STN: 125776
Proper Name: Prothrombin complex concentrate, human-lans
Tradename: BALFAXAR
Manufacturer: Octapharma Pharmazeutika Produktiosges.m.b.H.
Indication:

• For the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure.

Product Information

• Package Insert - BALFAXAR

Supporting Documents

• July 21, 2023 Approval Letter - BALFAXAR