Palivizumab (Synagis) is indicated for the prevention of serious lower respiratory tract disease requiring hospitalization caused by RSV in children at high risk for RSV disease
AstraZeneca Pharma India Limited will launch Palivizumab (Synagis) in October 2024 in India.
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 for RSV disease: Infants born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season; Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within the last 6 months; and Children less than 2 years of age and with hemodynamically significant congenital heart disease (CHD).
On September 30, 2023, the company received the receipt of Import and Market Permission in Form CT-20 from the Drugs Controller General of India (DCGI) 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).
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