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

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

hospira australia pty ltd - fludarabine phosphate -

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

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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - fludarabine phosphate 25 mg/ml - concentrate for solution for injection/infusion - 25 mg/ml - fludarabine phosphate 25 mg/ml - fludarabine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - fludarabine phosphate 50 mg/2 ml - concentrate for solution for injection/infusion - 25 mg/ml - fludarabine phosphate 25 mg/ml - fludarabine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - fludarabine phosphate 25 mg/ml - concentrate for solution for injection/infusion - 25 mg/ml - fludarabine phosphate 25 mg/ml - fludarabine

Israel - English - Ministry of Health

novartis israel ltd - fludarabine phosphate - concentrate for solution for injection / infusion - fludarabine phosphate 50 mg/dose - fludarabine - 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 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)

hospira australia pty ltd - fludarabine phosphate -

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

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

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

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