欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0277/002
药品名称
Midazolam Panpharma
活性成分
midazolam 1.0 mg/ml
剂型
Solution for injection
上市许可持有人
Panpharma ZI du Clairay 35133 Fougères France
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
Portugal (PT)
Germany (DE)
Sweden (SE)
Norway (NO)
许可日期
2006/02/22
最近更新日期
2023/07/21
药物ATC编码
N05C HYPNOTICS AND SEDATIVES
N05CD Benzodiazepine derivatives
N05CD08 midazolam
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_Leaflet 5 mg_ml 2023_06_21 track
Date of last change:2024/09/06
Final Labelling
|
common_Leaflet 5 mg_ml 2023_06_21 track
Date of last change:2024/09/06
Final Product Information
|
common_spc_1mg_ml_2023_06_21 track
Date of last change:2024/09/06
Final SPC
|
common_spc_5mg_ml_2023_06_21 track
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase