欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/0680/002
药品名称
Montelucaste Unimark
活性成分
montelukast sodium salt 5.0 mg
剂型
Chewable tablet
上市许可持有人
Unimark Remedies s.r.o. CZE
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Montelukast Unimark 5 mg Kautabletten
France (FR)
Italy (IT)
Poland (PL)
Belgium (BE)
Montelukast Unimark Remedies
许可日期
2013/03/08
最近更新日期
2024/08/06
药物ATC编码
R03DC03 montelukast
申请类型
TypeLevel1：
Abridged
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
PubAR
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55403_55404_55405_20140627_PAR_GBB
Date of last change:2024/09/06
Final Product Information
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common_blister
Date of last change:2024/09/06
Final Product Information
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common_blister_2
Date of last change:2024/09/06
Final Product Information
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common_outer
Date of last change:2024/09/06
Final Product Information
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common_outer_2
Date of last change:2024/09/06
Final Product Information
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common_pil_4mg_final_annexure_d
Date of last change:2024/09/06
Final Product Information
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common_pil_5mg_final_annexure_h
Date of last change:2024/09/06
Final Product Information
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common_pil_final_annexure_d
Date of last change:2024/09/06
Final Product Information
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common_spc_4mg_final_annexure_b
Date of last change:2024/09/06
Final Product Information
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common_spc_5mg_final_annexure_f
Date of last change:2024/09/06
Final Product Information
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common_spc_final_annexure_b
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase