欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/4435/001
药品名称Burana-Gel
活性成分
    • ibuprofen 2.5 g
剂型Gel
上市许可持有人Orion Corporation Orionintie 1 FIN-02200 ESPOO
参考成员国 - 产品名称Germany (DE)
Burana-Gel
互认成员国 - 产品名称
    • Finland (FI)
许可日期2016/10/19
最近更新日期2016/10/20
药物ATC编码
    • M02AA13 ibuprofen
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Bibliographic Art 10 a 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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