欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1146/003
药品名称
Fentanyl-HEXAL S 37,5 µg/h
活性成分
fentanyl 37.5 µg
剂型
Transdermal patch
上市许可持有人
HEXAL AG Industriestrasse 25 83607 Holzkirchen Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
许可日期
2008/08/04
最近更新日期
2023/11/09
药物ATC编码
N02AB03 fentanyl
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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 Labelling
|
final_common_outer_1146_1147_028_032
Date of last change:2023/08/17
Final SPC
|
final_common_spc_1146_1147_028_032
Date of last change:2023/08/17
Final PL
|
final_common_pl_1146_1147_028_032
Date of last change:2023/08/17
Final Product Information
|
common_final_spc_1146_1147_V024_028
Date of last change:2022/08/09
Final Product Information
|
common_final_pl_1146_1147_V024_028
Date of last change:2022/08/09
PAR
|
PAREN-DE1146-1148-Fentanyl Hexal-20100315-final
Date of last change:2013/06/05
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase