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

MR编号	SE/H/2336/003
药品名称	Paliperidon Zentiva
活性成分	Paliperidone palmitate 75.0 mg
剂型	Prolonged-release suspension for injection in pre-filled syringe
上市许可持有人	Zentiva k.s
参考成员国 - 产品名称	Sweden (SE)
互认成员国 - 产品名称	Germany (DE) Paliperidone ZENTIVA 75 mg Depot-Injektionssuspension in einer Fertigspritze Denmark (DK) Paliperidon Zentiva France (FR) Portugal (PT) Italy (IT) Norway (NO) Hungary (HU)
许可日期	2025/05/29
最近更新日期	2025/12/19
药物ATC编码	N05AX13 paliperidone
申请类型	TypeLevel1：Abridged TypeLevel2：Multiple (Copy) Application TypeLevel3：Generic TypeLevel4：Chemical Substance TypeLevel5：Prescription Only
附件文件下载	Final PL \| Final PL Final SPC \| Final SPC PubAR \| https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20221101000278_paliperidon_zentiva_75_mg_injektionsvatska_depotsuspension_i_forfylld_spruta PubAR Summary \| https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20221101000278_paliperidon_zentiva_75_mg_injektionsvatska_depotsuspension_i_forfylld_spruta_2
市场状态	Positive