欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号PT/H/2795/001
药品名称Ácido zoledrónico Seacross
活性成分
    • Zoledronic acid 5.0 mg/100 ml
剂型Solution for infusion
上市许可持有人Seacross Pharma (Europe) Limited
参考成员国 - 产品名称Portugal (PT)
互认成员国 - 产品名称
    • Netherlands (NL)
    • Ireland (IE)
    • France (FR)
    • Spain (ES)
    • Italy (IT)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Germany (DE)
      Zoledronsäure Seacross 5 mg/100 ml Infusionslösung
    • Denmark (DK)
      Zoledronsyre ”Sun Pharma”
许可日期2024/05/23
最近更新日期2024/10/11
药物ATC编码
    • M05BA08 zoledronic acid
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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