| MR编号 | NL/H/5359/001 |
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| 药品名称 | FERRIC CARBOXYMALTOSE Sandoz |
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| 活性成分 | - ferric carboxymaltose 50.0 mg/ml
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| 剂型 | Solution for injection/infusion |
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| 上市许可持有人 | Sandoz B.V.
Hospitaaldreef 29
1315 RC Almere, Flevoland
Netherlands |
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| 参考成员国 - 产品名称 | Netherlands (NL) IJzer(III)carboxymaltose Sandoz 50 mg/ml, oplossing voor injectie of infusie |
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| 互认成员国 - 产品名称 | - Spain (ES)
- Portugal (PT)
- Denmark (DK)
Xabogard - Italy (IT)
- France (FR)
- Sweden (SE)
- Greece (GR)
- Finland (FI)
- Norway (NO)
- Bulgaria (BG)
XABOGARD - Romania (RO)
XABOGARD 50 mg fer/ml solutie injectabila/perfuzabila - Poland (PL)
XABOGARD - Slovakia (SK)
- Hungary (HU)
- Germany (DE)
FerInfuse 50 mg/ml Injektions-/Infusionslösung - Slovenia (SI)
- Belgium (BE)
Ferric carboxymaltose Sandoz 50 mg ijzer/ml oplossing voor injectie/infusie - Malta (MT)
- Ireland (IE)
- Croatia (HR)
- Austria (AT)
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| 许可日期 | 2022/10/20 |
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| 最近更新日期 | 2025/09/11 |
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| 药物ATC编码 | - B03AC Iron, parenteral preparations
| 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Initial Application
- TypeLevel3：Generic Art 10.1 and 10.2 Dir 2001/83/EC
- TypeLevel4：Chemical Substance
- 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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