欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/1930/002
药品名称
Oralair 300 IR
活性成分
allergen extract mixture 300.0 IR
剂型
Sublingual tablet
上市许可持有人
Stallergènes S.A. 6, rue Alexis de Tocqueville 92160 Antony France
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
Ireland (IE)
Austria (AT)
ORALAIR 300 IR Sublingualtabletten
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Poland (PL)
Latvia (LV)
Lithuania (LT)
ORALAIR 300 IR poliežuvinės tabletės
Bulgaria (BG)
Oralair
Czechia (CZ)
OLARAIR 300 IR
Estonia (EE)
Hungary (HU)
ORALAIR 300 IR nyelvalatti tabletta
Romania (RO)
Oralair 300 IR
Slovenia (SI)
Slovakia (SK)
Oralair 300 IR
Denmark (DK)
Sweden (SE)
Norway (NO)
Finland (FI)
Croatia (HR)
许可日期
2009/11/26
最近更新日期
2024/03/22
药物ATC编码
V01AA02 grass pollen
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 Product Information
|
ORALAIR 100 300 IR_product_information_en_var045_clean
Date of last change:2024/03/22
Final SPC
|
ORALAIR 300 IR_product_information_en_var045_clean
Date of last change:2024/03/22
PAR Summary
|
ORALAIR_PAR_Summary
Date of last change:2024/02/29
PAR
|
ORALAIR_PAR_scientific_discussion
Date of last change:2024/02/29
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase