欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/0797/005
药品名称
Methotrexat ”Ebewe”
活性成分
methotrexate 10.0 mg/ml
剂型
Solution for injection
上市许可持有人
Ebewe Pharma Ges.m.b.H. Nfg. KG Mondseestrasse 11 4866 Unterach Østrig
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
许可日期
2009/11/03
最近更新日期
2020/03/06
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 Labelling
|
1_3_1 common_outer _ 4_837_tablets_final_cl
Date of last change:2024/09/06
Final PL
|
1_3_1 spc_label_pl _ common_PIL _ Clean
Date of last change:2024/09/06
Final PL
|
1_3_1 spc_label_pl _ common_PIL _ Concentrate for solution _ Clean
Date of last change:2024/09/06
Final PL
|
1_3_1 spc_label_pl _ common_PIL_Solution of injection _ Clean
Date of last change:2024/09/06
Final SPC
|
1_3_1 spc_label_pl _ common_spc _ Clean
Date of last change:2024/09/06
Final SPC
|
1_3_1 spc_label_pl _ common_spc _ Concentrate for solution _ Clean
Date of last change:2024/09/06
Final SPC
|
1_3_1 spc_label_pl _ common_spc_Solution of injection _ Clean
Date of last change:2024/09/06
Final Labelling
|
1_3_1_common_outer_004_concentrate for solution for infusion_final_cl
Date of last change:2024/09/06
Final Labelling
|
1_3_1_common_outer_0797_005_solution for injection_final_cl
Date of last change:2024/09/06
Final Product Information
|
Common LB_tablets 2_5 mg_5 mg_10 mg_Clean
Date of last change:2024/09/06
Final Product Information
|
Common PL_concentrate for solution for infusion 100mg_ml_Clean
Date of last change:2024/09/06
Final Product Information
|
Common PL_tablets 2_5 mg_5 mg_10 mg_Clean
Date of last change:2024/09/06
Final Product Information
|
Common SmPC_concentrate for solution for infusion 100mg_ml_Clean
Date of last change:2024/09/06
Final Product Information
|
Common SmPC_tablets 2_5 mg_5 mg_10 mg_clean
Date of last change:2024/09/06
PubAR
|
parmod5_dk079705methotrexatemeda_pdf
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase