Canada - English - Health Canada

agila jamp canada inc - fludarabine phosphate - solution - 25.0mg - fludarabine phosphate 25.0mg - antineoplastic agents

Canada - English - Health Canada

sanofi genzyme, a division of sanofi-aventis canada inc - fludarabine phosphate (fludarabine phosphate sodium) - powder for solution - 50mg - fludarabine phosphate (fludarabine phosphate sodium) 50mg - antineoplastic agents

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

actavis australia pty ltd - fludarabine phosphate -

Ireland - English - HPRA (Health Products Regulatory Authority)

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

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - fludarabine phosphate -

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

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

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

areva pharmaceuticals - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate injection 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 in previously untreated or non-refractory patients with cll have not been established. none [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/m 2 ) administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations (cleft palate, exencephaly, and fetal vertebrae deformities) and decreased fetal

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

lannett company, inc. - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate injection 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 in previously untreated or non-refractory patients with cll have not been established. none [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/m 2 ) administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations (cleft palate, exencephaly, and fetal vertebrae deformities) and decreased fetal body weights. m

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

mylan institutional llc - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 25 mg in 1 ml

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

pfizer laboratories div pfizer inc. - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 25 mg in 1 ml