欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SE/H/0192/003
药品名称Optinate Septimum
活性成分
    • Risedronic acid 35.0 mg
剂型Film-coated tablet
上市许可持有人Theramex Ireland Limited Ireland
参考成员国 - 产品名称Sweden (SE)
互认成员国 - 产品名称
    • Germany (DE)
    • Denmark (DK)
    • Belgium (BE)
    • Luxembourg (LU)
    • Austria (AT)
      Actonel einmal wöchentlich 35 mg Filmtabletten
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Finland (FI)
    • Hungary (HU)
      ACTONEL 35 mg filmtabletta
    • Cyprus (CY)
    • Netherlands (NL)
许可日期2002/12/03
最近更新日期2024/10/11
药物ATC编码
    • M05BA07 risedronic acid
申请类型
  • TypeLevel1:Line Extension
  • TypeLevel2:Initial Application
  • TypeLevel3:Full Dossier Article 4.8 Di 65/65
  • TypeLevel4:Chemical Substance
  • TypeLevel5:Prescription Only
附件文件下载
市场状态Positive
©2006-2025 Drugfuture->European Union HMA Authorisation of Medicines DataBase