Vortioxetine Film-Coated Tablets

Form: Film-Coated Tablets

Strength: 5 mg, 10 mg, 15 mg(EU only), 20 mg

Reference Brands: Trintellix®(US); Brintellix®(EU)

Category: Antipsychotropic Drugs

Vortioxetine film-coated tablets are FDA-approved in the United States for the treatment of major depressive disorder (MDD) in adults. As a serotonin modulator and stimulator, vortioxetine's approval includes strict labeling for suicidal thoughts and behaviors, particularly in young adults. Regulatory requirements in the U.S. include GMP-compliant manufacturing, bioequivalence standards for generics, and ongoing post-marketing surveillance. In the European Union, vortioxetine is authorized under the centralized EMA procedure for the treatment of MDD. EU regulations require a comprehensive Risk Management Plan (RMP), safety monitoring, and periodic safety update reports (PSURs). For dossier-ready sourcing and global supply options, visit Pharmatradz.com.