Mirtazapine Tablets/Odt

Form: Tablets/ODT

Strength: 15 mg, 30 mg, 45 mg

Reference Brands: US: Remeron®, Remeron SolTab®; EU: Zispin®, Mirtazapine Teva®, Mirtazon®, Espran®

Category: Antipsychotropic Drugs

Mirtazapine Tablets and Orally Disintegrating Tablets (ODT) are FDA-approved in the USA for the treatment of major depressive disorder (MDD). As a noradrenergic and specific serotonergic antidepressant (NaSSA), mirtazapine requires a Boxed Warning for the risk of suicidal thoughts in young adults. Regulatory compliance includes GMP, labeling accuracy, and robust post-marketing safety reporting. In the European Union, Mirtazapine is approved under national procedures or via mutual recognition, with strict guidelines for Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs). Explore global dossiers and reliable sources of Mirtazapine at Pharmatradz.com.