Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - fludarabine phosphate - concentrate for solution for infusion or injection - fludarabine phosphate 25 mg/ml - antineoplastic agents

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

antisoma research limited - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - tablet, film coated - 10 mg - fludarabine phosphate is indicated as a single agent for the treatment of adult patients with b-cell chronic lymphocytic leukemia (cll) whose disease has not responded to or has progressed during or after treatment with at least one standard alkylating-agent containing regimen. studies demonstrating clinical benefit such as prolongation of survival or relief of symptoms have not been performed. studies providing a direct comparison of the clinical efficacy and safety of orally administered fludarabine phosphate relative to intravenously administered fludarabine phosphate have not been performed. none “pregnancy category d. see ‘ warnings and precautions ’ section.” 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 in pregnant women. fludarabine phosphate was embryolethal and teratogenic in both rats and rabbits. if fludarabine phosphate is used during pregnancy, or if

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - fludarabine phosphate 25 mg/ml - concentrate for injection - 25 mg/ml - active: fludarabine phosphate 25 mg/ml excipient: dibasic sodium phosphate dihydrate sodium hydroxide water for injection - fludarabine ebewe is indicated for the treatment of b-cell chronic lymphocytic leukaemia.

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

juno pharmaceuticals pty ltd - fludarabine phosphate, quantity: 50 mg - injection, concentrated - excipient ingredients: sodium hydroxide; mannitol; water for injections - treatment of b-cell chronic lymphocytic leukaemia.

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

juno pharmaceuticals pty ltd - fludarabine phosphate, quantity: 50 mg - injection, powder for - excipient ingredients: mannitol; sodium hydroxide - treatment of b-cell chronic lymphocytic leukaemia.

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi oncology plc - fludarabine phosphate - powder for solution for injection/infusion - 50 milligram(s) - purine analogues; fludarabine

Malta - English - Medicines Authority

accord healthcare limited - fludarabine phosphate - concentrate for solution for infusion or injection - fludarabine phosphate 25 mg/ml - antineoplastic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare limited - fludarabine phosphate - concentrate for solution for infusion - 25 milligram(s)/millilitre - purine analogues; fludarabine

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - fludarabine phosphate - concentrate for solution for injection/infusion - 25 milligram(s)/millilitre - purine analogues; fludarabine

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - fludarabine phosphate - concentrate for solution for injection/infusion - 25 milligram(s)/millilitre - purine analogues; fludarabine