欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/3058/001
药品名称
Celecoxib AbZ 100 mg Hartkapseln
活性成分
celecoxib 100.0 mg
剂型
Capsule, hard
上市许可持有人
AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany
参考成员国 - 产品名称
Germany (DE)
Celecoxib-AbZ 100 mg Hartkapseln
互认成员国 - 产品名称
Belgium (BE)
Netherlands (NL)
Celecoxib 100 mg PCH, capsule, hard
France (FR)
Italy (IT)
许可日期
2012/06/15
最近更新日期
2023/11/27
药物ATC编码
M01AH01 celecoxib
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 Product Information
|
final-common-PL-3057-3058-012-021
Date of last change:2020/06/18
Final Product Information
|
final-common-SPC-3057-3058-012-021
Date of last change:2020/06/18
Final SPC
|
DE3057+3058_Celecoxib 100_200 mg hard capsules-SmPC_clean_20150911_renewal
Date of last change:2015/09/11
Final PL
|
DE3057+3058_Celecoxib 100 mg hard capsules-PIL_20150911_renewal
Date of last change:2015/09/11
Final PL
|
DE3057+3058_Celecoxib 200 mg hard capsules-PIL_clean_20150911_renewal
Date of last change:2015/09/11
Final Labelling
|
DE3057+3058_common-impack-100mg_blister_20150911_renewal
Date of last change:2015/09/11
Final Labelling
|
DE3057+3058_common-impack-100mg_tabletcontainer_20150911_renewal
Date of last change:2015/09/11
Final Labelling
|
DE3057+3058_common-impack-200mg_blister_20150911_renewal
Date of last change:2015/09/11
Final Labelling
|
DE3057+3058_common-impack-200mg_tabletcontainer_20150911_renewal
Date of last change:2015/09/11
Final Labelling
|
DE3057+3058_common-outer-100mg_cartonblister_20150911_renewal
Date of last change:2015/09/11
Final Labelling
|
DE3057+3058_common-outer-100mg_cartontabletcontainer-1_20150911_renewal
Date of last change:2015/09/11
Final Labelling
|
DE3057+3058_common-outer-100mg_cartontabletcontainer-2_20150911_renewal
Date of last change:2015/09/11
Final Labelling
|
DE3057+3058_common-outer-200mg_cartonblister_20150911_renewal
Date of last change:2015/09/11
PAR
|
PAREN-DE3057-3058-Celecoxib-20120924
Date of last change:2013/06/29
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase