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EMA guidance · 2013-12-06

PRAC considers benefits of Kogenate Bayer/Helixate NexGen outweigh risks in previously untreated patients

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Summary

PRAC concluded that the benefits of Kogenate Bayer/Helixate NexGen outweigh the risks in previously untreated patients, informing risk-benefit considerations.

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Diseases / indications

Drugs mentioned

  • Kogenate Bayer/Helixate NexGen (octocog alfa (recombinant factor VIII))