欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号SE/H/1428/001
药品名称Soolantra
活性成分
    • ivermectin 10.0 mg/g
剂型Cream
上市许可持有人Galderma Nordic AB Sweden
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Germany (DE)
      Soolantra Creme
    • Denmark (DK)
      Soolantra
    • Belgium (BE)
      Soolantra 10 mg/g crème
    • Netherlands (NL)
      Soolantra 10 mg/g crème
    • Luxembourg (LU)
      Soolantra 10 mg / 1 g crème
    • Iceland (IS)
      Soolantra 10 mg/g Krem
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Austria (AT)
      Soolantra 10 mg/g Creme
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
      SOOLANTRA
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
      Soolantra
    • Latvia (LV)
      Soolantra 10 mg/g krēms
    • Lithuania (LT)
      Soolantra 10 mg/g kremas
    • Estonia (EE)
      SOOLANTRA
    • Hungary (HU)
      SOOLANTRA 10 mg/g krém
    • Bulgaria (BG)
      Soolantra
    • Cyprus (CY)
      SOOLANTRA CREAM
    • Czechia (CZ)
      SOOLANTRA 10MG/G KRÉM
    • Romania (RO)
      SOOLANTRA
    • Slovakia (SK)
      Soolantra 10 mg/g krém
    • Malta (MT)
      Soolantra 10mg/g cream
许可日期2015/03/22
最近更新日期2023/09/07
药物ATC编码
    • D11AX22 ivermectin
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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