USA - engelsk - 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

Den europeiske union - maltesisk - EMA (European Medicines Agency)

astrazeneca ab - benralizumab - ażma - mediċini għall-imblokkar tal-passaġġ tan-nifs mard, - fasenra huwa indikat bħala żieda fit-trattament ta 'manteniment f'pazjenti adulti bi ħsara severa eżinofilika-ażma mhux ikkontrollati adegwatament, minkejja doża għolja ta' kortikosterojdi meħuda man-nifs biż-żieda fit-tul li jaġixxu β-agonisti.

Israel - engelsk - 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 - engelsk - 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 - engelsk - 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]).

Den europeiske union - nederlandsk - EMA (European Medicines Agency)

astrazeneca ab - benralizumab - astma - geneesmiddelen voor obstructieve aandoeningen van de luchtwegen, - fasenra is aangegeven als een add-on onderhoud van behandeling bij volwassen patiënten met ernstige eosinofiele astma onvoldoende beheerste, ondanks de hoge dosis inhalatiecorticosteroïden plus langwerkende β-agonisten.

Den europeiske union - svensk - EMA (European Medicines Agency)

astrazeneca ab - benralizumab - astma - läkemedel mot obstruktiv lungsjukdom, - fasenra anges som ett tillägg på underhållsbehandling hos vuxna patienter med svår eosinofil astma bristfälligt kontrollerad trots höga doser inhalerade kortikosteroider plus långverkande beta-agonister.

Den europeiske union - litauisk - EMA (European Medicines Agency)

astrazeneca ab - benralizumab - astma - vaistai nuo obstrukcinių kvėpavimo takų ligų, - fasenra yra nurodyta kaip pridėti priežiūra, gydymas suaugusiems pacientams, sergantiems sunkia eosinophilic astma nepakankamai kontroliuojama, nepaisant didelės dozės inhaliuojamųjų kortikosteroidų plius ilgo veikimo β agonistais.

Den europeiske union - latvisk - EMA (European Medicines Agency)

astrazeneca ab - benralizumabs - astma - zāles obstruktīvu elpceļu slimību, - fasenra ir norādīts, kā pievienot uz tehniskās apkopes ārstēšana pieaugušiem pacientiem ar smagu eosinophilic astmas nepietiekami kontrolē, neskatoties uz lielu devu inhalējamo kortikosteroīdu plus ilgstošas darbības beta agonistus.

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

astrazeneca sdn. bhd. - benralizumab -