欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/3553/001
药品名称Betamethasone Exeltis 1 mg/g cream
活性成分
    • betamethasone valerate 1.0 mg/g
剂型Cream
上市许可持有人Exeltis Healthcare S.L Calle Quintanapalla, 2 – 4a planta 28050 Madrid Spain
参考成员国 - 产品名称Netherlands (NL)
Betamethasone Exeltis 1 mg/g cream
互认成员国 - 产品名称
    • Czechia (CZ)
      BETAMETHASONE EXELTIS 1 mg/g cream
    • Germany (DE)
      Betamethasone Exeltis 1 mg / g Creme
    • Poland (PL)
      Unolte
    • Slovakia (SK)
      Betamethasone Exeltis 1 mg/g krém
许可日期2016/11/25
最近更新日期2017/01/12
药物ATC编码
    • D07AC01 betamethasone
申请类型
  • TypeLevel1:Known Active Substance
  • 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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