CDSCO Panel Recommends Updating Prescribing Information for Sanofi's Vaccine
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New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended updation of the Prescribing Information (PI) for Diphtheria, Tetanus, Pertussis (Acellular Component), Hepatitis B (r-DNA), Poliomyelitis (Inactivated) and Haemophilus Influenzae Type B Conjugate Vaccine (Adsorbed) I.P., marketed by Sanofi Healthcare India Private Limited.
In addition to the above, the expert panel suggested that the firm monitor the interaction of the vaccine with Varicella-containing vaccines in the Indian population and submit the same as part of the Periodic Safety Update Report (PSUR) submission
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