欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0211/001
药品名称
IXPRIM ATC code N02AX52
活性成分
Paracetamol 325.0 1
Tramadol 37.5 1
剂型
Film-coated tablet
上市许可持有人
Grunenthal
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Spain (ES)
Belgium (BE)
Portugal (PT)
许可日期
2002/10/07
最近更新日期
2025/01/07
药物ATC编码
N02AX Other opioids
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
FR_0211_01 _ common_pl_zaldiarfct_clean _ EOP
Date of last change:2024/12/13
Final SPC
|
FR_0211_01 _ common_spc_clean _ EOP
Date of last change:2024/12/13
Final Labelling
|
common_impack_tracked
Date of last change:2024/09/06
Final Product Information
|
common_spc_tracked
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase