欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号FR/H/0610/001
药品名称Ozaline 2 mg/ml, oral solution
活性成分
    • midazolam 2.0 mg/ml
剂型Oral solution
上市许可持有人PRIMEX PHARMACEUTICALS OY Mariankatu 21 C 00170 Helsinki FINLANDE
参考成员国 - 产品名称France (FR)
互认成员国 - 产品名称
    • Austria (AT)
    • Belgium (BE)
    • Germany (DE)
      OZALIN 2 mg/ml Lösung zum Einnehmen
    • Greece (GR)
    • Ireland (IE)
    • Poland (PL)
      OZASED
    • Portugal (PT)
    • Spain (ES)
    • Sweden (SE)
    • Denmark (DK)
    • Netherlands (NL)
      Ozalin 2 mg/ml, orale oplossing
    • Italy (IT)
    • Norway (NO)
      Ozalin
    • Finland (FI)
许可日期2018/09/10
最近更新日期2023/11/20
药物ATC编码
    • N05CD08 midazolam
申请类型
  • TypeLevel1:Known Active Substance
  • 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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