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

MR编号	NL/H/4253/002
药品名称	Sunitinib Mylan 25 mg harde capsules
活性成分	SUNITINIB 25.0 mg
剂型	Capsule, hard
上市许可持有人	Mylan Pharmaceuticals Limited Damastown Industrial Park Mulhuddart D15 XD71 Dublin 15
参考成员国 - 产品名称	Netherlands (NL) Sunitinib Mylan 25 mg, harde capsules RVG 123597
互认成员国 - 产品名称	Spain (ES) Sweden (SE) Denmark (DK) Iceland (IS) Sunitinib Mylan 25 mg hart hylki United Kingdom (Northern Ireland) (XI) France (FR) Portugal (PT) Italy (IT) Norway (NO) Sunitinib Mylan Finland (FI) Poland (PL) Sunitinib Mylan Hungary (HU) SZUNITINIB MYLAN 25 mg kemény kapszula Bulgaria (BG) Sunitinib Mylan Czechia (CZ) Sunitinib Mylan Romania (RO) Slovakia (SK) Malta (MT) Croatia (HR) Sunitinib Mylan 25 mg tvrde kapsule
许可日期	2019/02/27
最近更新日期	2024/03/29
药物ATC编码	L01EX01 sunitinib
申请类型	TypeLevel1：Abridged TypeLevel2：Multiple (Copy) 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-combined-nl4253-v005-trackedDate of last change:2021/06/30 Final Labelling \| common labelDate of last change:2021/02/04 Final Labelling \| common plDate of last change:2021/02/04 Final Labelling \| common spcDate of last change:2021/02/04 PAR Summary \| 190620 NL.H.4253.001-004.DC Sunitinib Mylan summary ENDate of last change:2019/08/01 PAR \| 190620 NL.H.4253.001-004.DC Sunitinib Mylan PARDate of last change:2019/08/01 Final Product Information \| NL-H-4250+51+52+53+54+55-001_004-DC - Sunitinib PharOS - ProdInfo combinedDate of last change:2019/07/06
市场状态	Positive