欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号BE/H/0213/001
药品名称Otipax
活性成分
    • lidocaine hydrochloride 1.0 % (W/W)
剂型Ear drops, solution
上市许可持有人Biocodex Benelux SA/NV Rue des Trois Arbres 16a 1180 Brussels Belgium
参考成员国 - 产品名称Belgium (BE)
Otipax 1% Solution pour instillation auriculaire
互认成员国 - 产品名称
    • Austria (AT)
    • Greece (GR)
      OTIPAX
    • Italy (IT)
    • Poland (PL)
      OTIPAX
    • Spain (ES)
    • Portugal (PT)
    • Finland (FI)
    • Cyprus (CY)
    • Sweden (SE)
    • Germany (DE)
      OTIPAX 1 %
    • Denmark (DK)
      Otipax
    • Norway (NO)
许可日期2016/04/28
最近更新日期2017/03/29
药物ATC编码
    • S02DA Analgesics and anesthetics
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Bibliographic Art 10 a Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
    市场状态Withdrawn(注:已撤市)
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