MR编号 | HR/H/0104/002 |
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药品名称 | Tramadol Krka 100 mg solution for injection |
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活性成分 | - tramadol chloride 50.0 mg/ml
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剂型 | Solution for injection |
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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 | Croatia (HR) Awardix 100 mg otopina za injekciju/infuziju |
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互认成员国 - 产品名称 | - Germany (DE)
Tramadol TAD 100 mg Injektions-/Infusionslösung - Belgium (BE)
Tramadol Krka 100 mg/2ml oplossing voor injectie/infusie - Spain (ES)
- Poland (PL)
Tramadol Krka - Hungary (HU)
TRAMADOL KRKA 100 mg/2 ml oldatos injekció vagy infúzió - Bulgaria (BG)
Olteron 100 mg/ml - Czechia (CZ)
OLTERON 100 mg/2ml injekční roztok - Slovakia (SK)
Tramadol Krka 100 mg/2 ml injekčný/infúzny roztok
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许可日期 | 2017/11/28 |
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最近更新日期 | 2024/07/19 |
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药物ATC编码 | |
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申请类型 | - TypeLevel1:Abridged
- 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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