欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
EE/H/0252/001
药品名称
Midazolam Kalceks
活性成分
Midazolam 5.0 mg/ml
剂型
Solution for injection/infusion
上市许可持有人
AS KALCEKS Krustpils iela 53, Rīga, Latvia
参考成员国 - 产品名称
Estonia (EE)
互认成员国 - 产品名称
Germany (DE)
Midazolam Kalceks 5 mg/ml Injektions-/Infusionslösung
Poland (PL)
Midazolam Kalceks
Latvia (LV)
Midazolam Kalceks 5 mg/ml šķīdums injekcijām/infūzijām
Lithuania (LT)
Midazolam Kalceks 5 mg/ml injekcinis ar infuzinis tirpalas
Hungary (HU)
MIDAZOLAM KALCEKS 5 mg/ml oldatos injekció vagy infúzió
Czechia (CZ)
Midazolam Kalceks
Slovakia (SK)
Midazolam Kalceks 5 mg/ml injekčný/infúzny roztok
Croatia (HR)
Austria (AT)
Belgium (BE)
Bulgaria (BG)
Midazolam Kalceks
France (FR)
Ireland (IE)
Italy (IT)
Netherlands (NL)
Sweden (SE)
许可日期
2018/06/10
最近更新日期
2025/04/02
药物ATC编码
N05CD08 midazolam
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
附件文件下载
PubAR
|
EE_252_PublicAR
Date of last change:2024/09/06
Final Labelling
|
Labelling_Midazolam_common_10ml_20190125_clean
Date of last change:2024/09/06
Final PL
|
PIL_Midazolam_common_10ml_batch_release_20190701_clean
Date of last change:2024/09/06
Final SPC
|
SmPC_Midazolam_common_10ml_20190125_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase