欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1569/001
药品名称
Visanne 2 mg Tabletten
活性成分
Dienogest 2.0 mg
剂型
Tablet
上市许可持有人
Jenapharm GmbH & Co. KG Otto-Schott-Str. 15 07745 Jena Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Germany (DE)
Visanne 2 mg Tabletten
Denmark (DK)
Visanne
Belgium (BE)
Luxembourg (LU)
Iceland (IS)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Sweden (SE)
Slovakia (SK)
Slovenia (SI)
Malta (MT)
Visabelle
Norway (NO)
Finland (FI)
Poland (PL)
Visanne
Latvia (LV)
Visannette 2 mg tabletes
Lithuania (LT)
Visannette 2 mg tabletės
Estonia (EE)
VISANNETTE
Hungary (HU)
VISANNE 2 mg tabletta
Czechia (CZ)
Visanne
Romania (RO)
Vissane 2 mg comprimate
Croatia (HR)
Visanne 2 mg tablete
许可日期
2009/12/02
最近更新日期
2025/08/13
药物ATC编码
G03DB08 dienogest
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial 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 PL
|
EU PIL Visanne _clean
Date of last change:2024/09/06
Final Labelling
|
Final Labelling _ clean
Date of last change:2024/09/06
Final SPC
|
Final SmPC _clean_
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase