欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0979/002
药品名称
Folac
活性成分
progesterone 200.0 mg
剂型
Capsule, soft
上市许可持有人
Laboratórios Effik, Sociedade Unipessoal, Lda
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Latvia (LV)
Gepretix 200 mg mīkstās kapsulas
Lithuania (LT)
Gepretix 200 mg minkštosios kapsulės
Estonia (EE)
GEPRETIX
许可日期
2014/04/29
最近更新日期
2024/05/09
药物ATC编码
G03DA04 progesterone
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
d106 common_labelling_blister _unchanged_
Date of last change:2024/09/06
Final Labelling
|
d210 common_labelling_carton Clean 100 mg _ 200 mg
Date of last change:2024/09/06
Final PL
|
D210_0978_0979_common PIL_clean
Date of last change:2024/09/06
Final SPC
|
D210_0978_0979_common spc_100mg_200mg clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase