MedDRA Version 25.0 – What’s New in MedDRA Version 25.0

• MedDRA Version 25.0 is a complex change version which means changes may made at any level of the MedDRA hierarchy.

• A total of 54 new COVID-19 related LLTs/PTs were added including terms related to vaccines which may be applicable in COVID-19.

• One new SMQs has been added for MedDRA Version 25.0 – SMQ Noninfectious myocarditis/pericarditis. The focus of this SMQ is to identify cases of noninfectious myocarditis and/or pericarditis possibly related to exposure to drugs, vaccines, and biologics.

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