| MR编号 | EE/H/0258/001 |
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| 药品名称 | Hydromorphone Kalceks |
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| 活性成分 | - Hydromorphone hydrochloride 2.0 mg/ml
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| 剂型 | Solution for injection/infusion |
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| 上市许可持有人 | AS KALCEKS
Krustpils iela 53
Riga LV-1057
Latvia |
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| 参考成员国 - 产品名称 | Estonia (EE) Hydromorphone Kalceks |
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| 互认成员国 - 产品名称 | - Germany (DE)
Hydromorphone Ethypharm 2 mg/ml Injektions-/Infusionslösung - Denmark (DK)
Hydromorphonhydrochlorid "Kalceks" - Netherlands (NL)
- Austria (AT)
Hydromorphon Kalceks 2 mg/ml Injektions-/Infusionslösung - Sweden (SE)
- Norway (NO)
Hydromorfonhydroklorid Kalceks - Finland (FI)
- Latvia (LV)
Hydromorphone Kalceks 2 mg/ml šķīdums injekcijām/infūzijām
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| 许可日期 | 2018/11/04 |
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| 最近更新日期 | 2025/08/21 |
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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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