欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/5636/001
药品名称Tacrolimus Sandoz, 0.5 mg, hard capsules
活性成分
    • tacrolimus monohydrate 0.5 mg
剂型Capsule, hard
上市许可持有人Sandoz B.V. Veluwezoom 22 1327 AH Almere Netherlands
参考成员国 - 产品名称Netherlands (NL)
Tacrolimus Sandoz 0,5 mg, harde capsules
互认成员国 - 产品名称
    • France (FR)
许可日期2023/10/06
最近更新日期2023/10/18
药物ATC编码
    • L04AD02 tacrolimus
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Generic Art 10.1 and 10.2 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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