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Displaying 1 - 15 of 55 items.

Health alert or recall IMVAMUNE Vaccine: Updated Storage Conditions and Shelf Life
On July 27, 2022, Bavarian Nordic submitted data to Health Canada characterizing shelf life for alternative storage conditions for IMVAMUNE. The IMVAMUNE Vaccine Product Monograph indicates: “Store frozen at -20°C ± 5°C or -50°C ± 10°C or -80°C ± 10°C.…
AlertHealth professional risk communication | 2022-07-29
Health alert or recall Distribution of a New Presentation of SPIKEVAX (elasomeran) COVID-19 Vaccine (0.10 mg/mL in 2.5 mL multidose vial) with English-only Vial and Carton Labels
A new presentation of SPIKEVAX (elasomeran) with a concentration of 0.10 mg/mL in a 2.5 mL multidose vial was authorized on June 01, 2022. In order to provide rapid access to the new presentation of SPIKEVAX (0.10 mg/mL, 2.5 mL multidose vial), Moderna…
AlertHealth professional risk communication | 2022-06-06
Health alert or recall 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
UPDATED INFORMATION – June 10, 2022 Further to the communication below, issued on May 9, 2022, Health Canada has issued a new DIN (i.e. DIN 02527863) for COMIRNATY (COVID-19 Vaccine, mRNA), 30 mcg/0.3 mL, which has a GRAY vial cap and GRAY label…
AlertHealth professional risk communication | 2022-05-09
Health alert or recall 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
Health alert or recall 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
Health alert or recall 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
Health alert or recall 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
Health alert or recall 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 alert or recall 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
Health alert or recall 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
Health alert or recall 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 alert or recall 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
Health alert or recall 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 alert or recall 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 alert or recall 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
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