欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0878/001
药品名称
Tramadol + Paracetamol Aurobindo
活性成分
Paracetamol 325.0 mg
Tramadol hydrochloride 37.5 mg
剂型
Film-coated tablet
上市许可持有人
Aurobindo Pharma (Portugal), Unip. Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Belgium (BE)
Netherlands (NL)
Italy (IT)
Spain (ES)
Malta (MT)
Tramadol/Paracetamol Aurobindo 37.5mg/325mg Film-coated tablets
许可日期
2012/12/16
最近更新日期
2024/09/11
药物ATC编码
N02AX52 tramadol, combinations
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 SPC
|
common_spc
Date of last change:2024/09/11
Final PL
|
common_pl
Date of last change:2024/09/11
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase