New Delhi: AstraZeneca Pharma India has announced the marketing approval from Central Drugs Standard Control Organization (CDSCO) to import and market ‘Palivizumab’ injection 100 mg/ml (r-DNA origin) (50mg/0.5mL & 100 mg/mL presentations in single-dose vials administered through intramuscular route) in India.
Respiratory Syncytial Virus (RSV) in children is a ‘major’ public health challenge faced across the globe today and is the second most common cause of death in children under 1 year of age (second only to malaria). WHO estimates that RSV accounts for >60% of acute respiratory infections in children and >80% in infants <1 year old. The disease is responsible for nearly 50% of pneumonia cases and up to 90% of bronchiolitis cases among infants.
In India, RSV is the most common cause of hospitalization in children <1 years old.
This innovative therapy is indicated for prevention of serious lower respiratory tract disease requiring hospitalisation caused by RSV in children at high risk for RSV disease:
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Infants born at 35 weeks of gestation or less and <6 months of age at the onset of the RSV season.
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Children <2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within last 6 months.
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Children <2 years of age and with haemodynamically significant congenital heart disease (CHD).
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