欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/7301/002
药品名称Beclometasondipropionat/Formoterol 200 µg / 6µg DOC Generici Dosieraerosol
活性成分
    • beclometasone dipropionate 200.0 µg
    • Formoterolfumarat dihydrate 6.0 µg
剂型Pressurised inhalation, solution
上市许可持有人Doc Generici S.r.l. Via Filippo Turati 40 Milan 20121 Italy
参考成员国 - 产品名称Germany (DE)
Beclometasondipropionat/Formoterol 200 μg / 6μg DOC Generici Druckgasinhalationslösung
互认成员国 - 产品名称
    • Italy (IT)
许可日期2022/07/06
最近更新日期2022/09/05
药物ATC编码
    • R03AK08 formoterol and beclometasone
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Other Generic application Art 10.3 Dir 2001/83/EC
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
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.
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