Language selection

Government of Canada / Gouvernement du Canada

Search

Health Product InfoWatch: November 2025

Download in PDF format
(389 KB, 5 pages)

Contents

Monthly recap of health product safety information

The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in October 2025 by Health Canada.

AtlantiScan (fludeoxyglucose 18F)

One lot of AtlantiScan has been recalled due to a broken vial.

Type I drug recall: AtlantiScan (fludeoxyglucose 18F)

Braftovi (encorafenib)

This safety review evaluated the risk of severe cutaneous adverse reactions (SCAR) with the use of Braftovi. Health Canada's review found a possible link. Health Canada has worked with the manufacturer to update the Canadian product monograph for Braftovi to include the risk of SCAR.

Summary Safety Review: Braftovi (encorafenib)

Fludarabine Phosphate Injection

Due to a shortage of Fludarabine Phosphate Injection in Canada, and given the medical necessity of this drug, Health Canada has permitted the exceptional, temporary importation and sale of US-authorized Fludarabine Phosphate Injection, USP with English-only labels. Healthcare professionals should be aware of important differences between the US-authorized and Canadian-authorized products.

Health Product Risk Communication: Fludarabine Phosphate Injection

Hypurin Regular Insulin, Pork

Due to the discontinuation of Hypurin Regular Insulin, Pork in Canada, and to extend the availability of pork insulin to May 2026, Health Canada has authorized the exceptional, temporary importation and sale of UK-authorized Hypurin Porcine Neutral with English-only labels. The products are identical, with the exception of important differences between the UK and Canadian labelling. No additional inventory of Hypurin vials will be available after the existing inventory has been depleted or has expired.

Health Product Risk Communication: Hypurin Regular Insulin, Pork

Itovebi (inavolisib)

Two cases of life-threatening or fatal ketoacidosis have been reported in diabetic patients treated with Itovebi in the post-market setting. Hyperglycemia, a defining feature of ketoacidosis, is a known risk associated with Itovebi. The Canadian product monograph for Itovebi has been updated to include warnings and recommendations about this risk.

Health Product Risk Communication: Itovebi (inavolisib)

New health product safety information

The following topics have been selected to raise awareness and encourage reporting of adverse reactions.

Product monograph update

The following safety labelling update, which was recently made to the Canadian product monograph, has been included for your awareness. A complete list of safety labelling updates for pharmaceuticals is available on Health Canada's Product monograph brand safety updates page. Canadian product monographs can be accessed through Health Canada's Drug Product Database.

Braftovi (encorafenib)

The Warnings and Precautions, Adverse Reactions (Post-Market Adverse Reactions) and Patient Medication Information sections of the Canadian product monograph for Braftovi have been updated with the risk of severe cutaneous adverse reactions (SCARs).

Key messages for healthcare professionals:Footnote 1

  • Cases of SCARs, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening, have been reported during treatment with encorafenib in combination with binimetinib or cetuximab.
  • Before initiating treatment, patients should be advised of the signs and symptoms, and monitored closely for skin reactions.
  • If signs and symptoms suggestive of SCAR appear, encorafenib and binimetinib or cetuximab should be withdrawn.

Notice of market authorization with conditions

A 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. Communicating a NOC/c is intended to raise awareness on the details of the drug and the type of authorization granted.

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.

The content of these notices reflects current information at the time of publication. Conditions associated with the NOC/c will remain until they have been fulfilled and authorized by Health Canada. For the most up-to-date information, consult Health Canada's NOC database.

Jaypirca (pirtobrutinib): Authorization with conditions

Health Canada has issued a Notice of Compliance, under the NOC/c policy, for Jaypirca (pirtobrutinib), 50 mg and 100 mg oral tablets. Jaypirca is indicated as monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma who have previously received at least two lines of systemic therapy including a Bruton tyrosine kinase (BTK) inhibitor. Jaypirca is also indicated as monotherapy in adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have received at least two prior lines of therapy including a BTK inhibitor and a BCL-2 inhibitor. Patients should be advised of the conditional market authorization for these indications.

For the complete prescribing information and information available for patients/caregivers, please consult the Jaypirca Canadian product monograph. The product monograph can be accessed through Health Canada's Drug Product Database, the Eli Lilly Canada Inc. website or by contacting Eli Lilly Canada Inc. at 1-888-545-5972. Contact the company for a copy of any references, attachments or enclosures.

Leqembi (lecanemab): Authorization with conditions

Health Canada has issued a Notice of Compliance, under the NOC/c policy, for Leqembi (lecanemab for Injection), solution for infusion, 500 mg/5 mL and 200mg/2 mL vials. Leqembi is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease (early Alzheimer's disease) who are apolipoprotein E ε4 (ApoE ε4) noncarriers or heterozygotes and who have confirmed amyloid pathology. Patients should be advised of the conditional market authorization for this indication.

For the complete prescribing information and information available for patients/caregivers, please consult the Leqembi Canadian product monograph. The product monograph can be accessed through Health Canada's Drug Product Database, the Eisai Limited website or by contacting Eisai Limited at 1-877-873-4724. Contact the company for a copy of any references, attachments or enclosures.

Scope

This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.

Reporting Adverse Reactions

Canada Vigilance Program
Telephone: 1-866-234-2345
Fax or mail: Form available on MedEffect Canada

For more information on how to report an adverse reaction, visit the Adverse Reaction and Medical Device Problem Reporting page.

Helpful links

Contact us

Your comments are important to us. Let us know what you think by reaching us at: infowatch-infovigilance@hc-sc.gc.ca

Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
Health Canada
Address Locator 1906C
Ottawa ON K1A 0K9

Page details

2025-11-27