欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号EE/H/0262/003
药品名称Olteron
活性成分
    • tramadol hydrochloride 200.0 mg
剂型Prolonged-release tablet
上市许可持有人KRKA, d.d., Novo mesto Šmarješka cesta 6 Novo mesto 8401 Slovenia
参考成员国 - 产品名称Estonia (EE)
Olteron
互认成员国 - 产品名称
    • Denmark (DK)
    • Belgium (BE)
      Tramadol Krka 200 mg tabletten met verlengde afgifte
    • Iceland (IS)
      Tramadol Krka 200 mg forðatafla
    • United Kingdom (Northern Ireland) (XI)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Sweden (SE)
      Tramadol Krka
    • Finland (FI)
    • Poland (PL)
      Tramadol Krka
    • Hungary (HU)
      TRAMADOL KRKA 200 mg retard tabletta
    • Slovakia (SK)
      Tramadol Krka 200 mg tablety s predĺženým uvoľňovaním
    • Croatia (HR)
      Tramadol Krka 200 mg tablete s produljenim oslobađanjem
许可日期2018/10/05
最近更新日期2024/07/12
药物ATC编码
    • N02AX02 tramadol
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
附件文件下载
    市场状态Positive
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