欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号ES/H/0105/002
药品名称Rupafin 1 mg/ml oral solution
活性成分
    • rupatadine fumarate 1.0 mg/ml
剂型Oral solution
上市许可持有人J.Uriach and Cia., S.A Avda. Camí Reial, 51-57 08184- Palau-solita i Plegamans Barcelona- Spain
参考成员国 - 产品名称Spain (ES)
Rupafin 1mg/ml solución oral
互认成员国 - 产品名称
    • Denmark (DK)
    • Iceland (IS)
    • Sweden (SE)
    • Norway (NO)
    • Bulgaria (BG)
      Rupafin
    • Romania (RO)
      Tamalis 1 mg/ml Soluţie orală
    • Croatia (HR)
    • Germany (DE)
      Rupafin 1 mg/ml Lösung zum Einnehmen
    • Belgium (BE)
    • Netherlands (NL)
      Rupafin 1 mg / mL oplossing voor oraal gebruik
    • Luxembourg (LU)
    • Ireland (IE)
    • Liechtenstein (LI)
    • Austria (AT)
      Rupafin 1 mg/ml Lösung zum Einnehmen
    • France (FR)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Poland (PL)
      Rupafin
    • Latvia (LV)
      Rupafin 1 mg/ml šķīdums iekšķīgai lietošanai
    • Lithuania (LT)
      Rupafin 1 mg/ml geriamasis tirpalas
    • Estonia (EE)
      RUPAFIN
    • Hungary (HU)
      TAMALIS 1 mg/ml belsőleges oldat
    • Cyprus (CY)
      RUPAFIN ORAL SOLUTION
    • Czechia (CZ)
      Tamalis 1 mg/ml Oral Solution
    • Slovakia (SK)
      Rupafin 1 mg/ml perorálny roztok
    • Slovenia (SI)
      Rupafin 1 mg/ml peroralna raztopina
    • Malta (MT)
许可日期2012/02/09
最近更新日期2024/08/16
药物ATC编码
    • R06AX28 rupatadine
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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