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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…

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…

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…

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…

Contains undeclared impurity, benzene, at elevated levels.

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…

The affected lots may contain an acetaldehyde concentration that is outside the acceptable limit.

EVUSHELD (tixagevimab and cilgavimab for injection) was authorized by Health Canada on April 14, 2022. In order to provide rapid access to EVUSHELD in the context of the global COVID-19 pandemic, AstraZeneca will distribute product vials and cartons with…

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…

NUVAXOVID was authorized by Health Canada on February 17, 2022. In order to provide earlier access to NUVAXOVID in the context of the global pandemic, Novavax, Inc. will distribute product vials, cartons and package inserts that are in English only for a…

Affected lot(s) may be missing risk statements and the non medicinal ingredient carbomer on the outer label. 

The affected lots may contain an acetaldehyde concentration that is outside the acceptable limit.

The affected lots may contain an acetaldehyde concentration that is outside the acceptable limit.

UPDATED INFORMATION - July 6, 2022 A new PAXLOVID dose pack for use in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min) is now available with a distinct DIN: 02527804. Pfizer has introduced this new packaging configuration to…

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…