欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/0919/001
药品名称
Tramadol + Paracetamol PTR
活性成分
paracetamol 325.0 mg
tramadol hydrochloride 37.5 mg
剂型
Tablet
上市许可持有人
PTR Pharma Consulting, Lda
参考成员国 - 产品名称
Portugal (PT)
Tramadol + Paracetamol Litexil
互认成员国 - 产品名称
Hungary (HU)
Italy (IT)
Poland (PL)
Tramadol + Paracetamol Sandoz
Romania (RO)
Tramadol/Paracetamol Sandoz 37,5 mg/325 mg comprimate
Slovenia (SI)
Slovakia (SK)
Luxembourg (LU)
Norway (NO)
Denmark (DK)
Sweden (SE)
许可日期
2013/03/27
最近更新日期
2024/08/20
药物ATC编码
N02AJ13 tramadol and paracetamol
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
|
1_3_1 spc_label_pl _ common_spc_325mg _ 12
Date of last change:2024/09/06
Final SPC
|
1_3_1 spc_label_pl _ common_spc_650mg _ 11
Date of last change:2024/09/06
Final Product Information
|
common_outer_37_5_325_clean_v02_00
Date of last change:2024/09/06
Final Product Information
|
common_outer_75_650_clean_v02_00
Date of last change:2024/09/06
Final Product Information
|
common_pil_37_5_325_clean_v03_00
Date of last change:2024/09/06
Final Product Information
|
common_pil_75_650_clean_v03_00
Date of last change:2024/09/06
Final Product Information
|
common_spc_37_5_325_clean_v03_00
Date of last change:2024/09/06
Final Product Information
|
common_spc_75_650_clean_v03_00
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase