欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号PT/H/0653/001
药品名称Ácido Zoledrónico Kabi
活性成分
    • zoledronic acid 0.8 mg/ml
剂型Concentrate for solution for infusion
上市许可持有人Fresenius Kabi Pharma Portugal, Lda.
参考成员国 - 产品名称Portugal (PT)
互认成员国 - 产品名称
    • Germany (DE)
      Zoledronsäure Kabi 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung
    • Denmark (DK)
      Zoledronsyre "Fresenius Kabi"
    • Belgium (BE)
    • Netherlands (NL)
    • Luxembourg (LU)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Austria (AT)
      Zoledronsäure Kabi 4 mg/5 ml Konzentrat zur Herstellung einer Infusionslösung
    • France (FR)
    • Spain (ES)
    • Italy (IT)
    • Sweden (SE)
    • Norway (NO)
      Zoledronsyre Fresenius Kabi
    • Finland (FI)
    • Poland (PL)
    • Latvia (LV)
      Zoledronic acid Fresenius Kabi 4 mg/5 ml koncentrāts infūziju šķīduma pagatavošanai
    • Lithuania (LT)
      Zoledronic acid Fresenius Kabi 4 mg/5 ml koncentratas infuziniam tirpalui
    • Estonia (EE)
      ZOLEDRONIC ACID FRESENIUS KABI 4MG/5ML
    • Hungary (HU)
      ZOLEDRONSAV FRESENIUS KABI 4 mg/5 ml koncentrátum oldatos infúzióhoz
    • Bulgaria (BG)
      Zoledronic acid Fresenius Kabi
    • Czechia (CZ)
      Zoledronic Acid Fresenius Kabi 4 mg/5 ml
    • Romania (RO)
      Acid zoledronic Fresenius Kabi 4 mg/5 ml concentrat pentru solutie perfuzabila
    • Slovakia (SK)
      Zoledronic Acid Fresenius Kabi 4 mg/5 ml infúzny koncentrát
    • Slovenia (SI)
许可日期2012/07/30
最近更新日期2023/11/21
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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