欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/5125/002
药品名称
Tizagelan 4 mg
活性成分
tizanidine hydrochloride 4.57 mg
剂型
Tablet
上市许可持有人
G.L. Pharma GmbH Schlossplatz 1 Lannach Steiermark 8502 Austria
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Austria (AT)
Tizagelan 4 mg-Tabletten
Italy (IT)
Finland (FI)
Poland (PL)
Hungary (HU)
United Kingdom (Northern Ireland) (XI)
许可日期
2021/08/11
最近更新日期
2024/05/29
药物ATC编码
M03BX02 tizanidine
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Additional Strength/Form
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 SPC
|
SmPC_Tizanidine_2_4 mg tablets_26_05_2023
Date of last change:2023/08/02
PAR Summary
|
PAR_5125_Tizagelan_3 nov 2021_EN
Date of last change:2022/06/02
PAR
|
PAR_5125_Tizagelan_3 nov 2021
Date of last change:2022/06/02
Final PL
|
PIL_Tizanidine_2_4 mg tablets
Date of last change:2021/09/30
Final Labelling
|
common-interpack-allmg
Date of last change:2021/09/30
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase