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Pfizer withdraws Emergency Use Authorisation application of COVID-19 vaccine in India

In pursuance of the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3. Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the compan

Pfizer withdraws Emergency Use Authorisation application in India

Story highlights Pfizer in its application submitted to the drug regulator in December 2020, had sought permission to import the vaccine for sale and distribution in India, besides waiver of clinical trials on Indian population. Pharma major Pfizer on Friday said it has decided to withdraw its application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in India. Pfizer was the first pharmaceutical firm to seek an emergency use authorisation from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine in the country, after it secured such clearance in the UK and Bahrain. In pursuance of the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3. Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time, a company sp

Coronavirus: Pfizer withdraws application for emergency-use approval of its vaccine in India

Coronavirus: Pfizer withdraws application for emergency-use approval of its vaccine in India The vaccine has been approved in the United States and United Kingdom. File photo: A pharmacist dilutes the Pfizer coronavirus vaccine while preparing for inoculation. | Brendan Smialowski/AFP American pharmaceutical company Pfizer has withdrawn the application for emergency-use authorisation of its coronavirus vaccine in India, PTI reported on Friday. “In pursuance of the Emergency Use Authorisation of its Covid-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3,” a spokesperson for the company said. “Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time.”

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