MR编号 | SI/H/0222/001 |
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药品名称 | Ampicillin/sulbactam AptaPharma 1 g/0,5 g powder for solution for injection/infusion |
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活性成分 | - Ampicillin sodium 1.0 g
- Sulbactam 0.5 g
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剂型 | Powder for solution for injection/infusion |
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上市许可持有人 | Apta Medica Internacional d.o.o.,
Likozarjeva Ulica 6,
1000 Ljubljana,
Slovenia |
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参考成员国 - 产品名称 | Slovenia (SI) Ampicillin/sulbactam AptaPharma 1 g/0,5 g prašek za raztopino za injiciranje/infundiranje |
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互认成员国 - 产品名称 | - Sweden (SE)
- Austria (AT)
Ampicillin/Sulbactam AptaPharma 1 g/0,5 g Pulver zur Herstellung einer Injektions-/Infusionslösung - Norway (NO)
- Poland (PL)
- Finland (FI)
- Hungary (HU)
Ampicillin/sulbactam AptaPharma 1 g/0,5 g por oldatos injekcióhoz vagy infúzióhoz - Bulgaria (BG)
Ampicillin/sulbactam AptaPharma - Cyprus (CY)
- Czechia (CZ)
Ampicillin/Sulbactam AptaPharma - Romania (RO)
Ampicilină/sulbactam AptaPharma 1 g/0,5 g pulbere pentru soluție injectabilă/perfuzabilă - Slovakia (SK)
- Malta (MT)
- Denmark (DK)
Ampicillin/Sulbactam ”AptaPharma” - Croatia (HR)
Ampicilin/sulbaktam AptaPharma 1 g/0,5 g prašak za otopinu za injekciju/infuziju - Netherlands (NL)
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许可日期 | 2021/07/14 |
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最近更新日期 | 2024/09/11 |
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药物ATC编码 | - J01CR01 ampicillin and beta-lactamase inhibitor
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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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