欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2410/002
药品名称
Figozap
活性成分
Dapagliflozin 10.0 mg
剂型
Film-coated tablet
上市许可持有人
Sun Pharmaceutical Industries Europe B.V.
参考成员国 - 产品名称
Sweden (SE)
Figozap
互认成员国 - 产品名称
Denmark (DK)
Figozap
Netherlands (NL)
France (FR)
Spain (ES)
Italy (IT)
Norway (NO)
Finland (FI)
Poland (PL)
Romania (RO)
Isaviam 10 mg comprimate filmate
Germany (DE)
ISAVIAM 10 mg Filmtabletten
许可日期
2025/02/26
最近更新日期
2025/04/02
药物ATC编码
A10BK01 dapagliflozin
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Additional Strength/Form
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 PL
|
Final PL
Final SPC
|
Final SPC
PubAR
|
PAR
PubAR Summary
|
PAR Summary
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase