Organization: Health Canada
Year: 2021
Month: January
Request Number: A-2020-001248
Request Summary: Master Data/Core Data/Core Safety data from the Periodic Safety Update Reports (PSURs) submitted between the initial marketing authorization date and 1995 for Engerix-B and Recombivax HB. Include all reviews done by the U.S. Food and Drug Administration submitted by the MAH (Merck) to Health Canada for its pharmacovigilance review.
Disposition: No records exist
Number of pages: 0