欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1700/001
药品名称
SIRANALEN OS
活性成分
pregabalin 20.0 mg/ml
剂型
Oral solution
上市许可持有人
Medochemie Ltd.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Greece (GR)
SIRANALEN OS
Bulgaria (BG)
Siranalen
Cyprus (CY)
SIRANALEN OS
Romania (RO)
Malta (MT)
许可日期
2017/07/12
最近更新日期
2024/07/30
药物ATC编码
N03AX16 pregabalin
申请类型
TypeLevel1:
Known Active Substance
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
|
609382_20170907_PAR_GBB
Date of last change:2024/09/06
Final Product Information
|
common_label_inner_bottle_1_1_clean
Date of last change:2024/09/06
Final Product Information
|
common_label_outer_carton_oral_1_1_clean
Date of last change:2024/09/06
Final Product Information
|
common_pil_1_2_clean
Date of last change:2024/09/06
Final Product Information
|
common_spc_1_2_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase