AstraZeneca Pharma India received import and market permission in September 2023, from the Drug 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).
Palivizumab (Synagis) is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation 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.
- Children less than 2 years of age and with hemodynamically significant congenital heart disease (CHD)