欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/2281/001
药品名称
Gasflat
活性成分
Mesalazine 500.0 mg
剂型
Suppository
上市许可持有人
Laboratórios Vitória, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Austria (AT)
Azzavix 500 mg Zäpfchen
Poland (PL)
Salaza
Slovakia (SK)
Salcrozine 500 mg čapíky
许可日期
2020/01/29
最近更新日期
2025/06/23
药物ATC编码
A ALIMENTARY TRACT AND METABOLISM
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial Application
TypeLevel3：
Bibliographic Art 10 a Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final SPC
|
Common mesalazine suppository 500 mg 2281 _ SmPC CLEAN
Date of last change:2025/06/09
Final PL
|
Common mesalazine suppository 500 mg 2281 _ PIL CLEAN
Date of last change:2025/06/09
Final Product Information
|
1_3_1 common_outer_500mg
Date of last change:2024/09/06
Final Product Information
|
1_3_1 common_pl_500mg
Date of last change:2024/09/06
Final Product Information
|
1_3_1 common_spc_500mg
Date of last change:2024/09/06
PubAR
|
2281_Mecolvix_PAR_4FEV2020
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase