Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Baxalta Innovations GmbH, Industriestrasse 67, A-1221, Vienna, Austria
OBIZUR 500 U powder and solvent for solution for injection.
| Pharmaceutical Form |
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Powder and solvent for solution for injection. The powder is white. The solvent is clear and colourless. |
Each powder vial contains nominally 500 Units of B domain deleted antihaemophilic Factor VIII (recombinant), porcine sequence, susoctocog alfa.
OBIZUR contains approximately 500 U/ml susoctocog alfa after reconstitution.
The potency (U) is determined using the one-stage coagulation assay (OSCA). The specific activity of OBIZUR is approximately 10,000 U/mg protein.
OBIZUR (antihaemophilic Factor VIII (recombinant), porcine sequence) is a purified protein that has 1448 amino acids with an approximate molecular mass of 175kDa. It is produced by recombinant DNA (rDNA) technology in baby hamster kidney (BHK) cells. The BHK cells are cultured in media that contains fetal bovine serum. The manufacturing process is free of human serum and human protein products and does not contain any additional animal derived materials.
Excipient(s) with known effect: Each vial contains 4.4 mg (198 mM) sodium per ml of reconstituted solution.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
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Powder: Polysorbate 80 Solvent: Sterilised water for injections |
One pack of OBIZUR contains 1, 5 or 10 each of the following:
Baxalta Innovations GmbH, Industriestrasse 67, A-1221, Vienna, Austria
EU/1/15/1035/001
EU/1/15/1035/002
EU/1/15/1035/003
Date of first authorisation: 11 November 2015
| Drug | Countries | |
|---|---|---|
| OBIZUR | Austria, Canada, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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