欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1994/001
药品名称
Posaconazole Generis
活性成分
posaconazole 40.0 mg/ml
剂型
Oral suspension
上市许可持有人
Generis Farmacêutica, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Posacona PUREN 40 mg/ml Suspension zum Einnehmen
France (FR)
Poland (PL)
Posaconazole Aurovitas
许可日期
2022/01/27
最近更新日期
2022/07/15
药物ATC编码
J02AC04 posaconazole
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
PubAR
|
648724_20220324_PAR_ACM
Date of last change:2024/09/06
Final Labelling
|
Labelling_final
Date of last change:2024/09/06
Final Product Information
|
PIL
Date of last change:2024/09/06
Final Product Information
|
SPC_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase