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

hospira australia pty ltd - fludarabine phosphate, quantity: 50 mg - injection, intravenous infusion - excipient ingredients: sodium hydroxide; mannitol - fludarabine phosphate for injection usp is indicated for second line therapy in patients with chronic lymphocytic leukemia (cll) and low-grade non-hodgkin's lymphoma (lg-nhl) who have failed other conventional therapies.

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

hospira australia pty ltd - fludarabine phosphate -

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - fludarabine phosphate 50mg - powder for injection - 50 mg - active: fludarabine phosphate 50mg excipient: mannitol sodium hydroxide - treatment of b-cell chronic lymphocytic leukaemia.

Israel - English - Ministry of Health

salomon,levin & elstein ltd - fludarabine phosphate 50 mg / 2 ml - concentrate for solution for injection / infusion - fludarabine - palliative treatment of patients with cll refractory to other therapy. treatment of less malignant non-hodgkin lymphoma of stage 3 to 4 in patients who have not responded to standard therapy with at least one alkylating agent or in whom the disease progressed during or after standard therapy. fludarabine teva is indicated for the initial treatment of patients with b- cell chronic lymphocytic leukaemia (cll) or after first line therapy, in patients with sufficient bone marrow reserves.

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

sandoz pty ltd - fludarabine phosphate -

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - fludarabine phosphate - lyophilisate for solution for injection - 50 milligram

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

accord healthcare, inc. - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) -

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

sanofi-aventis australia pty ltd - fludarabine phosphate, quantity: 10 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; hypromellose; purified talc; titanium dioxide; iron oxide yellow; iron oxide red - indicated for use as second-line tharapy in patients with chronic lymphocytic leukaemia (cll). indications as at 6 april 2004: for the treatment of b-cell chronic lymphocytic leukaemia.

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

actavis pharma, inc. - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 25 mg in 1 ml - fludarabine phosphate injection, usp is indicated for the treatment of adult patients with b-cell chronic lymphocytic leukemia (cll) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. the safety and effectiveness of fludarabine phosphate injection, usp in previously untreated or non-refractory patients with cll have not been established. none teratogenic effects: pregnancy category d. [see warnings and precautions (5.6)] based on its mechanism of action, fludarabine phosphate can cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies of fludarabine phosphate injection in pregnant women, in rats, repeated intravenous doses of fludarabine phosphate at 2.4 times and 7.2 times the recommended human intravenous dose (25 mg/m2 ) administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations (cleft palate, exencephaly, and fetal vertebra

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

teva uk ltd - fludarabine phosphate - solution for injection - 25mg/1ml