欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1870/001
药品名称
Gabrilen N 50 mg
活性成分
ketoprofen 50.0 mg
剂型
Capsule, hard
上市许可持有人
Trommsdorff GmbH & Co. KG Trommsdorffstr. 2-6 52477 Alsdorf Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Poland (PL)
Ketoprofen - SF
许可日期
2009/08/27
最近更新日期
2024/07/24
药物ATC编码
M01AE03 ketoprofen
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 PL
|
common_final_pl_1870_001_002__V032
Date of last change:2024/09/06
Final Labelling
|
DE_1870_Gabrilen_labip_50_100mg_cv_20140807_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_1870_Gabrilen_labip_inj_cv_20140807_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_1870_Gabrilen_labop_50mg_10mg_cv_20140807_renewal
Date of last change:2024/09/06
Final Labelling
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DE_1870_Gabrilen_labop_inj_cv_20140807_renewal
Date of last change:2024/09/06
Final SPC
|
DE_1870_Gabrilen_spcen_50_100 mg_cv_20140807_renewal
Date of last change:2024/09/06
Final SPC
|
DE_1870_Gabrilen_spcen_inj_cv_20140807_renewal
Date of last change:2024/09/06
Final Product Information
|
final_common_outer_sol_1870_024
Date of last change:2024/09/06
Final Product Information
|
final_common_PIL_sol_1870_024
Date of last change:2024/09/06
Final Product Information
|
final_common_smpc_cap_1870_024
Date of last change:2024/09/06
Final Product Information
|
final_common_smpc_sol_1870_024
Date of last change:2024/09/06
PubAR
|
PAREN_DE1870_Ketoprofen_20100303_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase