欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SK/H/0136/001
药品名称
Tiaprid PMCS 100 mg
活性成分
Tiapride chloride 100.0 mg
剂型
Tablet
上市许可持有人
PRO.MED.CS Praha a.s., Telčská 1 140 00 Praha 4 CZ
参考成员国 - 产品名称
Slovakia (SK)
Tiaprid PMCS 100 mg
互认成员国 - 产品名称
Poland (PL)
Lithuania (LT)
Tiapride PMCS 100 mg tabletės
许可日期
2012/02/15
最近更新日期
2025/01/28
药物ATC编码
N05AL03 tiapride
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 Product Information
|
Acknowledgement of approval_
Date of last change:2024/09/06
Final Labelling
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common_lab_tiaprid_pmcs_SK_H_0136_001_IB_010_G_clean
Date of last change:2024/09/06
Final Labelling
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common_lab_tiaprid_pmcs_SK_H_0136_001_IB_010_G_track
Date of last change:2024/09/06
Final PL
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common_pil_tiaprid_pmcs_SK_H_0136_001_IB_010_G_clean
Date of last change:2024/09/06
Final PL
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common_pil_tiaprid_pmcs_SK_H_0136_001_IB_010_G_track
Date of last change:2024/09/06
Final SPC
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common_spc_tiaprid_pmcs_SK_H_0136_001_IB_010_G_clean
Date of last change:2024/09/06
Final SPC
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common_spc_tiaprid_pmcs_SK_H_0136_001_IB_010_G_track
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase