欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
AT/H/1251/001
药品名称
Teruma 14 mg Filmtabletten
活性成分
teriflunomide 14.0 mg
剂型
Film-coated tablet
上市许可持有人
Teva B.V. Swensweg 5 2031GA Haarlem Netherlands
参考成员国 - 产品名称
Austria (AT)
互认成员国 - 产品名称
许可日期
2023/07/19
最近更新日期
2024/11/27
药物ATC编码
L04AA31 teriflunomide
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 PL
|
final_common_PIL_AT_H_1251_001_IA_004_clean
Date of last change:2024/09/30
Final SPC
|
final_common_SPC_AT_H_1251_001_IA_004_clean
Date of last change:2024/09/30
Final Labelling
|
Final_LAB_AT_H_1225_1226_1251_001_DC
Date of last change:2024/09/06
PubAR
|
PAR_AT_H_1251_001_barrierefrei
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase