欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
NL/H/4792/002
药品名称
Deferasirox Teva 180mg
活性成分
Deferasirox 180.0 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
Germany (DE)
Deferasirox-ratiopharm 180 mg Filmtabletten
Denmark (DK)
Deferasirox Teva B.V.
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Deferasirox ratiopharm 180 mg Filmtabletten
France (FR)
Portugal (PT)
Norway (NO)
Deferasirox Teva
Bulgaria (BG)
Deferasirox Teva
Slovakia (SK)
Deferasirox Teva 180 mg filmom obalené tablety
Croatia (HR)
Deferasiroks Pliva 180 mg filmom obložene tablete
Greece (GR)
许可日期
2020/07/28
最近更新日期
2025/02/03
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_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