AstraZeneca Pharma India Limited has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services (DGHS), Government of India, for Eculizumab concentrate for solution for infusion 300 mg (10mg/ml) (SOLIRIS).

Through this approval, Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) and atypical Hemolytic Uremic Syndrome (aHUS) to inhibit complement – mediated thrombotic microangiopathy.

The receipt of this permission paves way for the launch of Eculizumab Concentrate for solution for infusion 300 mg (10mg/ml) (SOLIRIS) in India for the above specified indications, subject to the receipt of related statutory approvals, if any.