欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0535/002
药品名称
Fluconazol 100 mg capsules
活性成分
fluconazole 100.0 mg
剂型
Capsule, hard
上市许可持有人
Sandoz B.V. P.O. Box 216 1380 AE Weesp The Netherlands
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Italy (IT)
Slovakia (SK)
许可日期
2004/12/08
最近更新日期
2024/03/13
药物ATC编码
J02AC01 fluconazole
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_pi_clean
Date of last change:2024/03/13
Final SPC
|
common_spc_clean
Date of last change:2024/03/13
Final Product Information
|
common-spc
Date of last change:2021/04/20
Final Product Information
|
common-pl
Date of last change:2021/04/20
Final Labelling
|
1.3.1 spc-label-pl - common-pl - 9,437
Date of last change:2018/10/25
Final Labelling
|
1.3.1 spc-label-pl - common-spc - 8,898
Date of last change:2018/10/25
Final Labelling
|
1.3.1 spc-label-pl - common-outer - 4,643
Date of last change:2018/10/25
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase