| MR编号 | NL/H/4757/001 |
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| 药品名称 | QIV HD |
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| 活性成分 | - A/Darwin/9/2021 (H3N2)-like virus 60.0 µg
- A/Victoria/4897/2022 (H1N1)pdm09-like virus 60.0 µg
- B/Austria/1359417/2021 (B/Victoria lineage)-like virus 60.0 µg
- B/Phuket/3073/2013 60.0 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 | Sanofi Pasteur Ltd,
14 Espace Henry Vallees
Lyon, France |
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| 参考成员国 - 产品名称 | Netherlands (NL) |
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| 互认成员国 - 产品名称 | - Germany (DE)
- Denmark (DK)
Efluelda - Belgium (BE)
Efluelda, suspension injectable en seringue préremplie Vaccin grippal quadrivalent (inactivé, à virion fragmenté), 60 microgrammes HA / souche - United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
Efluelda Injektionssuspension in einer Fertigspritze - France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Greece (GR)
- Sweden (SE)
- Norway (NO)
- Finland (FI)
- Poland (PL)
Efluelda - Latvia (LV)
Efluelda suspensija injekcijām pilnšļircē - Hungary (HU)
- Bulgaria (BG)
QIV HD - Cyprus (CY)
QUADRIVALENT INFLUENZA VACCINE SUSPENSION FOR INJECTION 60MCG-DOSE - Czechia (CZ)
Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High Dose, Suspension for injection in pre-filled syringe - Romania (RO)
- Slovakia (SK)
Efluelda - Slovenia (SI)
- Croatia (HR)
Efluelda, suspenzija za injekciju u napunjenoj štrcaljki, četverovalentno cjepivo protiv influence (fragmentirani virion, inaktivirano), 60 mikrograma HA/soju
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| 许可日期 | 2020/04/01 |
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| 最近更新日期 | 2024/04/10 |
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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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