欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/7499/001
药品名称Lacosamide Accordpharma 10 mg/ml Sirup
活性成分
    • LACOSAMIDE 10.0 mg/ml
剂型Syrup
上市许可持有人Accord Healthcare S.L.U. World Trade Center, Moll De Barcelona S/n Edificio Este Planta 6a 08039 Barcelona Spain
参考成员国 - 产品名称Germany (DE)
Lacosamide Accordpharma 10 mg/ml Sirup
互认成员国 - 产品名称
    • Austria (AT)
    • Denmark (DK)
    • Finland (FI)
    • France (FR)
    • Ireland (IE)
    • Netherlands (NL)
      Lacosamide Accordpharma 10 mg/ml stroop
    • Sweden (SE)
    • Spain (ES)
许可日期2024/04/11
最近更新日期2024/05/01
药物ATC编码
    • N03AX18 lacosamide
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：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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