欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NO/H/0286/001
药品名称
Ketorolac trometamol Macure
活性成分
ketorolac 30.0 mg/ml
剂型
Solution for injection
上市许可持有人
Macure Pharma ApS
参考成员国 - 产品名称
Norway (NO)
Ketorolac trometamol Macure
互认成员国 - 产品名称
Denmark (DK)
Sweden (SE)
Finland (FI)
许可日期
2019/03/15
最近更新日期
2024/05/27
药物ATC编码
M01AB15 ketorolac
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
18_06486_48 D210_SmPC_SALF_clean 35411783_1_0
Date of last change:2024/09/06
Final PL
|
18_06486_49 D210_PIL_clean format SALF_18_03_2019 35411793_1_0
Date of last change:2024/09/06
市场状态
Positive
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