MR编号 | HU/H/0598/004 |
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药品名称 | Rosamera 20 mg /5 mg /4 mg film-coated tablet |
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活性成分 | - Amlodipine 5.0 mg
- Perindopril 4.0 mg
- Rosuvastatin 20.0 mg
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剂型 | Film-coated tablet |
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上市许可持有人 | KRKA, d.d., Novo mesto
Šmarješka Cesta 6
Novo Mesto
8501 Slovenia
Telephone +38516312155
Telefax +38673322742
E-mail martina.crevar@krka.biz |
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参考成员国 - 产品名称 | Hungary (HU) ROXAMPEX 20 mg/ 5 mg/4 mg filmtabletta |
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互认成员国 - 产品名称 | - Portugal (PT)
- Finland (FI)
- Poland (PL)
Rosamera - Latvia (LV)
Roxampex 20 mg/5 mg/4 mg apvalkotās tabletes - Lithuania (LT)
Roxampex 20 mg /5 mg /4 mg plėvele dengtos tabletės - Estonia (EE)
- Bulgaria (BG)
Rosamera - Romania (RO)
- Slovakia (SK)
Roxampex 20 mg/5 mg/4 mg filmom obalené tablety - Slovenia (SI)
Roxampex 20 mg/5 mg/4 mg filmsko obložene tablete
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许可日期 | 2019/09/19 |
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最近更新日期 | 2025/01/13 |
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药物ATC编码 | - C10BX Lipid modifying agents in combination with other drugs
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申请类型 | - TypeLevel1:Known Active Substance
- TypeLevel2:Initial Application
- TypeLevel3:Fixed combination Art 10b 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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