欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2262/001
药品名称
Gemcitabina Hikma
活性成分
gemcitabine 38.0 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)
Gemcitabin Hikma 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Belgium (BE)
Gemcitabine Hikma 38 mg/ml concentraat voor oplossing voor infusie
Netherlands (NL)
Gemcitabine Hikma, 38 mg/ml, concentraat voor
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Gemcitabin Hikma 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung
France (FR)
Spain (ES)
Italy (IT)
许可日期
2020/05/20
最近更新日期
2024/02/02
药物ATC编码
L01BC05 gemcitabine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_pl_gemcitabine_38mgml_dcp_var007_clean_BDCF_20231227
Date of last change:2024/02/02
Final SPC
|
common_spc_gemcitabine_38mgml_dcp_var007_clean_BDCF_20231227
Date of last change:2024/02/02
Final Labelling
|
common_outer_gemcitabine_38mgml_dcp_var 005_clean
Date of last change:2023/11/09
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase