MR编号 | EE/H/0283/001 |
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药品名称 | Sodium oxybate Kalceks |
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活性成分 | - SODIUM OXYBATE 500.0 mg/ml
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剂型 | Oral solution |
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上市许可持有人 | AS KALCEKS, Krustpils iela 53, Rīga, LV-1057, Latvia |
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参考成员国 - 产品名称 | Estonia (EE) Sodium oxybate Kalceks |
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互认成员国 - 产品名称 | - Germany (DE)
Eplex 500 mg/ml Lösung zum Einnehmen - Denmark (DK)
- Belgium (BE)
Oxybate Kalceks 500 mg/ml solution buvable - Netherlands (NL)
- Ireland (IE)
- Austria (AT)
Natriumoxybat Kalceks 500 mg/ml Lösung zum Einnehmen - France (FR)
- Spain (ES)
- Italy (IT)
- Sweden (SE)
- Norway (NO)
Natriumoksybat Kalceks - Finland (FI)
- Latvia (LV)
Nartex 500 mg/ml šķīdums iekšķīgai lietošanai - Lithuania (LT)
Sodium oxybate Kalceks 500 mg/ml geriamasis tirpalas - Czechia (CZ)
Eplex - Slovakia (SK)
- Slovenia (SI)
Natrijev oksibat Kalceks 500 mg/ml peroralna raztopina
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许可日期 | 2019/07/29 |
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最近更新日期 | 2024/04/12 |
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药物ATC编码 | |
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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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