| MR编号 | DE/H/0473/001 |
|---|
| 药品名称 | Gamunex 10% |
|---|
| 活性成分 | - Human normal immunoglobulin 10.0 %
|
|---|
| 剂型 | Solution for infusion |
|---|
| 上市许可持有人 | Grifols Deutschland GmbH
Colmarer Str. 22
60528 Frankfurt am Main
Germany |
|---|
| 参考成员国 - 产品名称 | Germany (DE) Gamunex 10% |
|---|
| 互认成员国 - 产品名称 | - Norway (NO)
- Spain (ES)
- Czechia (CZ)
Gamunex 10 % - Cyprus (CY)
GAMUNEX 10% 100MG/ML SOLUTION FOR INFUSION - Hungary (HU)
GAMUNEX 100 mg/ml oldatos infúzió - Poland (PL)
Gamunex 10% - Finland (FI)
- Sweden (SE)
- Greece (GR)
- Portugal (PT)
- Austria (AT)
Gamunex 10 % - Infusionslösung - Ireland (IE)
- United Kingdom (Northern Ireland) (XI)
- Luxembourg (LU)
- Netherlands (NL)
- Belgium (BE)
- Denmark (DK)
- Iceland (IS)
- Slovakia (SK)
Gamunex 10 % - Italy (IT)
- France (FR)
|
|---|
| 许可日期 | 2006/06/08 |
|---|
| 最近更新日期 | 2024/12/13 |
|---|
| 药物ATC编码 | - J06BA02 immunoglobulins, normal human, for intravascular adm.
|
|---|
| 申请类型 | - TypeLevel1：New Active Substance
- TypeLevel2：Initial Application
- TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC
- TypeLevel4：Biological: Blood Product
- TypeLevel5：Prescription Only
|
|---|
| 附件文件下载 | |
|---|
| 市场状态 | Positive |
|---|