欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1291/003
药品名称
Pregabalina Tecnigen
活性成分
pregabalin 150.0 mg
剂型
Capsule, hard
上市许可持有人
Biofarmoz – Sociedade Técnico Medicinal, Unipessoal Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
Iceland (IS)
许可日期
2015/04/14
最近更新日期
2024/08/26
药物ATC编码
N03AX16 pregabalin
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
Final PL
|
1291_PIL_proposed_clean
Date of last change:2024/09/06
Final SPC
|
1291_SmPC_proposed_clean
Date of last change:2024/09/06
PubAR
|
586841_586842_586843_586844_20151218_PAR_IRS
Date of last change:2024/09/06
Final Product Information
|
Immediate packaging_clean
Date of last change:2024/09/06
Final Product Information
|
Outer_packaging_clean
Date of last change:2024/09/06
Final Product Information
|
package_leaflet_clean
Date of last change:2024/09/06
Final Product Information
|
smpc_caps_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase