欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0104/001
药品名称
Yarisen
活性成分
risedronate sodium salt 35.0 mg
剂型
Film-coated tablet
上市许可持有人
Valentis Polska Sp. z o.o. ul. 17 Stycznia 45B 02-146 Warszawa
参考成员国 - 产品名称
Poland (PL)
Yarisen
互认成员国 - 产品名称
France (FR)
Latvia (LV)
Norifaz 35 mg apvalkotās tabletes
Lithuania (LT)
NORIFAZ 35 mg plėvele dengtos tabletės
Estonia (EE)
NORIFAZ
Hungary (HU)
NORIFAZ 35 mg filmtabletta
许可日期
2008/06/19
最近更新日期
2024/09/13
药物ATC编码
M05BA07 risedronic acid
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) Application
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
|
2020_12 Risedronate sodium_35mg_PIL_common_track
Date of last change:2024/09/06
Final SPC
|
2020_12 Risedronate sodium_35mg_SPC_common_track
Date of last change:2024/09/06
Final Product Information
|
PL_H_0104_001_FinalPL
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase