| MR编号 | FI/H/1141/001 |
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| 药品名称 | Folinic acid Kalceks |
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| 活性成分 | - calcium folinate 10.0 mg/ml
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| 剂型 | Solution for injection/infusion |
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| 上市许可持有人 | AS Kalceks,
Krustpils iela 53
1057 Riga
Latvia |
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| 参考成员国 - 产品名称 | Finland (FI) |
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| 互认成员国 - 产品名称 | - Norway (NO)
- Germany (DE)
Folinsäure Kalceks 10 mg/ml Injektions-/Infusionslösung - Poland (PL)
Folinic acid Kalceks - Denmark (DK)
- Sweden (SE)
- Estonia (EE)
- Spain (ES)
- France (FR)
- Croatia (HR)
- Hungary (HU)
Calcium folinate Kalceks 10 mg/ml oldatos injekció vagy infúzió - Ireland (IE)
- Austria (AT)
- Lithuania (LT)
- - Belgium (BE)
- Latvia (LV)
- Bulgaria (BG)
Folinic acid Kalceks - Netherlands (NL)
Folinezuur Kalceks 10 mg/ml oplossing voor injectie/infusie - Czechia (CZ)
Folinic acid Kalceks
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| 许可日期 | 2022/09/21 |
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| 最近更新日期 | 2023/02/28 |
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| 药物ATC编码 | | 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| 市场状态 | Withdrawn（注：已撤市） 撤市原因：1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised. |
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