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

MR编号	NL/H/4342/002
药品名称	Cinacalcet Stada 60 mg, film-coated tablets
活性成分	CINACALCET HYDROCHLORIDE 60.0 mg
剂型	Film-coated tablet
上市许可持有人	Centrafarm B.V. Van De Reijtstraat 31 E 4814 NE Breda The Netherlands
参考成员国 - 产品名称	Netherlands (NL) Cinacalcet CF 60 mg, filmomhulde tabletten
互认成员国 - 产品名称	United Kingdom (Northern Ireland) (XI) Germany (DE) Cinacalcet AL 60 mg Filmtabletten Denmark (DK) Cinacalcet "Stada" Iceland (IS) Ireland (IE) Austria (AT) Cinacalcet STADA 60 mg Filmtabletten France (FR) Spain (ES) Italy (IT) Sweden (SE) Norway (NO) Finland (FI) Czechia (CZ) Cinacalcet STADA
许可日期	2019/01/21
最近更新日期	2023/10/17
药物ATC编码	H05BX01 cinacalcet
申请类型	TypeLevel1：Abridged TypeLevel2：Additional Strength/Form 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 PL \| PL_Cinacalcet_NL4342_20211103_clean_PL_Cinacalcet_NL4342_20211103_cleanDate of last change:2022/06/02 Final PL \| PL_Risperidone_NL918_clean_PL_Risperidone_NL918_cleanDate of last change:2022/06/02 Final PL \| PL_Fluoxetine_NL354_202111_AD_cl_PL_Fluoxetine_NL354_202111_AD_clDate of last change:2022/06/02 Final Product Information \| 1.3.1-LAB-outer-common-en-NL-H-4342-001-003-DC_clDate of last change:2020/11/13 Final Product Information \| SmPC_Cinacalcet_NL4342_20200529_clDate of last change:2020/11/13 Final Product Information \| PL_Cinacalcet_NL4342_20200529_clDate of last change:2020/11/13 PAR Summary \| summaryPAR_4342_001 003_DC_Cinacalcet CF_22 apr 2020_ENDate of last change:2020/04/23 PAR \| PAR_4342_001 003_DC_Cinacalcet CF_22 apr 2020Date of last change:2020/04/23 Final SPC \| 1.3.1-SmPC-common-en-NL-H-4342_d160-clDate of last change:2019/07/19 Final Labelling \| 1.3.1-Lab-inner-common-en-NL-H-4342_d0Date of last change:2019/07/19
市场状态	Positive