MR编号 | NL/H/2843/002 |
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药品名称 | Acetylcysteïne Alpex 600 mg Granulaat voor drank |
活性成分 |
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剂型 | Granules for oral solution |
上市许可持有人 | Alpex Pharma (UK) Limited PO BOX 849 -Haynes-Bedford MK45 9EG UK |
参考成员国 - 产品名称 | Netherlands (NL) Acetylcysteine Alpex |
互认成员国 - 产品名称 |
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许可日期 | 2016/02/09 |
最近更新日期 | 2016/02/16 |
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市场状态 | Withdrawn(注:已撤市) 撤市原因:1.The company decided to withdraw the application.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. |