欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1417/011
药品名称
Methotrexate Addenda
活性成分
methotrexate disodium 30.0 mg
剂型
Solution for injection in pre-filled syringe
上市许可持有人
Addenda Pharma S.r.I. Italy
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Italy (IT)
Czechia (CZ)
Aldesta 30 mg
Romania (RO)
Aldesta 30 mg Soluţie injectabilă în seringă preumplută
许可日期
2015/07/13
最近更新日期
2021/08/27
药物ATC编码
L01BA01 methotrexate
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
SE_H_1417_011_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1417_011_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1417_011_PAR
Date of last change:2024/09/06
PubAR Summary
|
SE_H_1417_011_PAR Summary
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase