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
Paliperidone 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
2025/07/10
药物ATC编码
N05AX13 paliperidone
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 PL
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Final PL
Final SPC
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Final SPC
市场状态
Positive
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