Paliperidone Once-Monthly Im Injection

Form: Once-Monthly IM Injection

Strength: 39 mg, 78 mg, 117 mg, 156 mg, 234 mg

Reference Brands: Xeplion®(EU); Invega Sustenna®(US)

Category: Antipsychotropic Drugs

Paliperidone once-monthly intramuscular injection (brand name: Invega Sustenna) is FDA-approved in the U.S. for the treatment of schizophrenia and schizoaffective disorder in adults. In the European Union, it is approved by the EMA via the centralized procedure for schizophrenia. Regulatory approval requires GMP-compliant long-acting injectable manufacturing, validated pharmacokinetic bridging studies, and robust clinical trial data supporting safety and relapse prevention. U.S. labeling includes a boxed warning for increased mortality in elderly patients with dementia-related psychosis. EU approvals mandate Risk Management Plans (RMPs) and ongoing pharmacovigilance. For sourcing and dossier-ready options, visit Pharmatradz.com.