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

glaxosmithkline llc - mepolizumab (unii: 90z2uf0e52) (mepolizumab - unii:90z2uf0e52) - mepolizumab 100 mg in 1 ml - nucala is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype [see use in specific populations (8.4), clinical studies (14.1)] . limitations of use nucala is not indicated for the relief of acute bronchospasm or status asthmaticus. nucala is indicated for the add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (crswnp) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. nucala is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (egpa). nucala is indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (hes) for ≥6 months without an identifiable non-hematologic secondary cause. nucala is contraindicated in patients with a history of hypersensitivity to mepolizumab or excipients in the formulation [see warnings and precautions (5.1), descrip

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

glaxosmithkline australia pty ltd - mepolizumab, quantity: 100 mg - injection, powder for - excipient ingredients: polysorbate 80; water for injections; dibasic sodium phosphate heptahydrate; sucrose - severe eosinophilic asthma,nucala is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over (see section 5.1 pharmacodynamic properties, clinical trials).,chronic rhinosinusitis with nasal polyps (crswnp),nucala is indicated as add-on treatment in adult patients (18 years and above) with severe chronic rhinosinusitis with nasal polyps (crswnp) with an inadequate response to intranasal corticosteroids (see section 5.1 pharmacodynamic properties, clinical 2 trials).,relapsed or refractory egpa,nucala is indicated as an add-on treatment for relapsing or refractory eosinophilic granulomatosis with polyangiitis (egpa) in adult patients aged 18 years and over (see section 5.1 pharmacodynamic properties, clinical trials).

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - mepolizumab - powder for solution for injection - mepolizumab 100 mg - mepolizumab - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adult patientschronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with corticosteroids and surgery in the last 10 years do not provide adequate disease control.eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (egpa).hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - mepolizumab - solution for injection - mepolizumab 100 mg / 1 ml - mepolizumab - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adult patientschronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with corticosteroids and surgery in the last 10 years do not provide adequate disease control.eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (egpa).hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

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

glaxosmithkline australia pty ltd - mepolizumab, quantity: 100 mg - injection, solution - excipient ingredients: sucrose; dibasic sodium phosphate heptahydrate; citric acid monohydrate; polysorbate 80; disodium edetate; water for injections - severe eosinophilic asthma,nucala is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over (see section 5.1 pharmacodynamic properties, clinical trials).,chronic rhinosinusitis with nasal polyps (crswnp),nucala is indicated as add-on treatment in adult patients (18 years and above) with severe chronic rhinosinusitis with nasal polyps (crswnp) with an inadequate response to intranasal corticosteroids (see section 5.1 pharmacodynamic properties, clinical 2 trials).,relapsed or refractory egpa,nucala is indicated as an add-on treatment for relapsing or refractory eosinophilic granulomatosis with polyangiitis (egpa) in adult patients aged 18 years and over (see section 5.1 pharmacodynamic properties, clinical trials).

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

glaxosmithkline australia pty ltd - mepolizumab, quantity: 100 mg - injection, solution - excipient ingredients: sucrose; dibasic sodium phosphate heptahydrate; citric acid monohydrate; polysorbate 80; disodium edetate; water for injections - severe eosinophilic asthma,nucala is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over (see section 5.1 pharmacodynamic properties, clinical trials).,chronic rhinosinusitis with nasal polyps (crswnp),nucala is indicated as add-on treatment in adult patients (18 years and above) with severe chronic rhinosinusitis with nasal polyps (crswnp) with an inadequate response to intranasal corticosteroids (see section 5.1 pharmacodynamic properties, clinical 2 trials).,relapsed or refractory egpa,nucala is indicated as an add-on treatment for relapsing or refractory eosinophilic granulomatosis with polyangiitis (egpa) in adult patients aged 18 years and over (see section 5.1 pharmacodynamic properties, clinical trials).

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - mepolizumab 144mg ((100 mg/ml after reconstitution with 1.2 ml of wfi, delivers 1 ml)) - powder for injection - 100 mg/ml - active: mepolizumab 144mg ((100 mg/ml after reconstitution with 1.2 ml of wfi, delivers 1 ml)) excipient: dibasic sodium phosphate heptahydrate hydrochloric acid polysorbate 80 sucrose - nucala is indicated as an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over.

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

glaxosmithkline pharmaceutical sdn. bhd. - mepolizumab -

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

glaxosmithkline pharmaceutical sdn. bhd. - mepolizumab -

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

glaxosmithkline pharmaceutical sdn. bhd. - mepolizumab -