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

MR编号	NL/H/3278/002
药品名称	Pregabaline Hetero 50 mg, hard capsules
活性成分	pregabalin 25.0 mg
剂型	Capsule, hard
上市许可持有人	Amarox Pharma B.V. Rouboslaan 32 2252 TR Voorschoten Netherlands
参考成员国 - 产品名称	Netherlands (NL) Pregabaline Hetero 50 mg harde capsules
互认成员国 - 产品名称	Germany (DE) Pregabalin Hetero 25 mg Hartkapseln
许可日期	2015/08/04
最近更新日期	2023/09/20
药物ATC编码	N02BF02 pregabalin
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 SPC \| Common SmpCDate of last change:2023/09/20 Final PL \| pl_common_pl_cleanDate of last change:2022/06/02 Final PL \| pl_common_spc_cleanDate of last change:2022/06/02 Final Labelling \| common-interpack-50mg-bottle-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-25mg-blisterbox-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-25mg-bottle-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-50mg-blisterbox-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-100mg-bottle-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-75mg-blisterbox-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-75mg-bottle-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-100mg-blisterbox-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-200mg-blisterbox-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-200mg-bottle-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-150mg-blisterbox-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-150mg-bottle-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-300mg-blisterbox-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-225mg-blisterbox-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-225mg-bottle-cleanDate of last change:2017/11/14 Final Labelling \| common-interpack-300mg-bottle-cleanDate of last change:2017/11/14 PAR Summary \| 161129 NL.H.3278.001-008.DC Pregabaline Hetero summary ENDate of last change:2016/12/14 PAR \| 161213 NL.H.3278.001-008.DC Pregabaline Hetero PARDate of last change:2016/12/14
市场状态	Positive