MR编号 | CZ/H/0503/002 |
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药品名称 | Betaklav 875 mg/ 125 mg |
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活性成分 | - amoxicillin 1000.0 mg
- clavulanic acid 125.0 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, 8501 Novo Mesto, Slovenia |
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参考成员国 - 产品名称 | Czechia (CZ) BETAKLAV |
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互认成员国 - 产品名称 | - Austria (AT)
Amoxicillin/Clavulansäure Krka 875 mg/125 mg Filmtabletten - Spain (ES)
- Italy (IT)
- Sweden (SE)
- Finland (FI)
- Poland (PL)
Hiconicl comb - Latvia (LV)
Betaklav 875 mg/125 mg apvalkotās tabletes - Lithuania (LT)
Betaklav 875 mg / 125 mg plėvele dengtos tabletės - Estonia (EE)
BETAKLAV - Hungary (HU)
BETAKLAV 875 mg/125 mg filmtabletta - Bulgaria (BG)
Betaklav - Slovakia (SK)
Betaklav 875 mg/125 mg filmom obalené tablety - Slovenia (SI)
- Croatia (HR)
Betaklav 875 mg/125 mg filmom obložene tablete
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许可日期 | 2015/06/15 |
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最近更新日期 | 2024/08/16 |
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药物ATC编码 | - J01CR02 amoxicillin and beta-lactamase inhibitor
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申请类型 | - TypeLevel1:Known Active Substance
- TypeLevel2:Additional Strength/Form
- 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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