欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/1712/001
药品名称
Rupatadina Teva
活性成分
Rupatadine fumarate 12.77 mg
剂型
Tablet
上市许可持有人
Teva Pharma - Produtos Farmacêuticos, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
许可日期
2017/07/19
最近更新日期
2025/10/31
药物ATC编码
R06AX28 rupatadine
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial Application
TypeLevel3：
Generic
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final Labelling
|
rupatadine_pt_h_1712_001_oup_imp_03_06_24_tracked
Date of last change:2025/10/31
Final PL
|
rupatadine_pt_h_1712_001_pil_06_10_25_tracked
Date of last change:2025/10/31
Final SPC
|
rupatadine_pt_h_1712_001_smpc_06_10_25_tracked
Date of last change:2025/10/31
Final Product Information
|
1_3_1 rupatadine_10mg_label_outer_common_clean
Date of last change:2024/09/06
Final Product Information
|
1_3_1 rupatadine_10mg_pil_common_clean
Date of last change:2024/09/06
Final Product Information
|
1_3_1 rupatadine_10mg_spc_common_clean
Date of last change:2024/09/06
PubAR
|
611164_20170810_PAR_GBB
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase