MR编号 | DE/H/0466/001 |
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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 | - Spain (ES)
BOOSTRIX POLIO SUSPENSIÓN INYECTABLE EN JERINGAS PRECARGABLES - Portugal (PT)
- Italy (IT)
- Greece (GR)
- Sweden (SE)
Boostrix Polio injektionsvätska, suspension i förfylld spruta - Norway (NO)
- Finland (FI)
- Belgium (BE)
- Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
- France (FR)
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许可日期 | 2004/08/09 |
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最近更新日期 | 2016/10/13 |
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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 Article 4.8 Di 65/65
- 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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