欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/1104/002
药品名称
Montelukast Teva
活性成分
Montelukast sodium salt 5.0 mg
剂型
Chewable tablet
上市许可持有人
Teva B.V. Swensweg 5 2031GA Haarlem Netherlands
参考成员国 - 产品名称
Denmark (DK)
Montelukast Teva
互认成员国 - 产品名称
Ireland (IE)
Austria (AT)
Montelukast Teva 5 mg Kautabletten
Spain (ES)
Portugal (PT)
Norway (NO)
Finland (FI)
Poland (PL)
Hungary (HU)
MONTELUKAST TEVA 5 mg rágótabletta
Czechia (CZ)
Slovakia (SK)
Montelukast Teva 5 mg
许可日期
2008/02/06
最近更新日期
2024/10/25
药物ATC编码
R03DC03 montelukast
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Additional Strength/Form
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 Labelling
|
1_3_1 combined_4mg_eu clean
Date of last change:2024/09/06
Final Labelling
|
1_3_1 combined_5mg_eu clean
Date of last change:2024/09/06
Final Product Information
|
common_combined_clean4mg
Date of last change:2024/09/06
Final Product Information
|
common_combined_clean5mg
Date of last change:2024/09/06
Final Product Information
|
common_pl_clean4mg
Date of last change:2024/09/06
Final Product Information
|
common_pl_clean5mg
Date of last change:2024/09/06
Final Product Information
|
common_spc_clean4mg
Date of last change:2024/09/06
Final Product Information
|
common_spc_clean5mg
Date of last change:2024/09/06
Final PL
|
Montelukast_DK_H_1104_002_PIL_19_12_23
Date of last change:2024/09/06
Final SPC
|
Montelukast_DK_H_1104_002_SmPC_09_08_23
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase