欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0374/003
药品名称
Fluconazol "Stada"
活性成分
fluconazole 150.0 mg
剂型
Capsule, hard
上市许可持有人
Stada Arzneimittel AG Stadastrasse 2 - 18 D-61118 Bad Vilbel Germany
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Germany (DE)
Luxembourg (LU)
Austria (AT)
Difluzol 150 mg - Kapseln
Italy (IT)
许可日期
2002/10/24
最近更新日期
2024/01/10
药物ATC编码
J02AC01 fluconazole
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
1_3_1_PIL_Fluconazole_0374_cl
Date of last change:2024/01/11
Final SPC
|
1_3_1_SPC_common_en_DK_H_0374_001_004_cl
Date of last change:2024/01/11
Final Labelling
|
1.3.1-SPC-common-en-DK-H-0374-001-004-clean
Date of last change:2020/02/28
Final Labelling
|
1.3.1-PIL-common-en-DK-H-0374-001-004-clean
Date of last change:2020/02/28
Final Labelling
|
1.3.1-Lab-common-outer-en-FLUCO-0374-001-004_clean
Date of last change:2020/02/28
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase