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

roche products pty ltd - emicizumab, quantity: 60 mg - injection, solution - excipient ingredients: poloxamer; arginine; aspartic acid; water for injections; histidine - 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: 30 mg - injection, solution - excipient ingredients: arginine; water for injections; histidine; aspartic acid; poloxamer - 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: 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.

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - emicizumab 150 mg/ml - solution for injection - 150 mg/ml - active: emicizumab 150 mg/ml excipient: arginine aspartic acid histidine poloxamer 188 water for injection - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - emicizumab 150 mg/ml - solution for injection - 150 mg/ml - active: emicizumab 150 mg/ml excipient: arginine aspartic acid histidine poloxamer 188 water for injection - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - emicizumab 150 mg/ml - solution for injection - 150 mg/ml - active: emicizumab 150 mg/ml excipient: arginine aspartic acid histidine poloxamer 188 water for injection - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - emicizumab 30 mg/ml - solution for injection - 30 mg/ml - active: emicizumab 30 mg/ml excipient: arginine aspartic acid histidine poloxamer 188 water for injection - 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

roche pharmaceuticals (israel) ltd - emicizumab - solution for injection - emicizumab 150 mg / 1 ml - emicizumab - hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in patients with hemophilia a (congenital factor viii deficiency) with or without factor viii inhibitors.