Ireland - English - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - human fibrinogen; aprotinin; human factor xiii; human thrombin; calcium chloride - solution for sealant - . - local hemostatics; tissue adhesives

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharmeng technology sdn. bhd. - human fibrinogen; human thrombin -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pharmeng technology sdn. bhd. - human fibrinogen; human thrombin -

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

csl behring australia pty ltd - factor ix, quantity: 500 iu; factor x, quantity: 500 iu; factor ii, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - prothrombinex-vf is indicated in - treatment and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex 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 and prophylaxis of bleeding in patients with single or multiple congenital deficiency of factor ix, ii or x when purified specific coagulation factor product is not available (see precautions).

Malta - English - Medicines Authority

baxter healthcare limited - human fibrinogen; aprotinin; human thrombin; calcium chloride dihydrate - solution for sealant - human fibrinogen 455 mg; aprotinin 1500 kiu/ml; human thrombin 2500 iu; calcium chloride dihydrate 200 mmol - antihemorrhagics

Malta - English - Medicines Authority

baxter healthcare limited - human fibrinogen; aprotinin; human thrombin; calcium chloride dihydrate - solution for sealant - human fibrinogen 182 mg; aprotinin 6000 kiu/ml; human thrombin 1000 iu; calcium chloride dihydrate 80 µmol - antihemorrhagics

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - human fibrinogen, aprotinin, human thrombin, calcium chloride, dihydrate - solution for sealant - human fibrinogen 182 mg aprotinin 6000 kiu/ml human thrombin 1000 iu calcium chloride dihydrate 80 µmol - antihemorrhagics

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - human fibrinogen, aprotinin, human thrombin, calcium chloride, dihydrate - solution for sealant - human fibrinogen 455 mg aprotinin 1500 kiu/ml human thrombin 2500 iu calcium chloride dihydrate 200 mmol - antihemorrhagics

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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

takeda uk ltd - human fibrinogen; thrombin - implant - 5.5mg/1square cm ; 2unit/1square cm