CDSCO Panel Recommends Updating Prescribing Information for Sanofi's Vaccine
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
This came after Sanofi Healthcare India presented its proposal for updation of prescribing information (PI) (CCDSv11 dated 14th Oct 2021 (LRR13886).
The vaccine is indicated for active immunization against Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, and Haemophilus Influenzae Type B in infants and children. It helps prevent serious infectious diseases by stimulating the body’s immune response to produce protective antibodies.
At the recent SEC meeting for vaccines, the expert panel reviewed a proposal for the updation of prescribing information (PI) (CCDSv11 dated 14th Oct 2021 (LRR13886) presented by Sanofi Healthcare India.
After detailed deliberation, the committee recommended updating the prescribing information in line with the European Union Summary of Product Characteristics (EU SmPC).
Additionally, the expert panel stated that the firm should 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.
