| MR编号 | DE/H/0215/002 |
|---|
| 药品名称 | Repevax, vial |
|---|
| 活性成分 | - adsorbed purified diphtheria toxoid, not less than 2.0 IU
- adsorbed purified filamentous haemagglutinin 5.0 µg
- adsorbed purified fimbrial agglutinogens 2 + 3 (FIM) 5.0 µg
- adsorbed purified pertactin (PRN) 3.0 µg
- adsorbed purified pertussis toxoid 2.5 µg
- adsorbed purified tetanus toxoid, not less than 20.0 IU
|
|---|
| 剂型 | Suspension for injection |
|---|
| 上市许可持有人 | Sanofi Pasteur MSD GmbH
Paul-Ehrlich-Str. 1
D-69181 Leimen |
|---|
| 参考成员国 - 产品名称 | Germany (DE) Repevax |
|---|
| 互认成员国 - 产品名称 | - France (FR)
- Norway (NO)
- Denmark (DK)
- Luxembourg (LU)
- Iceland (IS)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Greece (GR)
- Finland (FI)
|
|---|
| 许可日期 | 2002/06/12 |
|---|
| 最近更新日期 | 2024/08/19 |
|---|
| 药物ATC编码 | - J07CA02 diphtheria-pertussis-poliomyelitis-tetanus
|
|---|
| 申请类型 | - TypeLevel1：New Active Substance
- TypeLevel2：Additional Strength/Form
- TypeLevel3：Full Dossier Article 4.8 Di 65/65
- TypeLevel4：Biological: Vaccine
- TypeLevel5：Prescription Only
|
|---|
| 附件文件下载 | |
|---|
| 市场状态 | Positive |
|---|