欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/4792/001
药品名称
Deferasirox Teva 90mg
活性成分
DEFERASIROX 90.0 mg
剂型
Film-coated tablet
上市许可持有人
Teva B.V. Swensweg 5 2031 GA Haarlem The Netherlands
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Austria (AT)
Deferasirox ratiopharm 90 mg Filmtabletten
France (FR)
Spain (ES)
Portugal (PT)
Sweden (SE)
Norway (NO)
Deferasirox Teva
Slovenia (SI)
Greece (GR)
Germany (DE)
Deferasirox-ratiopharm 90 mg Filmtabletten
Denmark (DK)
Deferasirox Teva B.V.
United Kingdom (Northern Ireland) (XI)
许可日期
2020/07/28
最近更新日期
2024/10/24
药物ATC编码
V03AC03 deferasirox
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
|
Deferasirox_NL_H_4792_001_003_PIL_11_01_23
Date of last change:2024/09/06
Final SPC
|
deferasirox_nl_h_4792_001_003_smpc_06_06_24
Date of last change:2024/09/06
Final Labelling
|
label ENG
Date of last change:2024/09/06
PubAR Summary
|
PAR_4792_dc_deferasirox_27 sept 2020_summary Eng
Date of last change:2024/09/06
PubAR
|
PAR_4792_dc_deferasirox_27 sept 2021
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase