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

MR编号	SE/H/2335/006
药品名称	Palbran
活性成分	Paliperidone palmitate 100.0 mg Paliperidone palmitate 150.0 mg
剂型	Prolonged-release suspension for injection in pre-filled syringe
上市许可持有人	Exeltis Healthcare S.L.
参考成员国 - 产品名称	Sweden (SE)
互认成员国 - 产品名称	Hungary (HU) Czech Republic (CZ) Palbran Belgium (BE) Psylipax 100 mg + 150 mg suspension injectable à libération prolongée en seringue préremplie Slovak Republic (SK) Luxembourg (LU) Slovenia (SI) Austria (AT) Spain (ES) Portugal (PT) Italy (IT) Finland (FI) Poland (PL) Palbran Latvia (LV) Estonia (EE)
许可日期	2025/05/29
最近更新日期	2025/07/31
药物ATC编码	N05AX13 paliperidone
申请类型	TypeLevel1：Abridged TypeLevel2：Initial 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_20230216000110_psylipax_150_mg_100_mg_injektionsvatska_depotsuspension_i_forfylld_spruta PubAR Summary \| https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20230216000110_psylipax_150_mg_100_mg_injektionsvatska_depotsuspension_i_forfylld_spruta_2
市场状态	Positive