FIBRYGA
STN# 125612
Proper Name: Fibrinogen (Human)
Tradename: FIBRYGA
Manufacturer: Octapharma Pharmazeutika Produktionsges.m.b.H.
Indication:
- For the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Product Information
- 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.
Supporting Documents
- 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