Kenya - English - Pharmacy and Poisons Board

f. hoffmann-la roche ltd, grenzacherstrasse 124, ch-4070, basel - emicizumab - solution for injection - each vial of 0.7 ml contains 105 mg of emicizumab… - emicizumab

Kenya - English - Pharmacy and Poisons Board

f. hoffmann-la roche ltd, grenzacherstrasse 124, ch-4070, basel , - emicizumab - solution for injection - each vial of 1 ml contains 150 mg of emicizumab… - emicizumab

Kenya - English - Pharmacy and Poisons Board

f. hoffmann-la roche ltd, grenzacherstrasse 124, ch-4070, basel, switzerland - emicizumab - solution for injection - each vial of 1 ml contains 30 mg of emicizumab at… - emicizumab

Kenya - English - Pharmacy and Poisons Board

f. hoffmann-la roche ltd grenzacherstrasse 124, ch-4070, basel , - emicizumab - solution for injection - each vial of 0.4 ml contains 60 mg of emicizumab… - emicizumab

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

novartis corporation (malaysia) sdn. bhd. - omalizumab -

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

novartis corporation (malaysia) sdn. bhd. - omalizumab -

European Union - English - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - agents for dermatitis, excluding corticosteroids - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy.asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment.children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment.chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy.eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

European Union - English - EMA (European Medicines Agency)

roche registration limited - emicizumab - hemophilia a - antihemorrhagics - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype.hemlibra can be used in all age groups.

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - omalizumab - asthma; urticaria - drugs for obstructive airway diseases, - allergic asthmaxolair is indicated in adults, adolescents and children (6 to

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - omalizumab 150mg - powder for injection with diluent - 150 mg - active: omalizumab 150mg excipient: histidine histidine hydrochloride polysorbate 20 sucrose water for injection - xolair is indicated for the reduction of asthma exacerbations and control of asthma symptoms when given as add-on therapy for adult and adolescent patients, 6 years and older, with severe persistent allergic asthma who have ige > 30 iu/ml, a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled iwth inhaled corticosteroids.