欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0181/001
药品名称
Ciclosporina Generis
活性成分
ciclosporin 100.0 mg/ml
剂型
Oral solution
上市许可持有人
Generis Farmacêutica, S.A. Portugal
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
PL 20117/0043
许可日期
2010/05/27
最近更新日期
2024/02/19
药物ATC编码
L04AD01 ciclosporin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial 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 PL
|
common_pl_proposedclean
Date of last change:2024/09/06
Final SPC
|
common_spc_proposedclean
Date of last change:2024/09/06
Final Labelling
|
PT181_Ciclosporina_Germed_labelling_final
Date of last change:2024/09/06
市场状态
Positive
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