欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/2117/003
药品名称Desmopressin
活性成分
    • desmopressin acetate 240.0 µg
剂型Sublingual tablet
上市许可持有人Billev Pharma ApS, Denmark
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Romania (RO)
      Desmopresină 240 μg comprimate sublinguale
    • Czechia (CZ)
      Desmopressin 240 mcg sublingvální tablety
    • Finland (FI)
    • France (FR)
    • Italy (IT)
    • Netherlands (NL)
    • Norway (NO)
    • Poland (PL)
      Desmopressin Billev
    • Portugal (PT)
    • Slovakia (SK)
许可日期2021/12/22
最近更新日期2023/12/14
药物ATC编码
    • H01BA02 desmopressin
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Withdrawn（注：已撤市）
    撤市原因：1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised.
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