欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号ES/H/0105/001
药品名称Rupafin 10 mg tablets
活性成分
    • rupatadine fumarate 10.0 mg
剂型Tablet
上市许可持有人J. Uriach & Cía., S.A. Av. Camí Reial, 51-57 08184 Palau-solità i Plegamans (Barcelona) Spain
参考成员国 - 产品名称Spain (ES)
互认成员国 - 产品名称
    • Denmark (DK)
    • Iceland (IS)
    • Liechtenstein (LI)
    • Sweden (SE)
    • Norway (NO)
    • Bulgaria (BG)
      Rupafin
    • Romania (RO)
      Tamalis 10 mg Comprimate
    • Croatia (HR)
    • France (FR)
    • Italy (IT)
    • Slovenia (SI)
    • Czechia (CZ)
    • Belgium (BE)
    • Netherlands (NL)
    • Luxembourg (LU)
    • Ireland (IE)
    • Portugal (PT)
    • Greece (GR)
    • Poland (PL)
      Rupafin
    • Latvia (LV)
      Rupafin 10 mg tabletes
    • Lithuania (LT)
      Rupafin 10 mg tabletės
    • Estonia (EE)
      RUPAFIN 1MG/ML ORAL SOLUTION
    • Hungary (HU)
      TAMALIS 10 mg tabletta
    • Slovakia (SK)
      Rupafin 10 mg tablety
    • Austria (AT)
    • Cyprus (CY)
    • Malta (MT)
许可日期2001/10/30
最近更新日期2024/02/22
药物ATC编码
    • R06 ANTIHISTAMINES FOR SYSTEMIC USE
    • R RESPIRATORY SYSTEM
    • R06AX Other antihistamines for systemic use
    • R06A ANTIHISTAMINES FOR SYSTEMIC USE
申请类型
  • TypeLevel1：New Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Full Dossier Article 4.8 Di 65/65
  • TypeLevel4：[not specified]
  • TypeLevel5：Prescription Only
附件文件下载
市场状态Positive
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