Grecja - grecki - Εθνικός Οργανισμός Φαρμάκων

ΒΙΑΝΕΞ Α.Ε. ΑΝΩΝΥΜΟΣ ΕΜΠΟΡΟΒΙΟΜΗΧΑΝΙΚΗ-ΤΟΥΡΙΣΤΙΚΗ-ΞΕΝΟΔΟΧΕΙΑΚΗ ΚΑΙ ΝΑΥΤΙΛΙΑΚΗ ΑΝΩΝΥΜΟΣ ΕΤΑΙΡΕΙΑ Δ.Τ. ΒΙΑΝΕΞ Α.Ε. (0000010313) Οδ - human plasma coagulation factor ix concentrate - ΚΟΝΙΣ ΚΑΙ ΔΙΑΛΥΤΗΣ ΓΙΑ ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ - 1000 iu/vial - ineof01410 human plasma coagulation factor ix concentrate 1000.000000 iu - coagulation factor ix

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ix 1000 [iu] (100iu/ml when reconstituted with 10ml water for injection) - injection with diluent - 1000 iu - active: factor ix 1000 [iu] (100iu/ml when reconstituted with 10ml water for injection) excipient: antithrombin iii chloride citric acid monohydrate heparin phosphorus plasma protein fraction sodium water for injection - monofix®-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix®-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix®-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

csl behring (nz) ltd - factor ix 500 [iu] (50 iu/ml when reconstituted with 10 ml water for injections) - injection with diluent - 50 iu/ml - active: factor ix 500 [iu] (50 iu/ml when reconstituted with 10 ml water for injections) excipient: antithrombin iii chloride citric acid monohydrate heparin phosphorus plasma protein fraction sodium water for injection - monofix®-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix®-vf is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix®-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

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

csl behring australia pty ltd - factor ix, quantity: 50 iu/ml - injection, diluent for - excipient ingredients: water for injections - "tbsf" high purity factor ix concentrate is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. "tbsf" high purity factor ix concentrate is not indicated for the treatment of factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. "tbsf" high purity factor ix concentrate is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

Izrael - angielski - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 250 iu - coagulation factor viii - coagulation factor viii - is indicated for the prevention and control of bleeding in patients with moderate or severe factor viii deficiency due to classical hemophilia a .fanhdi is not effective in controlling the bleeding of patients with von willebrond's disease.

Izrael - angielski - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 500 iu - coagulation factor viii - coagulation factor viii - is indicated for the prevention and control of bleeding in patients with moderate or severe factor viii deficiency due to classical hemophilia a . fanhdi is not effective in controlling the bleeding of patients with von willebrond's disease.

Izrael - angielski - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 1000 iu - coagulation factor viii - coagulation factor viii - is indicated for the prevention and control of bleeding in patients with moderate or severe factor viii deficiency due to classical hemophilia a . fanhdi is not effective in controlling the bleeding of patients with von willebrond's disease.

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

csl behring australia pty ltd - factor viii, quantity: 1000 iu; von willebrand factor, quantity: 2400 iu - injection, diluent for - excipient ingredients: - the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von willebrand disease when desmopressin (ddavp) treatment is ineffective or contraindicated. the prophylaxis and treatment of non-surgical and surgical bleeding associated with factor viii deficiency due to haemophilia a.

Tajwan - chiński - 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

台灣武田藥品工業股份有限公司 台北市信義區松高路1號17樓 (03564609) - coagulation factor ix - 凍晶注射劑 - coagulation factor ix (2012102310) iu - coagulation factor ix - rixubis (第九凝血因子[基因重組]) 為一抗血友病因子產品，適用於成人及兒童b型血友病患：• 控制和預防出血事件，手術療程 (perioperative) 處置，及常規性預防處置 (routine prophylaxis)。rixubis 不適用於對b型血友病病患進行免疫耐受性的誘導 (請見警告與注意事項之5.3一節)。

Tajwan - chiński - 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

台灣武田藥品工業股份有限公司 台北市信義區松高路1號17樓 (03564609) - coagulation factor ix - 凍晶注射劑 - coagulation factor ix (2012102310) iu - coagulation factor ix - rixubis (第九凝血因子[基因重組]) 為一抗血友病因子產品，適用於成人及兒童b型血友病患：• 控制和預防出血事件，手術療程 (perioperative) 處置，及常規性預防處置 (routine prophylaxis)。rixubis 不適用於對b型血友病病患進行免疫耐受性的誘導 (請見警告與注意事項之5.3一節)。