欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/0211/002
药品名称Rhophylac 300
活性成分
    • human anti-D immunoglobulin 1500.0 IU
剂型Solution for injection
上市许可持有人CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg Germany
参考成员国 - 产品名称Germany (DE)
Rhophylac 300
互认成员国 - 产品名称
    • Cyprus (CY)
    • Denmark (DK)
    • Belgium (BE)
    • Netherlands (NL)
    • Luxembourg (LU)
    • Iceland (IS)
    • Austria (AT)
    • Romania (RO)
      Rhophylac 300 micrograme/2 ml, soluţie injectabilă în seringă preumplută
    • France (FR)
    • Spain (ES)
    • Italy (IT)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
      Rhophylac 300
    • Hungary (HU)
    • Czechia (CZ)
    • Slovakia (SK)
    • Slovenia (SI)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Portugal (PT)
    • Greece (GR)
    • Malta (MT)
许可日期2001/09/27
最近更新日期2024/04/05
药物ATC编码
    • J06BB01 anti-D (rh) 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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市场状态Positive
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