Patisiran

Form: Intravenous (IV) infusion

Strength: 0.3 mg/mL

Reference Brands: Onpattro

Category: Nanoemulsion/Nanoparticles

Patisiran (Onpattro) is regulated in both the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in compliance with GMP standards. In the US, FDA approval involved rigorous clinical validation, safety assessments, and pharmacovigilance. In the EU, CE marking certifies conformity under MDR standards. These biologics undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to effective, life-saving therapies supporting patients with hereditary ATTR amyloidosis worldwide, promoting safe and optimal patient outcomes.