| MR编号 | SI/H/0222/002 |
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| 药品名称 | Ampicillin/sulbactam AptaPharma 2 g/1 g powder for solution for injection/infusion |
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| 活性成分 | - AMPICILLIN SODIUM 2.0 g
- sulbactam 1.0 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 2 g/1 g prašek za raztopino za injiciranje/infundiranje |
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| 互认成员国 - 产品名称 | - Cyprus (CY)
- Finland (FI)
- Czechia (CZ)
Ampicillin/Sulbactam AptaPharma - Romania (RO)
Ampicilină/sulbactam AptaPharma 2 g/1 g pulbere pentru soluție injectabilă/perfuzabilă - Slovakia (SK)
- Malta (MT)
- Croatia (HR)
Ampicilin/sulbaktam AptaPharma 2 g/1 g prašak za otopinu za injekciju/infuziju - Denmark (DK)
Ampicillin/sulbactam AptaPharma - Austria (AT)
Ampicillin/Sulbactam AptaPharma 2 g/1 g Pulver zur Herstellung einer Injektions-/Infusionslösung - Netherlands (NL)
- Poland (PL)
- Sweden (SE)
- Hungary (HU)
Ampicillin/sulbactam AptaPharma 2 g/1 g por oldatos injekcióhoz vagy infúzióhoz - Bulgaria (BG)
Ampicillin/sulbactam AptaPharma - Norway (NO)
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| 许可日期 | 2021/07/14 |
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| 最近更新日期 | 2024/03/11 |
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| 药物ATC编码 | - J01CR01 ampicillin and beta-lactamase inhibitor
| 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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