欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1210/002
药品名称
Tramadol + Paracetamol Aristo
活性成分
Paracetamol 650.0 mg
Tramadol hydrochloride 75.0 mg
剂型
Effervescent tablet
上市许可持有人
Aristo Pharma GmbH
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
许可日期
2015/09/16
最近更新日期
2025/06/27
药物ATC编码
N02AX52 tramadol, combinations
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_pl_tramadol_paracetamol_37_5mg_325mg_eff_V02_0525_hl
Date of last change:2025/06/27
Final SPC
|
common_spc_tramadol_paracetamol_37_5mg_325mg_eff_V03_0525_hl
Date of last change:2025/06/27
Final Product Information
|
common_pl_eff_37_5_325_tracked
Date of last change:2025/05/27
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase