欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0800/001
药品名称
Eminocs 50 mg/ml
活性成分
Diclofenac potassium salt 50.0 mg/ml
剂型
Oral solution
上市许可持有人
Alfa Wassermann S.p.A. Via E. Fermi, 1 65020 Alanno (PE) Italy
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Italy (IT)
许可日期
2006/12/22
最近更新日期
2025/02/03
药物ATC编码
M01AB05 diclofenac
申请类型
TypeLevel1:
Known Active Substance
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 PL
|
CLEAN_131_PIL
Date of last change:2024/09/06
Final Labelling
|
EMINO_131_LABtotaal_en_clean
Date of last change:2024/09/06
Final Product Information
|
EMINO_131_PIL_common_clean proposed
Date of last change:2024/09/06
Final SPC
|
EMINO_131_SmPC_AP_NL_en_clean
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
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European Union HMA Authorisation of Medicines DataBase