欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/1949/001
药品名称Vaxigrip Tetra
活性成分
    • A/Cambodia/e0826360/2020 (H3N2)-like virus 15.0 µg
    • A/Victoria/4897/2022 (H1N1)pdm09-like virus 15.0 µg
    • B/Phuket/3073/2013 15.0 µg
    • B/Washington/02/2019-like strain 15.0 µg
剂型SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
上市许可持有人Sanofi Pasteur or Sanofi Pasteur MSD; Speciality for France Sanofi Pasteur SA is MAH and Sanofi Pasteur MSD SNC is legally responsible for placing the product on the market. For Germany: Sanofi Pastuer MSD GmbH Alexanderufer 3 10117 Berlin Germany
参考成员国 - 产品名称Germany (DE)
Vaxigrip Tetra
互认成员国 - 产品名称
    • Estonia (EE)
    • Denmark (DK)
    • Belgium (BE)
      Vaxigrip Tetra suspension injectable en seringue pré-remplie
    • Netherlands (NL)
    • Luxembourg (LU)
    • Iceland (IS)
      VaxigripTetra 15 míkróg Stungulyf, dreifa í áfylltri sprautu
    • United Kingdom (Northern Ireland) (XI)
      quadrivalent influenza vaccine (split virion, inactivated) sanofi pasteur MSD
    • Ireland (IE)
      quadrivalent influenza vaccine (split virion, inactivated) sanofi pasteur MSD
    • Austria (AT)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
      VAXIGRIP TETRA®
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
      VaxigripTetra
    • Latvia (LV)
      VaxigripTetra suspensija injekcijām pilnšļircē
    • Lithuania (LT)
      VaxigripTetra injekcinė suspensija užpildytame švirkšte
    • Hungary (HU)
      VAXIGRIP TETRA szuszpenziós injekció előretöltött fecskendőben
    • Bulgaria (BG)
    • Cyprus (CY)
    • Czechia (CZ)
      VaxigripTetra
    • Romania (RO)
    • Slovakia (SK)
      VaxigripTetra
    • Slovenia (SI)
    • Malta (MT)
      Vaxigrip Tetra
    • Croatia (HR)
许可日期2016/06/21
最近更新日期2024/01/12
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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