欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号IE/H/1111/001
药品名称Doxylamine/Pyridoxine Exeltis 10/10mg Gastro-resistant Tablet
活性成分
    • Doxylamine succinate 10.0 mg
    • PYRIDOXINE HYDROCHLORIDE 10.0 mg
剂型Gastro-resistant tablet
上市许可持有人Exeltis Healthcare S.L. Avda. Miralcampo 7 - Polígono Industrial Miralcampo 19200 - Azuqueca de Henares (Guadalajara) Spain
参考成员国 - 产品名称Ireland (IE)
互认成员国 - 产品名称
    • Czechia (CZ)
      Bonjesta
    • Poland (PL)
    • Belgium (BE)
    • Latvia (LV)
    • Hungary (HU)
      Bonjesta
    • Austria (AT)
    • Germany (DE)
      XONVEA 10 mg/10 mg magensaftresistente Tabletten
    • Estonia (EE)
    • France (FR)
    • Slovakia (SK)
    • Spain (ES)
    • Lithuania (LT)
      -
    • Italy (IT)
许可日期2021/09/09
最近更新日期2025/03/25
药物ATC编码
    • R06AA59 doxylamine, combinations
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
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市场状态Positive
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