欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0132/001
药品名称
TOBRINEB
活性成分
Tobramycin 300.0 mg
剂型
Nebuliser solution
上市许可持有人
Promedica S.r.l. – 26/A, Via Palermo, 43122 Parma, Italy
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
Germany (DE)
Netherlands (NL)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Bramitob 300 mg/4 ml Lösung für einen Vernebler im Einzeldosisbehältnis
Spain (ES)
Portugal (PT)
Greece (GR)
Poland (PL)
Hungary (HU)
Czechia (CZ)
Slovakia (SK)
Norway (NO)
Sweden (SE)
Cyprus (CY)
BRAMITOP NEBULISER SOLUTION 300MG/4ML
Denmark (DK)
许可日期
2006/10/26
最近更新日期
2024/10/10
药物ATC编码
J01GB01 tobramycin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
EN_INNER LABEL_clean
Date of last change:2024/09/06
Final Labelling
|
EN_OUTER LABEL_clean
Date of last change:2024/09/06
Final SPC
|
EN_SPC_clean
Date of last change:2024/09/06
Final PL
|
PIL_COMMON_tracked_revAIFA
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase