欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号MT/H/0642/001
药品名称Dabigatran etexilate STADA Arzneimittel AG Capsules Hard 75mg
活性成分
    • Dabigatran etexilate mesilate 75.0 mg
剂型Capsule, hard
上市许可持有人STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany
参考成员国 - 产品名称Malta (MT)
Dabigatran etexilate STADA Arzneimittel AG Capsules Hard 75mg
互认成员国 - 产品名称
    • Croatia (HR)
    • Denmark (DK)
      Dabigatran etexilate "Stada Nordic"
    • Netherlands (NL)
    • Iceland (IS)
    • Austria (AT)
    • Portugal (PT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Czechia (CZ)
      Dabigatran Etexilate SAG
    • Slovakia (SK)
    • Germany (DE)
      Dabigatran etexilieren SAG 75 mg Hartkapseln
许可日期2023/12/15
最近更新日期2024/12/03
药物ATC编码
    • B01AE07 dabigatran etexilate
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Multiple (Copy) 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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