MR编号 | DK/H/2887/001 | ||||||
---|---|---|---|---|---|---|---|
药品名称 | Paloregis | ||||||
活性成分 |
| ||||||
剂型 | Prolonged-release tablet | ||||||
上市许可持有人 | EGIS Pharmaceuticals PLC Kereszturi Ut 30-38. 1106 Budapest Hungary | ||||||
参考成员国 - 产品名称 | Denmark (DK) Paloregis | ||||||
互认成员国 - 产品名称 |
| ||||||
许可日期 | 2019/02/19 | ||||||
最近更新日期 | 2019/02/20 | ||||||
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申请类型 | 附件文件下载 | 市场状态 | Withdrawn(注:已撤市) | 撤市原因:1.The company decided to withdraw the application.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. |