当前位置:药药网 / 药品研发 / 美国药品上市后承诺数据库
SEVENFACT, Coagulation Factor VIIa (Recombinant)
申请企业
Laboratoire Francais du Fractionnement et des Biotechnologies S.A.
药品名称
SEVENFACT, Coagulation Factor VIIa (Recombinant)
承诺描述
Deferred pediatric study under PREA for “A phase III Study on the Safety, Pharmacokinetics, and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients from birth to less than 12 years old with Inhibitors to Factor VIII or IX.” Final Protocol Submission: Completed Study Completion Date: Completed Final Report Submission: July 10, 2020