| MR编号 | NL/H/4352/001 |
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| 药品名称 | Temelor solution for injection 4 mg/ml |
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| 活性成分 | |
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| 剂型 | Solution for injection |
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| 上市许可持有人 | Medochemie Ltd
1-10 Constantinoupoleos Street
3011 Limassol, Cyprus |
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| 参考成员国 - 产品名称 | Netherlands (NL) Temelor 4 mg/ml oplossing voor injectie |
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| 互认成员国 - 产品名称 | - Portugal (PT)
- Spain (ES)
- Latvia (LV)
Temelor 4 mg/ml šķīdums injekcijām - Lithuania (LT)
LIREZID 4 mg/ml injekcinis tirpalas - Estonia (EE)
TEMELOR - Bulgaria (BG)
Temelor - Cyprus (CY)
TEMELOR 4mg/ml solution for injection - Czechia (CZ)
Temelor - Romania (RO)
TEMELOR 4 mg/ml soluţie injectabilă - Malta (MT)
Temelor 4mg/ml solution for injection - Croatia (HR)
TEMELOR 4 mg/ml otopina za injekciju
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| 许可日期 | 2019/05/23 |
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| 最近更新日期 | 2025/02/27 |
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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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