MR编号 | NL/H/5138/001 | ||||||
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药品名称 | Monofree Fenil | ||||||
活性成分 |
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剂型 | Eye drops, solution in single-dose container | ||||||
上市许可持有人 | Laboratoires Thea S.A.S. 12 Rue Louis Bleriot Cs 30454 Clermont Ferrand Cedex 2 63017 France | ||||||
参考成员国 - 产品名称 | Netherlands (NL) Monofree Fenil 5%, oogdruppels, oplossing in verpakking voor éénmalig gebruik | ||||||
互认成员国 - 产品名称 |
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许可日期 | 2021/12/17 | ||||||
最近更新日期 | 2021/12/24 | ||||||
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申请类型 | 附件文件下载 | 市场状态 | Withdrawn(注:已撤市) | 撤市原因:1.The company decided to withdraw the application.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. |