Nýja-Sjáland - enska - 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.

Bretland - enska - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - influenza virus split virion - suspension for injection

Sádi-Arabía - enska - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

glaxo saudi arabia ltd, saudi arabia - monovalent inactivated spilit virion ah 1n1,monovalent inactivated spilit virion ah 3n2,monovalent inactivated spilit virion b strain victoria lineage,monovalent inactivated spilit virion b strain yamagate lineage - suspension for injection - 15,15,15,15 µg,

Filippseyjar - enska - FDA (Food And Drug Administration)

n/a; importer: glaxosmithkline philippines, inc.; distributor: glaxosmithkline philippines, inc. - quadrivalent seasonal influenza vaccine (split virion, inactivated) southern hemisphere 2023 strain - suspension for injection (im) - formulation: each dose (0.5 ml) contains:* a/sydney/5/2021 (h1n1)pdm09-like strain 15 μg ha** (a/sydney/5/2021, ivr-229) a/darwin/9/2021 (h3n2)-like strain 15 μg ha** (a/darwin/6/2021, ivr-227) b/austria/1359417/2021-like strain 15 μg ha** (b/austria/1359417/2021, bvr-26) [victoria lineage] b/phuket/3073/2013-like strain 15 μg ha** (b/phuket/3073/2013, wild type) [yamagata lineage] *propagated in embryonated eggs **haemagglutinin

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - fludarabine phosphate 10mg - film coated tablet - 10 mg - active: fludarabine phosphate 10mg excipient: colloidal silicon dioxide croscarmellose sodium hypromellose iron oxide red iron oxide yellow lactose monohydrate magnesium stearate microcrystalline cellulose purified talc titanium dioxide - the treatment of b-cell chronic lympocytic leukaemia.

Bandaríkin - enska - NLM (National Library of Medicine)

sagent pharmaceuticals - 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. 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 in pregnant women. in rats, repeated intravenous doses of fludarabine phosphate at 2.4 times and 7.2 times the recommended human iv dose (25 mg/m2 ) administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations (cleft palate, exencephaly, and fetal vertebrae deformities) and decreased f

Írland - enska - HPRA (Health Products Regulatory Authority)

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

Malta - enska - Medicines Authority

genzyme europe bv paasheuvelweg 25, 1105 bp amsterdam , netherlands - fludarabine phosphate - powder for solution for infusion or injection - fludarabine phosphate 25 mg/ml - antineoplastic agents

Singapúr - enska - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - fludarabine phosphate - injection, powder, for solution - 50 mg/vial - fludarabine phosphate 50 mg/vial

Nýja-Sjáland - enska - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - fludarabine phosphate 25 mg/ml;   - powder for injection - 50 mg/2ml - active: fludarabine phosphate 25 mg/ml   excipient: mannitol sodium hydroxide