欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
ES/H/0317/001
药品名称
Desketoprofeno / Tramadol
活性成分
Dexketoprofen trometamine 36.9 mg
Tramadol hydrochloride 75.0 mg
剂型
Film-coated tablet
上市许可持有人
Menarini
参考成员国 - 产品名称
Spain (ES)
Skudex
互认成员国 - 产品名称
Belgium (BE)
Skudexa 75 mg/25 mg filmomhulde tabletten
Netherlands (NL)
Luxembourg (LU)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Liechtenstein (LI)
France (FR)
Portugal (PT)
Italy (IT)
Greece (GR)
Sweden (SE)
Finland (FI)
Poland (PL)
Skudexa
Latvia (LV)
Skudex 75 mg/25 mg apvalkotās tabletes
Lithuania (LT)
Skudex 75 mg/ 25 mg plėvele dengtos tabletės
Estonia (EE)
Skudexa
Hungary (HU)
SKUDEXA 75 mg/25 mg filmtabletta
Bulgaria (BG)
Skudexa
Cyprus (CY)
Czechia (CZ)
SKUDEX 25 mg/75 mg film-coated tablets
Romania (RO)
Skudexa 75 mg/25 mg comprimate filmate
Slovakia (SK)
Skudex 75 mg/25 mg filmom obalené tablety
Slovenia (SI)
Malta (MT)
Skudex
Croatia (HR)
Skudex 75 mg/25 mg filmom obložene tablete
Iceland (IS)
许可日期
2016/01/07
最近更新日期
2025/09/16
药物ATC编码
M01AE17 dexketoprofen
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Fixed combination Art 10b Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final PL
|
common_pl_ tabs 317_clean
Date of last change:2025/09/16
Final SPC
|
common_spc_tabs 317_clean
Date of last change:2025/09/16
Final Product Information
|
common_outer_innercartonbox
Date of last change:2024/09/06
Final Product Information
|
common_outer_outercartonbox
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase