This brand name is authorized in Austria, Brazil, Canada, Croatia, Ecuador, Estonia, Finland, France, Ireland, Lithuania, Malta, Poland, Romania, Singapore, Spain, UK.
The drug FIBRYGA contains one active pharmaceutical ingredient (API):
1
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UNII
N94833051K - FIBRINOGEN HUMAN
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Human fibrinogen (coagulation factor I), in the presence of thrombin, activated coagulation factor XIII (F XIIIa) and calcium ions is converted into a stable and elastic three-dimensional fibrin haemostatic clot. The administration of human fibrinogen concentrate provides an increase in plasma fibrinogen level and can temporarily correct the coagulation defect of patients with fibrinogen deficiency. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| FIBRYGA Powder and solvent for solution for injection/infusion | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| B02BB01 | Human fibrinogen | B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BB Fibrinogen |
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 | 535320070003707 |
| CA | Health Products and Food Branch | 02464616 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 173-MBE-1220 |
| EE | Ravimiamet | 1788486, 1814026 |
| ES | Centro de información online de medicamentos de la AEMPS | 85322 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 099327 |
| FR | Base de données publique des médicaments | 69768123 |
| GB | Medicines & Healthcare Products Regulatory Agency | 384625 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-074022622 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1090886 |
| MT | Medicines Authority | MA1219/01201 |
| PL | Rejestru Produktów Leczniczych | 100375205 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W67066001 |
| SG | Health Sciences Authority | 15829P |
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