欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/1814/002
药品名称
Beta-histina Ciclum Farma
活性成分
betahistine 16.0 mg
剂型
Tablet
上市许可持有人
Ciclum Farma Unipessoal, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Betahistindihydrochlorid AL 16 mg Tabletten
Denmark (DK)
Italy (IT)
Sweden (SE)
Finland (FI)
Hungary (HU)
BETAHISTINE DIHYDROCHLORIDE STADA 16 mg tabletta
许可日期
2019/03/27
最近更新日期
2024/08/05
药物ATC编码
N07CA01 betahistine
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_Lab_outer_Betahistine_d106_cl
Date of last change:2024/09/06
Final Product Information
|
1_3_1_PL_Betahistine_common_d106_cl
Date of last change:2024/09/06
PubAR
|
PT_1814_PAR_FINAL
Date of last change:2024/09/06
Final Product Information
|
SmPC_Betahistin_PT1814__d160_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase