欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号AT/H/1156/001
药品名称Dabigatranetexilat Sandoz 75 mg - Hartkapseln
活性成分
    • Dabigatranetexilatmesilat 75.0 mg
剂型Capsule, hard
上市许可持有人Sandoz GmbH Biochemiestraße 10 6250 Kundl Austria
参考成员国 - 产品名称Austria (AT)
互认成员国 - 产品名称
    • Portugal (PT)
    • Italy (IT)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Germany (DE)
      Dabigatran Sandoz 75 mg - Hartkapseln
    • Hungary (HU)
      Dabigatran Sandoz 75 mg kemény kapszula
    • Denmark (DK)
      Dabigatran etexilate ”Sandoz”
    • United Kingdom (Northern Ireland) (XI)
    • Belgium (BE)
    • Netherlands (NL)
    • Iceland (IS)
      Dabigatran etexilate Sandoz XX mg hörð hylki
    • France (FR)
    • Spain (ES)
许可日期2023/08/11
最近更新日期2024/11/22
药物ATC编码
    • B01AE07 dabigatran etexilate
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Initial Application
  • TypeLevel3：Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
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市场状态Positive
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