Prothrombin Complex Concentrate (PCC) injection

Form: Injection

Strength: 250 IU to 300 IU

Reference Brands: Kcentra (4-factor PCC), Bebulin VH (3-factor PCC)(US)

Category: Blood Disorder

Prothrombin Complex Concentrate (PCC), marketed as Kcentra in the US and various brands in the EU, is approved for urgent reversal of warfarin anticoagulation and uncontrolled bleeding. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews detailed submissions, while the EMA ensures compliance with regional standards. Proper dossier preparation and adherence to regional guidelines are essential for timely approval. For expert guidance on dossier development, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance facilitates safe and effective clinical use of PCC worldwide, supporting patient care in critical bleeding situations.