MR编号 | NL/H/3864/001 | ||||||
---|---|---|---|---|---|---|---|
药品名称 | Olmesartan medoxomil/Amlodipine Apotex 20mg/5mg film-coated tablets | ||||||
活性成分 |
| ||||||
剂型 | Film-coated tablet | ||||||
上市许可持有人 | Apotex Europe B.V. Archimedesweg 2 2333 CN Leiden The Netherlands | ||||||
参考成员国 - 产品名称 | Netherlands (NL) | ||||||
互认成员国 - 产品名称 |
| ||||||
许可日期 | 2017/10/25 | ||||||
最近更新日期 | 2017/12/06 | ||||||
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申请类型 | 附件文件下载 | 市场状态 | Withdrawn(注:已撤市) | 撤市原因:1.The company decided to withdraw the application.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. |