欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2449/002
药品名称
Pregafra
活性成分
pregabalin 50.0 mg
剂型
Capsule, hard
上市许可持有人
Camland GmbH Forstweg 21a 21075 Hamburg Germany
参考成员国 - 产品名称
Denmark (DK)
Pregafra
互认成员国 - 产品名称
许可日期
2015/08/25
最近更新日期
2023/03/29
药物ATC编码
N03AX16 pregabalin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Common PL Pregacam_clean
Date of last change:2024/09/06
Final SPC
|
Common SPC Pregacam_clean
Date of last change:2024/09/06
PubAR
|
Final PAR Pregafra DKH2449_001_008_DC
Date of last change:2024/09/06
PubAR Summary
|
Final sPAR Pregafra DKH2449_001_008_DC
Date of last change:2024/09/06
Final Labelling
|
Final_labib_clean
Date of last change:2024/09/06
Final Labelling
|
Final_labop_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase