欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/4850/001
药品名称
Fingolimod Aristo
活性成分
fingolimod hydrochloride 0.5 mg
剂型
Capsule, hard
上市许可持有人
Aristo Pharma GmbH Wallenroder Straße 8-10 13435 Berlin Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
United Kingdom (GB)
Germany (DE)
Fingolimod Aristo 0,5 mg Hartkapseln
Spain (ES)
Italy (IT)
Poland (PL)
许可日期
2020/05/28
最近更新日期
2024/04/15
药物ATC编码
L04AA27 fingolimod
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 SPC
|
common-spc
Date of last change:2021/08/12
Final PL
|
common-pl
Date of last change:2021/08/12
Final Product Information
|
common-label
Date of last change:2021/08/12
PAR Summary
|
summaryPAR_4850_Fingolimod Aristo_4 mar 2021_EN
Date of last change:2021/03/22
PAR
|
PAR_4850_Fingolimod Aristo_4 mar 2021
Date of last change:2021/03/22
Final Labelling
|
Annex III
Date of last change:2020/08/20
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase