By: IPP Bureau
Last updated : January 17, 2025 10:33 am
Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome
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.