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

MR编号	DK/H/2546/001
药品名称	Sevelamercarbonate "Mylan Pharma"
活性成分	sevelamer carbonate 2.4 g
剂型	Powder for oral solution
上市许可持有人	Mylan S.A.S. 117 Allée des Parcs 69800 Saint Priest France
参考成员国 - 产品名称	Denmark (DK) Sevelamercarbonate "Mylan"
互认成员国 - 产品名称	France (FR)
许可日期	2016/09/15
最近更新日期	2023/07/02
药物ATC编码	V03 ALL OTHER THERAPEUTIC PRODUCTS V03AE02 sevelamer V VARIOUS V03AE Drugs for treatment of hyperkalemia and hyperphosphatemia
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 PL \| common_pl_dk2546_clean_v013Date of last change:2023/07/02 Final SPC \| common-spc-dk2546-clean-v009Date of last change:2020/04/24 Final Product Information \| common-spc-dk2546-cleanDate of last change:2019/05/03 Final Product Information \| common-pl-dk2546-cleanDate of last change:2019/05/03 PAR Summary \| Summary Public Assessment Report_DK_H_2546_001_DCDate of last change:2017/05/17 PAR \| Module 5 public summary and scientific discussion_DK_H_2546_001_DCDate of last change:2017/05/17 Final Labelling \| M1.3.1_02.SVL.car.pos.001.02.CoreDate of last change:2016/09/16
市场状态	Positive