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In this section: Approved Blood Products

VONVENDI

STN: 125577
Proper Name: von Willebrand factor (Recombinant)
Tradename: VONVENDI
Manufacturer: Baxalta US Inc.
Indication:

Indicated for on-demand treatment, control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease receiving on-demand therapy.

Product Information

Package Insert - VONVENDI

Supporting Documents

January 28, 2022 Approval Letter - VONVENDI
April 13, 2018 Summary Basis for Regulatory Action - VONVENDI
April 13, 2018 Approval Letter - Vonvendi
To include a new indication and usuage for the perioperative management of bleeding, based on data from a Phase 3 Study.
Approval History, Letters, Reviews, and Related Documents - VONVENDI
Supporting Documents older than three years - VONVENDI

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