欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/0215/002
药品名称Repevax, vial
活性成分
    • adsorbed purified diphtheria toxoid, not less than 2.0 IU
    • adsorbed purified filamentous haemagglutinin 5.0 µg
    • adsorbed purified fimbrial agglutinogens 2 + 3 (FIM) 5.0 µg
    • adsorbed purified pertactin (PRN) 3.0 µg
    • adsorbed purified pertussis toxoid 2.5 µg
    • adsorbed purified tetanus toxoid, not less than 20.0 IU
剂型Suspension for injection
上市许可持有人Sanofi Pasteur MSD GmbH Paul-Ehrlich-Str. 1 D-69181 Leimen
参考成员国 - 产品名称Germany (DE)
Repevax
互认成员国 - 产品名称
    • France (FR)
    • Norway (NO)
    • Denmark (DK)
    • Luxembourg (LU)
    • Iceland (IS)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Greece (GR)
    • Finland (FI)
许可日期2002/06/12
最近更新日期2024/08/19
药物ATC编码
    • J07CA02 diphtheria-pertussis-poliomyelitis-tetanus
申请类型
  • TypeLevel1：New Active Substance
  • TypeLevel2：Additional Strength/Form
  • TypeLevel3：Full Dossier Article 4.8 Di 65/65
  • TypeLevel4：Biological: Vaccine
  • TypeLevel5：Prescription Only
附件文件下载
市场状态Positive
©2006-2024 Drugfuture->European Union HMA Authorisation of Medicines DataBase