欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0848/001
药品名称
Otrivin comp
活性成分
Ipratropium bromide 0.5 mg/ml
Xylometazoline hydrochloride 0.6 mg/ml
剂型
Nasal spray, solution
上市许可持有人
Haleon Denmark ApS
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Denmark (DK)
Belgium (BE)
Netherlands (NL)
Luxembourg (LU)
Iceland (IS)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Spain (ES)
Portugal (PT)
Italy (IT)
Greece (GR)
Norway (NO)
Finland (FI)
Poland (PL)
Latvia (LV)
Lithuania (LT)
Estonia (EE)
Hungary (HU)
Cyprus (CY)
Czechia (CZ)
Romania (RO)
Slovakia (SK)
Slovenia (SI)
Malta (MT)
许可日期
2008/10/02
最近更新日期
2025/01/27
药物ATC编码
R01AB06 xylometazoline
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Fixed combination Art 10b Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Non Prescription (including OTC)
附件文件下载
Final PL
|
SE_H_0848_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0848_001_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_0848_001_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase