欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DK/H/2486/002
药品名称Bosentan Cipla
活性成分
    • bosentan monohydrate 125.0 mg
剂型Film-coated tablet
上市许可持有人Cipla (EU) Limited Dixcart House Addlestone Road Bourne Business Park Addlestone, Surrey KT15 2LE United Kingdom
参考成员国 - 产品名称Denmark (DK)
Bosentan Cipla
互认成员国 - 产品名称
    • Germany (DE)
      Bosentan Cipla 125 mg Filmtabletten
    • Spain (ES)
    • Norway (NO)
      Bosentan Cipla
    • Slovakia (SK)
      Bosentan Cipla 125 mg filmom obalené tablety
    • Croatia (HR)
      Bosentan Cipla 125 mg filmom obložene tablete
许可日期2016/05/18
最近更新日期2024/08/14
药物ATC编码
    • C02KX01 bosentan
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Additional Strength/Form
  • 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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