欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
IS/H/0406/001
药品名称
Rivaroxaban G.L. Pharma
活性成分
RIVAROXABAN 2.5 mg
剂型
Film-coated tablet
上市许可持有人
G.L. Pharma GmbH Schlossplatz 1, 8502 Lannach Austria
参考成员国 - 产品名称
Iceland (IS)
Rivaroxaban G.L. Pharma
互认成员国 - 产品名称
Austria (AT)
Rivaroxaban G.L. 2,5 mg-Filmtabletten
Slovakia (SK)
许可日期
2020/08/25
最近更新日期
2024/10/23
药物ATC编码
B01AF01 rivaroxaban
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
|
IS_H_0406_001_IB_004_PIL_Rivaroxaban_G_L__Pharma_2_5mg_19_9_2022
Date of last change:2024/09/06
Final SPC
|
IS_H_0406_001_IB_004_SmPC_Rivaroxaban_G_L__Pharma_2_5mg_19_9_2022
Date of last change:2024/09/06
Final PL
|
IS_H_0406_002_IB_004_PIL_Rivaroxaban_G_L__Pharma_10mg_19_9_2022
Date of last change:2024/09/06
Final SPC
|
IS_H_0406_002_IB_004_SmPC_Rivaroxaban_G_L__Pharma_10mg_19_9_2022
Date of last change:2024/09/06
Final PL
|
IS_H_0406_003_004_IB_004_PIL_Rivaroxaban_G_L__Pharma_15_20mg_19_9_2022
Date of last change:2024/09/06
Final SPC
|
IS_H_0406_003_IB_004_SmPC_Rivaroxaban_G_L__Pharma_15mg_19_9_2022
Date of last change:2024/09/06
Final SPC
|
IS_H_0406_004_IB_004_SmPC_Rivaroxaban_G_L__Pharma_20mg_19_9_2022
Date of last change:2024/09/06
Final PL
|
IS_H_0406_005_IB_004_PIL_Rivaroxaban_G_L__Pharma_initiation_19_9_2022
Date of last change:2024/09/06
Final SPC
|
IS_H_0406_005_IB_004_SmPC_Rivaroxaban_G_L__Pharma_initiation_19_9_2022
Date of last change:2024/09/06
PubAR Summary
|
IS_H_0406_Rivaroxaban G_L_ Pharma _PAR_summary
Date of last change:2024/09/06
PubAR
|
IS_H_0406_Rivaroxaban G_L_ Pharma_PAR
Date of last change:2024/09/06
Final Product Information
|
IS_H_406_001_005_IA_011_PI_clean_Rivaroxaban_G_L__Pharma_11_1_2024
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase