欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
SE/H/2381/001
药品名称
Kelzyn
活性成分
Dienogest 2.0 mg
ethinyl estradiol 0.02 mg
剂型
Prolonged-release tablet
上市许可持有人
Exeltis Healthcare S.L.
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Denmark (DK)
Norway (NO)
Finland (FI)
许可日期
2024/02/28
最近更新日期
2024/09/27
药物ATC编码
G03AA16 dienogest and ethinylestradiol
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Multiple (Copy) Application
TypeLevel3：
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final Labelling
|
Final LAB
Date of last change:2024/09/06
Final PL
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Final PL
Date of last change:2024/09/06
Final SPC
|
Final SPC
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20230214000082_kelzyn_2_mg_0_02_mg_depottablett_medProdName_kelzyn_activeTab_1
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20230214000082_kelzyn_2_mg_0_02_mg_depottablett_medProdName_kelzyn_activeTab_1_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase