欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号DE/H/1933/002
药品名称Covaxis/Triaxis/Adacel
活性成分
    • Aluminium phosphate 1.5 mg
    • diphtheria toxoid, adsorbed 2.0 IU
    • filamentous haemagglutinin of bordetella pertussis 5.0 µg
    • fimbrial-2 and -3 antigens of Bordetella pertussis 5.0 µg
    • pertactin 3.0 µg
    • Pertussis toxoid 2.5 µg
    • tetanus toxoid, adsorbed 20.0 IU
剂型SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
上市许可持有人Sanofi Pasteur Europe 14 Espace Henry Vallée 69007 Lyon Frankreich
参考成员国 - 产品名称Germany (DE)
Covaxis
互认成员国 - 产品名称
    • Denmark (DK)
    • Netherlands (NL)
    • Belgium (BE)
      TRIAXIS suspensie voor injectie in een voorgevulde spuit
    • Luxembourg (LU)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • Austria (AT)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
      TRIAXIS
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
      Adacel
    • Latvia (LV)
      Adacel suspensija injekcijām pilnšļircē
    • Lithuania (LT)
      ADACEL injekcinė suspensija užpildytame švirkšte
    • Estonia (EE)
      ADACEL
    • Hungary (HU)
      ADACEL szuszpenziós injekció előretöltött fecskendőben
    • Bulgaria (BG)
    • Cyprus (CY)
      ADACEL SOL FOR INJ IN PFS
    • Czechia (CZ)
      ADACEL INJEKČNÍ SUSPENZE V PŘEDPLNĚNÉ INJEKČNÍ STŘÍKAČCE
    • Romania (RO)
      ADACEL suspensie injectabilă în seringă preumplută
    • Slovakia (SK)
      ADACEL injekčná suspenzia naplnená v injekčnej striekačke
    • Slovenia (SI)
    • Malta (MT)
      Adacel suspension for injection in pre-filled syringe
    • Croatia (HR)
      Adacel
许可日期2016/04/04
最近更新日期2024/12/20
药物ATC编码
    • J07AJ52 pertussis, purified antigen, combinations with toxoids
申请类型
  • TypeLevel1:Line Extension
  • TypeLevel2:Additional Strength/Form
  • TypeLevel3:Full Dossier Art 8.3(i) Dir 2001/83/EC
  • TypeLevel4:Biological: Vaccine
  • TypeLevel5:Prescription Only
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市场状态Positive
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