欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号SK/H/0119/001
药品名称Ropinirol Krka 2 mg
活性成分
    • ropinirole hydrochloride 2.0 mg
剂型Prolonged-release tablet
上市许可持有人Krka, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto Slovenia
参考成员国 - 产品名称Slovakia (SK)
Ropinirol Krka 2 mg tablety s predĺženým uvoľňovaním
互认成员国 - 产品名称
    • Denmark (DK)
    • Netherlands (NL)
    • Ireland (IE)
    • Austria (AT)
      Ropinirol Krka 2 mg Retardtabletten
    • Spain (ES)
    • Italy (IT)
    • Sweden (SE)
      Ropinirol Krka
    • Finland (FI)
      ROPINIROL KRKA 2 mg depottabletti
许可日期2010/11/15
最近更新日期2023/07/26
药物ATC编码
    • N04BC04 ropinirole
申请类型
  • TypeLevel1:Abridged
  • TypeLevel2:Multiple (Copy) 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Positive
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