申请企业

ALK - Abello A/S

药品名称

Odactra, House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract

状态

未间断

承诺描述

You commit to conduct a postmarket electronic health record (EHR) study to further describe the safety profile of ODACTRA in marketed use in the United States. The study will enroll all new users of ODACTRA identified through a large integrated electronic health records dataset. The study will aim to accrue 10,000 patients over a 5 year period. The primary objective of the study is to estimate the incidence of serious allergic reactions and eosinophilic esophagitis among patients exposed to ODACTRA. The study will assess the first in-office exposures to ODACTRA and subsequent exposures and outcomes (i.e., serious allergic reactions and eosinophilic esophagitis) to the extent that they are available within the EHR system.

承诺状态描述

报告接收日期

2020/4/29 0:00:00

批准日期

2017/3/1 0:00:00

截止日期

2025/2/28 0:00:00

CDER/CBER

CB

子类型标记