OBIZUR

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

Active ingredients

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

1 Susoctocog alfa 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 about Susoctocog alfa

Medication package inserts

Below package inserts are available for further reading:

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