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May 7th, 2007
Octaplex® approved in Canada
On May 1st, the Health Products and Food Branch of Health Canada approved Octapharma's prothrombin complex concentrate - Octaplex®.
Octaplex has been approved in Canada for: the treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.
Octaplex offers a good haemostatic balance of coagulation factors II, VII, IX and X and the naturally occuring coagulation factor inhibitors, protein C and protein S.
Virus reduction measures utilised in the manufacture of Octaplex include solvent detergent (SD) treatment and nanofiltration.
The registration of Octaplex brings to 5 the number of Octapharma products approved in Canada. Also licensed are:
- Octalbin 25%
- Octagam 5%
- Octaplas
- Wilate
"The registration of Octaplex in Canada is a significant milestone for Octapharma and will provide clinicians with a state-of-the-art treatment option for patients with complex bleeding disorders" commented Mr Frederic Marguerre, Board Member .
Please click here for the Canadia product monograph for Octaplex.
Octapharma hopes to introduce Octaplex to Canada during 2007.
© Octapharma AG, 2007 |