欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2182/001
药品名称
Dexamethasone sodium phosphate NewLine Pharma
活性成分
Dexamethasone 1.5 mg/ml
剂型
Eye drops, solution
上市许可持有人
NewLine Pharma, S.L.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
France (FR)
Spain (ES)
Greece (GR)
Cyprus (CY)
Dexamethasone Sodium Phosphate NewLine Pharma 1,5mg/ml eye drops solution
Romania (RO)
Etacortilen 1,5 mg/ml picături oftalmice, soluție
Germany (DE)
Dexamethasone sodium phosphate NewLine Pharma
Netherlands (NL)
Ireland (IE)
Poland (PL)
Etafry
许可日期
2019/08/21
最近更新日期
2025/02/03
药物ATC编码
S01BA01 dexamethasone
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 SPC
|
common_spc_clean
Date of last change:2024/09/06
市场状态
Positive
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