欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/1587/001
药品名称Kyleena
活性成分
    • levonorgestrel 19.5 mg
剂型Intrauterine delivery system
上市许可持有人Bayer AB, Sweden
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Germany (DE)
      Sofitta, 19,5 mg, Intrauterines Wirkstofffreisetzungssystem
    • Denmark (DK)
    • Belgium (BE)
      Kyleena 19,5 mg afleveringsysteem voor intra-uterien gebruik
    • Netherlands (NL)
    • Ireland (IE)
    • Austria (AT)
      Kyleena 19,5 mg intrauterines Wirkstofffreisetzungssystem
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Norway (NO)
      Kyleena
    • Finland (FI)
    • Poland (PL)
      Sofitta
    • Latvia (LV)
      Kyleena 19,5 mg intrauterīna ierīce
    • Lithuania (LT)
      Kyleena 19,5 mg vartojimo į gimdos ertmę sistema
    • Estonia (EE)
      KYLEENA
    • Iceland (IS)
    • Czechia (CZ)
      Sofitta 19.5 mg intrauterinní inzert
    • Slovenia (SI)
许可日期2016/10/03
最近更新日期2023/12/18
药物ATC编码
    • G02BA03 plastic IUD with progestogen
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Art 8.3(i) 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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