欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1205/001
药品名称
Metotrexat Accord
活性成分
Methotrexate 25.0 mg/ml
剂型
Solution for injection
上市许可持有人
Accord Healthcare B.V. Netherlands
参考成员国 - 产品名称
Sweden (SE)
Metotrexat Accord
互认成员国 - 产品名称
Germany (DE)
Methotrexat Accord 25 mg/ml Injektionslösung
Belgium (BE)
Methotrexaat Accord Healthcare 25 mg/ml oplossing voor injectie
Netherlands (NL)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Methotrexat Accord 25 mg/ml Injektionslösung
Portugal (PT)
Cyprus (CY)
METHOTREXATE SOLUTION FOR INJECTION
Czechia (CZ)
Methotrexat Accord 25 mg/ml injekční roztok
Finland (FI)
Spain (ES)
France (FR)
Denmark (DK)
Lithuania (LT)
Methotrexate Accord 25 mg/ ml injekcinis tirpalas
Norway (NO)
Estonia (EE)
METHOTREXATE ACCORD
Italy (IT)
许可日期
2012/05/21
最近更新日期
2024/11/26
药物ATC编码
L01BA01 methotrexate
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
|
SE_H_1205_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1205_001_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1205_001_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase