欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/6101/001
药品名称Bisacodyl Schmid Pharma, Gastro-resistant tablet, 5 mg
活性成分
    • Bisacodyl 5.0 mg
剂型Gastro-resistant tablet
上市许可持有人Schmid Pharma B.V. Blokweg 8 4761 RA Zevenbergen The Netherlands
参考成员国 - 产品名称Netherlands (NL)
Bisacodyl Schmid Pharma 5 mg gastro-resistant tablet
互认成员国 - 产品名称
    • Poland (PL)
    • Romania (RO)
      Bisacodyl Schmid Pharma 5 mg comprimate gastrorezistente
    • Sweden (SE)
许可日期2025/08/06
最近更新日期2025/08/06
药物ATC编码
    • A06AB02 bisacodyl
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Bibliographic Art 10 a 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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