欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1776/004
药品名称
Hydofon
活性成分
hydromorphone hydrochloride 50.0 mg/ml
剂型
Solution for injection/infusion
上市许可持有人
2care4 Generics ApS Denmark
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Denmark (DK)
Norway (NO)
Hydofon
Finland (FI)
许可日期
2019/03/12
最近更新日期
2023/08/31
药物ATC编码
N02AA03 hydromorphone
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 PL
|
SE_H_1776_004_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1776_004_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1776_004_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase