FEIBA

This brand name is authorized in Austria, Brazil, Canada, Croatia, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

The drug FEIBA contains a combination of these active pharmaceutical ingredients (APIs):

1
UNII CS849DUN3M - ANTI-INHIBITOR COAGULANT COMPLEX
 
Read more about Factor VIII inhibitor bypass activity
2
UNII 25ADE2236L - THROMBIN
 
Read more about Thrombin
3
UNII 6U90Y1795T - COAGULATION FACTOR IX HUMAN
 

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.

 
Read more about Coagulation factor IX
4
UNII 0P94UQE6SY - COAGULATION FACTOR X HUMAN
 

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.

 
Read more about Coagulation factor X
5
UNII 4156XVB4QD - COAGULATION FACTOR VII HUMAN
 
Read more about Coagulation factor VII

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 FEIBA Powder and solvent for solution for infusion MPI, EU: SmPC Health Products Regulatory Authority (IE)

Medicine classification

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

ATC Group 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
Discover more medicines within B02BD03

Authorization and marketing

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 501121010036917, 501121010037017, 501121010037117, 501121010037217, 501121010037317, 501121010037417, 501121010037517, 501121010037617
CA Health Products and Food Branch 02202581, 02353903
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 29195-03-10
EE Ravimiamet 1021329, 1021330, 1680410, 1680421, 1680432, 1743397
ES Centro de información online de medicamentos de la AEMPS 80119
FI Lääkealan turvallisuus- ja kehittämiskeskus 186799
FR Base de données publique des médicaments 67621498
GB Medicines & Healthcare Products Regulatory Agency 174903, 393851, 393854, 95079
HK Department of Health Drug Office 56854, 57891
HR Agencija za lijekove i medicinske proizvode HR-H-348186000, HR-H-682573334
IL מִשְׂרַד הַבְּרִיאוּת 6807
JP 医薬品医療機器総合機構 6343414X2058
LT Valstybinė vaistų kontrolės tarnyba 1000755, 1007752, 1071195, 1072764, 1080040, 1080041, 1085816, 1085817
MT Medicines Authority MA1047/00201, MA1047/00202
NL Z-Index G-Standaard 14281244
NL Z-Index G-Standaard, PRK 62464, 62472
NZ Medicines and Medical Devices Safety Authority 10039, 10040, 14564
PL Rejestru Produktów Leczniczych 100023736, 100195220, 100427356
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W62498001, W62498002, W62499001, W62499002, W62499003, W62499004, W62499005
SG Health Sciences Authority 10886P, 10889P
TN Direction de la Pharmacie et du Médicament 10623041H
TR İlaç ve Tıbbi Cihaz Kurumu 8681429550073, 8681429550363
ZA Health Products Regulatory Authority T/30.3/597, T/30.3/598

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