欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0132/001
药品名称
Remeron 45 mg
活性成分
mirtazapine 45.0 mg
剂型
Film-coated tablet
上市许可持有人
N.V. Organon Kloosterstraat 6 5349 AB OSS The Netherlands
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
France (FR)
Italy (IT)
Greece (GR)
Norway (NO)
许可日期
1998/01/12
最近更新日期
2024/06/05
药物ATC编码
N06AX11 mirtazapine
申请类型
TypeLevel1:
New Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Article 4.8 Di 65/65
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
Approved PI NL_H_0132_II_ 070
Date of last change:2022/07/09
Final Labelling
|
Common label text (clean)
Date of last change:2018/02/06
Final PL
|
Common PIL (clean)
Date of last change:2018/02/06
Final SPC
|
Common SmPC (clean)
Date of last change:2018/02/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase