欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
SE/H/2270/001
药品名称
Zemograc
活性成分
omeprazole 10.0 mg
剂型
Gastro-resistant capsule, hard
上市许可持有人
Laboratorios Leon Farma S.A. Spain
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Finland (FI)
Norway (NO)
许可日期
2023/06/14
最近更新日期
2024/07/24
药物ATC编码
A02BC01 omeprazole
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Multiple (Copy) Application
TypeLevel3：
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20220401000230_zemograc_10_mg_enterokapsel_hard
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20220401000230_zemograc_10_mg_enterokapsel_hard_2
Date of last change:2024/09/06
Final SPC
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220401000230
Date of last change:2024/09/06
Final PL
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220401000230_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase