MR编号 | DE/H/7289/002 |
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药品名称 | Beclometasone dipropionate/formoterol fumarate dihydrate Polpharma pressurised inhalation solution; 200/6 mcg per actuation |
活性成分 |
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剂型 | Pressurised inhalation, solution |
上市许可持有人 | Zakłady Farmaceutyczne Polpharma S.A. Ul. Peplinska 19 Starogard Gdanski Pomorskie 83-200 Poland |
参考成员国 - 产品名称 | Germany (DE) Beclometasone dipropionate/formoterol fumarate dihydrate Druckgasinhalation, Lösung; 200/6 mcg pro Anwendung |
互认成员国 - 产品名称 |
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许可日期 | 2022/07/06 |
最近更新日期 | 2023/04/19 |
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市场状态 | Withdrawn(注:已撤市) 撤市原因:1.The company decided to withdraw the application.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. |