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In 2013, ISTODAX (romidepsin) was authorized under a Notice of Compliance with conditions (NOC/c) for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one…

Canada is experiencing a shortage of nitroglycerin 0.4 MG/ACT sprays due to supply issues with the raw materials used to make the sprays as well as an increase in demand. Nitroglycerin sublingual spray is applied under the tongue and is used to treat…

Currently available data from the NOVA study, based on a data cut-off date of October 1, 2020, shows that the median OS may be lower with ZEJULA compared to placebo for patients in the overall non-gBRCAmut cohort and the non-gBRCAmut / Homologous…

UPDATED INFORMATION – January 20, 2023 On January 10, 2023, following a Federal Court of Appeal decision, the June 24, 2021 decision of the Minister of Health on the application of the data protection provisions was restored, and a new Notice of…

UPDATED INFORMATION – 2023/01/17 Neutralization data for the following SARS-CoV-2 Omicron subvariants have been added to the Canadian Product Monograph: Omicron BA.2.75.2, BF.7, BJ.1, BN.1, BQ.1, BQ.1.1, and XBB. See Table 1 (below) for a summary…

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…

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…

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 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…

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.…

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…

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.…

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…