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

celltrion healthcare australia pty ltd - rituximab, quantity: 500 mg - injection, concentrated - excipient ingredients: sodium citrate dihydrate; polysorbate 80; water for injections; sodium chloride - non-hodgkin?s lymphoma ritemvia is indicated for treatment of patients with: -cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma; - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma;

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

ebewe pharma - fludarabine phosphate - solution for injection - 25 mg/ml

Canada - English - Health Canada

mylan pharmaceuticals ulc - fludarabine phosphate - solution - 25mg - fludarabine phosphate 25mg - antineoplastic agents

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

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

sandoz inc - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 25 mg in 1 ml - 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. fludarabine phosphate injection should not be used in patients with severe renal impairment (creatinine clearance less than 30 ml/min/1.73 m2 ). [see warnings and precautions (5.7) ] none pregnancy category d. [see warnings and precautions (5.9) ] it is not known whether fludarabine phosphate is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions including tumorigenicity in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug for the mother

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

actavis uk ltd - fludarabine phosphate - powder for solution for injection - 50mg

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

novartis pharmaceuticals australia pty ltd - ofatumumab, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; arginine; sodium acetate; disodium edetate; polysorbate 80 - 1. previously untreated cll : arzerra is indicated, in combination with chlorambucil or bendamustine, for the treatment of patients with chronic lymphocytic leukaemia (cll) who have not received prior therapy and are inappropriate for fludarabine-based therapy.,2. refractory cll: arzerra, as a single agent, is indicated for the treatment of patients chronic lymphocytic leukaemia (cll) refractory to fludarabine and alemtuzumab.

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

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

novartis pharmaceuticals australia pty ltd - ofatumumab, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; arginine; sodium acetate; disodium edetate; polysorbate 80 - 1. previously untreated cll: arzerra is indicated, in combination with chlorambucil or bendamustine, for the treatment of patients with chronic lymphocytic leukaemia (cll) who have not received prior therapy and are inappropriate for fludarabine-based therapy.,2. refractory cll: arzerra, as a single agent, is indicated for the treatment of patients chronic lymphocytic leukaemia (cll) refractory to fludarabine and alemtuzumab.

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - bendamustine hydrochloride - powder for concentrate for solution for infusion - 100 milligram(s) - nitrogen mustard analogues; bendamustine