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Home Industry News Octapharma files for European approval of Uniplas

Octapharma files for European approval of Uniplas

31st August 2010

Octapharma is applying for registration of its new universal blood plasma treatment Uniplas in Europe following the completion of clinical development for the product.

The pharmaceutical company is filing for approval of its human pooled plasma for infusion after demonstrating its efficacy and tolerability in a clinical trial programme, which involved patients undergoing liver resection or open-heart surgery.

Uniplas is designed to be a universally applicable and blood group independent plasma, the use of which eliminates the traditional health risks associated with transfusions from incompatible plasma units.

The safety profile of Uniplas has been shown to be similar to Octaplas and OctaplasLG, two Octapharma treatments which have already been made commercially available.

Registration of Uniplas is expected to be completed in the fourth quarter of this year, ahead of a planned US submission.

Last month, Octapharma published its latest fiscal report, expressing confidence that the second half of 2010 will be marked by business growth, thanks to the launch of new products such as a treatment for haemophilia A.ADNFCR-8000103-ID-800044706-ADNFCR

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