欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/4104/001
药品名称
Gefitinib Krka
活性成分
gefitinib 250.0 mg
剂型
Film-coated tablet
上市许可持有人
Krka, d.d., Novo mesto
参考成员国 - 产品名称
Netherlands (NL)
Gefitinib Synthon
互认成员国 - 产品名称
France (FR)
Lithuania (LT)
Gefitinib Krka 250 mg plėvele dengtos tabletės
Hungary (HU)
Slovenia (SI)
Gefitinib Krka 250 mg filmsko obložene tablete
许可日期
2018/07/11
最近更新日期
2023/09/04
药物ATC编码
L01XE02 gefitinib
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
PubAR
|
181123 NL_H_4104_001_DC Gefitinib Krka PAR
Date of last change:2024/09/06
PubAR Summary
|
181123 NL_H_4104_001_DC Gefitinib Krka summary EN
Date of last change:2024/09/06
Final PL
|
common_pil_clean
Date of last change:2024/09/06
Final SPC
|
common_smpc_clean
Date of last change:2024/09/06
Final Labelling
|
M1_3_1_02_GBF_tab_001_05_core
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase