欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/0210/001
药品名称Boostrix, prefilled syringe
活性成分
    • Diphtherie-Toxoid, adsorbiert 2.0 IU
    • Filamentöses Hämagglutinin 8.0 µg
    • Pertactin (PRN) 2.5 µg
    • Pertussis-Toxoid 8.0 µg
    • Tetanus-Toxoid, adsorbiert 20.0 IU
剂型Suspension for injection
上市许可持有人GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 80339 München Germany
参考成员国 - 产品名称Germany (DE)
Boostrix
互认成员国 - 产品名称
    • Lithuania (LT)
      Boostrix >2 TV/>=20 TV/8 µg/8 µg/2,5 µg injekcinė suspensija užpildytame švirkšte
    • Estonia (EE)
    • Hungary (HU)
    • Bulgaria (BG)
    • Cyprus (CY)
    • Czechia (CZ)
    • Slovakia (SK)
    • Slovenia (SI)
    • Malta (MT)
    • Croatia (HR)
    • Romania (RO)
    • Denmark (DK)
    • Belgium (BE)
    • Netherlands (NL)
    • Luxembourg (LU)
    • Iceland (IS)
    • Ireland (IE)
    • Austria (AT)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Italy (IT)
    • Greece (GR)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
    • Latvia (LV)
许可日期2000/10/03
最近更新日期2024/03/29
药物ATC编码
    • J07AJ52 pertussis, purified antigen, combinations with toxoids
申请类型
  • TypeLevel1：New Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Full Dossier Article 4.8 Di 65/65
  • TypeLevel4：Biological: Vaccine
  • TypeLevel5：Prescription Only
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市场状态Positive
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