欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2873/003
药品名称
Betolo orange
活性成分
amylmetacresol 0.6 mg
DICHLOROBENZYL ALCOHOL 1.2 mg
lidocaine hydrochloride 2.0 mg
剂型
Lozenge
上市许可持有人
Mundipharma A/S Frydenlundsvej 30 2950 Vedbaek Denmark
参考成员国 - 产品名称
Denmark (DK)
Betolo Appelsin
互认成员国 - 产品名称
Belgium (BE)
Norway (NO)
Luxembourg (LU)
Finland (FI)
Sweden (SE)
许可日期
2019/05/09
最近更新日期
2024/04/25
药物ATC编码
R02AA20 various
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Non Prescription (including OTC)
附件文件下载
Final PL
|
common_pil_lozenges_clean
Date of last change:2023/12/22
Final Labelling
|
common_outer_lozenges_clean
Date of last change:2023/01/26
Final SPC
|
common_spc_lozenges_clean
Date of last change:2022/12/20
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase