欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/0236/001
药品名称
Apteor 160 mg Filmtablette
活性成分
fenofibrate 160.0 mg
剂型
Film-coated tablet
上市许可持有人
Mylan Healthcare GmbH Freundallee 9A 30173 Hannover Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
France (FR)
Italy (IT)
许可日期
2000/07/12
最近更新日期
2019/05/09
药物ATC编码
C10AB05 fenofibrate
申请类型
TypeLevel1：
Line Extension
TypeLevel2：
Multiple (Copy) Application
TypeLevel3：
Full Dossier Article 4.8 Di 65/65
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
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 PL
|
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