Organization: Health Canada
Year: 2025
Month: January
Request Number: A-2024-001295
Request Summary: With respect to generic drug in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2022-06-22 for the medicinal ingredient mesalazine, any documents or correspondence referring to pharmacodynamic studies used to establish in vivo comparability of the drug product under review to the reference product.
Disposition: No records exist
Number of pages: 0