欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号HR/H/0254/001
药品名称DIclofenac Alkaloid-INT 1.16 % gel
活性成分
    • Diclofenac diethylamine 1.16 %
剂型Gel
上市许可持有人Alkaloid INT Šlandrova ulica 4, 1231 Ljubljana - Črnuče, Slovenia
参考成员国 - 产品名称Croatia (HR)
互认成员国 - 产品名称
    • Bulgaria (BG)
      Mazenid
    • Czechia (CZ)
      Diclofenac Alkaloid-INT
    • Greece (GR)
    • Italy (IT)
    • Poland (PL)
      Diclofenac Alkaloid-INT
    • Romania (RO)
    • Slovenia (SI)
    • Slovakia (SK)
      Diklofenak-dietylamín Alkaloid-INT 11,6 mg/g gél
许可日期2025/06/23
最近更新日期2025/07/18
药物ATC编码
    • M02AA15 diclofenac
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Hybrid application (Art 10.3 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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