FIBRYGA

This brand name is authorized in Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Malta, Poland, Romania, Singapore, United Kingdom

Active ingredients

The drug FIBRYGA contains one active pharmaceutical ingredient (API):

1 Human fibrinogen
UNII N94833051K - FIBRINOGEN HUMAN

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.

Read about Human fibrinogen

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
FIBRYGA Powder and solvent for solution for injection/infusion Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
B02BB01 Human fibrinogen B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BB Fibrinogen
Discover more medicines within B02BB01

Authorization and marketing

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): 535320070003707
Country: CA Health Products and Food Branch Identifier(s): 02464616
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 173-MBE-1220
Country: EE Ravimiamet Identifier(s): 1788486, 1814026
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 85322
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 099327
Country: FR Base de données publique des médicaments Identifier(s): 69768123
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 384625
Country: HR Agencija za lijekove i medicinske proizvode Identifier(s): HR-H-074022622
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1090886
Country: MT Medicines Authority Identifier(s): MA1219/01201
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100375205
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W67066001
Country: SG Health Sciences Authority Identifier(s): 15829P

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