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.

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix; human coagulation factor x; protein c; protein s - powder and solvent for solution for infusion - 1000 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma limited - human coagulation factor ii, human coagulation factor vii, human coagulation factor ix, human coagulation factor x, protein c, protein s - pdr+solv for soln for inf - 1000 international unit - blood coagulation factors

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; human protein c - powder and solvent for solution for injection - coagulation factor ix, ii, vii and x in combination

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

octapharma benelux sa-nv - human coagulation factor ii 14 iu/ml - 38 iu/ml; human coagulation factor ix 25 iu/ml; protein c 13 iu/ml - 31 iu/ml; human coagulation factor vii 9 iu/ml - 24 iu/ml; human coagulation factor x 18 iu/ml - 30 iu/ml; protein s 12 iu/ml - 32 iu/ml - powder and solvent for solution for infusion - 1000 ui - human coagulation factor ii; human coagulation factor vii; human coagulation factor ix 25 iu/ml; human coagulation factor x; protein c; protein s - coagulation factor ix, ii, vii and x in combination

Israel - English - Ministry of Health

dover medical & scientific equipment ltd, israel - coagulation factor ii (human); coagulation factor ix (human- rfixfc); coagulation factor vii (human); coagulation factor x (human); protein; protein c; protein s antigen - powder and solvent for solution for infusion - coagulation factor ix (human- rfixfc) 25 iu/ml; coagulation factor ii (human) 14 - 38 iu/ml; coagulation factor vii (human) 9 - 24 iu/ml; coagulation factor x (human) 18 - 30 iu/ml; protein 13 - 41 mg/ml; protein c 13 - 31 iu/ml; protein s antigen 12 - 32 iu/ml - coagulation factor 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 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. treatment of bleeding and perioperative prophylaxis in congenital deficiency of any of the vitamin k dependent coagulation factors when purified specific coagulation factor product is not available.

Ireland - English - HPRA (Health Products Regulatory Authority)

octapharma (ip) sprl - human plasma coagulation factor ii; human plasma coagulation factor vii; human plasma coagulation factor ix; human plasma coagulation factor x; protein c; protein s - powder and solvent for solution for infusion - 500 international unit(s) - blood coagulation factors; coagulation factor ix, ii, vii and x in combination

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

csl behring gmbh - human coagulation factor x 440 iu - 1200 iu; human coagulation factor vii 200 iu - 500 iu; protein c 300 iu - 900 iu; human coagulation factor ii 400 iu - 960 iu; human coagulation factor ix 400 iu - 620 iu; protein s 240 iu - 760 iu - powder and solvent for solution for injection - 500 iu - human coagulation factor x; human coagulation factor vii; human coagulation factor ii; human coagulation factor ix; protein s; protein c - coagulation factor ix, ii, vii and x in combination

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

csl behring gmbh - human coagulation factor x 880 iu - 2400 iu; human coagulation factor ii 800 iu - 1920 iu; human coagulation factor vii 400 iu - 1000 iu; protein c 600 iu - 1800 iu; human coagulation factor ix 800 iu - 1240 iu; protein s 480 iu - 1520 iu - powder and solvent for solution for injection - 1000 iu - protein c; protein s; human coagulation factor x; human coagulation factor ii; human coagulation factor ix; human coagulation factor vii - coagulation factor ix, ii, vii and x in combination

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxalta innovations gmbh - human coagulation factor vii 500 iu; protein c >= 400 iu; human coagulation factor ii 480 iu - 900 iu; human coagulation factor ix 600 iu; human coagulation factor x 600 iu - powder and solvent for solution for injection - 600 iu - protein c 400 iu; human coagulation factor ii; human coagulation factor x 600 iu; human coagulation factor ix 600 iu; human coagulation factor vii 500 iu - coagulation factor ix, ii, vii and x in combination