欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/3911/001
药品名称
Dymistin Nasenspray 137 Mikrogramm/50 Mikrogramm pro Sprühstoß Nasenspray, Suspension
活性成分
Azelastine 1.0 mg/g
Fluticasone 0.36 mg/g
剂型
Nasal spray, suspension
上市许可持有人
Viatris Healthcare GmbH Lütticher Straße 5 53842 Troisdorf Germany
参考成员国 - 产品名称
Germany (DE)
Dymistin Nasenspray 137 Mikrogramm / 50 Mikrogramm pro Sprühstoß Nasenspray, Suspension
互认成员国 - 产品名称
许可日期
2014/10/07
最近更新日期
2025/11/04
药物ATC编码
R01AD58 fluticasone, combinations
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Multiple (Copy) Application
TypeLevel3：
Fixed Combination
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final Product Information
|
common_final_pl_3911_V028
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_3911_V028
Date of last change:2024/09/06
Final Labelling
|
DE_3355_labip_001_6_4g_20180411_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3355_labip_002_23g_20180411_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3355_labop_001_serialisation_clean_20180411_renewal
Date of last change:2024/09/06
Final PL
|
DE_3355_palen_nasal ulcers_clean_20180411_renewal
Date of last change:2024/09/06
Final SPC
|
DE_3355_spcen_nasal ulcers_clean_20180411_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3356_labip_001_6_4g_20180411_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3356_labip_002_23g_20180411_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3356_labop_001_serialisation_clean_20180411_renewal
Date of last change:2024/09/06
Final PL
|
DE_3356_palen_nasal ulcers_clean_20180411_renewal
Date of last change:2024/09/06
Final SPC
|
DE_3356_spcen_nasal ulcers_clean_20180411_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3910_labip_001_6_4g_20180411_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3910_labip_002_23g_20180411_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3910_labop_001_serialisation_clean_20180411_renewal
Date of last change:2024/09/06
Final PL
|
DE_3910_spcen_nasal ulcers_clean_20180411_renewal
Date of last change:2024/09/06
Final SPC
|
DE_3910_spcen_nasal ulcers_clean_20180411_renewal_2
Date of last change:2024/09/06
Final Labelling
|
DE_3911_labip_001_6_4g_20180411_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3911_labip_002_23g_20180411_renewal
Date of last change:2024/09/06
Final Labelling
|
DE_3911_labop_001_serialisation_clean__20180411_renewal
Date of last change:2024/09/06
Final PL
|
DE_3911_palen_nasal ulcers_clean_20180411_renewal
Date of last change:2024/09/06
Final SPC
|
DE_3911_spcen_nasal ulcers_clean_20180411_renewal
Date of last change:2024/09/06
PubAR
|
PAREN_DE 3910_11_Dymistalin_Dymistin
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase