| 商品名称 | Optimark |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Magnetic Resonance Imaging |
| 通用名/非专利名称 | gadoversetamide |
| 活性成分 | gadoversetamide |
| 产品号 | EMEA/H/C/000745 |
| 患者安全信息 | no |
| 授权状态 | Withdrawn |
| ATC编码 | V08CA06 |
| 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 | 2007/07/23 |
| 上市许可持有人/公司名称 | Mallinckrodt Deutschland GmbH |
| 人用药物治疗分组 | Contrast media |
| 决定日期 | 2017/04/11 |
| 修订号 | 14 |
| 适应症 | This medicinal product is for diagnostic use only.Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology. |
| 首次发布日期 | 2017/04/11 |
| 修订日期 | 2017/12/11 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/optimark-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/optimark |