Search

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…

OCALIVA received a Notice of Compliance with Conditions in May 2017 for the treatment of PBC, pending the results of trials to verify its clinical benefit. OCALIVA is now contraindicated for PBC patients with advanced disease, such as those with Child…

GlaxoSmithKline Consumer Healthcare ULC is recalling one lot of TUMS Peppermint Regular Strength tablets after some tablets were found to contain fragments of fibreglass and other material, including paper and aluminum foil. The product is sold in a…

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…

Health Canada is warning that ozone saunas may pose serious health risks to users and to anyone in close proximity. In Canada, ozone saunas require a medical device licence from Health Canada to be imported and sold. To date, Health Canada has not…

The Canadian labelling for all Janus Kinase (JAK) inhibitors is being updated to include the risks of serious heart-related problems, fatal blood clots and cancer. This is being done as a precautionary measure. To date, Canadian labelling for the drugs…

The final results of a clinical trial conducted with XELJANZ showed higher risks of MACE, thrombosis, malignancy, serious infections and fatal events, compared to TNFi, a group of medicines that suppress the body's natural response to tumor necrosis…

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.…

Since earlier this year, supplies of various formats of non-prescription pediatric/infant and children’s acetaminophen and ibuprofen products have been limited in retail and pharmacy locations and hospitals across Canada. This shortage is due to…

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…

Certain Philips Respironics sleep therapy masks used with Continuous Positive Airway Pressure (CPAP) or Bi-Level Positive Airway Pressure (BiPAP) machines have magnets in their headgear clips or straps. These magnets could cause safety concerns for…

Certain lots of hand sanitizers do not meet Health Canada requirements. Issues include: containing (or possibly containing) ingredients that are not permitted by Health Canada; containing undeclared impurities at elevated levels; improper…

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…

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’s Consumer Product Safety Program found that the product poses a health and safety risk to consumers. The product was sold as real-time radon monitor, but reports a low value regardless of the actual radon level (with errors greater than 90…