欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1541/001
药品名称
FERANT
活性成分
Palonosetron hydrochloride 250.0 µg
剂型
Solution for injection
上市许可持有人
Medochemie Ltd, Cyprus
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Greece (GR)
FERANT
Latvia (LV)
Ferant 250 mikrogrami šķīdums injekcijām
Lithuania (LT)
FERANT 250 mikrogramų injekcinis tirpalas
Estonia (EE)
FERANT
Bulgaria (BG)
Ferant
Cyprus (CY)
Czechia (CZ)
FERANT 250 MIKROGRAMŮ INJEKČNÍ ROZTOK
Romania (RO)
Slovakia (SK)
FERANT 250 mikrogramov injekčný roztok
Malta (MT)
Croatia (HR)
Ferant 250 mikrograma otopina za injekciju
Spain (ES)
Portugal (PT)
Slovenia (SI)
许可日期
2016/04/20
最近更新日期
2024/12/11
药物ATC编码
A04AA05 palonosetron
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Final PL
Final SPC
|
Final SPC
PubAR
|
PAR
PubAR Summary
|
PAR Summary
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase