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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.…

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…

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…

Health Canada has updated its 2019 and 2017 safety reviews on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare but serious cancer of the immune system that can develop next to a breast implant. This review found that there…

UPDATED INFORMATION - March 11, 2022 On March 10, 2022, for the second time, the Federal Court set aside Health Canada’s decision to authorize RUZURGI (amifampridine), and the second Notice of Compliance (NOC) that had been issued on June 24, 2021…

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…

Following an increase in reports to poison control centres, Health Canada is advising Canadians about potential risks associated with the misuse or accidental ingestion or spillage of COVID-19 rapid antigen test kit solutions on the skin. Health Canada…

An increased incidence of intraocular inflammation (IOI), including retinal vasculitis (RV) and retinal vascular occlusion (RO), was observed in patients who received BEOVU 6 mg with every 4 weeks (q4 week) dosing beyond the first 3 doses compared to…

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…

A post-authorization safety study in RA patients 50 years of age or older with at least one additional CV risk factor showed an increased risk of MACE and malignancy in patients treated with XELJANZ (5 mg BID or 10 mg BID) in comparison to TNFi. An…

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…

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…

UPDATED INFORMATION – October 29, 2021 Further to the Health Canada communications below issued on June 14, 2021 (and updated on June 24, 2021, and August 3, 2021), Health Canada has authorized a 2-month shelf life extension (from 7 months to 9 months…

Health Canada clarifies position on Platelet Rich Plasma treatments Starting date: July 26, 2019 Type of communication: Information Update Subcategory: Biologic/vaccine Source…

Important Safety Information on Alaris Infusion Sets and Alaris 8100 Pump Module - Risk of Over-Infusion Starting date: April 28, 2019 Posting date: May 30, 2019 Type of…