欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/0448/003
药品名称
Tramadolor 200 mg ID
活性成分
Tramadol hydroiodide 200.0 mg
剂型
Prolonged-release tablet
上市许可持有人
HEXAL AG Industriestraße 25 DE-83607 Holzkirchen
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Sweden (SE)
United Kingdom (Northern Ireland) (XI)
许可日期
2004/12/15
最近更新日期
2024/11/20
药物ATC编码
N02AX02 tramadol
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
final_common_PL_DE_H_0448_003_IA_052_G
Date of last change:2024/11/06
Final SPC
|
final_common_SmPC_DE_H_0448_001_003_IA_052_G
Date of last change:2024/11/06
Final Labelling
|
common_final_label_448
Date of last change:2024/09/06
Final Product Information
|
common_final_pl_0448_001__V044
Date of last change:2024/09/06
Final Product Information
|
common_final_pl_0448_002__V044
Date of last change:2024/09/06
Final Product Information
|
common_final_pl_0448_003__V044
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_0448_V044
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase