商品名称 | Exubera |
---|---|
适用类别 | Human |
治疗领域 | Diabetes Mellitus |
通用名/非专利名称 | insulin human |
活性成分 | Insulin human |
产品号 | EMEA/H/C/000588 |
患者安全信息 | no |
授权状态 | Withdrawn |
ATC编码 | A10AF01 |
是否额外监管 | no |
是否仿制药 | no |
是否生物类似药 | no |
是否附条件批准 | no |
是否特殊情形 | no |
是否加速审评 | no |
是否罕用药 | no |
批准上市日期 | 2006/01/24 |
上市许可持有人/公司名称 | Pfizer Limited |
人用药物治疗分组 | Drugs used in diabetes |
决定日期 | 2008/07/09 |
修订号 | 6 |
适应症 | EXUBERA is indicated for the treatment of adult patients with type 2 diabetes mellitus notadequately controlled with oral antidiabetic agents and requiring insulin therapy.EXUBERA is also indicated for the treatment of adult patients with type 1 diabetes mellitus, inaddition to long or intermediate acting subcutaneous insulin, for whom the potential benefits ofadding inhaled insulin outweigh the potential safety concerns (see section 4.4). |
首次发布日期 | 2008/07/09 |
修订日期 | 2008/11/16 |
产品信息 | https://www.ema.europa.eu/en/documents/product-information/exubera-epar-product-information_en.pdf |
公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/exubera |