欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
SE/H/2205/001
药品名称
Jivolar
活性成分
Metformin hydrochloride 850.0 mg
Sitagliptin 50.0 mg
剂型
Film-coated tablet
上市许可持有人
Medochemie Ltd., Cyprus
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Slovakia (SK)
Slovenia (SI)
Spain (ES)
Malta (MT)
Jimantex 50 mg/850 mg film coated tablets
Portugal (PT)
Croatia (HR)
Greece (GR)
Latvia (LV)
Lithuania (LT)
Estonia (EE)
Bulgaria (BG)
Jimantex
Cyprus (CY)
Jimantex 50/850mg film coated tablet
Czechia (CZ)
Jimantex
Romania (RO)
Jimantex 50mg/ 850 mg comprimate filmate
许可日期
2023/01/23
最近更新日期
2024/10/25
药物ATC编码
A10BD07 metformin and sitagliptin
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 SPC
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211129000145
Date of last change:2024/09/06
Final PL
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211129000145_2
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211129000145_3
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20211129000145_4
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase