欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3254/001
药品名称
Ambroxol Teva
活性成分
ambroxol 60.0 mg
剂型
Effervescent tablet
上市许可持有人
Teva B.V. Swensweg 5 2031 GA Haarlem The Netherlands
参考成员国 - 产品名称
Denmark (DK)
Ambroxol Teva
互认成员国 - 产品名称
Portugal (PT)
Finland (FI)
Latvia (LV)
Lithuania (LT)
Ambroxol hydrochloride ratiopharm 60 mg šnypščiosios tabletės
Estonia (EE)
Hungary (HU)
Ambroxol-TEVA 60 mg pezsgőtabletta belsőleges oldathoz
Czechia (CZ)
Ambrobene
Slovakia (SK)
许可日期
2022/07/06
最近更新日期
2023/01/02
药物ATC编码
R05CB06 ambroxol
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:
Non Prescription (including OTC)
附件文件下载
Final Labelling
|
1_3_1 label_outer and immediate_ambroxol 60mg_3254_clean_2
Date of last change:2024/09/06
Final PL
|
1_3_1 pil_ambroxol_60 mg_3254 clean
Date of last change:2024/09/06
Final SPC
|
1_3_1_smpc_ambroxol_3254_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase