| MR编号 | SE/H/2192/001 |
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| 药品名称 | Peditrace Novum |
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| 活性成分 | - Copper chloride dihydrate 107.4 µg/ml
- Manganese chloride tetrahydrate 3.6 µg/ml
- Potassium iodide 2.57 µg/ml
- Sodium selenite 15.33 µg/ml
- Zinc chloride 1.04 mg/ml
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| 剂型 | Concentrate for solution for infusion |
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| 上市许可持有人 | Fresenius Kabi AB,
Sweden |
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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 | - Poland (PL)
Peditrace Novum - Netherlands (NL)
- Malta (MT)
Peditrace Novum Concentrate for solution for infusion - Finland (FI)
Peditrace Novum - Belgium (BE)
- Slovenia (SI)
- Norway (NO)
- Denmark (DK)
- Slovakia (SK)
- Greece (GR)
- Germany (DE)
Peditrace Novum - Romania (RO)
Peditrace Novum concentrate pentru soluţie perfuzabilă - Italy (IT)
- Czechia (CZ)
Peditrace Novum - Portugal (PT)
- Cyprus (CY)
Peditrace Novum concentrate for solution for infusion - Spain (ES)
- France (FR)
- Hungary (HU)
Peditrace Novum concentrate for solution for infusion - Austria (AT)
- Estonia (EE)
- Ireland (IE)
- Lithuania (LT)
- - Iceland (IS)
- Latvia (LV)
- Luxembourg (LU)
- Croatia (HR)
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| 许可日期 | 2023/04/18 |
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| 最近更新日期 | 2025/09/04 |
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| 药物ATC编码 | - B05XA31 electrolytes in combination with other drugs
| 申请类型 | - TypeLevel1：Known Active Substance
- TypeLevel2：Initial Application
- TypeLevel3：Bibliographic Art 10 a 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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