| MR编号 | DE/H/1939/001 |
|---|
| 药品名称 | Fluarix Tetra (other EU countries)
Influsplit Tetra (Germany) |
|---|
| 活性成分 | - A/Thailand/8/2022 (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
- B/Phuket/3073/2013 15.0 µg
|
|---|
| 剂型 | Suspension for injection |
|---|
| 上市许可持有人 | GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München
Germany |
|---|
| 参考成员国 - 产品名称 | Germany (DE) Influsplit Tetra |
|---|
| 互认成员国 - 产品名称 | - Denmark (DK)
- Belgium (BE)
- Netherlands (NL)
- Luxembourg (LU)
- Iceland (IS)
- Ireland (IE)
- Austria (AT)
- France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Greece (GR)
- Sweden (SE)
- Norway (NO)
- Finland (FI)
- Poland (PL)
- Latvia (LV)
- Lithuania (LT)
- Estonia (EE)
- Hungary (HU)
- Bulgaria (BG)
- Cyprus (CY)
- Czechia (CZ)
- Slovakia (SK)
- Slovenia (SI)
- Malta (MT)
- Croatia (HR)
|
|---|
| 许可日期 | 2013/02/19 |
|---|
| 最近更新日期 | 2024/09/30 |
|---|
| 药物ATC编码 | - J07BB02 influenza, inactivated, split virus or surface antigen
| 申请类型 | - TypeLevel1：New Active Substance
- TypeLevel2：Initial Application
- TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC
- TypeLevel4：Biological: Vaccine
- TypeLevel5：Prescription Only
|
|---|
| 附件文件下载 | |
|---|
| 市场状态 | Positive |
|---|
|
|---|