欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/0791/001
药品名称
Levobens-TEVA 50 mg/ 12,5 mg Hartkaspeln
活性成分
benserazide hydrochloride 12.5 mg
levodopa 50.0 mg
剂型
Capsule, hard
上市许可持有人
TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Denmark (DK)
Netherlands (NL)
Levodopa/Benserazide 50/12.5 PCH, capsules 50/12.5 mg
United Kingdom (Northern Ireland) (XI)
France (FR)
许可日期
2007/10/18
最近更新日期
2024/04/17
药物ATC编码
N04BA02 levodopa and decarboxylase inhibitor
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
|
common_pl
Date of last change:2024/09/06
Final SPC
|
common_spc_clean
Date of last change:2024/09/06
Final Labelling
|
Levobens_TEVA_DE_1391_01_02_R02_label_inner_eu clean_20161019_renewal
Date of last change:2024/09/06
Final Labelling
|
Levobens_TEVA_DE_1391_01_02_R02_label_outer_eu clean_20161019_renewal
Date of last change:2024/09/06
Final Labelling
|
Levobens_TEVA_DE_791_01_03_R02_label_inner_eu_clean_20161019_renewal
Date of last change:2024/09/06
Final Labelling
|
Levobens_TEVA_DE_791_01_03_R02_label_outer_eu_clean_20161019_renewal
Date of last change:2024/09/06
Final Product Information
|
PL_Levodopa_benserazide_DE_H_0791_RMS tracked
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase