欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/3764/001
药品名称Solifenacin, 5 mg, film-coated tablets
活性成分
    • solifenacin succinate 5.0 mg
剂型Film-coated tablet
上市许可持有人Stada Arzneimittel AG Stadastr. 2-18 61118 Bad Vilbel Germany
参考成员国 - 产品名称Netherlands (NL)
Solifenacine STADA Arzneimittel AG 5 mg, filmomhulde tabletten
互认成员国 - 产品名称
    许可日期2016/12/19
    最近更新日期2017/05/30
    药物ATC编码
      • G04BD08 solifenacin
    申请类型
    • TypeLevel1：Known Active Substance
    • 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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