| MR编号 | DE/H/0466/003 |
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| 药品名称 | Boostrix Polio, prefilled syringe |
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| 活性成分 | - Diphtheria toxoid 2.5 Lf
- filamentous haemagglutinin of bordetella pertussis 8.0 µg
- inactivated type I poliovirus 40.0 D-Antigeneinhe
- inactivated type II poliovirus 8.0 D-Antigeneinhe
- inactivated type III poliovirus 32.0 [no unit]
- pertactin 2.5 µg
- Pertussis toxoid 0.0 µg
- Tetanus toxoid 5.0 Lf
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| 剂型 | Suspension for injection |
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| 上市许可持有人 | GlaxoSmithKline GmbH & Co.KG
Theresienhöhe 11
D-80339 München |
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| 参考成员国 - 产品名称 | Germany (DE) |
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| 互认成员国 - 产品名称 | - 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)
- Lithuania (LT)
- Hungary (HU)
- Bulgaria (BG)
- Czechia (CZ)
- Romania (RO)
- Slovakia (SK)
- Slovenia (SI)
- Malta (MT)
|
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| 许可日期 | 2006/09/01 |
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| 最近更新日期 | 2024/12/21 |
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| 药物ATC编码 | - J07CA02 diphtheria-pertussis-poliomyelitis-tetanus
|
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| 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
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| 附件文件下载 | |
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| 市场状态 | Positive |
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