欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/2300/003
药品名称Bilaxten 2,5 mg / ml Lösung zum Einnehmen
活性成分
    • bilastine 2.5 mg
剂型Oral solution
上市许可持有人Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare 1611 Luxembourg Luxembourg
参考成员国 - 产品名称Germany (DE)
Bilaxten 2,5 mg/ml Lösung zum Einnehmen
互认成员国 - 产品名称
    • Denmark (DK)
    • Belgium (BE)
    • Luxembourg (LU)
    • Iceland (IS)
    • Ireland (IE)
    • Austria (AT)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
      Clatra
    • Latvia (LV)
      Opexa 2,5 mg/ml šķīdums iekšķīgai lietošanai
    • Lithuania (LT)
    • Estonia (EE)
      OPEXA
    • Hungary (HU)
      LENDIN 2,5 mg/ml belsőleges oldat
    • Bulgaria (BG)
    • Cyprus (CY)
    • Czechia (CZ)
    • Romania (RO)
    • Slovakia (SK)
    • Slovenia (SI)
    • Malta (MT)
    • United Kingdom (Northern Ireland) (XI)
许可日期2017/06/12
最近更新日期2025/09/19
药物ATC编码
    • R06AX29 bilastine
申请类型
  • TypeLevel1：Abridged
  • TypeLevel2：Additional Strength/Form
  • 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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