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Displaying 1 - 15 of 58 items.
COMIRNATY (COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine): New Formulation/Presentation for Use in Individuals 12 Years of Age and Older
COMIRNATY received a Notice of Compliance (NOC) under the Food and Drug Regulations on September 16, 2021, replacing the previous authorization under the Interim Order.
On March 15, 2022, COMIRNATY also received a NOC for an additional formulation…
AlertHealth professional risk communication | 2022-05-09
Sotrovimab for Injection - Risk of Treatment Failure due to Circulation of SARS-CoV-2 Omicron BA.2 Subvariant
Sotrovimab, 500 mg IV, is unlikely to maintain efficacy against the Omicron BA.2 subvariant. Sotrovimab demonstrates reduced in vitro neutralization against the Omicron BA.2 subvariant.
Audience
Healthcare professionals responsible…
AlertHealth professional risk communication | 2022-04-14
Shelf Life Extension for the SPIKEVAX (elasomeran) COVID-19 Vaccine with Printed Expiry Dates on Vial and Carton Labels
On December 23, 2021, Health Canada authorized a shelf-life extension, from 7 months to 9 months, for SPIKEVAX / COVID-19 Vaccine Moderna 5 mL vials. This 2-month extension may be retroactively applied to vials that are currently on the market with…
AlertHealth professional risk communication | 2022-01-11
Casirivimab and Imdevimab – High Risk of Treatment Failure Due to Circulation of SARS-CoV-2 Omicron Variant
There is a high risk of treatment failure with the casirivimab and imdevimab combination based on analysis of neutralization activity against selected mutations of the SARS-CoV-2 Omicron variant. The Canadian Product Monograph for casirivimab and…
AlertHealth professional risk communication | 2022-01-07
COMIRNATY (COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine): New Formulation for Use in Children Aged 5 Years to Less Than 12 Years
IMPORTANT: Access to Canadian-specific labelling information during the distribution of COMIRNATY (COVID-19 Vaccine, mRNA also referred to as Pfizer-BioNTech COVID-19 Vaccine) for Children Aged 5 Years to Less Than 12 Years.
Audience…
AlertHealth professional risk communication | 2021-11-19
Distribution of SPIKEVAX (elasomeran) COVID-19 Vaccine with English-only Vial and Carton Labels
IMPORTANT: Access to Canadian-specific labelling information during the distribution of the SPIKEVAX (elasomeran) COVID-19 Vaccine with English-only vial and carton labels.
Audience
Healthcare professionals including infectious disease physicians,…
AlertHealth professional risk communication | 2021-11-10
Health Canada is updating the labels of the Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines
Health Canada is informing Canadians and healthcare professionals about changes to the product labels of the Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines.
The Department is updating the label of the Janssen COVID-19 Vaccine to provide…
AlertPublic advisory | 2021-11-09
Importation of Janssen COVID-19 Vaccine with European Union (EU) English-only Vial and Carton Labels
IMPORTANT: Access to storage and expiry date instructions during the distribution of the Janssen COVID-19 Vaccine with EU English-only labels.
Audience
Healthcare professionals including infectious disease physicians, pharmacists, family…
AlertHealth professional risk communication | 2021-11-05
Authorization of Sotrovimab for Injection for Use in Relation to the COVID-19 Pandemic
Authorization of Sotrovimab for Injection for Use in Relation to the COVID-19 Pandemic
Starting date:
September 22, 2021
Posting date:
October 4, 2021
Type of communication:…
AlertHealth professional risk communication | 2021-10-04
One lot of the hypoglycemia treatment Glucagon recalled as it may pose serious health risks
One lot of the hypoglycemia treatment Glucagon recalled as it may pose serious health risks
Starting date:
September 25, 2021
Posting date:
September 25, 2021
Type of…
AlertPublic advisory | 2021-09-25
Health Canada updates Pfizer-BioNTech COVID-19 vaccine label to reflect very rare reports of Bell's Palsy
Health Canada updates Pfizer-BioNTech COVID-19 vaccine label to reflect very rare reports of Bell's Palsy
Starting date:
August 6, 2021
Type of communication:
Advisory…
AlertPublic advisory | 2021-08-06
Authorization of Casirivimab and Imdevimab with English-only Labels for Use in Relation to the COVID-19 Pandemic
Authorization of Casirivimab and Imdevimab with English-only Labels for Use in Relation to the COVID-19 Pandemic
Starting date:
July 30, 2021
Posting date:
July 30, 2021
Type…
AlertHealth professional risk communication | 2021-07-30
Health Canada updates Pfizer-BioNTech and Moderna COVID-19 vaccine labels to include information on myocarditis and pericarditis
Health Canada updates Pfizer-BioNTech and Moderna COVID-19 vaccine labels to include information on myocarditis and pericarditis
Starting date:
June 30, 2021
Posting date:…
AlertPublic advisory | 2021-06-30
AstraZeneca COVID-19 Vaccine and COVISHIELD: Risk of Capillary Leak Syndrome
AstraZeneca COVID-19 Vaccine and COVISHIELD: Risk of Capillary Leak Syndrome
Starting date:
June 29, 2021
Posting date:
June 29, 2021
Type of communication:
Dear Healthcare…
AlertHealth professional risk communication | 2021-06-29
Health Canada issues label change on the AstraZeneca and COVISHIELD COVID-19 vaccines
Health Canada issues label change on the AstraZeneca and COVISHIELD COVID-19 vaccines
Starting date:
April 14, 2021
Posting date:
June 29, 2021
Type of communication:
Advisory…
AlertPublic advisory | 2021-06-29