Regulatory Decision Summary for FLUZONE High-Dose
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Summary of Cancellation: Haemagglutinin-strain A (H1N1), Haemagglutinin-strain A (H3N2) and Haemagglutinin-strain B. (*FLUZONE High-Dose)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
June 19, 2019
What was the purpose of this submission?
The purpose of the submission was to seek amendments to the product monograph for FLUZONE High-Dose to revise the INDICATIONS AND CLINICAL USE section by removing the wording "caused by the specific strains of influenza virus contained in the vaccine" and adding "influenza disease and its associated complications".
What did the company submit to support its submission?
The company submitted clinical trial reports, references and labeling components including from their completed clinical trials and other published literature references.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
Health Canadas review of the submission identified deficiencies in the data provided to support the proposed changes to the indication. The sponsor chose to voluntarily withdraw their submission without prejudice to refiling.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
N/A. The product is approved for use in Canada and the proposed changes to the indication have no impact on patients for whom Fluzone HD is indicated.
Additional information
*Proposed Brand Name:
FLUZONE High Dose