欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/2348/001
药品名称Ethinylestradiol/Drospirenon 0.02/3 mg 24+4 Theramex film coated tablets
活性成分
    • Drospirenone 3.0 mg
    • ethinyl estradiol 0.02 mg
剂型Film-coated tablet
上市许可持有人Theramex Ireland Limited Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1 D01 YE64 Ierland
参考成员国 - 产品名称Netherlands (NL)
互认成员国 - 产品名称
    • Belgium (BE)
    • Luxembourg (LU)
    • Ireland (IE)
    • Italy (IT)
    • Poland (PL)
    • Czechia (CZ)
      Drospirenone / Ethinylestradiol Teva
    • Romania (RO)
许可日期2012/07/04
最近更新日期2024/11/19
药物ATC编码
    • G03AA12 drospirenone and ethinylestradiol
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Multiple (Copy) 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Positive
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