欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/2023/002
药品名称Utrogestan
活性成分
    • Progesterone 400.0 mg
剂型Vaginal capsule, soft
上市许可持有人Besins Healthcare Ireland Limited Ireland
参考成员国 - 产品名称Sweden (SE)
Utrogestan
互认成员国 - 产品名称
    • Iceland (IS)
    • Latvia (LV)
    • Ireland (IE)
    • Lithuania (LT)
      Progesterone Besins 400 mg makšties minkštosios kapsulės
    • France (FR)
    • Poland (PL)
      Utrogestan
    • Spain (ES)
    • Slovenia (SI)
    • Norway (NO)
    • Portugal (PT)
    • Slovakia (SK)
    • Finland (FI)
    • Italy (IT)
    • Cyprus (CY)
      Utrogestan Vaginal 400 mg Capsule, soft
    • Bulgaria (BG)
      Urogestan
    • Malta (MT)
      Utrogestan 400mg soft vaginal capsules
    • Denmark (DK)
      Progestan
    • Czechia (CZ)
      Progesteron Besins
    • Belgium (BE)
      Utrogestan Vaginal 400 mg capsule molle vaginale
    • Estonia (EE)
    • Netherlands (NL)
      Utrogestan 400 mg, zachte capsules voor vaginaal gebruik
    • Croatia (HR)
    • Luxembourg (LU)
    • Hungary (HU)
      Utrogestan
许可日期2023/09/20
最近更新日期2025/08/14
药物ATC编码
    • G03DA04 progesterone
申请类型
  • TypeLevel1：Line Extension
  • 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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