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FIBRYNA; FIBRYGA, Fibrinogen (Human)
申请企业
Octapharma Pharmazeutika Produktionsges.m.b.H.
药品名称
FIBRYNA; FIBRYGA, Fibrinogen (Human)
承诺描述
Deferred pediatric study under PREA for the treatment of acute bleeding in pediatric patients ages less than 12 years of age with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
承诺状态描述
Per FDA letter dated December 23, 2020, this PMR/PMC has been fulfilled.