MR编号 | NL/H/5463/001 | ||||||
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药品名称 | Ovalute vaginal capsules | ||||||
活性成分 |
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剂型 | Vaginal capsule, soft | ||||||
上市许可持有人 | Theramex Ireland Ltd 3rd Floor, Kilmore House, Park Lane Spencer Dock, Dublin 1, DOI YE64 Ireland | ||||||
参考成员国 - 产品名称 | Netherlands (NL) Ovalute 100 mg, zachte capsule voor vaginaal gebruik | ||||||
互认成员国 - 产品名称 |
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许可日期 | 2023/03/27 | ||||||
最近更新日期 | 2023/03/28 | ||||||
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申请类型 | 附件文件下载 | 市场状态 | Withdrawn(注:已撤市) | 撤市原因:1.The company decided to withdraw the application.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. |