| MR编号 | DE/H/0473/001 |
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| 药品名称 | Gamunex 10% |
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| 活性成分 | - Human normal immunoglobulin 10.0 %
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| 剂型 | Solution for infusion |
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| 上市许可持有人 | Grifols Deutschland GmbH
Colmarer Str. 22
60528 Frankfurt am Main
Germany |
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| 参考成员国 - 产品名称 | Germany (DE) Gamunex 10% |
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| 互认成员国 - 产品名称 | - Iceland (IS)
- Denmark (DK)
- Belgium (BE)
- Netherlands (NL)
- Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
Gamunex 10 % - Infusionslösung - Portugal (PT)
- Greece (GR)
- Sweden (SE)
- Finland (FI)
- Poland (PL)
Gamunex 10% - Hungary (HU)
GAMUNEX 100 mg/ml oldatos infúzió - Cyprus (CY)
GAMUNEX 10% 100MG/ML SOLUTION FOR INFUSION - Czechia (CZ)
Gamunex 10 % - Spain (ES)
- Italy (IT)
- Norway (NO)
- Slovakia (SK)
Gamunex 10 % - France (FR)
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| 许可日期 | 2006/06/08 |
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| 最近更新日期 | 2025/09/26 |
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| 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
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| 附件文件下载 | |
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| 市场状态 | Positive |
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