Updated: May 5, 2021 8:47:36 pm
Central Drugs Standards Control Organisation has provided an emergency use authorisation (EUA) for Roche’s antibody cocktail of casirivimab and imdevimab for the treatment of mild to moderate Covid-19 in India, announced Roche India.
The approval is based on data filed for the EUA in the US and scientific opinion of Committee for Medicinal Products for Human Use (CHMP) in European Union.
This EUA will now enable Roche to import globally manufactured product batches to India that will be marketed as well as distributed in India through a strategic partnership with Cipla Ltd, read a statement issued on Wednesday.
The antibody cocktail is to be administered to adults and paediatric patients (12 years or older, weighing at least 40 kg), who are confirmed to be infected with the novel coronavirus and are at high risk of developing severe disease, further read the statement.
This treatment will be complementary to the ongoing vaccination drive and support the fight against the pandemic in India, said V Simpson Emmanuel, managing director, Roche Pharma India.
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