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
1213 articles about Health Canada
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Chiesi Global Rare Diseases Announces Health Canada Approval of MYALEPTA™ (metreleptin for injection) for the Treatment of Patients with Lipodystrophy
2/5/2024
Chiesi Global Rare Diseases is pleased to announce the Health Canada approval of MYALEPTA™ (metreleptin for injection).
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Arch Biopartners Receives Health Canada Approval to Conduct Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury
1/10/2024
Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
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HEALTH CANADA APPROVES PFIZER CANADA'S GENE THERAPY IN HEMOPHILIA B
1/3/2024
Pfizer Canada ULC announced that Health Canada approved BEQVEZ (fidanacogene elaparvovec), an adeno-associated viral (AAV) vector-based gene therapy for the treatment of adults (aged 18 years or older) with moderately severe to severe hemophilia B.
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Health Canada Approves DOPTELET (avatrombopag) for Two Indications in Thrombocytopenia
11/6/2023
Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB, announced that Health Canada has approved DOPTELET®, an oral thrombopoietin receptor agonist, for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment and for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.
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Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment of Attention Deficit Hyperactivity Disorder
9/25/2023
Tris Pharma, Inc. today announced that Health Canada has authorized the use of Quillivant ® ER (extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 12.
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Ultragenyx Launches Evkeeza® (evinacumab for injection) in Canada for the Treatment of Homozygous Familial Hypercholesterolemia (HoFH)
9/25/2023
Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare genetic diseases, announced the approval of Evkeeza® in Canada.
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argenx Announces VYVGART (efgartigimod alfa) Authorized for Sale by Health Canada for Generalized Myasthenia Gravis
9/21/2023
argenx SE announced that Health Canada has issued a Notice of Compliance authorizing VYVGARTⓇ for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.
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Health Canada authorizes Moderna COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant
9/12/2023
Health Canada has authorized the use of the Moderna SPIKEVAX™ COVID-19 vaccine targeting the Omicron XBB.1.5 subvariant for people six months of age and older.
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Femasys Inc. Obtains Medical Device Establishment License from Health Canada
8/31/2023
Femasys Inc. announced that it has obtained a Medical Device Establishment License from Health Canada.
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Health Canada approves Lynparza in combination with abiraterone and prednisone or prednisolone for patients with BRCA mutated metastatic castration-resistant prostate cancer
7/13/2023
Health Canada has granted a Notice of Compliance with Conditions (NOC/c) for Lynparza® (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA.
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Dexcom G7 Receives Health Canada Approval: Next-Generation Continuous Glucose Monitoring System With Unmatched Accuracy Coming to Canadians
7/4/2023
Dexcom, Inc. announced that Health Canada has approved the next-generation Dexcom G7 Continuous Glucose Monitoring System for people with all types of diabetes, ages two years and older.
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Endo Announces Approval of XCOPRI™ (cenobamate tablets) in Canada
6/29/2023
Endo International plc (OTC: ENDPQ) announced today that Paladin Labs Inc., an Endo operating company, received Health Canada's approval of XCOPRI ™ (cenobamate tablets) for adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.
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Sun Pharma Announces Health Canada Approval of (PR)WINLEVI (clascoterone cream 1%) for Topical Treatment of Acne
6/19/2023
WINLEVI is the first and only topical Androgen Receptor Inhibitor, and the newest Health Canada-approved formulation to target the hormonal component of acne in 40 years.
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Government of Canada Supports Research on COVID-19 Treatments for Transplant Recipients
6/9/2023
The Government of Canada recognizes the lifesaving impact that organ donation has on those in need of a transplantation.
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Development in Alzheimer's disease diagnosis in Canada: New tests help patients and caregivers make timely decisions
6/8/2023
Roche Diagnostics, a division of Hoffmann-La Roche Limited, is proud to announce Health Canada approval for its Cerebrospinal Fluid (CSF) assays* to measure three biomarkers that are hallmarks of Alzheimer's pathology, beta-amyloid and tau proteins, in adults aged 55 and older being evaluated for the disease.
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Alzheimer Society of Ontario Welcomes Health Canada Approval of New Test for Alzheimer’s Disease Detection
6/8/2023
The Alzheimer Society of Ontario is encouraged by today’s Health Canada approval of three biomarker tests developed by Roche Diagnostics to detect indicators of Alzheimer’s disease pathology.
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BRUKINSA® Approved in Canada for the Treatment of Chronic Lymphocytic Leukemia
5/30/2023
BeiGene, Ltd. announced today that BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor (BTKi), has been approved by Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL).
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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.