欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号AT/H/1170/002
药品名称Isotretinoin Pharmabide 20 mg Capsules, soft
活性成分
    • isotretinoin 20.0 mg
剂型Capsule, soft
上市许可持有人Laboratoires Bailleul S.A. 10-12 Avenue Pasteur 2310 Luxemburg, Luxembourg
参考成员国 - 产品名称Austria (AT)
互认成员国 - 产品名称
    • Slovakia (SK)
    • Germany (DE)
      Isotretinoin Pharmabide 20 mg Weichkapseln
    • Belgium (BE)
      Isotiorga 20 mg capsules molles
    • Luxembourg (LU)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Estonia (EE)
      Isotiorga
    • Hungary (HU)
      Isotretinoin Pharmabide 20 mg lágy kapszula
    • Czechia (CZ)
      Isotretinoin Pharmabide 20mg cps mol
    • Romania (RO)
许可日期2022/01/11
最近更新日期2024/03/19
药物ATC编码
    • D10BA01 isotretinoin
申请类型
  • TypeLevel1:Known Active Substance
  • TypeLevel2:Initial Application
  • TypeLevel3:Generic Art 10.1 and 10.2 Dir 2001/83/EC
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
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市场状态Positive
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