欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0195/002
药品名称
Bicalutamidum Genthon 150 mg, film-coated tablets
活性成分
bicalutamide 150.0 mg
剂型
Film-coated tablet
上市许可持有人
t
参考成员国 - 产品名称
Czechia (CZ)
互认成员国 - 产品名称
Germany (DE)
Bicalut 150 mg Filmtabletten
Denmark (DK)
Bicalutamid Stada
Belgium (BE)
Netherlands (NL)
Iceland (IS)
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Bicalutamid STADA 150 mg Filmtabletten
Spain (ES)
Portugal (PT)
Italy (IT)
Greece (GR)
Sweden (SE)
Bikalutamid Actavis
Norway (NO)
Finland (FI)
Lithuania (LT)
Bicalutamid Actavis 150 mg plėvele dengtos tabletės
Hungary (HU)
Bicusan 150 mg
Romania (RO)
Androbloc 150 mg
许可日期
2008/06/30
最近更新日期
2021/03/08
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 Labelling
|
CZ_0195 bicalutamide 150mg label
Date of last change:2024/09/06
Final PL
|
CZ_0195 bicalutamide 150mg PIL
Date of last change:2024/09/06
Final SPC
|
CZ_0195 bicalutamide 150mg SPC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase