Imipenem + Cilastatin IV

Form: Intravenous (IV) Solutions

Strength: 500 mg/500 mg, 1 g/1 g per vial

Reference Brands: Primaxin, Gemax (US & EU)

Category: Antibiotics

Imipenem + Cilastatin intravenous (IV) is approved in both the EU and US for serious bacterial infections, including pneumonia, intra-abdominal, and urinary tract infections. In the EU, brands like Primaxin are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical trial data; generic formulations are widely available. Both regions require comprehensive dossiers, including trial results, quality controls, and pharmacovigilance plans, for approval and safety monitoring. For expert support with regulatory dossiers, compliance, and registration, visit PharmaTradz. We facilitate seamless market access ensuring adherence to European and US standards for effective, safe antibacterial therapy.