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

roche products pty ltd - emicizumab, quantity: 150 mg - injection, solution - excipient ingredients: aspartic acid; histidine; arginine; poloxamer; water for injections - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

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

roche products pty ltd - emicizumab, quantity: 105 mg - injection, solution - excipient ingredients: arginine; poloxamer; aspartic acid; histidine; water for injections - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.

Israel - English - Ministry of Health

sanofi israel ltd - dupilumab - solution for injection - dupilumab 175 mg/ml - dupilumab - atopic dermatitis dupixent is indicated for the treatment of treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (ad) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. dupixent can be used with or without topical corticosteroids. asthma dupixent is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. limitation of use: dupixent is not indicated for the relief of acute bronchospasm or status asthmaticus.

Israel - English - Ministry of Health

sanofi israel ltd - dupilumab - solution for injection - dupilumab 150 mg/ml - dupilumab - atopic dermatitisdupixent is indicated for the treatment of treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (ad) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. dupixent can be used with or without topical corticosteroids.asthmadupixent is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.limitation of usedupixent is not indicated for the relief of acute bronchospasm or status asthmaticus. chronic rhinosinusitis with nasal polyposisdupixent 300mg is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (crswnp).eosinophilic esophagitisdupixent is indicated for the treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (eoe).prurigo nodularisdupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - omalizumab 150 mg/ml - solution for injection - 150 mg/ml - active: omalizumab 150 mg/ml excipient: arginine hydrochloride histidine histidine hydrochloride monohydrate polysorbate 20 water for injection - xolair (omalizumab) 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 greater than or equal to 30 iu/ml, a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - omalizumab 150 mg/ml - solution for injection - 75 mg/0.5ml - active: omalizumab 150 mg/ml excipient: arginine hydrochloride histidine histidine hydrochloride monohydrate polysorbate 20 water for injection - xolair (omalizumab) 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 greater than or equal to 30 iu/ml, a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

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

novimmune sa - emapalumab (unii: 3s252o2z4x) (emapalumab - unii:3s252o2z4x) - gamifant is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (hlh) with refractory, recurrent or progressive disease or intolerance with conventional hlh therapy. none. risk summary there are no available data on gamifant use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in an animal reproduction study, a murine surrogate anti-mouse ifnγ antibody administered to pregnant mice throughout gestation crossed the placental barrier, and no fetal harm was observed (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in a mouse embryo-fetal development s

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

swedish orphan biovitrum ab (publ) - emapalumab (unii: 3s252o2z4x) (emapalumab - unii:3s252o2z4x) - gamifant is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (hlh) with refractory, recurrent or progressive disease or intolerance with conventional hlh therapy. none. risk summary there are no available data on gamifant use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in an animal reproduction study, a murine surrogate anti-mouse ifnγ antibody administered to pregnant mice throughout gestation crossed the placental barrier, and no fetal harm was observed (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in a mouse embryo-fetal development

Israel - English - Ministry of Health

astrazeneca (israel) ltd - durvalumab - solution for infusion - durvalumab 50 mg/ml - durvalumab - urothelial carcinoma imfinzi is indicated for the treatment of patients with pd-l1 high (tumor cell ≥25% or ic ≥25%) locally advanced or metastatic urothelial carcinoma who: - have disease progression during or following platinum-containing chemotherapy. - have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy. non-small cell lung cancer - imfinzi is indicated for the treatment of patients with unresectable stage iii non-small cell lung cancer (nsclc) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.- imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations.small cell lung cancer imfinzi, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc).biliary tract cancersimfinzi in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (btc).hepatocellular carcinomaimfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Israel - English - Ministry of Health

astrazeneca (israel) ltd - durvalumab - solution for infusion - durvalumab 50 mg/ml - durvalumab - urothelial carcinoma imfinzi is indicated for the treatment of patients with pd-l1 high (tumor cell ≥25% or ic ≥25%) locally advanced or metastatic urothelial carcinoma who: - have disease progression during or following platinum-containing chemotherapy. - have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy. non-small cell lung cancer - imfinzi is indicated for the treatment of patients with unresectable stage iii non-small cell lung cancer (nsclc) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.- imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations.small cell lung cancer imfinzi, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc).biliary tract cancersimfinzi in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (btc).hepatocellular carcinomaimfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).