欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/6039/002
药品名称
Nintedanib Olainfarm 150 mg, zachte capsules
活性成分
nintedanib esilate 100.0 mg
剂型
Capsule, soft
上市许可持有人
Olainfarm AS
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Germany (DE)
Nintedanib Olainfarm 150 mg Weichkapseln
许可日期
2024/09/26
最近更新日期
2024/09/26
药物ATC编码
L01EX09 nintedanib
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 PL
|
PL 150mg
Date of last change:2024/09/26
Final Labelling
|
common_labelling
Date of last change:2024/09/26
Final SPC
|
common_spc
Date of last change:2024/09/26
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase