The antibody cocktail by Roche India has got ‘Emergency Use Authorization’ in India. The Central Drugs Standards Control Organisation (CDSCO) has granted the ‘Emergency Use Authorization’ for the medicine manufactured by the company in the country.
The CDSCO has given the approval after studying the data filed by the company for the EUA in the US, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union. The CDSCO has approved the antibody cocktail of Casirivimab and Imdevimab in India.
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“This Emergency Use Authorization will now enable Roche to import the globally manufactured product batches to India and will be marketed as well as distributed in India through a strategic partnership with Cipla Limited,” a statement issued by the company said.
“The antibody cocktail is to be administered for the treatment of mild to moderate coronavirus disease in adults and pediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2 and who are at high risk of developing severe COVID-19 disease”, the statement said.
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