欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号NL/H/4787/001
药品名称Ambrisentan AOP 5 mg
活性成分
    • ambrisentan 5.0 mg
剂型Film-coated tablet
上市许可持有人AOP Orphan Pharmaceuticals AG Wilhelminenstrasse 91/IIf Ottakring Wien Austria
参考成员国 - 产品名称Netherlands (NL)
Ambrisentan 5 mg
互认成员国 - 产品名称
    • Germany (DE)
      Ambrisentan AOP 5 mg Filmtabletten
    • Denmark (DK)
    • Austria (AT)
      Ambrisentan AOP 5 mg Filmtabletten
    • Sweden (SE)
    • Norway (NO)
      Ambrisentan AOP
    • Poland (PL)
      Ambrisentan AOP
    • Latvia (LV)
      Ambrisentan AOP 5 mg apvalkotās tabletes
    • Lithuania (LT)
      Ambrisentan AOP 5 mg plėvele dengtos tabletės
    • Estonia (EE)
      AMBRISENTAN AOP
    • Hungary (HU)
    • Czechia (CZ)
      Ambrisentan AOP
    • Romania (RO)
    • Slovakia (SK)
      Ambrisentan AOP 5 mg filmom obalené tablety
    • Slovenia (SI)
    • Croatia (HR)
      Ambrisentan AOP 5 mg filmom obložene tablete
许可日期2020/09/29
最近更新日期2024/03/18
药物ATC编码
    • C02KX02 ambrisentan
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Positive
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