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Displaying 1 - 15 of 31 items.

" " EVUSHELD (tixagevimab and cilgavimab for injection) - Risk of Prophylaxis or Treatment Failure due to Antiviral Resistance to specific SARS-CoV-2 Subvariants
UPDATED INFORMATION – 2023/01/17 Neutralization data for the following SARS-CoV-2 Omicron subvariants have been added to the Canadian Product Monograph: Omicron BA.2.75.2, BF.7, BJ.1, BN.1, BQ.1, BQ.1.1, and XBB. See Table 1 (below) for a summary…
AlertHealth professional risk communication | 2023-01-17
" " COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children 5 to Less Than 12 Years of Age
On December 9, 2022, Health Canada authorized a new formulation of the bivalent vaccine, COMIRNATY Original & Omicron BA.4/BA.5, as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory…
AlertHealth professional risk communication | 2022-12-09
" " SPIKEVAX Bivalent (Original / Omicron BA.4/5) (elasomeran/davesomeran) COVID-19 Vaccine with English-only Vial and Carton Labels
Health Canada authorized SPIKEVAX Bivalent (Original / Omicron BA.4/5) (elasomeran/davesomeran) on November 3, 2022. In order to provide rapid access to the vaccine, Moderna will distribute product vials and cartons labelled in English only with the…
AlertHealth professional risk communication | 2022-11-18
" " EVUSHELD (tixagevimab and cilgavimab for injection) - Risk of Prophylaxis or Treatment Failure due to Antiviral Resistance
EVUSHELD (tixagevimab and cilgavimab for injection) may not be effective against certain SARS-CoV-2 Omicron subvariants.   Audience Healthcare professionals including physicians, pharmacists, nursing staff and public health officials.…
AlertHealth professional risk communication | 2022-10-26
" " COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels
On October 7, 2022, Health Canada authorized the bivalent vaccine, COMIRNATY Original & Omicron BA.4/BA.5, as a booster dose for active immunization against coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2…
AlertHealth professional risk communication | 2022-10-07
" " Distribution of SPIKEVAX Bivalent (elasomeran/imelasomeran) COVID-19 Vaccine with English-only Vial and Carton Labels
Health Canada authorized SPIKEVAX Bivalent (elasomeran/imelasomeran) on September 01, 2022. In order to provide rapid access to SPIKEVAX Bivalent, Moderna will distribute product vials and cartons labelled in English only with the brand name “SPIKEVAX 0…
AlertHealth professional risk communication | 2022-09-02
" " 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
" " 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
" " 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 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
" " 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 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 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
" " 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
" " 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
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