欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/1740/001
药品名称
Fentanilo Kalceks
活性成分
fentanyl citrate 0.78 mg
剂型
Solution for injection
上市许可持有人
ELC Group, s.r.o.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Poland (PL)
Fentanyl ELC
Czechia (CZ)
Fentanyl ELC 0.05 mg/ml injekční roztok
Malta (MT)
Fentanyl ELC 0.05 mg/ml solution for injection
许可日期
2017/08/16
最近更新日期
2024/08/02
药物ATC编码
N01AH01 fentanyl
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
|
PIL_Fentanyl citrate_DCP_PSUSA _2_3_4__ MAH address change_20240209_track
Date of last change:2024/09/13
Final SPC
|
SPC_Fentanyl citrate_DCP_PSUSA _2_3_4__ MAH address change_20240209_track
Date of last change:2024/09/13
Final Labelling
|
LAB_Fentanyl citrate_DCP_MAH address change_20240122_track
Date of last change:2024/09/13
PubAR
|
612322_20170825_PAR_GBB
Date of last change:2024/09/06
Final Product Information
|
Fentanyl citrate_PIL_common_20170725_clean
Date of last change:2024/09/06
Final Product Information
|
Fentanyl citrate_SPC_common_20170616_clean
Date of last change:2024/09/06
Final Product Information
|
Fentanyl_inj_labelling_inner_20170404_clean
Date of last change:2024/09/06
Final Product Information
|
Fentanyl_inj_labelling_outer_20170616_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase