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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Health Canada approves BEYFORTUS (nirsevimab) for the prevention of RSV disease in infants
4/24/2023
Health Canada has issued a Notice of Compliance (NOC) approving BEYFORTUS™ (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants during their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
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Apex Labs Granted Approval for 160 Patient Macrodose Multi-Dose Psilocybin Clinical Trial by Health Canada
4/20/2023
Apex Labs Ltd. is pleased to announce approval of SUMMIT-90. SUMMIT-90 is a landmark double-blind, placebo controlled phase 2b study evaluating multiple doses of APEX-90 administered in-clinic with assisted psychotherapy for the treatment of severe depression within diagnosed PTSD.
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AB Science announces that it has submitted its response to the day 120 questions in the EMA regulatory review of masitinib in amyotrophic lateral sclerosis and clarifies the new timeline for responding to Health Canada
4/4/2023
AB Science S.A. provides an update on the schedule for the evaluation by the Committee for Medicinal Products for Human Use of the European Medicines Agency and by Health Canada of its applications for conditional approval of masitinib in the treatment of amyotrophic lateral sclerosis.
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Juno Pharmaceuticals receives approval to import Eptifibatide as Canadian hospitals continue to grapple with shortages of critical medicines
3/29/2023
Juno Pharmaceuticals Canada (“Juno”), a Canadian specialty pharmaceutical company, announced that it has received approval from Health Canada to import Eptifibatide solution for infusion and injection (“Eptifibatide”) pursuant to Health Canada’s exceptional importation and sale guidelines.
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bioLytical Laboratories Inc. Receives Health Canada Authorization for its INSTI® Multiplex HIV-1/2 Syphilis Antibody Test
3/27/2023
bioLytical Laboratories Inc., a global leader in rapid in-vitro medical diagnostics, announced that it has received Health Canada authorization for its INSTI® Multiplex HIV-1/2 Syphilis Antibody Test, allowing its immediate entry into the Canadian market.
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COLUMVI® (Glofitamab for Injection) Receives Health Canada Authorization with Conditions for Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma
3/25/2023
Hoffmann-La Roche Limited announced that on March 24, 2023 Health Canada authorized COLUMVI® for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, DLBCL arising from follicular lymphoma, or primary mediastinal B-cell lymphoma, who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy.
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Notice of Compliance issued regarding Rezurock(TM) (belumosudil tablets)
3/21/2023
sanofi-aventis Canada Inc. is pleased to announce that Health Canada has issued a Notice of Compliance for Rezurock™, for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy.
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Public Advisory - Two lots of cystic fibrosis drug Cayston recalled due to the potential of cracked glass vials
3/18/2023
Health Canada is advising the public that Gilead Sciences Incorporated recalled two lots of the cystic fibrosis drug Cayston on March 1, 2023, due to the potential of cracked glass vials in those lots, which may introduce glass particles into the medication.
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Numinus Receives Clinical Trial Application Approval from Health Canada for Experiential Psychedelic-Assisted Therapy Training using Psilocybe Cubensis Tea
2/1/2023
Numinus Wellness Inc. today announced that it has received approval from Health Canada for its experiential training study that will test the safety and clinical efficacy of whole Psilocybe cubensis tea for therapeutic use, and enable practitioners to further their understanding of psychedelic-assisted therapy through experiential training.
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Edesa Biotech Receives Regulatory Approval for Phase 2 Vitiligo Study
2/1/2023
Edesa Biotech, Inc. today announced that it has received approval from Health Canada for a Phase 2 clinical study of the company's EB06 monoclonal antibody candidate as a treatment for vitiligo.
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Diamond Therapeutics Announces Health Canada Approval of Phase 2 Clinical Trial with Low-Dose Psilocybin
1/24/2023
Diamond Therapeutics Inc. is pleased to announce it has received Health Canada approval to begin a Phase 2 clinical trial evaluating the safety, tolerability and efficacy of repeat low-doses of psilocybin for the treatment of generalized anxiety disorder (GAD).
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Apex Labs Granted Approval for 294 Patient Take Home Psilocybin Clinical Trial
1/19/2023
Apex Labs Ltd. (APEX or the Company), a pharmaceutical company optimizing the standard of mental health care with psilocybin, is pleased to announce its approval by Health Canada to begin APEX-002-A01-03, the world's largest take home psilocybin clinical trial approved to date.
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Ultomiris approved in Canada for adults with generalized myasthenia gravis (gMG)
1/17/2023
Ultomiris (ravulizumab) has been approved in Canada for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.1 [PM, p.4A]
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GERMSTOP(SQ) IS FIRST EVER DISINFECTANT TO KILL HUMAN CORONAVIRUS 229E ON SURFACES FOR UP TO 24 HOURS
1/17/2023
GermStopSQ has been issued a Notice of Compliance by Health Canada and granted a Drug Identification Number, making Good Theorem the first to launch a residual* disinfectant that keeps killing 99.999% of bacteria and 99.9% of Human Coronavirus 229E for 24 hours, making it the first of its kind on the market.
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Enhertu Approved by Health Canada as the First HER2-Directed Therapy for Patients with HER2-Low Metastatic Breast Cancer
1/12/2023
Health Canada approved Enhertu ™ (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
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Novocure’s Optune® Approved in Canada for the Treatment of Newly Diagnosed and Recurrent Glioblastoma
11/29/2022
Novocure (NASDAQ: NVCR) today announced that Health Canada has approved Optune® for the treatment of newly diagnosed and recurrent glioblastoma (GBM).
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Health Canada Authorizes POLIVY® (polatuzumab vedotin for injection) for the First-Line Treatment of Adults With Large B-Cell Lymphoma
11/24/2022
Hoffmann-La Roche Limited is pleased to announce that on November 14, 2022, Health Canada has authorized POLIVY® in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone for the treatment of adult patients with previously untreated large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, high grade B-cell lymphoma, Epstein-Barr virus-positive DLBCL NOS, and T-cell/histiocyte rich LBCL.
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Advisory - Canadian labelling for all JAK inhibitors to include risks of serious heart-related problems, fatal blood clots and cancer
11/1/2022
The Canadian labelling for all Janus Kinase inhibitors is being updated to include the risks of serious heart-related problems, fatal blood clots and cancer.
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Cerus Corporation Announces Health Canada Approval for INTERCEPT Blood System for Platelets with Seven-Day Storage
11/1/2022
Cerus Corporation (Nasdaq:CERS) today announced it has received approval from Health Canada to extend the storage of platelets treated with the INTERCEPT Blood System from five days to seven days from the time of collection, joining other territories where INTERCEPT platelets are approved for seven-day storage.
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Sonendo® Announces Health Canada Regulatory Approval for Next Generation GentleWave® G4 System
11/1/2022
Sonendo , Inc. (NYSE: SONX), a leading dental technology company and developer of the GentleWave® System, today announced that it has received Health Canada regulatory approval for commercial sales of its recently announced GentleWave G4 System.