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

teva respiratory, llc - reslizumab (unii: 35a26e427h) (reslizumab - unii:35a26e427h) - reslizumab 10 mg in 1 ml - cinqair® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see clinical studies (14)] . limitation of use: - cinqair is not indicated for treatment of other eosinophilic conditions. - cinqair is not indicated for the relief of acute bronchospasm or status asthmaticus [see warnings and precautions (5.2)] . cinqair is contraindicated in patients who have known hypersensitivity to reslizumab or any of its excipients [see warnings and precautions (5.1)] . risk summary the data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. monoclonal antibodies, such as reslizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy. reslizumab has a long half-life [see clinical pharmacology (12.3)] . this should be taken into consideration. in anima

Israel - English - Ministry of Health

teva israel ltd - reslizumab - concentrate for solution for infusion - reslizumab 10 mg / 1 ml - reslizumab - cinqair is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see clinical studies (14)].limitation of use:• cinqair is not indicated for treatment of other eosinophilic conditions.• cinqair is not indicated for the relief of acute bronchospasm or status asthmaticus

European Union - English - EMA (European Medicines Agency)

teva b.v. - reslizumab - asthma - other systemic drugs for obstructive airway diseases, - cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

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

teva pharma australia pty ltd - reslizumab -

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

teva pharma australia pty ltd - reslizumab, quantity: 100 mg - injection, concentrated - excipient ingredients: sodium acetate trihydrate; glacial acetic acid; water for injections; sucrose - cinqair is indicated as add-on therapy in adult patients with severe eosinophilic asthma (blood eosinophil count greater than or equal to 400 cells/?l) (see clinical trials).

Canada - English - Health Canada

teva canada limited - reslizumab - solution - 10mg - reslizumab 10mg - interleukin antagonists

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - reslizumab - solution for infusion - 10mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - reslizumab - solution for infusion - 10mg/1ml

Ireland - English - HPRA (Health Products Regulatory Authority)

animalcare limited - isoflurane - inhalation vapour liquid - 1000 mg/g - reslizumab - avian, canine, equine - food, feline, ferret, gerbils, guinea pigs, hamsters, reptile - neurological preparations