| MR编号 | DE/H/0215/001 |
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| 药品名称 | Repevax, prefilled syringe |
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| 活性成分 | - adsorbed purified diphtheria toxoid, not less than 2.0 IU
- adsorbed purified filamentous haemagglutinin 5.0 µg
- adsorbed purified fimbrial agglutinogens 2 + 3 (FIM) 5.0 µg
- adsorbed purified pertactin (PRN) 3.0 µg
- adsorbed purified pertussis toxoid 2.5 µg
- adsorbed purified tetanus toxoid, not less than 20.0 IU
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| 剂型 | Suspension for injection |
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| 上市许可持有人 | Sanofi Pasteur MSD GmbH
Alexanderufer 3, 10117 Berlin |
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| 参考成员国 - 产品名称 | Germany (DE) Repevax |
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| 互认成员国 - 产品名称 | - Czechia (CZ)
Adacel Polio - Hungary (HU)
ADACEL POLIO szuszpenziós injekció előretöltött fecskendőben - Italy (IT)
- Poland (PL)
- Romania (RO)
Adacel Polio suspensie injectabila in seringa preumpluta - Slovakia (SK)
- Slovenia (SI)
Adacel - Sweden (SE)
- Spain (ES)
- Denmark (DK)
- Belgium (BE)
- Luxembourg (LU)
- Iceland (IS)
- Ireland (IE)
- Austria (AT)
REPEVAX Injektionssuspension in einer Fertigspritze - France (FR)
- Greece (GR)
- Norway (NO)
- Finland (FI)
- United Kingdom (Northern Ireland) (XI)
- Bulgaria (BG)
Adacel Polio - Croatia (HR)
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| 许可日期 | 2002/06/12 |
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| 最近更新日期 | 2025/02/07 |
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| 药物ATC编码 | - J07CA02 diphtheria-pertussis-poliomyelitis-tetanus
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| 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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| 附件文件下载 | |
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| 市场状态 | Positive |
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