欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DK/H/3066/002
药品名称Levosert One
活性成分
    • levonorgestrel 52.0 mg
剂型Intrauterine delivery system
上市许可持有人Chemical Works Of Gedeon Richter PLC Gyömrői Út 19-21 1103 Budapest Hungary
参考成员国 - 产品名称Denmark (DK)
Levosert One
互认成员国 - 产品名称
    • Spain (ES)
    • Italy (IT)
    • Sweden (SE)
    • Norway (NO)
      Levosertone
    • Cyprus (CY)
      Levosert One 52 mcg (20mcg/24h) Intrauterine delivery system
    • Slovenia (SI)
      Levosert SHI 20 mikrogramov/24 ur intrauterini dostavni sistem
    • Malta (MT)
    • United Kingdom (Northern Ireland) (XI)
    • Germany (DE)
      Levosert One
    • Iceland (IS)
      Levosertone 20/24 míkróg/klst. Leginnlegg
    • Ireland (IE)
    • Austria (AT)
      Levosert One 20 Mikrogramm/24 Stunden intrauterines Wirkstofffreisetzungssystem
许可日期2021/04/22
最近更新日期2024/07/31
药物ATC编码
    • G02BA03 plastic IUD with progestogen
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
附件文件下载
市场状态Positive
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