欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3137/002
药品名称
Deferasirox Orifarm
活性成分
DEFERASIROX 180.0 mg
剂型
Film-coated tablet
上市许可持有人
Orifarm Generics A/S Energivej 15 5260 Odense S Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Sweden (SE)
Norway (NO)
Deferasirox Orifarm
Finland (FI)
许可日期
2021/01/21
最近更新日期
2023/12/01
药物ATC编码
V03AC03 deferasirox
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
Final PL
|
Deferasirox Orifarm PIL ENG__FCT 20230118 A8768 ATU clean
Date of last change:2024/09/06
Final SPC
|
Deferasirox Orifarm SPC ENG__FCT 20230118 A8768 ATU clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase