欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
MT/H/0518/001
药品名称
Morphine sulfate 10 mg/ml Solution for injection
活性成分
Morphine sulfate 10.0 mg/ml
剂型
Solution for injection
上市许可持有人
AS KALCEKS Krustpils iela 53 Rīga LV-1057 Latvia
参考成员国 - 产品名称
Malta (MT)
Morphine sulfate 10 mg/ml solution for injection
互认成员国 - 产品名称
Ireland (IE)
Iceland (IS)
许可日期
2018/09/19
最近更新日期
2025/12/17
药物ATC编码
N02AA01 morphine
申请类型
TypeLevel1:
TypeLevel2:
TypeLevel3:
TypeLevel4:
TypeLevel5:
附件文件下载
Final Product Information
|
LAB_Morphine_sulfate_common_IB_QRD_20220613_clean
Date of last change:2024/09/06
Final Product Information
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LAB_Morphine_sulfate_common_IB_QRD_20220613_track
Date of last change:2024/09/06
Final Labelling
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MT_H_0518_001_003_R_001_LAB_COMMON_2
Date of last change:2024/09/06
Final PL
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PIL_Morphine sulfate_PSUSA_2__20230810_clean
Date of last change:2024/09/06
Final Product Information
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PIL_Morphine_sulfate_common_IB_QRD_resp to comments_20220613_clean
Date of last change:2024/09/06
Final Product Information
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PIL_Morphine_sulfate_common_IB_QRD_resp to comments_20220613_track
Date of last change:2024/09/06
Final SPC
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SmPC_Morphine sulfate_PSUSA_2__20230810_clean
Date of last change:2024/09/06
Final Product Information
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SmPC_Morphine_sulfate_common_IB_QRD_resp to comments_20220613_clean
Date of last change:2024/09/06
Final Product Information
|
SmPC_Morphine_sulfate_common_IB_QRD_resp to comments_20220613_track
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase