Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2023

Month: September

Request Number: A-2023-000162

Request Summary: The safety summary reports of the hematological monitoring for GEN-Clozapine-associated neutropenia/agranulocytosis. Manufacturer: Mylan. The request references all marketed strengths of GEN-Clozapine tablets (Drug Indentification Numbers (DIN), 02247243, 02247244, 02305003 and 02305011).

Disposition: Disclosed in part

Number of pages: 859

Date modified: