Prothrombin Complex Concentrate (pcc) Injectable Concentrates Generics - Manufacturers & Suppliers
NovoSeven, AryoSeven, BS-505(US)
| Product/Composition:- | Prothrombin Complex Concentrate (PCC) Injectable concentrates |
|---|---|
| Strength:- | 1,200 IU/vial |
| Form:- | Injection |
| Reference Brands:- | NovoSeven, AryoSeven, BS-505(US) |
| MOQ | As per the manufacturer batch size |
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Recombinant Factor VIIa stimulates the extrinsic pathway of blood coagulation by activating factor X, promoting clot formation. It effectively controls bleeding in hemophilia with inhibitors and other bleeding disorders. Benefits include rapid bleeding cessation, reduced transfusion needs, and improved hemostasis during surgery or trauma, supporting patient safety and recovery.
Recombinant Factor VIIa (e.g., NovoSeven) is approved in the US by the FDA and in the EU via EMA for controlling bleeding in hemophilia patients with inhibitors, and in other bleeding disorders. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing details, and pharmacovigilance plans. In the US, FDA review involves detailed assessment of clinical trial data, while the EMA ensures compliance with regional standards for quality and safety. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring thorough regulatory compliance is essential for the safe, effective, and timely worldwide approval of Factor VIIa products, supporting optimal patient outcomes.