acute - antineoplastic agents - mylotarg is indicated for combination therapy with daunorubicin (dnr) and cytarabine (arac) for the treatment of patients age 15 years and above with previously untreated, de novo cd33-positive acute myeloid leukaemia (aml), except acute promyelocytic leukaemia (apl).

Canada - English - Health Canada

pfizer canada ulc - gemtuzumab ozogamicin - powder for solution - 4.5mg - gemtuzumab ozogamicin 4.5mg - antineoplastic agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - gemtuzumab ozogamicin - powder for solution for infusion - 5mg

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - gemtuzumab ozogamicin - powder, for solution - gemtuzumab ozogamicin 5.0 mg/vial

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - gemtuzumab ozogamicin 5mg - powder for injection - 5 mg - active: gemtuzumab ozogamicin 5mg excipient: dextran 40 dibasic sodium phosphate monobasic sodium phosphate monohydrate sodium chloride sucrose - mylotarg is indicated for combination therapy with standard anthracycline and cytarabine (arac) for the treatment of patients age 15 years and above with previously untreated, de novo cd33-positive acute myeloid leukaemia (aml), except acute promyelocytic leukaemia (apl).

European Union - English - EMA (European Medicines Agency)

wyeth europa ltd - gemtuzumab ozogamicin - leukemia, myeloid, acute - antineoplastic agents - re-induction treatment of cd33-positive aml adult patients in first relapse who are not candidates for other intensive re-induction chemotherapy regimens (e.g. high-dose ara-c) and meet at least one of the following criteria: duration of first remission 60 years.

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

pfizer pharmaceuticals inc. - gemtuzumab ozogamicin (genetical recombination) - injection