欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/6315/001
药品名称
Sapropterin Aurobindo 100 mg soluble tablets
活性成分
Sapropterin dihydrochloride 100.0 mg
剂型
Soluble tablet
上市许可持有人
Aurobindo Pharma (Malta) Limited
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Germany (DE)
SaproPUREN 100 mg Tabletten zur Herstellung einer Lösung zum Einnehmen
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
许可日期
2023/01/19
最近更新日期
2024/12/06
药物ATC编码
A16AX07 sapropterin
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final SPC
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220104000049
Date of last change:2024/09/06
Final PL
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220104000049_2
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220104000049_3
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20220104000049_4
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase