欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1651/001
药品名称
Femanor
活性成分
estradiol 2.0 mg
norethisterone acetate 1.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz A/S, Edvard Thomsens Vej 14 2300 København S Danmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Germany (DE)
SANESTELLE 2 mg/1 mg Filmtabletten
许可日期
2009/09/17
最近更新日期
2023/09/11
药物ATC编码
G03FA01 norethisterone and estrogen
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 Labelling
|
common_lbl_cl
Date of last change:2022/11/17
Final PL
|
common_pl_cl
Date of last change:2022/11/17
Final SPC
|
common_spc_cl
Date of last change:2022/11/17
Final Product Information
|
1_3_1_common_spc_002827006_dkh1651_clean
Date of last change:2022/09/22
Final Product Information
|
1_3_1_common_pl_003049599_clean
Date of last change:2022/09/22
PAR
|
parmod5_dk1651estradiolnorethisteronacetatjacobsen pharma_pdf
Date of last change:2022/06/02
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase