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Displaying 1 - 15 of 71 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
Allergenic extract non pollens (Peanut allergy): False negative for skin test
Affected lot may result in a false negative for skin test (peanut allergy).
RecallHealth product recall | 2022-12-14
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
Allergenic extract non pollens (Peanut allergy): False negative for skin test
Affected lot may result in a false negative for skin test (peanut allergy)
RecallHealth product recall | 2022-11-15
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
BOOSTRIX: Syringes may be cracked in affected lot.
Syringes may be cracked in affected lot.
RecallHealth product recall | 2022-10-07
ZOLGENSMA (onasemnogene abeparvovec) and Fatal Cases of Acute Liver Failure
Two cases of fatal acute liver failure associated with ZOLGENSMA have recently been reported internationally. The deaths occurred 6-7 weeks post-ZOLGENSMA infusion, following the initiation of corticosteroid taper. No fatal cases of acute liver failure…
AlertHealth professional risk communication | 2022-09-12
COMIRNATY (COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine): New Presentation for Use in Children Aged 6 Months to Less Than 5 Years with English-only Vial and Carton Labels
On September 9, 2022, Health Canada authorized a new presentation of COMIRNATY (COVID-19 Vaccine, mRNA) 3 mcg/0.2 mL dose (DIN 02530325) for use in children aged 6 months to less than 5…
AlertHealth professional risk communication | 2022-09-09
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
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
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
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
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