
Cefepime (4th Gen) Injectable (IV/IM)
Form: Injectable (IV/IM)
Strength: 1 g, 2 g, 4 g per vial
Reference Brands: Maxipime(US & EU)
Category: Antibiotics
Cefepime IV injection is approved in the EU and US for treating severe bacterial infections, including pneumonia, sepsis, and febrile neutropenia. In the EU, brands like Maxipime are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data; generic formulations are available. Both regions require detailed dossiers, including clinical trial results, quality assurance, and pharmacovigilance plans, for approval and continuous safety monitoring. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support seamless market access for cefepime injection, ensuring adherence to European and US standards for safe, effective treatment of serious infections.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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