欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号ES/H/0626/001
药品名称Amiodarone Accord 300 mg/ml solution for injection/infusion in pre-filled syringe
活性成分
    • Amiodarone hydrochloride 30.0 mg/ml
剂型Solution for injection/infusion in pre-filled syringe
上市许可持有人ACCORD HEALTHCARE, S.L.U Moll de Barcelona s/n. World Trade Center. Edifici Est 6ª planta Barcelona SPAIN
参考成员国 - 产品名称Spain (ES)
互认成员国 - 产品名称
    • Germany (DE)
      Amiodaron 300 mg Lösung zur Injektion/Infusion in einer Fertigspritze
    • Portugal (PT)
    • Italy (IT)
    • Norway (NO)
      Amiodarone Accord
    • Czechia (CZ)
      Amiodarone Accord 300 mg injekční/infuzní roztok v předplněné injekční stříkačce
    • Romania (RO)
      Amiodarona Accord 300 mg soluție injectabilă / perfuzabilă în seringă preumplută
许可日期2020/10/06
最近更新日期2024/10/01
药物ATC编码
    • C01BD01 amiodarone
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Initial Application
  • TypeLevel3:Other Generic application Art 10.3 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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    市场状态Positive
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