Expert Panel Approves Post-Marketing Surveillance Study of Eculizumab (Soliris) by AstraZeneca in India
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to AstraZeneca Pharma India Ltd to conduct a Post Marketing Surveillance (PMS) study for its monoclonal antibody drug Eculizumab (Soliris) in India.
As per the official minutes, “The firm presented the proposal to conduct the Post Marketing Surveillance Study (PMS) in India for Eculizumab concentrate for solution for infusion 300 mg (10mg/ml) (Soliris) titled ‘A Prospective, Observational, Multicenter, Post Marketing Surveillance Study to assess safety of Eculizumab in Indian patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)’ vide study code D7414R00002 Version 1.0 dated 09.04.2025 as per the condition of Marketing Authorization approval.”
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