AstraZeneca gets CDSCO Panel nod to study Palivizumab solution for injection
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-01-27 12:30 GMT | Update On 2025-01-27 12:30 GMT
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New Delhi: Citing that clinical trial sites should be geographically distributed, including government sites, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major AstraZeneca to conduct the study of Palivizumab solution for injection 50 mg/0.5 mL and 100 mg/mL.
This came after AstraZeneca presented the proposal to conduct a Phase IV clinical trial titled “A Multicentre, Interventional, Phase IV, Open-label Study to Evaluate the Safety of Palivizumab in Children Less Than 24 Months of Age With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease” via Protocol No. D4800L00014 Version 1.0 dated 09 Sep 2024.
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