| MR编号 | DE/H/4923/001 |
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| 药品名称 | Vaxigrip |
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| 活性成分 | - A/Croatia/10136RV/2023 (H3N2)-like virus 15.0 µg
- A/Victoria/4897/2022 (H1N1)pdm09-like virus 15.0 µg
- B/Austria/1359417/2021 (B/Victoria lineage)-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 | Sanofi Winthrop Industrie
82 Avenue Raspail
Bp 35
94250 Gentilly
France |
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| 参考成员国 - 产品名称 | Germany (DE) Vaxigrip |
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| 互认成员国 - 产品名称 | - Sweden (SE)
- Estonia (EE)
- Austria (AT)
- Lithuania (LT)
Vaxigrip injekcinė suspensija užpildytame švirkšte - Ireland (IE)
- Latvia (LV)
- Iceland (IS)
- Croatia (HR)
- Poland (PL)
Vaxigrip - Luxembourg (LU)
- Malta (MT)
- Finland (FI)
- Netherlands (NL)
- Slovenia (SI)
- Norway (NO)
Vaxigrip - Belgium (BE)
- Slovakia (SK)
- Denmark (DK)
Vaxigrip - Romania (RO)
Vaxigrip suspensie injectabilă în seringa Preumplută - Greece (GR)
- Czechia (CZ)
Vaxigrip - Italy (IT)
- Cyprus (CY)
Vaxigrip Suspension for injection in pre-filled syringe 15 micrograms of haemagglutinin antigen/strain/dose µg HA - Portugal (PT)
- Bulgaria (BG)
Vaxigrip - Spain (ES)
- Hungary (HU)
- France (FR)
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| 许可日期 | 2024/11/08 |
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| 最近更新日期 | 2025/06/02 |
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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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