New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organization (CDSCO), has approved an additional indication for Sanofi Healthcare India's combination vaccine, Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component) and Inactivated Poliomyelitis Vaccine, in line with the EU SmPC, excluding the statement that "Tetraxim can be used to reconstitute the Haemophilus influenzae type b conjugate vaccine (Act-Hib)".

This came after the firm presented the proposal for approval of the change in indication of Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component) and Inactivated Poliomyelitis Vaccine, as below, along with various changes in prescribing information.

The company sought permission to update the vaccine’s indication to co

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