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
2024/08/06
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 Product Information
|
common_final_pl_1146_1147_V024_028
Date of last change:2024/09/06
Final PL
|
common_final_pl_DE1146_1147_V033_038
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_1146_1147_V024_028
Date of last change:2024/09/06
Final SPC
|
common_final_spc_DE1146_1147_V033_038
Date of last change:2024/09/06
Final Labelling
|
final_common_outer_1146_1147_028_032
Date of last change:2024/09/06
PubAR
|
PAREN_DE1146_1148_Fentanyl Hexal_20100315_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase