欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号NL/H/2181/004
药品名称Letiram 1000 mg, tablets
活性成分
    • levetiracetam 250.0 mg
    • levetiracetam 500.0 mg
    • levetiracetam 750.0 mg
    • levetiracetam 1000.0 mg
剂型Film-coated tablet
上市许可持有人PharOS - Pharmaceutical Oriented Services Ltd. 87, Marathonos Ave & Salaminas str. 153 51 Pallini Attikis, Greece
参考成员国 - 产品名称Netherlands (NL)
Letiram 1000 mg, filmomhulde tabletten
互认成员国 - 产品名称
    • Poland (PL)
      TRUND
    • Latvia (LV)
      Epiletam 1000 mg apvalkotās tabletes
    • Lithuania (LT)
      EPILETAM 1000 mg plėvele dengtos tabletės
    • Hungary (HU)
    • Bulgaria (BG)
      Letiram
    • Cyprus (CY)
      LETIRAM FC TABS
    • Czechia (CZ)
      Epiletam 1000 mg
    • Romania (RO)
      Epiletam 1000mg comprimate filmate
    • Slovakia (SK)
      Epiletam 1000 mg
许可日期2011/08/24
最近更新日期2012/07/30
药物ATC编码
    • N03AX14 levetiracetam
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Multiple (Copy) 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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