欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
AT/H/0636/003
药品名称
Clozapin Ratiopharm 200 mg Tabletten
活性成分
clozapine 200.0 mg
剂型
Tablet
上市许可持有人
Teva B.V Swensweg 5 2031 GA Haarlem, Netherlands
参考成员国 - 产品名称
Austria (AT)
互认成员国 - 产品名称
Italy (IT)
许可日期
2017/01/18
最近更新日期
2021/12/22
药物ATC编码
N05AH02 clozapine
申请类型
TypeLevel1:
Known Active Substance
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
|
AT_H_0636_001_003_R_001_LAB_final
Date of last change:2024/09/06
Final PL
|
AT_H_0636_001_003_R_001_PL_final
Date of last change:2024/09/06
Final SPC
|
AT_H_0636_001_003_R_001_SmPC_final
Date of last change:2024/09/06
PubAR
|
PAR_AT_H_0636_001_003_barriere frei
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase