欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2806/001
药品名称
Ganirelix Fagron
活性成分
Ganirelix acetate 0.25 0,5 mg/ml
剂型
Solution for injection in pre-filled syringe
上市许可持有人
Fagron Nederland B.V.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Netherlands (NL)
许可日期
2023/01/27
最近更新日期
2025/02/05
药物ATC编码
H01CC01 ganirelix
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 SPC
|
GAN_0_25__FAG_DCP_PT_NL__131_common_spc_v01_varII_plung_clean
Date of last change:2025/02/05
Final PL
|
GAN_0_25__FAG_DCP_PT_NL__131_common_pil_v01_Notif 61_3 IFU_clean_May24
Date of last change:2024/09/06
PubAR
|
PAR_PT_2806_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase