STN# 125612
Proper Name: Fibrinogen (Human)
Tradename: FIBRYGA
Manufacturer: OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Indication:
FIBRYGA is a human fibrinogen concentrate indicated for:
- fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency
- treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Limitations of Use:
- FIBRYGA is not indicated for dysfibrinogenemia
Product Information
Supporting Documents
- June 23, 2025 Approval Letter – FIBRYGA
- July 31, 2024 Clinical Review Memo-FIBRYGA
- July 31, 2024 Statistical Review Memo-FIBRYGA
- July 31, 2024 Approval Letter – FIBRYGA
- Clinical Review – FIBRYGA
- Statistical Review (125612/67) -FIBRYGA
- Clinical Pharmacology Supplemental Review – FIBRYGA
- December 23, 2020 Approval Letter – FIBRYGA
- June 7, 2017 Approval Letter – FIBRYNA
- June 9, 2017 Summary Basis for Regulatory Action – FIBRYNA
- Statistical Review – FIBRYNA
- Approval History, Letters, Reviews, and Related Documents – FIBRYNA
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Content current as of:
06/24/2025
