欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/4426/001
药品名称
Bupropion Hcl retard Teva 300 mg
活性成分
Bupropion hydrochloride 300.0 mg
剂型
Modified-release tablet
上市许可持有人
Teva B.V. Swensweg 5 2031 GA Haarlem
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Germany (DE)
Bupropion-ratiopharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung
Austria (AT)
Bupropion ratiopharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung
Spain (ES)
Sweden (SE)
Norway (NO)
Bupropion hydrochloride Teva
Belgium (BE)
Portugal (PT)
Iceland (IS)
许可日期
2018/09/10
最近更新日期
2025/01/23
药物ATC编码
N06AX12 bupropion
申请类型
TypeLevel1:
Known Active Substance
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
|
Bupropion_nl_h_4426_001_pil_14_11_2024
Date of last change:2024/11/14
Final Labelling
|
Bupropion_nl_h_4426_001_oup_imp_14_11_2024
Date of last change:2024/11/14
Final SPC
|
Bupropion_nl_h_4426_001_smpc_14_11_2024
Date of last change:2024/11/14
Final Product Information
|
common_outerlabelling_clean
Date of last change:2024/09/06
Final Product Information
|
common_pil_clean
Date of last change:2024/09/06
Final Product Information
|
common_smpc_clean
Date of last change:2024/09/06
PubAR
|
PAR_4426_bupropion_7 maart 2019
Date of last change:2024/09/06
PubAR Summary
|
PAR_4426_dc_bupropion_7 maart 2019_summary Eng
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase