欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0192/003
药品名称
Optinate Septimum
活性成分
Risedronic acid 35.0 mg
剂型
Film-coated tablet
上市许可持有人
Theramex Ireland Limited Ireland
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Denmark (DK)
Belgium (BE)
Luxembourg (LU)
Austria (AT)
Actonel einmal wöchentlich 35 mg Filmtabletten
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Greece (GR)
Finland (FI)
Hungary (HU)
ACTONEL 35 mg filmtabletta
Cyprus (CY)
Netherlands (NL)
许可日期
2002/12/03
最近更新日期
2024/10/11
药物ATC编码
M05BA07 risedronic acid
申请类型
TypeLevel1:
Line Extension
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
SE_H_0192_003_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0192_003_Final SPC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase