Glassia, Alpha-1-Proteinase Inhibitor (Human)_美国药品上市后承诺数据库

Glassia, Alpha-1-Proteinase Inhibitor (Human)

申请企业

Kamada Ltd.

药品名称

Glassia, Alpha-1-Proteinase Inhibitor (Human)

状态

延迟

承诺描述

Kamada Ltd. commits to conduct and report the results of a Human Factors study, to evaluate the types of problems that patients/caregivers may encounter in self-infusing. This information will be used to revise, as needed, the training program and educational materials for self-infusion/non-healthcare provider caregiver infusion of GLASSIA®.

承诺状态描述

The study completion date has passed and the study has not yet been completed. The final report due date has passed with no final report received.

报告接收日期

2020/9/1 0:00:00

批准日期

2010/7/1 0:00:00

截止日期

2018/8/31 0:00:00

CDER/CBER

CB

子类型标记