欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IS/H/0533/003
药品名称
Bosutinib TEVA
活性成分
Bosutinib dihydrate 500.0 mg
剂型
Film-coated tablet
上市许可持有人
Teva GmbH Graf-Arco-Str. 3 89079 Ulm Germany Germany
参考成员国 - 产品名称
Iceland (IS)
Bosutinib TEVA
互认成员国 - 产品名称
Denmark (DK)
Bosutinib "Teva"
Romania (RO)
Belgium (BE)
Bosutinib Teva 500 mg filmomhulde tabletten
Croatia (HR)
Netherlands (NL)
Luxembourg (LU)
Austria (AT)
France (FR)
Portugal (PT)
Italy (IT)
Sweden (SE)
Norway (NO)
Bulgaria (BG)
Bosutinib TEVA
Germany (DE)
Bosutinib-ratiopharm 500 mg Filmtabletten
Czechia (CZ)
Bosutinib Teva
许可日期
2024/08/12
最近更新日期
2025/01/10
药物ATC编码
L01EA04 bosutinib
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 Product Information
|
IS_H_0533_P_001_PI_Bosutinib_Teva_10_1_2025
Date of last change:2025/01/10
市场状态
Positive
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