欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/5037/002
药品名称
Apixaban 1A Pharma 5 mg
活性成分
Apixaban 5.0 mg
剂型
Film-coated tablet
上市许可持有人
1A Pharma GmbH Keltenring 1+3 82041 Oberhaching Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Austria (AT)
Apixaban 1A Pharma 5 mg – Filmtabletten
Germany (DE)
Apixaban 1A Pharma 5 mg Filmtabletten
许可日期
2021/07/14
最近更新日期
2025/12/19
药物ATC编码
B01AF02 apixaban
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Final common_pl_002_clean
Date of last change:2025/11/27
Final SPC
|
Final common_spc_002_clean
Date of last change:2025/11/27
Final Labelling
|
1_3_1 spc_label_pl _ Common_outer _ 868 _ clean
Date of last change:2024/09/06
PubAR
|
PAR_5037_Apixaban 1A Pharma_23Mar2023
Date of last change:2024/09/06
PubAR Summary
|
sPAR_5037_Apixaban 1A Pharma_23Mar2023_EN
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase