欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）

MR编号	NL/H/3352/002
药品名称	Kosidina 0,075 mg/0,030 mg 21+7, tabletten
活性成分	ethinyl estradiol 30.0 µg gestodene 75.0 µg
剂型	Tablet
上市许可持有人	Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands
参考成员国 - 产品名称	Netherlands (NL) RVG 116281
互认成员国 - 产品名称	Czechia (CZ) Tanielle 0,075 mg/0,030 mg
许可日期	2015/11/24
最近更新日期	2023/09/04
药物ATC编码	G03AA10 gestodene and ethinylestradiol
申请类型	TypeLevel1：Abridged TypeLevel2：Additional Strength/Form TypeLevel3：Other Generic application Art 10.3 Dir 2001/83/EC TypeLevel4：Chemical Substance TypeLevel5：Prescription Only
附件文件下载	Final SPC \| SmPCDate of last change:2023/03/16 Final PL \| 1_3_1_common_pl_002975879_116281Date of last change:2022/09/21 Final Product Information \| Kosidina_1_3_1 spc_label_pl _ common_outer_002 cleanDate of last change:2022/06/02 Final Product Information \| Kosidina_1_3_1 spc_label_pl _ common_spc_001 cleanDate of last change:2022/06/02 Final Product Information \| Kosidina_1_3_1 spc_label_pl _ common_pl_002 cleanDate of last change:2022/06/02 Final Product Information \| Kosidina_1_3_1 spc_label_pl _ common_spc_002 cleanDate of last change:2022/06/02 Final Product Information \| Kosidina_1_3_1 spc_label_pl _ common_p_001 cleanDate of last change:2022/06/02 Final Product Information \| Kosidina_1_3_1 spc_label_pl _ common_outer_001 cleanDate of last change:2022/06/02 Final Labelling \| Common Labelling 0.075_0.03_clean versionDate of last change:2018/03/22 PAR Summary \| summaryPAR_NL.H.3352.001-002.DC_Kosidina_29-09-2016_ENDate of last change:2017/01/25 PAR \| PAR_NL.H.3352.001-002.DC_Kosidina_29-9-2016Date of last change:2017/01/25
市场状态	Positive