欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号AT/H/0631/001
药品名称Cuvitru 200 mg/ml Solution for Injection
活性成分
    • Human normal immunoglobulin 200.0 mg/ml
剂型Solution for injection
上市许可持有人Baxalta Innovations GmbH Industriestrasse 67 1221 Vienna Austria
参考成员国 - 产品名称Austria (AT)
Cuvitru 200 mg/ml Injektionslösung zur subkutanen Anwendung
互认成员国 - 产品名称
    • Germany (DE)
    • Denmark (DK)
    • Belgium (BE)
      Cuvitru 200 mg/ml solution injectable sous-cutanée
    • Netherlands (NL)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • France (FR)
    • Spain (ES)
    • Italy (IT)
    • Sweden (SE)
    • Norway (NO)
      Cuvitru
    • Finland (FI)
    • Poland (PL)
      Cuvitru
    • Czechia (CZ)
      Ventygard 200 mg/ ml solution for injection
    • Slovakia (SK)
许可日期2016/06/08
最近更新日期2024/10/07
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
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市场状态Positive
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