Organization: Health Canada
Year: 2024
Month: August
Request Number: A-2023-001324
Request Summary: The Product Information Template: Regulatory Enrollment Process (the equivalent of Section #67 of the previous Health Canada (HC)/Sante Canda (SC)-3011 Drug Submission Application Form) for the Mesalazine Abbreviated New Drug Submission (ANDS), setting out the proposed indication(s)/use(s) of the drug product.
Disposition: Disclosed in part
Number of pages: 4