MR编号 | NL/H/5552/001 |
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药品名称 | Edicot-Opto 3.35 mg/ml eye drops, solution in single-dose container |
活性成分 |
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剂型 | Eye drops, solution in single-dose container |
上市许可持有人 | Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. 14th km National Road 1, Building B Kifisia 145 64 Greece |
参考成员国 - 产品名称 | Netherlands (NL) Edicot-Opto 3,35 mg/ml oogdruppels, oplossing |
互认成员国 - 产品名称 |
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许可日期 | 2023/10/18 |
最近更新日期 | 2023/10/26 |
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市场状态 | Withdrawn(注:已撤市) 撤市原因:1.The company decided to withdraw the application.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. |