欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/1898/001
药品名称Amiodaron-hameln 50 mg/ml Konzentrat zur Herstellung einer Injektions- /Infusionslösung
活性成分
    • amiodarone hydrochloride 50.0 mg/ml
剂型Solution for injection/infusion
上市许可持有人hameln pharma GmbH Inselstraße 1 31787 Hameln German
参考成员国 - 产品名称Germany (DE)
2174800
互认成员国 - 产品名称
    • United Kingdom (Northern Ireland) (XI)
    • Sweden (SE)
    • Finland (FI)
    • Denmark (DK)
      Amiodaron "Hameln"
    • Netherlands (NL)
      Amiodaron HCl Hameln 50 mg/ml, concentraat voor oplossing voor injectie/infusie
    • Austria (AT)
    • Norway (NO)
    • Poland (PL)
      Amiodaron Hameln
    • Hungary (HU)
      AMIODARON HAMELN 50 mg/ml koncentrátum oldatos injekcióhoz vagy infúzióhoz
    • Bulgaria (BG)
      Amiodaron Hameln
    • Czechia (CZ)
      Amiodaron hameln 50 mg/ml, koncentrát pro injekční roztok/infuzní roztok
    • Romania (RO)
      Amiodaronă hameln 50 mg/ml concentrat pentru soluţie injectabilă/perfuzabilă
    • Slovakia (SK)
    • Slovenia (SI)
    • Croatia (HR)
许可日期2010/07/21
最近更新日期2024/02/01
药物ATC编码
    • C01BD01 amiodarone
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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