Givosiran

Form: Intravenous infusion

Strength: 2.5 mg/kg IV infusion

Reference Brands: Givlaari

Category: Nanoemulsion/Nanoparticles

Givlaari (Givosiran) is regulated in the US and EU, supported by dossiers demonstrating safety, efficacy, and quality manufacturing in line with GMP standards. In the US, FDA approval involved extensive clinical validation, safety assessments, and pharmacovigilance. In the EU, approval is pending or granted in some countries, with CE marking certifying conformity with MDR standards. These formulations undergo validation, stability testing, and audits, with comprehensive documentation including safety profiles, clinical trial data, and manufacturing practices. For licensing procedures, approved dossiers, and regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to effective Givosiran therapy supporting patients with hepatic porphyria worldwide.