欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/5108/001
药品名称Tiolair
活性成分
    • tiotropium bromide 8.8 µg
剂型Inhalation powder, hard capsule
上市许可持有人Laboratoires S.M.B. Rue de la Pastorale 26-28 Molenbeek-Saint-Jean Brussels 1080 Belgium
参考成员国 - 产品名称Netherlands (NL)
Tiolair 8,8 µg, inhalatiepoeder in harde capsule
互认成员国 - 产品名称
    • Belgium (BE)
    • Germany (DE)
      Tiolair 8,8 μg Hartkapsel mit Pulver zur Inhalation
    • Greece (GR)
    • Hungary (HU)
    • Italy (IT)
    • Luxembourg (LU)
    • Portugal (PT)
    • Sweden (SE)
    • Denmark (DK)
许可日期2021/11/19
最近更新日期2022/06/21
药物ATC编码
    • R03BB04 tiotropium bromide
申请类型
  • TypeLevel1:Abridged
  • 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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