This brand name is authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Ireland, Lithuania, Netherlands, Poland, Singapore, Spain, Tunisia, UK.
The drug OCTAPLEX contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
8FB1K07F16 - PROTHROMBIN
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2
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UNII
4156XVB4QD - COAGULATION FACTOR VII HUMAN
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3
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UNII
6U90Y1795T - COAGULATION FACTOR IX HUMAN
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Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton. It is a vitamin-K dependent coagulation factor and it is synthesised in the liver. Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway. Activated factor IX, in combination with activated factor VIII, activates factor X. |
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4
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UNII
0P94UQE6SY - COAGULATION FACTOR X HUMAN
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Coagulation factor X is derived from human plasma and used as a replacement for the naturally existing coagulation factor X in patients with hereditary factor X deficiency. |
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5
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UNII
3Z6S89TXPW - PROTEIN C
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Protein C is a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. Protein C exerts its effect by the inactivation of the activated forms of factors V and VIII which leads to a decrease in thrombin formation. Protein C has also been shown to have profibrinolytic effects. |
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6
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UNII
90J3F6N5FN - PROTEIN S HUMAN
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This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| B02BD01 | Coagulation factor IX, II, VII and X in combination | B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 535300401137315 |
| CA | Health Products and Food Branch | 02294664, 02434970 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 27-MBE-0915 |
| EE | Ravimiamet | 1230174, 1664232 |
| ES | Centro de información online de medicamentos de la AEMPS | 66447, 80417 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 064742, 399482 |
| FR | Base de données publique des médicaments | 60259993, 67877234 |
| GB | Medicines & Healthcare Products Regulatory Agency | 151214, 325005 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-107880130 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1022335, 1074454, 1075279 |
| NL | Z-Index G-Standaard | 16168054 |
| NL | Z-Index G-Standaard, PRK | 130524, 71935 |
| PL | Rejestru Produktów Leczniczych | 100139798, 100354717 |
| SG | Health Sciences Authority | 14933P |
| TN | Direction de la Pharmacie et du Médicament | 10043031H |
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