欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/3649/001
药品名称
Memantinhydrochlorid-neuraxpharm 5 mg Filmtabletten
活性成分
memantine hydrochloride 5.0 mg
剂型
Film-coated tablet
上市许可持有人
neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
参考成员国 - 产品名称
Germany (DE)
Memantin-HCl neuraxpharm 5 mg Filmtabletten
互认成员国 - 产品名称
许可日期
2012/09/18
最近更新日期
2020/09/15
药物ATC编码
N06DX01 memantine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
DE_3649_Memantin_Neuraxpharm_blister_fcte_cv_20170907_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3649_Memantin_Neuraxpharm_inner_oso_cv_20170907_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3649_Memantin_Neuraxpharm_outer_fct_cv_20170907_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3649_Memantin_Neuraxpharm_outer_oso_cv__20170907_renewal
Date of last change:2024/09/06
Final PL
|
DE_3649_Memantin_Neuraxpharm_pl_fct_cv_20170907_renewal
Date of last change:2024/09/06
Final PL
|
DE_3649_Memantin_Neuraxpharm_pl_oso_cv_20170907_renewal
Date of last change:2024/09/06
Final SPC
|
DE_3649_Memantin_Neuraxpharm_spc_fct_cv_20170907_renewal
Date of last change:2024/09/06
Final SPC
|
DE_3649_Memantin_Neuraxpharm_spc_oso_cv_20170907_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3650_Memantin Aristo_bl_fct_20170907_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3650_Memantin Aristo_bl_initiation_20170907_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3650_Memantin Aristo_inner_oso_cv_20170907_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3650_Memantin Aristo_outer_fct_cv_20170907_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3650_Memantin Aristo_outer_initiation_cv_20170907_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3650_Memantin Aristo_outer_oso_cv_20170907_renewal
Date of last change:2024/09/06
Final PL
|
DE_3650_Memantin Aristo_pl_fct_cv_20170907_renewal
Date of last change:2024/09/06
Final PL
|
DE_3650_Memantin Aristo_pl_initiation_cv_20170907_renewal
Date of last change:2024/09/06
Final PL
|
DE_3650_Memantin Aristo_pl_oso_cv_20170907_renewal
Date of last change:2024/09/06
Final SPC
|
DE_3650_Memantin Aristo_spc_fct_cv_20170907_renewal
Date of last change:2024/09/06
Final SPC
|
DE_3650_Memantin Aristo_spc_initiation_cv_20170907_renewal
Date of last change:2024/09/06
Final SPC
|
DE_3650_Memantin Aristo_spc_oso_cv_20170907_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_5051_Memantin_Neuraxpharm_impack_odt_cv_20170907_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_5051_Memantin_Neuraxpharm_outer_odt_cv_20170907_renewal
Date of last change:2024/09/06
Final PL
|
DE_5051_Memantin_Neuraxpharm_pl_memantin_odt_cv_20170907_renewal
Date of last change:2024/09/06
Final SPC
|
DE_5051_Memantin_Neuraxpharm_spc_memantin_odt_cv_20170907_renewal
Date of last change:2024/09/06
PubAR
|
PAREN_DE3649_Memantin neuraxpharm_20120921_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase