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

astrazeneca pharmaceuticals lp - benralizumab (unii: 71492ge1fx) (benralizumab - unii:71492ge1fx) - benralizumab 30 mg in 1 ml - fasenra is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype [see clinical studies (14)] . limitations of use: fasenra is contraindicated in patients who have known hypersensitivity to benralizumab or any of its excipients [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to fasenra during pregnancy. healthcare providers can enroll patients or encourage patients to enroll themselves by calling 1-877-311-8972 or visiting mothertobaby.org/fasenra. risk summary the data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. in a prenatal and postnatal devel

Israel - English - Ministry of Health

astrazeneca (israel) ltd - benralizumab - solution for injection - benralizumab 30 mg / 1 ml - benralizumab - fasenra is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.

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

astrazeneca pty ltd - benralizumab, quantity: 30 mg - injection, solution - excipient ingredients: polysorbate 20; trehalose; histidine; histidine hydrochloride monohydrate; water for injections - fasenra is indicated as add-on therapy in patients aged 12 years and over with severe eosinophilic asthma (blood eosinophil count greater than or equal to 300 cells/microlitre or greater than or equal to 150 cells/microlitre if on oral corticosteroid treatment) (see section 5.1 pharmacodynamic properties [clinical trials]).

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

astrazeneca pty ltd - benralizumab, quantity: 30 mg - injection, solution - excipient ingredients: polysorbate 20; trehalose; histidine; histidine hydrochloride monohydrate; water for injections - fasenra pen is indicated as add-on therapy in patients aged 12 years and over with severe eosinophilic asthma (blood eosinophil count greater than or equal to 300 cells/microlitre or greater than or equal to150 cells/microlitre if on oral corticosteroid treatment) (see section 5.1 pharmacodynamic properties [clinical trials]).

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

astrazeneca sdn. bhd. - benralizumab -

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

astrazeneca sdn. bhd. - benralizumab -

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - benralizumab - asthma - drugs for obstructive airway diseases, - fasenra is indicated as an add on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long acting β agonists.

Singapore - English - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - benralizumab - injection, solution - benralizumab 30 mg/ml

Canada - English - Health Canada

astrazeneca canada inc - benralizumab - solution - 30mg - benralizumab 30mg - interleukin antagonists

Canada - English - Health Canada

astrazeneca canada inc - benralizumab - solution - 30mg - benralizumab 30mg - interleukin antagonists