BALFAXAR
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
- Demographic Subgroup Information – Prothrombin complex concentrate, human-lans
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- July 21, 2023 Approval Letter - BALFAXAR
- July 19, 2023 Summary Basis for Regulatory Action - BALFAXAR
- Approval History, Letters, Reviews, and Related Documents - BALFAXAR