Data from EMA (European Medicines Agency) - Curated by Marshall Pearce - Last updated 19 May 2017

Indication(s)

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry can be used for all age groups.

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Category Value
Agency product number EMEA/H/C/003825
Orphan designation No
Date First Approved 18-02-2016
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Bayer Pharma AG
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions