欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1881/001
药品名称
Duloxetin Teva
活性成分
Duloxetine hydrochloride 30.0 mg
剂型
Gastro-resistant capsule, hard
上市许可持有人
Teva B.V. Netherlands
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Duloxetin-ratiopharm 30 mg magensaftresistente Hartkapseln
Belgium (BE)
Duloxetine Teva 30 mg harde maagsapresistente capsules
Netherlands (NL)
Austria (AT)
Duloxetin ratiopharm GmbH 30 mg magensaftresistente Hartkapseln
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Croatia (HR)
许可日期
2019/07/30
最近更新日期
2025/01/30
药物ATC编码
N06AX21 duloxetine
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
|
SE_H_1881_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1881_001_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1881_001_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase