The content of these notices reflects current information at the time of publication. Healthcare professionals are encouraged to report to Health Canada any adverse reactions suspected of being associated with marketed health products, including drugs authorized under the NOC/c policy. Communicating a NOC/c is intended to raise awareness on the details of the drug and the type of authorization granted. Notice of market authorization with conditionsĪ Notice of Compliance with Conditions (NOC/c) is a form of market authorization with conditions granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Health Canada will continue to monitor the safety of all COVID-19 vaccines and will take appropriate action should new health risks be identified. Healthcare professionals and vaccine recipients are encouraged to report adverse reactions suspected of being associated with COVID-19 vaccines. No updates to the Canadian product monographs for Comirnaty and Spikevax about HMB are planned further to this review. The Canadian product safety information for Comirnaty and Spikevax accurately reflects the current evidence and accounts for the evolving nature of the data. Health Canada's review of the available information, which included data from clinical trials, Canadian and international post-market reports and scientific literature, found no scientific or medical evidence that vaccination with monovalent mRNA vaccines increases the risk of HMB. The scope of the review included monovalent mRNA vaccines (Comirnaty and Spikevax), as data were limited with the bivalent vaccines (Comirnaty Original & Omicron BA.4/BA.5, Spikevax Bivalent, Spikevax Bivalent Original / Omicron BA.4/5) at the time of the review. The following descriptive terms, which traditionally have been used to characterize HMB patterns, were considered: menorrhagia (heavy cyclic vaginal bleeding with blood loss of more than 80 mL per cycle), menometrorrhagia (heavy irregular vaginal bleeding) and polymenorrhagia (heavy prolonged cycles consistently lasting more than 8 days). Health Canada reviewed the risk of heavy menstrual bleeding (HMB) following vaccination with Comirnaty or Spikevax. Both vaccines are indicated for active immunization against COVID-19 in individuals 6 months of age and older. In Canada, authorized monovalent mRNA COVID-19 vaccines include Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) and Spikevax (COVID-19 Vaccine Moderna). Safety Brief mRNA COVID-19 vaccines (Comirnaty and Spikevax) and the risk of heavy menstrual bleeding The following topics have been selected to raise awareness and encourage reporting of adverse reactions. Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.Īdvisory: Unauthorized sexual enhancement products New health product safety information Summary Safety Review: Soliris (eculizumab) Unauthorized health products Health Canada will continue to monitor safety information involving Soliris. Health Canada's review did not find sufficient evidence to support a link. This safety review evaluated the risk of drug-induced liver injury associated with Soliris (eculizumab). Only the mislabelled bottles were recalled.Īdvisory: JAMP Venlafaxine XR Soliris (eculizumab) JAMP Pharma Corporation recalled mislabelled bottles from one lot of Venlafaxine extended release capsules after one bottle labelled to contain 37.5 mg capsules was found to contain 150 mg capsules. Health product risk communication: Idhifa (enasidenib mesylate) JAMP Venlafaxine XR Apply to Health Canada's Special Access Program to request Idhifa for patients who require continued treatment. Idhifa was withdrawn from the Canadian market on June 30, 2023. Idhifa failed to demonstrate improved overall survival in adult patients with late stage acute myeloid leukemia and an isocitrate dehydrogenase-2 mutation versus conventional care regimens in a Phase 3 confirmatory study evaluating efficacy and safety. The following is a list of health product advisories, type I recalls and summaries of completed safety reviews published in June 2023 by Health Canada. Unauthorized health products Monthly recap of health product safety information Akeega (niraparib and abiraterone acetate)Īkeega (niraparib and abiraterone acetate)Ĭomirnaty (Pfizer-BioNTech COVID-19 Vaccine).Notice of market authorization with conditions.mRNA COVID-19 vaccines (Comirnaty and Spikevax) and the risk of heavy menstrual bleeding.Monthly recap of health product safety information.Health products mentioned in this issue.
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