Sanofi gets CDSCO panel okay to market Quadrivalent Inactivated Influenza vaccine
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New Delhi: Pharma major, Sanofi has got the go-head from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organization (CDSCO) to market Quadrivalent Inactivated Influenza vaccine (Split Viron) in the age group of 6 to 35 months.
This approval is subjected to condition that the firm should conduct observational Post Marketing Surveillance study as per the protocol presented before the Committee.
FluQuadri (Quadrivalent Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde.
At recent SEC meeting to review proposals and advice Drugs Controller General (India) in matters for Biologicals & PAC proposals held on 03.03.2022, the committee extensively reviewed the drug maker Sanofi's proposal for grant of market authorization for Quadrivalent Inactivated Influenza Vaccine (split virion) I.P. (for 0.5ml dose) in the age group of 6 to 35 months with protocol for observational Post Marketing Surveillance study.
After detailed deliberation, the committee recommended the grant of market authorization for Quadrivalent Inactivated Influenza vaccine (Split Viron)I.P (for a a0.5ml dose) in the age group of 6 to 35 months with condition to conduct observational Post Marketing Surveillance study as per the protocol presented before the Committee.
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