欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/5335/005
药品名称
Xaboplax
活性成分
RIVAROXABAN 15.0 mg
RIVAROXABAN 20.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz B.V. Veluwezoom 22 1327 AH Almere Nederland
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Poland (PL)
Runaplax SZ 15 mg en 20 mg, filmomhulde tabletten
Bulgaria (BG)
Greece (GR)
Latvia (LV)
Lithuania (LT)
Xaboplax 15mg plėvele dengtos tabletės Xaboplax 20 mg plėvele dengtos tabletės
Romania (RO)
Estonia (EE)
Croatia (HR)
Slovakia (SK)
Slovenia (SI)
许可日期
2022/03/22
最近更新日期
2024/10/02
药物ATC编码
B01AF01 rivaroxaban
申请类型
TypeLevel1:
Abridged
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 Labelling
|
Common
Date of last change:2024/10/02
PubAR
|
PAR_5335_Xaboplax_08Sep2022
Date of last change:2024/09/06
Final PL
|
pl_15mg_20mg_treatmentinitiationpack_clean
Date of last change:2024/09/06
PubAR Summary
|
sPAR_5335_Xaboplax_08Sep2022_ENG
Date of last change:2024/09/06
Final SPC
|
spc_15mg_20mg_treatmentinitiationpack_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase