United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

1 glass vial powder + 1 vial with 20ml solvent + 1 baxject ii hi-flow + 1 kit -

Namibia - English - Namibia Medicines Regulatory Council

adcock ingram critical care (pty) ltd - factor viii inhibitor - injection - each 1 ml solution contains: factor viii inhibitor bypassing activity 50 u

Namibia - English - Namibia Medicines Regulatory Council

adcock ingram critical care (pty) ltd - factor viii inhibitor - injection - each 1 ml solution contains: factor viii inhibitor bypassing activity 50 iu

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

takeda manufacturing ag, austria - anti inhibitor coagulant complex - powder and solvent for solution for infusion - 50 iu/ml

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

takeda manufacturing ag, austria - omfiloctocog alfa - powder and solvent for solution for infusion - 25 iu/ml

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: takeda healthcare philippines inc.; distributor: takeda healthcare philippines inc. - factor viii inhibitor bypassing activity - powder for solution for infusion (iv) - 1000 u/20 ml (50 u/ml)

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: takeda healthcare philippines inc.; distributor: takeda healthcare philippines inc. - powder for solution for infusion (iv) - powder for solution for infusion (iv) - 2500 u/50 ml (50 u/ml)

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

takeda pharmaceuticals australia pty ltd - 45156 - medicine administration kit, percutaneous, medicated, single-use - the procedure pack is intended for preparing the injection solution of feiba nf for administration. the pack consists of the a drug powder vial, a diluent vial and a baxject ii reconstitution device. baxject ii is a needleless transfer device which is intended for transferring and mixing the diluent and the drug powder contained in the two vials into a syringe for administration. this procedure pack is for single-use only.

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.