| MR编号 | SE/H/1589/002 | ||||||
|---|---|---|---|---|---|---|---|
| 药品名称 | Quetiapine Amneal | ||||||
| 活性成分 |
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| 剂型 | Prolonged-release tablet | ||||||
| 上市许可持有人 | Amneal Pharma Europe Limited | ||||||
| 参考成员国 - 产品名称 | Sweden (SE) | ||||||
| 互认成员国 - 产品名称 |
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| 许可日期 | 2016/10/27 | ||||||
| 最近更新日期 | 2016/11/04 | ||||||
| 药物ATC编码 |
申请类型 | 附件文件下载 | 市场状态 | Withdrawn（注：已撤市） | 撤市原因：1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised. |