当前位置:药药网 / 药品研发 / 美国药品上市后承诺数据库
VISTASEAL, Fibrin Sealant (Human)
申请企业
Instituto Grifols, S.A.
药品名称
VISTASEAL, Fibrin Sealant (Human)
承诺描述
Instituto Grifols, S.A. commits to evaluating the safety and efficacy of FIBRIN SEALANT (Human) as an adjunct to hemostasis during surgery in pediatric patients less than 18 years of age in the deferred pediatric clinical trial under protocol IG1405 entitled “A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis during Surgery in Paediatric Subjects.” Instituto Grifols, S.A. also commits to conducting a study of the Human Factors assessment as part of the pediatric trial.
报告接收日期
2020/11/24 0:00:00