| MR编号 | NL/H/3844/001 |
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| 药品名称 | Influvac Tetra |
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| 活性成分 | - A/California/7/2009 (H1N1)pdm09-like virus 15.0 µg
- A/Texas/50/2012 (H3N2) like virus 15.0 µg
- B/Brisbane/60/2008 15.0 µg
- B/Massachusetts/2/2012-like virus 15.0 µg
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| 剂型 | SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE |
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| 上市许可持有人 | Abbott Biologicals B.V.
C.J. van Houtenlaan 36
Weesp
the Netherlands |
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| 参考成员国 - 产品名称 | Netherlands (NL) Influvac Tetra, suspensie voor injectie in voorgevulde spuit 0,5 ml |
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| 互认成员国 - 产品名称 | - Germany (DE)
- Belgium (BE)
Influvac Tetra, suspension injectable en seringue préremplie Vaccin contre la grippe (antigène de surface, inactivé) Saison 2014/2015 - Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
Influvac Tetra Injektionssuspension in einer Fertigspritze - France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Iceland (IS)
- Hungary (HU)
INFLUVAC TETRA szuszpenziós injekció előretöltött fecskendőben - Greece (GR)
INFLUVAC SUB-UNIT TETRA® - Denmark (DK)
- Sweden (SE)
- Finland (FI)
- Norway (NO)
Influvac Tetra - Lithuania (LT)
Influvac Tetra injekcinė suspensija užpildytame švirkšte - Poland (PL)
Influvac Tetra - Latvia (LV)
Influvac Tetra suspensija injekcijām pilnšļircē - Bulgaria (BG)
- Estonia (EE)
INFLUVAC TETRA - Cyprus (CY)
Influvac® subunit Tetra, suspension for inj - Slovenia (SI)
- Czechia (CZ)
Influvac Tetra, injekční suspenze - Croatia (HR)
Influvac Tetra, suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv influence (površinski antigen), inaktivirano - Romania (RO)
- Slovakia (SK)
Influvac Tetra - Malta (MT)
Influvac sub-unit Tetra, suspension for injection
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| 许可日期 | 2017/07/10 |
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| 最近更新日期 | 2025/06/12 |
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| 药物ATC编码 | - J07BB02 influenza, inactivated, split virus or surface antigen
| 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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