欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/1104/001
药品名称
Montelukast Teva
活性成分
montelukast sodium salt 4.0 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 4 mg Kautabletten
Spain (ES)
Portugal (PT)
Norway (NO)
Finland (FI)
Estonia (EE)
Monteleukast Teva
Hungary (HU)
MONTELUKAST TEVA 4 mg rágótabletta
Czechia (CZ)
Montelukast Teva 4 mg
Slovakia (SK)
Montelukast-Teva 4 mg
许可日期
2008/02/06
最近更新日期
2024/01/08
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
Final PL
|
IS_H_0329_001_IB_006_PIL_Montelukast_ratiopharm_4mg_26_1_2022
Date of last change:2022/06/02
Final PL
|
IS_H_0329_002_IB_006_PIL_Montelukast_ratiopharm_5mg_26_1_2022
Date of last change:2022/06/02
Final SPC
|
IS_H_0329_002_IB_006_SmPC_Montelukast_ratiopharm_5mg_26_1_2022
Date of last change:2022/06/02
Final SPC
|
IS_H_0329_001_IB_006_SmPC_Montelukast_ratiopharm_4mg_26_1_2022
Date of last change:2022/06/02
Final Product Information
|
common-combined-clean4mg
Date of last change:2020/12/18
Final Product Information
|
common-pl-clean5mg
Date of last change:2020/12/18
Final Product Information
|
common-combined-clean5mg
Date of last change:2020/12/18
Final Product Information
|
common-pl-clean4mg
Date of last change:2020/12/18
Final Product Information
|
common-spc-clean4mg
Date of last change:2020/12/18
Final Product Information
|
common-spc-clean5mg
Date of last change:2020/12/18
Final Labelling
|
1.3.1 combined-5mg-eu clean
Date of last change:2018/03/26
Final Labelling
|
1.3.1 combined-4mg-eu clean
Date of last change:2018/03/26
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase