AstraZeneca Pharma India Limited has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from Central Drugs Standard Control Organisation for Palivizumab (Synagis) solution for injection 100 mg/ml (r-DNA origin) (50mg/0.5mL & 100 mg/mL presentations in single-dose vials administered through intramuscular route).
Through this approval, Palivizumab (Synagis) is indicated for the prevention of serious lower respiratory tract disease requiring hospitalization caused by respiratory syncytial virus (RSV) in children at high risk.
The receipt of this permission paves way for the launch of Palivizumab (Synagis) solution for Injection 100 mg/ml (50mg/0.5mL & 100 mg/mL presentations in single-dose vials administered through intramuscular route) in India for the specified indication, subject to the receipt of related statutory approvals, if any.
