申请企业

ALK - Abello A/S

药品名称

RAGWITEK, Short Ragweed Pollen Allergen Extract

状态

延迟

承诺描述

A postmarket electronic medical record study to further describe the safety profile of RAGWITEK in marketed use in the United States. The study will enroll all new users of RAGWITEK identified through electronic medical records in a large U.S. integrated health system for a period of at least three years from launch of RAGWITEK. The study observation period will last for at least 3 years and until at least 10,000 patients are accrued between both postmarketing studies. This study will include early exposures to RAGWITEK, including administration through starter packs provided in physician offices as well as all subsequent exposures.

承诺状态描述

The study completion date has passed and the study has not yet been completed.

报告接收日期

2020/6/15 0:00:00

批准日期

2014/4/17 0:00:00

截止日期

2018/6/30 0:00:00

CDER/CBER

CB

子类型标记