欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/2580/001
药品名称
Aclonia
活性成分
alendronic acid 70.0 mg
cholecalciferol 70.0 mg
剂型
Tablet
上市许可持有人
Pharmathen S.A. 6, Dervenakion str., Pallini 15351 Attiki Greece
参考成员国 - 产品名称
Denmark (DK)
Felendrono
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Spain (ES)
Italy (IT)
Greece (GR)
FELENDRONO®
Cyprus (CY)
许可日期
2017/05/03
最近更新日期
2022/10/14
药物ATC编码
M05BB03 alendronic acid and colecalciferol
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Multiple (Copy) 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 SPC
|
Alendr_Cholec_2580_IA011G_common_SPC_clean
Date of last change:2022/08/11
Final PL
|
Alendr_Cholec_2580_IA010_common_PL_clean_1__2
Date of last change:2022/06/02
Final Labelling
|
Alendronate-Cholecalciferol 5600 IU 2580-IB006 var. common-LBL-clean
Date of last change:2021/02/03
Final Labelling
|
Alendronate-Cholecalciferol 2800 IU 2580-IB006 var. common-LBL-clean
Date of last change:2021/02/03
PAR Summary
|
Final sPAR Aclonia DKH2580_001-002_DC
Date of last change:2018/05/29
PAR
|
Final PAR Aclonia DKH2580_001-002_DC
Date of last change:2018/05/29
市场状态
Positive
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