Malta - anglès - Medicines Authority

central procurement & supplies unit - busulfan - film-coated tablet - busulfan 2 milligram(s) - antineoplastic agents

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - busulfan, quantity: 2 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; magnesium stearate; lactose; titanium dioxide; hypromellose; triacetin - indications as at 10 february 2005: treatment of chronic granulocytic leukaemia. it has been shown to be superior to splenic irradiation when judged by survival times, control of spleen size and maintenance of haemoglobin levels. although not curative, busulfan reduces the total granulocyte mass, relieves disease symptoms and improves the clinical state of the patient. busulfan is not useful once blast transformation has occurred. busulfan produces prolonged remission in polycythaemia vera. it is especially useful in cases resistant to radiophosphorus (32 p) and where there is marked thrombocytosis. busulfan is useful in selected cases of essential thrombocythaemia and myelofibrosis.

Malàisia - anglès - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - busulfan -

Estats Units - anglès - NLM (National Library of Medicine)

otsuka america pharmaceutical, inc. - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - busulfan 6 mg in 1 ml - busulfex is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. busulfex is contraindicated in patients with a history of hypersensitivity to any of its components. risk summary busulfex can cause fetal harm when administered to a pregnant woman based on animal data. busulfan was teratogenic in mice, rats, and rabbits following administration during organogenesis. the solvent, dma, may also cause fetal harm when administered to a pregnant woman. in rats, dma doses of approximately 40% of the daily dose of dma in the busulfex dose on a mg/m2 basis given during organogenesis caused significant developmental anomalies (see data ). there are no available human data informing the drug-associated risk. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - busulfan, quantity: 60 mg - injection, solution - excipient ingredients: dimethylacetamide; macrogol 400 - busulfan injection is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - busulfan, quantity: 60 mg - injection, solution - excipient ingredients: macrogol 400; dimethylacetamide - busulfan injection is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation.

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - busulfan, quantity: 60 mg - injection, concentrated - excipient ingredients: dimethylacetamide; macrogol 400 - busulfan intas is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation.

Estats Units - anglès - NLM (National Library of Medicine)

esp pharma, inc. - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - injection - 60 mg in 10 ml - busulfex® (busulfan) injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. busulfex is contraindicated in patients with a history of hypersensitivity to any of its components.

Israel - anglès - Ministry of Health

tzamal bio-pharma ltd - busulfan - solution for injection - busulfan 60 mg / 10 ml - busulfan - busulfan - for use in combination with other chemotherapeutic agents and/or radiotherapy as a conditioning regimen prior to hematopoietic progenitor cell transplantation.

Aràbia Saudita - anglès - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

pharma pharmaceutical industries (ppi), saudi arabia - busulfan - solution - 6 mg/ml