This brand name is authorized in Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa
The drug FEIBA contains a combination of these active pharmaceutical ingredients (APIs):
1
Factor VIII inhibitor bypass activity
UNII CS849DUN3M - ANTI-INHIBITOR COAGULANT COMPLEX
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2
Coagulation factor II
UNII 25ADE2236L - THROMBIN
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3
Coagulation factor IX
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. |
4
Coagulation factor X
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. |
5
Coagulation factor VII
UNII 4156XVB4QD - COAGULATION FACTOR VII HUMAN
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Below package inserts are available for further reading:
Title | Information Source | Document Type | |
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FEIBA Powder and solvent for solution for infusion | Health Products Regulatory Authority (IE) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC code | Group title | Classification |
---|---|---|
B02BD03 | Factor VIII inhibitor bypassing activity | 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) |
---|---|---|
Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 501121010036917, 501121010037017, 501121010037117, 501121010037217, 501121010037317, 501121010037417, 501121010037517, 501121010037617 |
Country: CA | Health Products and Food Branch | Identifier(s): 02202581, 02353903 |
Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 29195-03-10 |
Country: EE | Ravimiamet | Identifier(s): 1021329, 1021330, 1680410, 1680421, 1680432, 1743397 |
Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 80119 |
Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 186799 |
Country: FR | Base de données publique des médicaments | Identifier(s): 67621498 |
Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 174903, 393851, 393854, 95079 |
Country: HK | Department of Health Drug Office | Identifier(s): 56854, 57891 |
Country: HR | Agencija za lijekove i medicinske proizvode | Identifier(s): HR-H-348186000, HR-H-682573334 |
Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 6807 |
Country: JP | 医薬品医療機器総合機構 | Identifier(s): 6343414X2058 |
Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1000755, 1007752, 1071195, 1072764, 1080040, 1080041, 1085816, 1085817 |
Country: MT | Medicines Authority | Identifier(s): MA1047/00201, MA1047/00202 |
Country: NL | Z-Index G-Standaard | Identifier(s): 14281244 |
Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 62464, 62472 |
Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 10039, 10040, 14564 |
Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100023736, 100195220, 100427356 |
Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W62498001, W62498002, W62499001, W62499002, W62499003, W62499004, W62499005 |
Country: SG | Health Sciences Authority | Identifier(s): 10886P, 10889P |
Country: TN | Direction de la Pharmacie et du Médicament | Identifier(s): 10623041H |
Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8681429550073, 8681429550363 |
Country: ZA | Health Products Regulatory Authority | Identifier(s): T/30.3/597, T/30.3/598 |
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