欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3303/001
药品名称
Pantoprazole Kalceks
活性成分
Pantoprazole sodium sesquihydrate 40.0 mg
剂型
Powder for solution for injection
上市许可持有人
AS Kalceks Krustpils iela 71E 1057 Riga Latvia
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Hungary (HU)
Pantoprazole Kalceks 40 mg por oldatos injekcióhoz
Austria (AT)
Bulgaria (BG)
Pantoprazole Kalceks
France (FR)
Czechia (CZ)
Pantoprazole Kalceks
Spain (ES)
Romania (RO)
Portugal (PT)
Slovakia (SK)
Italy (IT)
Slovenia (SI)
Sweden (SE)
Croatia (HR)
Norway (NO)
Finland (FI)
Germany (DE)
Pantoprazol Kalceks 40 mg Pulver zur Herstellung einer Injektionslösung
Poland (PL)
Belgium (BE)
Latvia (LV)
Netherlands (NL)
Lithuania (LT)
Pantoprazole Kalceks 40 mg milteliai injekciniam tirpalui
Ireland (IE)
许可日期
2023/04/26
最近更新日期
2025/06/02
药物ATC编码
A02BC02 pantoprazole
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 Labelling
|
LAB_Pantoprazole_common_Day106_20220607_clean
Date of last change:2024/09/06
Final PL
|
PIL_Pantoprazole_common_resp_ to Day203 comments_20230420_clean
Date of last change:2024/09/06
Final SPC
|
SmPC_Pantoprazole_common_resp_ to Day180_ 195 comments_20230404_clean
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase