欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1465/008
药品名称
Pregabalin Medical Valley
活性成分
Pregabalin 225.0 mg
剂型
Capsule, hard
上市许可持有人
Medical Valley Invest AB Sweden
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Pregabalin AXiromed 225 mg Hartkapseln
Norway (NO)
许可日期
2022/11/30
最近更新日期
2025/01/16
药物ATC编码
N02BF02 pregabalin
申请类型
TypeLevel1:
Line Extension
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
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220201000010
Date of last change:2024/09/06
Final SPC
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220201000010_2
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220201000010_3
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220201000010_4
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase