欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/0214/001
药品名称Hepatect CP
活性成分
    • human hepatitis B immunoglobulin 50.0 IU/ml
剂型Solution for infusion
上市许可持有人Biotest Pharma GmbH Landsteinerstrasse 5 D-63303 Dreieich Germany
参考成员国 - 产品名称Germany (DE)
Hepatect CP
互认成员国 - 产品名称
    • Belgium (BE)
    • Netherlands (NL)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Austria (AT)
      Hepatect CP 50 I.E./ml Infusionslösung
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Spain (ES)
    • Poland (PL)
    • Hungary (HU)
      HEPATECT 50 NE/ml oldatos infúzió
    • Bulgaria (BG)
    • Czechia (CZ)
    • Romania (RO)
      HEPATECT CP 50 UI/ml soluţie perfuzabilă
    • Slovenia (SI)
    • Denmark (DK)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Croatia (HR)
    • Lithuania (LT)
      Hepetra 50 TV/ml infuzinis tirpalas
许可日期2001/12/21
最近更新日期2024/08/11
药物ATC编码
    • J06BB04 hepatitis B immunoglobulin
申请类型
  • TypeLevel1：New Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Full Dossier Article 4.8 Di 65/65
  • TypeLevel4：Biological: Blood Product
  • TypeLevel5：Prescription Only
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