欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/4538/002
药品名称
Omeprazole 20mg Gastro-restant Capsules
活性成分
OMEPRAZOLE SODIUM 20.0 mg
剂型
Gastro-resistant capsule, hard
上市许可持有人
TEVA Pharma B.V.
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Omeprazole 20mg Gastro-restant Capsules
Germany (DE)
Omeprazol-ratiopharm NT 10mg magensaftresistente Hartkapseln
Denmark (DK)
Belgium (BE)
Luxembourg (LU)
Ireland (IE)
France (FR)
Italy (IT)
Hungary (HU)
OMEPRAZOL-TEVA 20 mg gyomornedv-ellenálló kemény kapszula
许可日期
2012/08/02
最近更新日期
2023/12/20
药物ATC编码
A02BC01 omeprazole
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final PL
|
omeprazole_nl_h_4538_01_03_pil_12_10_23
Date of last change:2023/12/20
Final Labelling
|
Omeprazole_NL_H_4538_01_03_OuP_ImP_25_04_23
Date of last change:2023/12/20
Final SPC
|
omeprazole_nl_h_4538_01_03_smpc_12_10_23
Date of last change:2023/12/20
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase