欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/0497/001
药品名称
Lipidil 145 ONE
活性成分
fenofibrate 145.0 mg
剂型
Film-coated tablet
上市许可持有人
Viatris Healthcare GmbH Lütticher Straße 5 53842 Troisdorf Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Spain (ES)
Belgium (BE)
Luxembourg (LU)
Ireland (IE)
France (FR)
Italy (IT)
Greece (GR)
Finland (FI)
Poland (PL)
Lipanthyl NT 145
Hungary (HU)
LIPANTHYL NT 145 mg filmtabletta
Czechia (CZ)
Slovakia (SK)
LIPANTHYL NT 145 mg
Malta (MT)
Lipantil Supra 145 mg film-coated tablet
许可日期
2005/04/05
最近更新日期
2024/08/09
药物ATC编码
C10AB05 fenofibrate
申请类型
TypeLevel1：
Line Extension
TypeLevel2：
Initial Application
TypeLevel3：
Full Dossier [Article 8.3(i)]
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final Product Information
|
common_final_pl_0497_V057
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_0497_V057
Date of last change:2024/09/06
Final PL
|
common_pl_annotated_fenofibrate 145 mg_WS_Feb 2017final
Date of last change:2024/09/06
Final PL
|
common_pl_annotated_fenofibrate 160 mg_WS_Feb 2017final
Date of last change:2024/09/06
Final PL
|
common_pl_annotated_fenofibrate 200mg_WS_Feb 2017final
Date of last change:2024/09/06
Final PL
|
common_pl_annotated_fenofibrate 215 mg_WS_Feb 2017final
Date of last change:2024/09/06
Final PL
|
common_pl_annotated_fenofibrate 67mg_WS_Feb 2017final
Date of last change:2024/09/06
Final PL
|
common_pl_clean_fenofibrate 145 mg_WS_Feb 2017final
Date of last change:2024/09/06
Final PL
|
common_pl_clean_fenofibrate 160 mg_WS_Feb 2017final
Date of last change:2024/09/06
Final PL
|
common_pl_clean_fenofibrate 200mg_WS_Feb 2017final
Date of last change:2024/09/06
Final PL
|
common_pl_clean_fenofibrate 215 mg_WS_Feb 2017final
Date of last change:2024/09/06
Final PL
|
common_pl_clean_fenofibrate 67mg_WS_Feb 2017final
Date of last change:2024/09/06
Final SPC
|
common_spc_annotated_feno 145 mg_WS_Feb 2017final
Date of last change:2024/09/06
Final SPC
|
common_spc_annotated_fenofibrate 200mg_WS_Feb 2017final
Date of last change:2024/09/06
Final SPC
|
common_spc_annotated_fenofibrate 215 mg_WS_Feb 2017final
Date of last change:2024/09/06
Final SPC
|
common_spc_annotated_fenofibrate 67mg_WS_Feb 2017final
Date of last change:2024/09/06
Final SPC
|
common_spc_annotated_fenofibrate_160mg_WS_Feb 2017final
Date of last change:2024/09/06
Final SPC
|
common_spc_clean_fenofibrate 145 mg_WS_Feb 2017final
Date of last change:2024/09/06
Final SPC
|
common_spc_clean_fenofibrate 200mg_WS_Feb 2017final
Date of last change:2024/09/06
Final SPC
|
common_spc_clean_fenofibrate 215 mg_ WS_ Feb 2017final
Date of last change:2024/09/06
Final SPC
|
common_spc_clean_fenofibrate 67mg_WS_Feb 2017final
Date of last change:2024/09/06
Final SPC
|
common_spc_clean_fenofibrate_160mg_WS_Feb 2017final
Date of last change:2024/09/06
Final Labelling
|
DE_H_497 et al_II_23 et al_Final Outer and Inner labelling 145mg
Date of last change:2024/09/06
Final PL
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pl_fenofibrate all strengths_annotated_WS_Feb 2017final
Date of last change:2024/09/06
Final PL
|
pl_fenofibrate all strengths_clean_WS_Feb 2017final
Date of last change:2024/09/06
Final SPC
|
spc_feno all strengths_annotated_WS_Feb 2017final
Date of last change:2024/09/06
Final SPC
|
spc_fenofibrate all strengths_clean_WS_Feb 2017final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase