欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
UK/H/1649/001
药品名称
Fosatrol Once Weekly
活性成分
alendronic acid 70.0 mg
剂型
Tablet
上市许可持有人
Merck Sharp & Dohme Limited
参考成员国 - 产品名称
United Kingdom (GB)
互认成员国 - 产品名称
United Kingdom (GB)
许可日期
2008/06/12
最近更新日期
2018/05/16
药物ATC编码
M05BA04 alendronic acid
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Informed Consent Art 10c Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
06-5-container
Date of last change:2011/08/05
Final Labelling
|
m1-3-1-labelling-PL-00025-0399-fosamax-annotated (1)
Date of last change:2011/08/05
Final Labelling
|
m1-3-1-labelling-PL-00025-0400-adronat-annotated
Date of last change:2011/08/05
Final Labelling
|
m1-3-1-labelling-PL-00025-0401-Alegen-annotated
Date of last change:2011/08/05
Final Labelling
|
m1-3-1-labelling-PL-00025-0402-alendros-annotated
Date of last change:2011/08/05
Final Labelling
|
m1-3-1-labelling-PL-00025-0403-dronal-annotated
Date of last change:2011/08/05
Final Labelling
|
m1-3-1-labelling-PL-00025-0508-fosatrol-annotated
Date of last change:2011/08/05
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase