申请企业

Octapharma Pharmazeutika Produktionsges.m.b.H.

药品名称

CUTAQUIG, Immune Globulin Subcutaneous (Human)-hipp

状态

提交

承诺描述

1. Deferred pediatric study (protocol SCGAM-01) under PREA for the treatment of primary humoral immunodeficiency in pediatric patients ages two to less than 17 years of age. The study will provide pharmacokinetic data for at least two subjects ages two to less than 6 years, at least six subjects ages six to less than 12 years, and at least four subjects ages 12 to less than 17 years of age, as well as safety and efficacy data for at least four subjects ages two to less than 6 years, at least 10 subjects ages six to less than 12 years, and at least six subjects ages 12 to less than 17 years of age. The final report will compare efficacy and safety between pediatric age cohorts and between pediatric and adult subjects included in the study.

承诺状态描述

The final report was submitted to FDA on December 14, 2020.

报告接收日期

2020/12/14 0:00:00

批准日期

2018/12/12 0:00:00

截止日期

2020/12/31 0:00:00

CDER/CBER

CB

子类型标记

P