| MR编号 | SE/H/0734/001 |
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| 药品名称 | MonoFer |
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| 活性成分 | - iron(III) isomaltoside 1000 100.0 mg/ml
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| 剂型 | solution for injection or infusion |
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| 上市许可持有人 | Pharmacosmos A/S
Denmark |
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| 参考成员国 - 产品名称 | Sweden (SE) |
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| 互认成员国 - 产品名称 | - Germany (DE)
MonoFer 100 mg/ml Infusions- und Injektionslösung - Denmark (DK)
MonoFer - Netherlands (NL)
- Luxembourg (LU)
- Iceland (IS)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
Monofer 100 mg/ml Injektions- oder Infusionslösung - Portugal (PT)
- Norway (NO)
- Finland (FI)
- Poland (PL)
- Latvia (LV)
Monofer 100 mg/ml šķīdums injekcijām vai infūzijām - Lithuania (LT)
Monofer 100 mg/ml injekcinis ar infuzinis tirpalas - Estonia (EE)
- Bulgaria (BG)
MonoFer - Romania (RO)
MONOFER 100 mg/ml soluţie injectabilă/perfuzabilă - Italy (IT)
- Slovenia (SI)
- Croatia (HR)
Monofer 100 mg/ml otopina za injekciju/infuziju - Belgium (BE)
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| 许可日期 | 2009/11/26 |
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| 最近更新日期 | 2024/03/20 |
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| 药物ATC编码 | - B03AC Iron, parenteral preparations
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| 申请类型 | - TypeLevel1：Known Active Substance
- TypeLevel2：Initial Application
- TypeLevel3：Full Dossier Art 8.3(i) 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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