欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/4915/001
药品名称Xembify
活性成分
    • Human normal immunoglobulin 200.0 mg/ml
剂型Solution for injection
上市许可持有人Instituto Grifols, S.A., Calle Can Guasch 2, Poligono Industrial Levante, 08150 Parets Del Vallès, Barcelona, Spain
参考成员国 - 产品名称Germany (DE)
Xembify 200 mg/ml solution for injection
互认成员国 - 产品名称
    • Austria (AT)
    • Iceland (IS)
    • Spain (ES)
    • Greece (GR)
    • Portugal (PT)
    • Italy (IT)
    • Norway (NO)
    • Sweden (SE)
    • Poland (PL)
      Xembify
    • Finland (FI)
    • Czechia (CZ)
      Xembify
    • Slovakia (SK)
    • United Kingdom (Northern Ireland) (XI)
    • Belgium (BE)
    • Netherlands (NL)
      Xembify 200 mg/ml oplossing voor subcutane injectie
    • Denmark (DK)
    • France (FR)
许可日期2021/09/23
最近更新日期2025/08/18
药物ATC编码
    • J06BA01 immunoglobulins, normal human, for extravascular adm.
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4：Biological: Blood Product
  • TypeLevel5：Prescription Only
附件文件下载
市场状态Positive
©2006-2025 Drugfuture->European Union HMA Authorisation of Medicines DataBase