欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/2277/001
药品名称
Oltrola
活性成分
acetylsalicylic acid 75.0 mg
剂型
Gastro-resistant tablet
上市许可持有人
Pfizer ApS Lautrupvang 8 2750 Ballerup DK- Danmark
参考成员国 - 产品名称
Denmark (DK)
Oltrola
互认成员国 - 产品名称
France (FR)
许可日期
2014/04/16
最近更新日期
2023/11/13
药物ATC编码
B01AC06 acetylsalicylic acid
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Bibliographic Art 10 a Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Non Prescription (including OTC)
附件文件下载
Final SPC
|
common_oltrola_tablets_spc_75mg_100mg_clean
Date of last change:2023/12/20
Final PL
|
common-pil-oltrola-clean
Date of last change:2021/01/16
PAR
|
Final PAR Scientific discussion Oltrola DKH2277_001-002_DC
Date of last change:2015/01/13
Final Labelling
|
m1-3-1-bottle-label 75mg April 2014 clean OTC
Date of last change:2014/10/08
Final Labelling
|
m1-3-1-bottle-label 75mg April 2014 clean Rx
Date of last change:2014/10/08
Final Labelling
|
m1-3-1-bottle-label 100mg April 2014 clean OTC
Date of last change:2014/10/08
Final Labelling
|
m1-3-1-bottle-label 100mg April 2014 clean Rx
Date of last change:2014/10/08
Final Labelling
|
m1-3-1-carton 75mg April 2014 clean OTC
Date of last change:2014/10/08
Final Labelling
|
m1-3-1-carton 75mg April 2014 clean Rx
Date of last change:2014/10/08
Final Labelling
|
m1-3-1-carton 100mg April 2014 clean OTC
Date of last change:2014/10/08
Final Labelling
|
m1-3-1-carton 100mg April 2014 clean Rx
Date of last change:2014/10/08
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase