| MR编号 | FR/H/0511/001 |
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| 药品名称 | IZINOVA, concentrate for oral solution |
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| 活性成分 | - Magnesium sulfate 3.28 g
- Potassium sulfate 3.13 g
- Sodium sulfate 17.51 g
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| 剂型 | Concentrate for oral solution |
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| 上市许可持有人 | IPSEN PHARMA
65 quai Georges Gorse
92100 BOULOGNE BILLANCOURT
FRANCE |
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| 参考成员国 - 产品名称 | France (FR) |
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| 互认成员国 - 产品名称 | - Germany (DE)
Izinova 24 g-Flasche Lösung zum Einnehmen - Belgium (BE)
Eziclen - Netherlands (NL)
Eziclen, concentraat voor drank - Luxembourg (LU)
- United Kingdom (Northern Ireland) (XI)
- Portugal (PT)
- Italy (IT)
- Greece (GR)
- Poland (PL)
Izinova - Latvia (LV)
- Lithuania (LT)
Eziclen koncentratas geriamajam tirpalui - Estonia (EE)
EZICLEN - Czechia (CZ)
Eziclen koncentrát pro perorální roztok - Romania (RO)
Eziclen Concentrat pentru soluţie orală
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| 许可日期 | 2013/01/17 |
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| 最近更新日期 | 2025/01/27 |
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| 药物ATC编码 | - A06AD10 mineral salts in combination
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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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