Malta - English - Medicines Authority

csl behring gmbh emil-von-behring-strasse 76, 35041 marburg, germany - factor ii, prothrombin, factor vii, human, factor ix, factor x, protein c - powder and solvent for solution for injection - factor ii (prothrombin) 20-48 iu factor vii, human 10-25 iu factor ix, human 20-31 iu factor x, human 22-60 iu protein c 15-45 iu - antihemorrhagics

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - factor ii, prothrombin, factor ix, human, factor x, factor vii - powder and solvent for solution for injection - factor ii (prothrombin) 24-45 iu/mg factor ix, human 30 iu/mg factor x, human 30 iu/mg factor vii, human 25 iu/mg - antihemorrhagics

Israel - English - Ministry of Health

csl behring ltd., israel - coagulation factor ii (human); coagulation factor ix (human- rfixfc); coagulation factor vii (human); coagulation factor x (human); protein c; protein s antigen - powder and solvent for solution for injection - coagulation factor ii (human) 200 - 480 iu; coagulation factor vii (human) 100 - 250 iu; coagulation factor ix (human- rfixfc) 200 - 310 iu; coagulation factor x (human) 220 - 600 iu; protein c 150 - 450 iu; protein s antigen 120 - 380 iu - coagulation factor ix, ii, vii and x in combination - coagulation factor ix, ii, vii and x in combination - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

Israel - English - Ministry of Health

csl behring ltd., israel - coagulation factor ii (human); coagulation factor ix (human- rfixfc); coagulation factor vii (human); coagulation factor x (human); protein c; protein s antigen - powder and solvent for solution for injection - coagulation factor ii (human) 400 - 960 iu; coagulation factor vii (human) 200 - 500 iu; coagulation factor ix (human- rfixfc) 400 - 620 iu; coagulation factor x (human) 440 - 1200 iu; protein c 300 - 900 iu; protein s antigen 240 - 760 iu - coagulation factor ix, ii, vii and x in combination - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

Israel - English - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 1500 iu/dose - factor viii inhibitor bypassing activity - factor viii inhibitor bypassing activity - 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.

Israel - English - 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.

Israel - English - 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.

Israel - English - 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.

Namibia - English - Namibia Medicines Regulatory Council

national bioproducts institute - human factor ix, factor ii, factor viii and factor x - lyophilised powder - each 10ml of reconstituted solution contains human factor ix 500 iu, factor ii 400 iu, factor viii 200 iu and factor x 400 iu

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; protein c - powder and solvent for solution for injection - 600 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination - antihemorrhagics, coagulation factors ix, ii, vii and x in combination - treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors, such as a deficiency caused by treatment with vitamin k antagonists or in case of overdose with vitamin k antagonists, when rapid correction of the deficiency is required. treatment and perioperative prophylaxis of hemorrhages in congenital deficiency of vitamin k-dependent coagulation factors, when purified specific coagulation factor concentrate is not available.