欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/1108/001
药品名称
Montelukast Teva
活性成分
Montelukast sodium salt 10.0 mg
剂型
Film-coated tablet
上市许可持有人
Teva B.V. Swensweg 5 Haarlem, 2031ga 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 10 mg Filmtabletten
Spain (ES)
Portugal (PT)
Norway (NO)
Finland (FI)
Poland (PL)
Estonia (EE)
MONTELUKAST TEVA
Hungary (HU)
MONTELUKAST TEVA 10 mg filmtabletta
Czechia (CZ)
Slovakia (SK)
许可日期
2008/02/06
最近更新日期
2025/01/03
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 Product Information
|
1_3_1 combined label_10 mg_eu tracked _ Final
Date of last change:2024/09/06
Final Product Information
|
1_3_1 pil_eu tracked
Date of last change:2024/09/06
Final Product Information
|
1_3_1 spc_eu tracked
Date of last change:2024/09/06
Final Labelling
|
1_3_1_label_outer_eu_clean
Date of last change:2024/09/06
Final PL
|
common_PIL_DK_H_1108_001_cl
Date of last change:2024/09/06
Final SPC
|
common_SPC_DK_H_1108_001_cl
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase