欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/3481/002
药品名称Tacrolimus Glenmark 1 mg, capsules, hard
活性成分
    • tacrolimus monohydrate 1.0 mg
剂型Capsule, hard
上市许可持有人Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2 B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom
参考成员国 - 产品名称Netherlands (NL)
Tacrolimus Glenmark 1 mg, capsules, hard
互认成员国 - 产品名称
    • United Kingdom (GB)
许可日期2016/07/21
最近更新日期2016/07/29
药物ATC编码
    • L04AD02 tacrolimus
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Additional Strength/Form
  • 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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