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

astrazeneca pharmaceuticals lp - exenatide (unii: 9p1872d4ol) (exenatide - unii:9p1872d4ol) - exenatide 2 mg in 0.65 ml - bydureon is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus [see clinical studies (14)]. limitations of use : bydureon is contraindicated in patients with: limited data with exenatide, the active ingredient in bydureon, in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . based on animal reproduction studies, there may be risks to the fetus from exposure to bydureon during pregnancy. bydureon should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide extended-release during pregnancy, or from exposure to exenatide, during pregnancy and lactation, in associatio

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

astrazeneca pharmaceuticals lp - moxetumomab pasudotox (unii: 2ndx4b6n8f) (moxetumomab pasudotox - unii:2ndx4b6n8f) - lumoxiti is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (hcl) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (pna). limitations of use lumoxiti is not recommended in patients with severe renal impairment (crcl ≤ 29 ml/min) [see dosage and administration (2.3), warnings and precautions (5.3), and use in specific populations (8.5)] . none. risk summary based on its mechanism of action and findings in non-pregnant female animals, lumoxiti is expected to cause maternal and embryo-fetal toxicity when administered to a pregnant woman [see clinical pharmacology (12.1) and nonclinical toxicology (13.2)] . there are no available data on lumoxiti use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. animal reproduction or developmental toxicity studies have not been conducted with lumoxiti. advise pregnant women of the potential risk to a fetus. the estimated background ris

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

astrazeneca pharmaceuticals (pty) ltd - granules - see ingredients - each sachet contains esomeprazole 10,0 mg

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

astrazeneca pharmaceuticals (pty) ltd - granules - see ingredients - each sachet contains esomeprazole 2,5 mg

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

astrazeneca pharmaceuticals (pty) ltd - granules - see ingredients - each sachet contains esomeprazole 5,0 mg

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

astrazeneca pharmaceuticals (pty) ltd - tablet - 250,0 mg - each tablet contains gefitinib 250,0 mg

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - chadox1-sars-cov-2 - covid-19 virus infection - vaccines - vaxzevria is indicated for active immunisation to prevent covid 19 caused by sars cov 2, in individuals 18 years of age and older.the use of this vaccine should be in accordance with official recommendations.

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

astrazeneca pharmaceuticals (pty) ltd - injection - see ingredients - each 5,0 ml solution contains fulvestrant 250,0 mg

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

astrazeneca pharmaceuticals (pty) ltd - capsules - see ingredients - each capsule contains acalabrutinib 100,0 mg

Philippines - English - FDA (Food And Drug Administration)

astrazeneca pharmaceuticals (phils.), inc. - seroquel xr - extended-release tablet - 50 mg