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)
Austria (AT)
Visanne 2 mg Tabletten
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
2025/02/13
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