| MR编号 | HU/H/0403/005 | ||||||
|---|---|---|---|---|---|---|---|
| 药品名称 | Vamloset 10 mg/320 mg film-coated tablet | ||||||
| 活性成分 |
| ||||||
| 剂型 | Film-coated tablet | ||||||
| 上市许可持有人 | Krka, d.d., Novo mesto (SI) in HR: KRKA–FARMA d.o.o. (HR) in DE: HCS bvba (BE) | ||||||
| 参考成员国 - 产品名称 | Hungary (HU) | ||||||
| 互认成员国 - 产品名称 |
| ||||||
| 许可日期 | 2015/10/28 | ||||||
| 最近更新日期 | 2016/10/13 | ||||||
| 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申请类型 | 附件文件下载 | 市场状态 | Withdrawn（注：已撤市） | 撤市原因：1.The company decided to withdraw the application.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. |