欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0133/002
药品名称
Bicaluplex 150 mg
活性成分
bicalutamide 150.0 mg
剂型
Tablet
上市许可持有人
Teva Pharmaceuticals CR, s.r.o. Radlická 3185/1c Prague Czech Republic
参考成员国 - 产品名称
Czechia (CZ)
互认成员国 - 产品名称
France (FR)
Germany (DE)
Denmark (DK)
Bicalutamid "Teva"
Netherlands (NL)
United Kingdom (Northern Ireland) (XI)
Portugal (PT)
Italy (IT)
Sweden (SE)
Norway (NO)
Latvia (LV)
Lithuania (LT)
Bicalutamide-Teva 150 mg plėvele dengtos tabletės
Estonia (EE)
Slovakia (SK)
Slovenia (SI)
许可日期
2007/11/22
最近更新日期
2023/03/16
药物ATC编码
L02BB03 bicalutamide
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 Product Information
|
1_3_1 combined_eu tracked
Date of last change:2024/09/06
Final PL
|
Bicalutamid_CZ_H_0133_001 _ PIL
Date of last change:2024/09/06
Final SPC
|
Bicalutamid_CZ_H_0133_001 _ SmPC
Date of last change:2024/09/06
Final PL
|
Bicalutamid_CZ_H_0133_002 _ PIL
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase