OBIZUR

This brand name is authorized in Austria, Canada, Croatia, Estonia, Finland, France, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, UK.

Active ingredients

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

1
UNII 6892UQT2GK - SUSOCTOCOG ALFA
 

Susoctocog alfa is a recombinant, B-domain deleted, porcine sequence Factor VIII. It is a glycoprotein. Acquired haemophilia is a rare bleeding disorder in which patients with normal Factor VIII genes develop inhibitory autoantibodies directed against Factor VIII. These autoantibodies neutralize circulating human Factor VIII thus creating a deficiency of available Factor VIII. Susoctocog alfa temporarily replaces the inhibited endogenous Factor VIII that is needed for effective haemostasis.

 
Read more about Susoctocog alfa

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 OBIZUR Powder and solvent for solution for injection MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

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

ATC Group Classification
B02BD02 Coagulation factor VIII B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors
Discover more medicines within B02BD02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
CA Health Products and Food Branch 02447401
EE Ravimiamet 1703124, 1703135, 1703146
FI Lääkealan turvallisuus- ja kehittämiskeskus 475471
FR Base de données publique des médicaments 65982247
GB Medicines & Healthcare Products Regulatory Agency 326858, 326859, 326860
IT Agenzia del Farmaco 044557015, 044557027, 044557039
LT Valstybinė vaistų kontrolės tarnyba 1078670, 1078671, 1078672
NL Z-Index G-Standaard, PRK 135127
PL Rejestru Produktów Leczniczych 100358856
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W66930001, W66930002, W66930003

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