Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2025

Month: January

Request Number: A-2023-000160

Request Summary: The safety summary reports of the hematological monitoring for AA-Clozapine-associated neutropenia/agranulocytosis. Date ranges: All available reports. Manufacturer: AA Pharma Inc. The request references all marketed strengths of AA-Clozapine tablets (Drug Identification Numbers (DINs), 02248034, 02248035, 02458748 and 02458756).

Disposition: Disclosed in part

Number of pages: 17

Date modified: