Givosiran Infusion 2.5 mg/kg IV infusion Suppliers & Bulk Manufacturers

Available Forms: Intravenous infusion

Available Strengths: 2.5 mg/kg IV infusion

Reference Brands: Givlaari

Category: Nanoemulsion/Nanoparticles

Givlaari (Givosiran) is an RNA interference therapy that reduces the production of hepatic aminolevulinic acid synthase 1 (ALAS1), decreasing neurovisceral attacks in acute hepatic porphyria. Benefits include fewer attacks, improved quality of life, and reduced hospitalization when administered regularly in specialized care settings.

Product Description:

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. Ensuring compliance guarantees access to effective Givosiran therapy supporting patients with hepatic porphyria worldwide.