Gentamicin IV

Form: Injectable (IV, IM)

Strength: 40 mg/mL, 80 mg/mL, 80 mg/2 mL, 160 mg/2 mL

Reference Brands: Garamycin, Bramycin(US)

Category: Antibiotics

Gentamicin IV is approved in both the EU and US for serious bacterial infections, including sepsis and pneumonia. In the EU, brands like Garamycin are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data, with generics widely available. Both regions require detailed dossiers, including clinical trial results, manufacturing practices, and pharmacovigilance plans, for approval and ongoing safety monitoring. Due to its potent activity and potential toxicity, strict prescribing and monitoring are enforced. For expert support with regulatory dossiers, compliance, and registration, visit PharmaTradz. We facilitate effective market access aligned with European and US standards.