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  • CDSCO Panel Recommends...

CDSCO Panel Recommends Updating Prescribing Information for Sanofi's Vaccine

Susmita RoyWritten by Susmita Roy Published On 2025-09-28T13:15:35+05:30  |  Updated On 28 Sept 2025 1:15 PM IST
CDSCO Panel Recommends Updating Prescribing Information for Sanofis 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

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.

Also Read: Sanofi Tolebrutinib faces USFDA review delay; new target action date set for December 28

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.

Also Read: CDSCO Panel Asks Takeda to Submit Full Phase III Data on Dengue Tetravalent Vaccine
sanofivaccinecdscodiphtheriatetanuspertussishepatitis bpoliomyelitisHaemophilus influenza
Susmita Roy
Susmita Roy

    Mpharm (Pharmacology)

    Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

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