MR编号 | HU/H/0403/004 | ||||||
---|---|---|---|---|---|---|---|
药品名称 | Vamloset 5 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申请类型 | 附件文件下载 | 市场状态 | Withdrawn(注:已撤市) | 撤市原因:1.The company decided to withdraw the application.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. |