欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
SE/H/2106/004
药品名称
Metylfenidat Amdipharm
活性成分
methylphenidate hydrochloride 40.0 mg
剂型
Modified-release capsule, hard
上市许可持有人
Amdipharm Ltd., Ireland
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
许可日期
2022/09/27
最近更新日期
2024/07/16
药物ATC编码
N06BA04 methylphenidate
申请类型
TypeLevel1：
Line Extension
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 SPC
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220331000096
Date of last change:2024/09/06
Final PL
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220331000096_2
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220331000096_3
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220331000096_4
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase