Paliperidone Extended-Release Tablets

Form: Extended-Release Tablets

Strength: 1.5 mg, 3 mg, 6 mg, 9 mg

Reference Brands: Invega®(US & EU)

Category: Antipsychotropic Drugs

Paliperidone extended-release tablets (brand name: Invega) are FDA-approved in the United States for the treatment of schizophrenia and schizoaffective disorder in adults. In the European Union, they are authorized under the centralized procedure for schizophrenia. Regulatory requirements include GMP-compliant manufacturing, osmotic-controlled release oral delivery system (OROS) data, and comprehensive clinical efficacy and safety studies. The product labeling in the U.S. includes a boxed warning for increased mortality in elderly patients with dementia-related psychosis. EU authorization also mandates Risk Management Plans (RMPs) and post-marketing safety monitoring. To explore dossier-ready Paliperidone ER tablets, visit Pharmatradz.com.