欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2286/001
药品名称
Cisplatina Hikma
活性成分
cisplatin 1.0 mg/ml
剂型
Concentrate for solution for infusion
上市许可持有人
Hikma Farmacêutica (Portugal), S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Cisplatin Hikma 1mg/ml Konzentrat zur Herstellung einer Infussionslösung
Netherlands (NL)
Cisplatine Hikma 1 mg/ ml, concentraat voor oplossing voor infusie
Austria (AT)
France (FR)
Spain (ES)
Italy (IT)
United Kingdom (Northern Ireland) (XI)
许可日期
2021/10/06
最近更新日期
2024/03/01
药物ATC编码
L01XA01 cisplatin
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
PAR
|
648985_20220622_PAR_MSP
Date of last change:2024/02/02
Final PL
|
common_pl_cisplatin1mg_ml_open vial_clean
Date of last change:2023/11/23
Final Labelling
|
common_outer_cisplatin1mg_ml_open vial clean
Date of last change:2023/11/23
Final SPC
|
common_spc_cisplatin1mg_ml_open vial_clean
Date of last change:2023/11/23
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase