Search

IDHIFA failed to demonstrate improved OS in adult patients with late stage AML and an IDH2 mutation versus conventional care regimens in a Phase 3 confirmatory study evaluating efficacy and safety. Do not initiate IDHIFA in new patients. IDHIFA is…

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…

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…

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…

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…

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.…

EVUSHELD (tixagevimab and cilgavimab for injection) was authorized by Health Canada on April 14, 2022. In order to provide rapid access to EVUSHELD in the context of the global COVID-19 pandemic, AstraZeneca will distribute product vials and cartons with…

UPDATED INFORMATION – May 6, 2022 Further to the communication below, issued on March 15, 2022, regarding the potential for the presence of particulate matter in vials of Sodium Acetate Injection, USP (DIN 02139529) from lot 6126554, Fresenius Kabi…

Intravenous bags of Baxter’s 0.9% Sodium Chloride Injection, USP 500 mL and Lactated Ringer’s Injection, USP 500 mL from certain lots have the potential to leak when administered under pressure infusion due to a weak seal formation. Affected lots are…

NUVAXOVID was authorized by Health Canada on February 17, 2022. In order to provide earlier access to NUVAXOVID in the context of the global pandemic, Novavax, Inc. will distribute product vials, cartons and package inserts that are in English only for a…

An increased incidence of intraocular inflammation (IOI), including retinal vasculitis (RV) and retinal vascular occlusion (RO), was observed in patients who received BEOVU 6 mg with every 4 weeks (q4 week) dosing beyond the first 3 doses compared to…

UPDATED INFORMATION - July 6, 2022 A new PAXLOVID dose pack for use in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min) is now available with a distinct DIN: 02527804. Pfizer has introduced this new packaging configuration to…

A post-authorization safety study in RA patients 50 years of age or older with at least one additional CV risk factor showed an increased risk of MACE and malignancy in patients treated with XELJANZ (5 mg BID or 10 mg BID) in comparison to TNFi. An…

Authorization of Casirivimab and Imdevimab with English-only Labels for Use in Relation to the COVID-19 Pandemic Starting date: July 30, 2021 Posting date: July 30, 2021 Type…