欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1947/001
药品名称
ACARIZAX
活性成分
allergen extract mixture 12.0 SQ-HDM
剂型
Oral lyophilisate
上市许可持有人
ALK-Abelló A/S Boge Allé 6-8. DK-2970 Horsholm Denmark
参考成员国 - 产品名称
Germany (DE)
ACARIZAX
互认成员国 - 产品名称
Slovakia (SK)
Czechia (CZ)
MITIZAX ®
Norway (NO)
Acarizax
Sweden (SE)
Italy (IT)
France (FR)
Austria (AT)
ACARIZAX 12 SQ-HDM Lyophilisat zum Einnehmen
Denmark (DK)
Acarizax
Finland (FI)
Acarizax
Poland (PL)
Acarizax
许可日期
2015/08/30
最近更新日期
2023/11/24
药物ATC编码
V01AA03 house dust mites
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4:
Biological: Other
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
common_spc
Date of last change:2023/05/12
Final PL
|
common_pl
Date of last change:2023/05/12
Final Labelling
|
common_interpack
Date of last change:2023/05/12
PAR Summary
|
DE_H_1947_II_001_G_ACARIZAX_Summary_PAR_update_May_2017
Date of last change:2022/05/09
PAR
|
DE-H-1947-001-DC_Public Assessment Report_ACARIZAX_update Feb 2021
Date of last change:2022/05/09
Final Product Information
|
ACARIZAX common-spc-D210
Date of last change:2015/11/27
市场状态
Positive
©2006-2024
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase