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Heparin Interpharma
Heparin Interpharma (heparin sodium) was approved for the following therapeutic use:
Prophylaxis and treatment of deep vein thrombosis for use in patients 18 years and older.
Heparin is a naturally occurring mucopolysaccharide which inhibits the clotting of blood in vitro and in vivo. It enhances the rate at which antithrombin III neutralises thrombin and activated factor X (Xa). Antithrombin III also neutralises other activated coagulation factors, for example, factors IX, XI, XII and plasmin.
With low dose heparin therapy, anticoagulation appears to result from neutralisation of Xa which prevents the conversion of prothrombin to thrombin. With full dose heparin therapy, anticoagulation appears to result primarily from neutralisation of thrombin which prevents the conversion of fibrinogen to fibrin. Full dose heparin therapy also prevents the formation of a stable fibrin clot by inhibiting activation of fibrin stabilising factor.
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology) and clinical (pharmacology, safety and efficacy) information submitted by the sponsor. The benefit-risk profile of Heparin Interpharma was considered favourable for the therapeutic use approved.