| MR编号 | CZ/H/0701/001 |
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| 药品名称 | Metamizole Kalceks 500 mg/ml injekční roztok |
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| 活性成分 | - Metamizole sodium monohydrate 500.0 mg
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| 剂型 | Solution for injection |
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| 上市许可持有人 | AS Kalceks
Krustpils iela 53
LV-1057 Riga
Latvia |
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| 参考成员国 - 产品名称 | Czechia (CZ) METAMIZOLE KALCEKS |
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| 互认成员国 - 产品名称 | - Germany (DE)
- Spain (ES)
- Bulgaria (BG)
Metamizole Kalceks - Hungary (HU)
METAMIZOLE KALCEKS 500 mg/ml oldatos injekció - Romania (RO)
Metamizol Kalceks 500 mg/ml soluție injectabilă - Austria (AT)
Metamizol Kalceks 500 mg/ml Injektionslösung - Poland (PL)
Metamizole Kalceks - Lithuania (LT)
Metamizole sodium Kalceks 500 mg / ml injekcinis tirpalas - Slovakia (SK)
Metamizole Kalceks 500 mg/ml injekčný roztok - Slovenia (SI)
Natrijev metamizolat Kalceks 500 mg/ml raztopina za injiciranje - Croatia (HR)
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| 许可日期 | 2017/05/16 |
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| 最近更新日期 | 2024/11/25 |
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| 药物ATC编码 | - N02BB02 metamizole sodium
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| 申请类型 | - TypeLevel1：Known Active Substance
- 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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