欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0779/001
药品名称
Exicyt
活性成分
cytisine 1.5 mg
剂型
Film-coated tablet
上市许可持有人
Creative Pharma Solutions s.r.o. Italská 209/17 120 00 Praha 2 Czechia
参考成员国 - 产品名称
Poland (PL)
Exicyt
互认成员国 - 产品名称
Czechia (CZ)
Exicyt
许可日期
2022/09/12
最近更新日期
2024/01/05
药物ATC编码
N07BA04 cytisinicline
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:
Non Prescription (including OTC)
附件文件下载
Final Labelling
|
131_common_interpack_clean
Date of last change:2024/09/06
Final PL
|
131_common_pil_clean
Date of last change:2024/09/06
Final SPC
|
131_common_spc_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase