欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/0575/004
药品名称Abstral
活性成分
    • fentanyl citrate 300.0 µg
剂型Sublingual tablet
上市许可持有人Kyowa Kirin Holdings B.V. Netherlands
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Germany (DE)
    • Portugal (PT)
    • Greece (GR)
    • Netherlands (NL)
    • Czechia (CZ)
    • Lithuania (LT)
      Lunaldin 300 mikrogramų poliežuvinės tabletės
    • Finland (FI)
    • Norway (NO)
    • Italy (IT)
    • Spain (ES)
    • France (FR)
    • Ireland (IE)
    • United Kingdom (Northern Ireland) (XI)
    • Iceland (IS)
      Abstral 300 míkróg tungurótartafla
    • Denmark (DK)
    • Latvia (LV)
    • Slovenia (SI)
    • Cyprus (CY)
    • Romania (RO)
      Lunaldin 300 micrograme comprimate sublinguale
    • Estonia (EE)
      LUNALDIN
许可日期2008/09/12
最近更新日期2024/08/30
药物ATC编码
    • N02AB03 fentanyl
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Additional Strength/Form
  • 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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