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Displaying 1 - 15 of 153 items.
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
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
August 25, 2019
For immediate release
OTTAWA – Health Canada is reminding Canadians that plasma pens are not authorized for sale in Canada and that these devices may pose health risks. Health Canada is also underlining that consumers should be wary…
AlertInformation update | 2022-05-11
November 26, 2018
For immediate release
OTTAWA – Health Canada is advising consumers that plasma pens (also known as “fibroblast” devices) promoted for cosmetic skin treatments such as eyelid lifts, wrinkle reduction and…
AlertInformation update | 2022-05-11
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, 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
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…
AlertHealth professional risk communication | 2022-04-14
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…
AlertPublic advisory | 2022-04-06
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…
AlertHealth professional risk communication | 2022-03-15
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…
AlertHealth professional risk communication | 2022-03-11
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…
AlertHealth professional risk communication | 2022-03-10
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…
AlertHealth professional risk communication | 2022-03-09
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…
AlertHealth professional risk communication | 2022-02-23
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…
AlertHealth professional risk communication | 2022-02-03
Health Canada is aware of six reports of fatal injuries in Canada since 2017 resulting from the use of wood-burning devices know as Lichtenberg generators. This information was reported from provincial and territorial electrical safety authorities.…
AlertPublic advisory | 2022-01-19