Updated:
May 05, 2021 20:18 IST
This will enable Roche to import the globally manufactured product batches to India where it has a partnership with Cipla to market as well as distribute the same
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The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland. | Photo Credit:
Reuters
This will enable Roche to import the globally manufactured product batches to India where it has a partnership with Cipla to market as well as distribute the same
Roche India on Wednesday said it has received emergency use authorisation (EUA) of the Central Drugs Standards Control Organisation for antibody cocktail (Casirivimab and Imdevimab) that is indicated for treatment of mild to moderate COVID-19.
For treatment of mild to moderate Covid-19Roche India today announced that the Central Drugs Standards
Control Organisation (CDSCO) has provided an Emergency Use Authorisation (EUA) for Roche s antibody cocktail (Casirivimab and Imdevimab) in India.
This approval was based on the data that have been filed for the EUA in the United States, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.
This Emergency Use Authorisation 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.
Cipla MD and Global CEO Umang Vohra said, This partnership with Roche is a significant step in enabling access to promising treatments in furtherance to our purpose of Caring for Life .
Roche India gets emergency use approval for antibody cocktail used in COVID-19 treatment
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Last Updated: May 05, 2021, 08:04 PM IST
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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.
PTI
Drug firm Roche India on Wednesday said it has received Emergency Use Authorisation (EUA) from the Central Drugs Standards Control Organisation (CDSCO) for Roche s investigational antibody cocktail used in the treatment of COVID-19. The approval of antibody cocktail of Casirivimab and Imdevimab in India was based on the data filed for the EUA in the US, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union, Roche India said in a statement.
Covid: Roche gets emergency use nod for antibody cocktail jab in India
By IANS |
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New Delhi: Vaccination officer inject vaccine for Covid-19 above 18 to 44 ages people at a Government school Yamuna vihar in New Delhi on Monday, 03 May 2021.(Photo: Wasim Sarvar/IANS). Image Source: IANS News
Mumbai, May 5 : The Central Drugs Standards Control Organisation (CDSCO) on Wednesday gave Roche India emergency use authorisation (EUA) for its antibody cocktail jab of Casirivimab and Imdevimab.
The Casirivimab-Imdevimab injection is a cocktail of two monoclonal antibodies and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes Covid-19. The monoclonal antibodies are produced by recombinant DNA technology.