MR编号 | DK/H/3022/001 |
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药品名称 | Dronedarone Medical Valley |
活性成分 |
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剂型 | Film-coated tablet |
上市许可持有人 | Medical Valley Invest AB Brädgårdsvägen 28 236 32 - Höllviken Sweden |
参考成员国 - 产品名称 | Denmark (DK) Dronedarone Medical Valley |
互认成员国 - 产品名称 |
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许可日期 | 2021/03/31 |
最近更新日期 | 2021/04/07 |
药物ATC编码 |
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申请类型 |
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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市场状态 | Withdrawn(注:已撤市) 撤市原因:1.The company decided to withdraw the application.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. |