欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/4079/005
药品名称
Lenalidomide Synthon 15 mg
活性成分
lenalidomide 20.0 mg
剂型
Capsule, hard
上市许可持有人
Synthon B.V.
参考成员国 - 产品名称
Netherlands (NL)
Lenalidomide Synthon 15 mg
互认成员国 - 产品名称
Cyprus (CY)
Lenalidomide Norameda 15 mg capusle, hard
Estonia (EE)
LENALIDOMIDE AUXILIA
Slovakia (SK)
Lenalidomid Synthon 15 mg
Latvia (LV)
Lenalidomide Norameda 15 mg cietās kapsulas
Lithuania (LT)
Lenalidomide Norameda 15 mg kietosios kapsulės
Iceland (IS)
Finland (FI)
Sweden (SE)
Greece (GR)
France (FR)
许可日期
2018/08/08
最近更新日期
2024/07/24
药物ATC编码
L04AX04 lenalidomide
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
PubAR
|
190214 NL_H_4079_001_007_DC Lenalidomide Synthon PAR
Date of last change:2024/09/06
PubAR Summary
|
190214 NL_H_4079_001_007_DC Lenalidomide Synthon summary EN
Date of last change:2024/09/06
Final Labelling
|
Labelling_EN_Common
Date of last change:2024/09/06
Final PL
|
PIL_M1_3_1_03_LNL_cap_001_09_core
Date of last change:2024/09/06
Final Product Information
|
PL_EN_Common
Date of last change:2024/09/06
Final SPC
|
SmPC_EN Common
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase