Health Canada
A.L. 0904A
Ottawa
K1A 0K9
Canada
Tel: 613-957-2991
Fax: 613-941-5366
Website: http://www.hc-sc.gc.ca/
Email: info@www.hc-sc.gc.ca
1216 articles about Health Canada
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AstraZeneca Canada Files for Health Canada Authorization of AZD7442 for Prevention Of COVID-19
11/3/2021
AstraZeneca Canada has initiated a rolling review New Drug Submission with Health Canada for authorization of AZD7442, its long-acting antibody combination, for prevention of symptomatic COVID-19.
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OPDIVO® Receives Two New Health Canada Approvals for: Use with Chemotherapy for the Treatment for Patients with HER2 Negative Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma Cancers;
11/2/2021
Bristol Myers Squibb Canada announces two recent Health Canada approvals for OPDIVO®.
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Health Canada issues Notice of Compliance (NOC) for Jardiance® (empagliflozin) for the treatment of heart failure with reduced ejection fraction
11/2/2021
Boehringer Ingelheim Ltd and Eli Lilly Canada Inc. are pleased to announce that Jardiance® has been granted marketing authorization by Health Canada as a treatment for heart failure with reduced ejection fraction, as an adjunct to standard of care therapy, in adults with an eGFR as low as 20 mL/min/1.73 m2.
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Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to European Medicines Agency
11/1/2021
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced the completion of its rolling submission to Health Canada for authorization of its COVID-19 vaccine candidate, the first filing of a protein-based COVID-19 vaccine in Canada.
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Health Canada Approves NGENLA (somatrogon) Injection for Pediatric Growth Hormone Deficiency
10/29/2021
New offering expands Pfizer's growth hormone portfolio of medicines and treatment options for rare diseases
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Information Update - UPDATE: Mint Pharmaceuticals Inc. recalls all lots of losartan
10/27/2021
Mint Pharmaceuticals Inc. is recalling all lots of its prescription losartan tablets, in 50 mg and 100 mg strengths, after tests found an azido impurity -2-butyl-4-chloro-1H imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-1H tetrazole) above the acceptable limit.
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Subtle Medical Receives Health Canada Approval for Increased Imaging Efficiency
10/13/2021
Subtle Medical, a healthcare technology company improving the quality and efficiency of medical imaging, announced today Health Canada/Santé Canada approval for their suite of AI-powered image enhancement solutions.
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New SARCLISA® (isatuximab for injection) Combination Now Approved by Health Canada for Adults with Relapsed and/or Refractory Multiple Myeloma
10/13/2021
Sanofi Canada is pleased to announce that Health Canada has approved SARCLISA® in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
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The Product Monograph for Protopic® has been updated
10/4/2021
LEO Pharma Inc. announced that Health Canada has approved an update to the Product Monograph of Protopic®, removing the Serious Warnings and Precautions box, also referred to as a boxed warning, regarding a potential association with the use of topical calcineurin inhibitors and malignancy.
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Advisory - BlackOxygen Organics recalls fulvic acid tablets and powder due to potential health risks
9/23/2021
BlackOxygen Organcs is recalling all lots of BlackOxygen Tablets and BlackOxygen Organics Powder due to potential health risks.
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OPSENS Receives Approval from Health Canada to Initiate First In-Man Clinical Study for its New Guidewire for the TAVR Procedure
9/20/2021
OpSens Inc., a cardiology medical device company providing innovative product solutions based on its patented optical technology, announced that it has received Health Canada approval to commence the first in-man study with its SavvyWire, a guidewire developed specifically for transcatheter aortic valve replacement.
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Health Canada approves LUMAKRAS™ (sotorasib), the first and only targeted treatment for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer
9/14/2021
Amgen announced that Health Canada has approved LUMAKRASTM for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received at least one prior systemic therapy.
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Health Canada approval of low-dose colchicine for cardiovascular disease based on the COLCOT study
8/27/2021
People with coronary disease now have a new treatment option to reduce the risk of cardiovascular events.
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Advisory - One lot of pms-PROGESTERONE 100 mg capsules recalled because it may pose serious risks to individuals with severe peanut allergies
8/24/2021
Pharmascience Inc. is recalling one lot of pms-PROGESTERONE 100 mg capsules because the bottles may contain Akorn 100 mg progesterone gelatin capsules in addition to or instead of the intended pms-PROGESTERONE 100 mg gelatin capsules.
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Statement from Health Canada on false claims made by the Cord Blood Bank of Canada
8/9/2021
Health Canada is aware that the Cord Blood Bank of Canada is making claims on its website that Health Canada's recent site visit led to the company having no option but to remove cord blood units and related samples under its control from cryogenic storage.
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Advisory - Health Canada updates Pfizer-BioNTech COVID-19 vaccine label to reflect very rare reports of Bell's Palsy
8/6/2021
Health Canada has updated the product information for the Pfizer-BioNTech COVID-19 vaccine to describe very rare reports of Bell's Palsy following vaccination.
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Government of Canada pauses decision on Glyphosate as it strengthens the capacity and transparency of review process for pesticides
8/4/2021
The controlled use of pesticides is an important tool for the agricultural sector.
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Health Canada releases What We Heard Report from the Public Engagement on the National Strategy for Drugs for Rare Diseases
7/26/2021
Too many Canadians are struggling to access the drugs they need, especially if they have a rare condition. Work continues on the national strategy to support Canadians who rely on these drugs.
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Advisory - Update: Graphene face masks by Shandong Shengquan New Materials Co. Ltd. can resume sale in Canada; Health Canada found no health risks of concern with these products
7/13/2021
Health Canada previously advised Canadians not to use face masks that contain graphene after a preliminary assessment identified some potential for inhaled graphene particles to cause early lung effects in animals.
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Numinus Announces Health Canada Approval of MAPS-Sponsored Open Label Study for MDMA-Assisted Therapy for PTSD
7/12/2021
Real-world study expands access to MDMA-assisted therapy for patients with PTSD and concurrent disorders and will provide data on a regulated model for MDMA-assisted therapy.