| MR编号 | DE/H/1933/002 |
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| 药品名称 | Covaxis/Triaxis/Adacel |
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| 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
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| 剂型 | SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE |
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| 上市许可持有人 | Sanofi Pasteur Europe
14 Espace Henry Vallée
69007 Lyon
Frankreich |
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| 参考成员国 - 产品名称 | Germany (DE) Covaxis |
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| 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
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| 许可日期 | 2016/04/04 |
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| 最近更新日期 | 2025/09/10 |
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| 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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| 附件文件下载 | |
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| 市场状态 | Positive |
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