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

MR编号	NL/H/3318/002
药品名称	Imatinib Sandoz 400 mg
活性成分	imatinib 400.0 mg
剂型	Film-coated tablet
上市许可持有人	Sandoz B. V. Veluwezoom 22, 1327 AH Almere P.O. box 10332, 1301 AH Almere The Netherlands
参考成员国 - 产品名称	Netherlands (NL) Imatinib Sandoz 400 mg, filmomhulde tabletten
互认成员国 - 产品名称	Italy (IT) Sweden (SE) Norway (NO) Finland (FI) Latvia (LV) Lithuania (LT) Estonia (EE) Hungary (HU) Czechia (CZ) Slovakia (SK) Germany (DE) Croatia (HR) Denmark (DK) United Kingdom (Northern Ireland) (XI) Belgium (BE) Ireland (IE) Austria (AT) France (FR) Spain (ES)
许可日期	2015/10/14
最近更新日期	2024/04/11
药物ATC编码	L01XE01 imatinib
申请类型	TypeLevel1：Known Active Substance TypeLevel2：Initial Application 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_spcDate of last change:2022/10/26 Final PL \| common_plDate of last change:2022/10/26 Final Labelling \| common_outerDate of last change:2022/10/26 PAR Summary \| 170905 NL.H.3318.001-002.DC Imatinib summary ENDate of last change:2017/09/06 PAR \| 170905 NL.H.3318.001-002.DC Imatinib Sandoz PAR_finalDate of last change:2017/09/06 Final Product Information \| NL H 3318-3319 IB 003_common-outer-cleanDate of last change:2016/07/01 Final Product Information \| NL H 3318-3319 IB 003_common-pl-cleanDate of last change:2016/07/01 Final Product Information \| NL H 3318-3319 IB 003_common-spc-cleanDate of last change:2016/07/01
市场状态	Positive