Proper Name: Fibrinogen (Human)
Manufacturer: Octapharma Pharmazeutika Produktionsges.m.b.H.
- For the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
- Package Insert - FIBRYGA
- Demographic Subgroup Information - Fibrinogen Concentrate (Human)
Refer to Section 1.1 of the clinical reviewer memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- 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