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

MR编号	NL/H/2843/003
药品名称	Acetylcystein Alpex 600 mg granules for oral solution
活性成分	ACETYLCYSTEIN 600.0 mg
剂型	Granules for oral solution
上市许可持有人	Alpex Pharma (UK) Limited PO BOX 849 -Haynes-Bedford MK45 9EG UK
参考成员国 - 产品名称	Netherlands (NL) Acetylcysteïne Alpex 600 mg Granulaat voor drank
互认成员国 - 产品名称	France (FR)
许可日期	2017/05/14
最近更新日期	2024/02/13
药物ATC编码	R05CB01 acetylcysteine
申请类型	TypeLevel1：Line Extension TypeLevel2：Initial Application TypeLevel3：Other Generic application Art 10.3 Dir 2001/83/EC TypeLevel4：Chemical Substance TypeLevel5：Non Prescription (including OTC)
附件文件下载	Final PL \| commonDate of last change:2021/03/01 PAR Summary \| 180201 NL.H.2843.003.DC Acetylcysteine Alpex summary ENDate of last change:2018/02/05 PAR \| 180201 NL.H.2843.003.DC Acetylcysteine Alpex final PARDate of last change:2018/02/05 Final Product Information \| common-spc-granules-rev2 without TCDate of last change:2017/05/15 Final Product Information \| common-impack-granules-rev2 without TCDate of last change:2017/05/15 Final Product Information \| common-outer-granules-rev2 without TCDate of last change:2017/05/15 Final Product Information \| common-pl-granules - rev2 without TCDate of last change:2017/05/15
市场状态	Positive