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

MR编号	NL/H/3647/001
药品名称	Twicor 10 mg/10 mg film-coated tablets
活性成分	ezetimibe 10.0 mg rosuvastatin calcium salt 10.0 mg
剂型	Film-coated tablet
上市许可持有人	Mylan Healthcare B.V. Krijgsman 20 1186 DM Amstelveen Nederland
参考成员国 - 产品名称	Netherlands (NL) Twicor 10 mg/10 mg, filmomhulde tabletten
互认成员国 - 产品名称	Spain (ES) Portugal (PT) Czechia (CZ) TWICOR
许可日期	2017/05/18
最近更新日期	2023/12/19
药物ATC编码	C10BA Combinations of various lipid modifying agents
申请类型	TypeLevel1：Known Active Substance TypeLevel2：Initial Application TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC TypeLevel4：Chemical Substance TypeLevel5：Prescription Only
附件文件下载	Final SPC \| SmPCDate of last change:2023/06/28 Final PL \| common_pil_ezro_en_nl_h_3647_001_cleanDate of last change:2022/08/25 Final Product Information \| common-smpc- RVG 118789Date of last change:2021/10/13 Final Product Information \| common-pil-RVG 118789Date of last change:2021/10/13 Final Product Information \| common-spc-RVG 121835 & 121836.docDate of last change:2021/10/13 Final Product Information \| common-pil-RVG 121835 & 121836.docDate of last change:2021/10/13 Final Product Information \| common-smpc-rvg 121849Date of last change:2021/10/13 Final Product Information \| common-pil-RVG 121849Date of last change:2021/10/13 PAR Summary \| 180205 NL.H.3647.001.DC Twicor summary ENDate of last change:2018/04/19 PAR \| 180301 NL.H.3647.001.DC Twicor PARDate of last change:2018/04/19 Final Labelling \| common-interpack-clean-3647-0004Date of last change:2017/09/26
市场状态	Positive