欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2212/001
药品名称
Dimethyl fumarate STADA
活性成分
dimethyl fumarate 120.0 mg
剂型
Gastro-resistant capsule, hard
上市许可持有人
STADA Arzneimittel AG
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Hungary (HU)
Iceland (IS)
Ireland (IE)
Czechia (CZ)
Dimethyl fumarate Kappler
Slovakia (SK)
Portugal (PT)
Slovenia (SI)
Greece (GR)
Malta (MT)
Dimethyl fumarate Kappler 120/240 mg gastro-resistant capsules
Norway (NO)
Croatia (HR)
Finland (FI)
Poland (PL)
Dimethyl fumarate Stada
Latvia (LV)
Lithuania (LT)
Dimethyl fumarate Kappler 120 mg skrandyje neirios kietosios kapsulės
Belgium (BE)
Estonia (EE)
Luxembourg (LU)
许可日期
2023/01/18
最近更新日期
2024/08/05
药物ATC编码
L04AX07 dimethyl fumarate
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
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Final PL
Final SPC
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Final SPC
PubAR
|
PAR
PubAR Summary
|
PAR Summary
市场状态
Positive
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