欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/2145/001
药品名称
Melenor 5 mg
活性成分
risedronate sodium salt 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Medochemie Ltd 1-10 Constantinoupoleos Street Limassol 3011 Cyprus
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Cyprus (CY)
许可日期
2011/07/18
最近更新日期
2021/04/08
药物ATC编码
M05BA07 risedronic acid
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_combined_pil_30mg_oct2020_clean
Date of last change:2024/09/06
Final PL
|
common_combined_pil_35mg_oct2020_clean
Date of last change:2024/09/06
Final PL
|
common_combined_pil_5mg_oct2020_clean
Date of last change:2024/09/06
Final SPC
|
common_combined_spc_30mg_oct2020_clean
Date of last change:2024/09/06
Final SPC
|
common_combined_spc_35mg_oct2020_clean
Date of last change:2024/09/06
Final SPC
|
common_combined_spc_5mg_oct2020_clean
Date of last change:2024/09/06
Final Labelling
|
ETE_100805_Outer_30 m_final_clean
Date of last change:2024/09/06
Final Labelling
|
ETE_100805_Outer_35 mg_final_clean
Date of last change:2024/09/06
Final Labelling
|
ETE_100805_Outer_5 mg_final_clean
Date of last change:2024/09/06
PubAR
|
PAR_2145_DC_melenor_30 apr 2014
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase