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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…

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…

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…

Serious and fatal events of cardiac arrhythmia or cardiac failure have occurred in patients treated with IMBRUVICA.   Audience Healthcare professionals including emergency room physicians, hematologists and hematologist-oncologists.…

Pharmascience Inc. is recalling one lot of pms-Hydromorphone, 2 mg tablets, (lot 639268) as the bottles may contain hydromorphone tablets of a different strength (8 mg), meaning they contain higher amounts of hydromorphone. Products from the affected lot…

Pharmascience Inc. is recalling one lot of pms-Hydromorphone, 2 mg tablets, (lot 639268) as the bottles may contain hydromorphone tablets of a different strength (8 mg), meaning they contain higher amounts of hydromorphone. Products from the affected lot…

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.…

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…

UPDATED INFORMATION – May 6, 2022 Further to the communication below, issued on March 15, 2022, regarding the potential for the presence of particulate matter in vials of Sodium Acetate Injection, USP (DIN 02139529) from lot 6126554, Fresenius Kabi…

UPDATED INFORMATION – March 10, 2022 Further to the Health Canada communication below, issued on June 15, 2021, while initial estimates of supply and demand forecasted that the global shortage could impact Canada’s supply in early 2022, careful…

Intravenous bags of Baxter’s 0.9% Sodium Chloride Injection, USP 500 mL and Lactated Ringer’s Injection, USP 500 mL from certain lots have the potential to leak when administered under pressure infusion due to a weak seal formation. Affected lots are…

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…

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