欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号IE/H/1132/001
药品名称Ibuprofen 200mg Oral Lyophilisate
活性成分
    • ibuprofen 200.0 mg
剂型Oral lyophilisate
上市许可持有人Catalent Germany Schorndorf GmbH Steinbeisstr. 1 and 2 Schorndorf, Baden-Wuerttemberg 73614 Germany
参考成员国 - 产品名称Ireland (IE)
互认成员国 - 产品名称
    • Italy (IT)
许可日期2022/01/25
最近更新日期2022/02/25
药物ATC编码
    • M01AE01 ibuprofen
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:Non Prescription (including OTC)
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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