欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/0719/001
药品名称
Clozapin HEXAL 200 mg Tabletten
活性成分
clozapine 200.0 mg
剂型
Tablet
上市许可持有人
Hexal Aktiengesellschaft Industriestr. 25 D-83607 Holzkirchen
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Netherlands (NL)
许可日期
2007/07/10
最近更新日期
2020/07/10
药物ATC编码
N05AH02 clozapine
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 Product Information
|
common-final-pl-0719-V029
Date of last change:2020/07/10
Final Product Information
|
common-final-labop-0719-V029
Date of last change:2020/07/10
Final Product Information
|
common-final-spc-0719-V029
Date of last change:2020/07/10
Final Labelling
|
DE_719_Clozapin_outer_clean_20160115_renewal
Date of last change:2016/01/20
Final PL
|
DE_719_Clozapin_pl_clean_20160115_renewal
Date of last change:2016/01/20
Final SPC
|
DE_719_Clozapin_spc_clean_20160120_renewal
Date of last change:2016/01/20
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase