欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DK/H/3528/001
药品名称Acetylsalicylic acid Uni-Pharma
活性成分
    • acetylsalicylic acid 50.0 mg
剂型Gastro-resistant tablet
上市许可持有人Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. 14th km National Road 1 Building B 145 64 Kifisia Greece
参考成员国 - 产品名称Denmark (DK)
Acetylsalicylic acid Uni-Pharma
互认成员国 - 产品名称
    • Cyprus (CY)
    • Greece (EL)
许可日期2025/12/18
最近更新日期2025/12/18
药物ATC编码
    • B01AC06 acetylsalicylic acid
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Bibliographic
  • 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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