欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号MT/H/0582/001
药品名称Dabigatran Etexilate Galgenicum 75 mg hard capsules
活性成分
    • Dabigatran etexilate mesilate 75.0 mg
剂型Capsule, hard
上市许可持有人Galenicum Health S.L. Av. Diagonal 123 Planta 11 08005 – Barcelona Spain
参考成员国 - 产品名称Malta (MT)
Dabigatran Etexilate Galgenicum 75 mg hard capsules
互认成员国 - 产品名称
    • Germany (DE)
      Dabigatran Etexilate Galgenicum 75 mg Hartkapseln
    • Sweden (SE)
    • Denmark (DK)
    • Spain (ES)
    • Finland (FI)
    • France (FR)
    • Greece (GR)
    • Hungary (HU)
      Dabigatran Etexilate Galgenicum 75 mg kemény kapszula
    • Iceland (IS)
    • Netherlands (NL)
    • Austria (AT)
    • Norway (NO)
    • Belgium (BE)
    • Portugal (PT)
许可日期2022/09/15
最近更新日期2022/09/16
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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