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

sanofi-aventis australia pty ltd - alemtuzumab, quantity: 30 mg - injection, intravenous infusion - excipient ingredients: disodium edetate; water for injections; polysorbate 80; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; sodium chloride; potassium chloride - the treatment of patients with b-cell chronic lymphocytic leukaemia (cll) who have relapsed after failure of two prior therapies.,mabcampath is indicated for the treatment of patients with b-cell chronic lymphocytic leukaemia (b-cll).

European Union - English - EMA (European Medicines Agency)

genzyme europe b.v. - alemtuzumab - leukemia, lymphocytic, chronic, b-cell - antineoplastic agents - mabcampath is indicated for the treatment of patients with b-cell chronic lymphocytic leukaemia (bcll) for whom fludarabine combination chemotherapy is not appropriate.

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

genzyme corporation - alemtuzumab (unii: 3a189dh42v) (alemtuzumab - unii:3a189dh42v) - alemtuzumab 30 mg in 1 ml - campath is indicated as a single agent for the treatment of b-cell chronic lymphocytic leukemia (b-cll). none. risk summary based on findings from animal studies, campath may cause fetal harm when administered to a pregnant woman. available data from published cohort studies in pregnant women are insufficient to establish a campath-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. alemtuzumab was embryolethal in pregnant hucd52 transgenic mice when administered during organogenesis (see data) . human igg antibodies are known to cross the placental barrier; therefore, campath may be transmitted from the mother to the developing fetus. advise women of the potential risk to the fetus. infants born to pregnant women treated with campath may be at increased risk of infection (see clinical considerations) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other

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

genzyme australasia pty ltd - alemtuzumab -

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

schering -

Canada - English - Health Canada

genzyme corporation - alemtuzumab - solution - 10mg - alemtuzumab 10mg - antineoplastic agents

Canada - English - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - alemtuzumab - solution - 30mg - alemtuzumab 30mg - antineoplastic agents

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - alemtuzumab 30 mg/ml - concentrate for infusion - 30 mg/ml - active: alemtuzumab 30 mg/ml excipient: dibasic sodium phosphate dihydrate disodium edetate dihydrate monobasic potassium phosphate polysorbate 80 potassium chloride sodium chloride water for injection

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

schering health care ltd - alemtuzumab - solution for infusion - 10mg/1ml

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

genzyme therapeutics ltd - alemtuzumab - solution for infusion - 30mg/1ml