欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/4910/001
药品名称Atgam
活性成分
    • IMMUNOSERA FOR HUMAN USE, ANIMAL 50.0 mg/ml
剂型Concentrate for solution for infusion
上市许可持有人Pfizer Pharma GmbH Linkstrasse 10 10785 Berlin Germany
参考成员国 - 产品名称Germany (DE)
Atgam
互认成员国 - 产品名称
    • Austria (AT)
    • France (FR)
      Atgam 50 mg/mL solution à diluer pour perfusion
    • Italy (IT)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
    • Denmark (DK)
      Atgam
    • Latvia (LV)
    • Belgium (BE)
      Atgam 50 mg/ml Solution à diluer pour perfusion
    • Romania (RO)
    • Netherlands (NL)
    • Slovenia (SI)
    • Luxembourg (LU)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
许可日期2021/12/07
最近更新日期2024/03/08
药物ATC编码
    • L04AA03 antilymphocyte immunoglobulin (horse)
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
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