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Displaying 1 - 15 of 47 items.
COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels: New Formulation for Use in Children 5 to Less Than 12 Years of Age
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…
AlertHealth professional risk communication | 2022-12-09
OCALIVA (obeticholic acid) – New Contraindication for the Treatment of Primary Biliary Cholangitis (PBC)
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…
AlertHealth professional risk communication | 2022-12-05
Privigen: Series of adverse reactions
Affected lot being voluntarily recalled due to a series of adverse reactions.
RecallHealth product recall | 2022-12-01
SPIKEVAX Bivalent (Original / Omicron BA.4/5) (elasomeran/davesomeran) COVID-19 Vaccine with English-only Vial and Carton Labels
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…
AlertHealth professional risk communication | 2022-11-18
Canadian labelling for all JAK inhibitors to include risks of serious heart-related problems, fatal blood clots and cancer
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…
AlertPublic advisory | 2022-11-01
Janus Kinase Inhibitors and the Risk of Major Adverse Cardiovascular Events, Thrombosis (Including Fatal Events) and Malignancy
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…
AlertHealth professional risk communication | 2022-10-31
EVUSHELD (tixagevimab and cilgavimab for injection) - Risk of Prophylaxis or Treatment Failure due to Antiviral Resistance
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.…
AlertHealth professional risk communication | 2022-10-26
COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine with English-only Vial and Carton Labels
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…
AlertHealth professional risk communication | 2022-10-07
ZOLGENSMA (onasemnogene abeparvovec) and Fatal Cases of Acute Liver Failure
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…
AlertHealth professional risk communication | 2022-09-12
COMIRNATY (COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine): New Presentation for Use in Children Aged 6 Months to Less Than 5 Years with English-only Vial and Carton Labels
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…
AlertHealth professional risk communication | 2022-09-09
Distribution of SPIKEVAX Bivalent (elasomeran/imelasomeran) COVID-19 Vaccine with English-only Vial and Carton Labels
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…
AlertHealth professional risk communication | 2022-09-02
IMBRUVICA (ibrutinib) - Risk of Serious and Fatal Cardiac Arrhythmias or Cardiac Failure
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.…
AlertHealth professional risk communication | 2022-08-29
NERFASIN 20: Affected lot may contain the presence of particles
Affected lot may contain the presence of particles
RecallHealth product recall | 2022-08-29
PMS-Hydromorphone: Affected lot may contain tablets that could potentially lead to overdose
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…
RecallHealth product recall | 2022-08-22
Recall of one lot of pms-Hydromorphone due to packaging error that could potentially lead to overdose
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…
AlertPublic advisory | 2022-08-20