MR编号 | FI/H/1208/001 |
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药品名称 | Calcium folinate Kalceks 10 mg/ml solution for injection/infusion |
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活性成分 | - Calcium folinate hydrate 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 | Kalceks AS
Krustpils Iela 71 e
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 | - Germany (DE)
Folinsäure Kalceks 10 mg/ml Injektions-/Infusionslösung - Lithuania (LT)
Folinic acid Kalceks 10 mg/ml injekcinis ar infuzinis tirpalas - Denmark (DK)
Calcium folinate Kalceks - Estonia (EE)
- Luxembourg (LU)
- Belgium (BE)
- Hungary (HU)
Calcium folinate Kalceks 10 mg/ml oldatos injekció vagy infúzió - Netherlands (NL)
- Bulgaria (BG)
Calcium folinate Kalceks - Ireland (IE)
- Czechia (CZ)
Calcium folinate Kalceks - Austria (AT)
- Croatia (HR)
- France (FR)
- Spain (ES)
- Romania (RO)
- Sweden (SE)
- Norway (NO)
- Poland (PL)
- Latvia (LV)
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许可日期 | 2023/11/29 |
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最近更新日期 | 2024/12/04 |
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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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