欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2106/002
药品名称
Metylfenidat Amdipharm
活性成分
methylphenidate hydrochloride 20.0 mg
剂型
Modified-release capsule, hard
上市许可持有人
Amdipharm Limited, Ireland
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
许可日期
2021/09/22
最近更新日期
2024/07/16
药物ATC编码
N06BA04 methylphenidate
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
PubAR
|
New Document
Date of last change:2024/09/06
Final PL
|
SE_H_2106_002_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_2106_002_Final SPC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase