欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/4925/001
药品名称Influsplit (Fluarix)
活性成分
    • A/Croatia/10136RV/2023 (H3N2)-like virus 15.0 µg
    • A/Victoria/4897/2022 (H1N1)pdm09-like virus 15.0 µg
    • B/Austria/1359417/2021 (B/Victoria lineage)-like virus 15.0 µg
剂型Suspension for injection in pre-filled syringe
上市许可持有人GlaxoSmithKline GmbH & Co. KG Prinzregentenplatz 9 81675 Munich Germany
参考成员国 - 产品名称Germany (DE)
Influsplit
互认成员国 - 产品名称
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Sweden (SE)
      Fluarix
    • Norway (NO)
    • Finland (FI)
    • Belgium (BE)
      Alpharix suspension injectable en seringue préremplie
    • Poland (PL)
      Fluarix
    • Netherlands (NL)
    • Luxembourg (LU)
    • Austria (AT)
    • France (FR)
许可日期2025/02/06
最近更新日期2025/07/17
药物ATC编码
    • J07BB02 influenza, inactivated, split virus or surface antigen
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4：Biological: Vaccine
  • TypeLevel5：Prescription Only
附件文件下载
市场状态Positive
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