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

MR编号	NL/H/4250/001
药品名称	Sunitinib Sandoz 12,5 mg, harde capsules
活性成分	SUNITINIB 12.5 mg
剂型	Capsule, hard
上市许可持有人	Sandoz B.V. Veluwezoom 22 Almere
参考成员国 - 产品名称	Netherlands (NL) Sunitinib Sandoz 12,5 mg, harde capsules RVG 122359
互认成员国 - 产品名称	Germany (DE) Denmark (DK) Belgium (BE) United Kingdom (Northern Ireland) (XI) Ireland (IE) Austria (AT) Sunitinib Sandoz 12,5 mg - Hartkapseln France (FR) Portugal (PT) Greece (GR) Sweden (SE) Norway (NO) Sunitinib Sandoz Finland (FI) Poland (PL) Sunitinib Sandoz Latvia (LV) Sunitinib Sandoz 12,5 mg cietās kapsulas Lithuania (LT) Sunitinib Sandoz 12,5 mg kietosios kapsulės Estonia (EE) SUNITINIB SANDOZ Hungary (HU) SZUNITINIB SANDOZ 12,5 mg kemény kapszula Bulgaria (BG) Sunitinib Sandoz Cyprus (CY) Sunitinib Sandoz 12,5 mg Czechia (CZ) Sunitinib Sandoz Romania (RO) Slovakia (SK) Sunitinib Sandoz 12,5 mg tvrdé kapsuly Slovenia (SI) Sunitinib Sandoz 12,5 mg trde kapsule Malta (MT) Croatia (HR) Sunitinib Sandoz 12,5 mg tvrde kapsule
许可日期	2019/02/27
最近更新日期	2024/01/18
药物ATC编码	L01XE04 sunitinib
申请类型	TypeLevel1：Abridged 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:2021/07/23 Final PL \| common-spc-spcDate of last change:2019/11/14 Final PL \| common-pl-plDate of last change:2019/11/14 Final Product Information \| NL-H-4250+51+52+53+54+55-001_004-DC - Sunitinib PharOS - ProdInfo combinedDate of last change:2019/09/06 PAR Summary \| 190612 NL.H.4250.001-004.DC Sunitinib Sandoz summary ENDate of last change:2019/08/01 PAR \| 190620 NL.H.4250.001-004.DC Sunitinib Sandoz PARDate of last change:2019/08/01
市场状态	Positive