| MR编号 | EE/H/0262/001 |
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| 药品名称 | Olteron |
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| 活性成分 | - tramadol hydrochloride 100.0 mg
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| 剂型 | Prolonged-release tablet |
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| 上市许可持有人 | KRKA, d.d., Novo mesto
Šmarješka cesta 6
Novo mesto
8401 Slovenia |
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| 参考成员国 - 产品名称 | Estonia (EE) Olteron |
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| 互认成员国 - 产品名称 | - Denmark (DK)
- Belgium (BE)
Tramadol Krka 100 mg tabletten met verlengde afgifte - Iceland (IS)
Tramadol Krka 100 mg forðatafla - United Kingdom (Northern Ireland) (XI)
- France (FR)
- Spain (ES)
- Portugal (PT)
- Sweden (SE)
Tramadol Krka - Finland (FI)
- Poland (PL)
Tramadol Krka - Hungary (HU)
TRAMADOL KRKA 100 mg retard tabletta - Bulgaria (BG)
Tramadol Krka - Czechia (CZ)
Tramadol Krka - Slovakia (SK)
Tramadol Krka 100 mg tablety s predĺženým uvoľňovaním - Croatia (HR)
Tramadol Krka 100 mg tablete s produljenim oslobađanjem
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| 许可日期 | 2018/10/05 |
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| 最近更新日期 | 2024/07/12 |
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| 药物ATC编码 | | 申请类型 | - TypeLevel1：Abridged
- 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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