欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2030/001
药品名称
Methylphenidate 1A Farma
活性成分
methylphenidate hydrochloride 18.0 mg
剂型
Prolonged-release tablet
上市许可持有人
Sandoz A/S
参考成员国 - 产品名称
Denmark (DK)
Methylphenidate 1A Farma
互认成员国 - 产品名称
许可日期
2011/12/20
最近更新日期
2012/02/24
药物ATC编码
N06BA04 methylphenidate
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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 Labelling
|
1_3_1 spc_label_pl _ common_outer _ 943
Date of last change:2024/09/06
Final PL
|
1_3_1 spc_label_pl _ common_pl _ 1_310
Date of last change:2024/09/06
Final SPC
|
1_3_1 spc_label_pl _ common_spc _ 1_149
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase