欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0664/001
药品名称
Tiapride ratiopharm 100 mg
活性成分
tiapride hydrochloride 100.0 mg
剂型
Tablet
上市许可持有人
Ratiopharm GmbH Graf-Arco-strasse 3 D-89079 ULM Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
许可日期
2005/11/29
最近更新日期
2020/03/17
药物ATC编码
N05AL03 tiapride
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) Application
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
Annex A Tiapride 100 mg tablets_SmPC renewal final
Date of last change:2024/09/06
Final Product Information
|
Annex B Tiapride 100 mg tablets_P renewal final
Date of last change:2024/09/06
Final Product Information
|
Annex C labelling blister renewal final
Date of last change:2024/09/06
Final Product Information
|
Annex C labelling outer renewal final
Date of last change:2024/09/06
Final Labelling
|
Tiapride 100 mg tablets_OuP_NL_H_0664_001_MR_26_07_17
Date of last change:2024/09/06
Final PL
|
Tiapride 100 mg tablets_PIL_NL_H_0664_001_26_07_17
Date of last change:2024/09/06
Final SPC
|
Tiapride 100 mg tablets_SmPC_NL_H_0664_001_26_07_17
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase