欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/5625/002
药品名称Ambrisentan Accord 10 mg Filmtabletten
活性成分
    • Ambrisentan 10.0 mg
剂型Film-coated tablet
上市许可持有人Accord Healthcare B.V. Winthontlaan 200 3526 KV UTRECHT Niederlande
参考成员国 - 产品名称Germany (DE)
Ambrisentan Accord 10 mg Filmtabletten
互认成员国 - 产品名称
    • Denmark (DK)
      Ambrisentan "Accord"
    • Belgium (BE)
      Ambrisentan Accord 10 mg Filmomhulde tablet
    • Netherlands (NL)
      Ambrisentan Accord 10 mg, filmomhulde tabletten
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Austria (AT)
      Ambrisentan Accord 10 mg Filmtabletten
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
      Ambrisentan Accord
    • Finland (FI)
    • Poland (PL)
      Ambrisentan Accord
    • Bulgaria (BG)
      Ambrisentan Accord
    • Slovenia (SI)
      Ambrisentan Accord 10 mg filmsko obložene tablete
许可日期2019/09/03
最近更新日期2025/08/27
药物ATC编码
    • C02KX02 ambrisentan
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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