Otsuka Canada Pharmaceutical announces Health Canada approval of Korsuva (difelikefalin) for the treatment of moderate to severe pruritus associated with chronic kidney disease in adult haemodialysis patients

16 August 2022 - Launch of Korsuva in Canada is expected in the second quarter of 2023. ...

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Lynparza receives Health Canada approval as adjuvant treatment for patients with germline BRCA mutated HER2 negative high-risk early breast cancer

11 August 2022 - First and only approved medicine targeting germline BRCA mutations in high-risk early breast cancer. ...

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Paladin Labs announces Health Canada's filing acceptance of cenobamate tablets as an adjunctive therapy for the management of partial-onset seizures in adults with epilepsy

8 August 2022 - Paladin Labs announced today that Health Canada has accepted its new drug submission for cenobamate tablets as ...

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Pfizer announces Prevnar 20 (pneumococcal 20 valent conjugate vaccine) is now available in Canada for the prevention of pneumonia and invasive pneumococcal disease in adults 18 years of age and older

21 July 2022 - Prevnar 20 is the first conjugate vaccine indicated to help protect against 20 serotypes responsible for ...

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Health Canada approves AbbVie's Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis

20 July 2022 - Approval is supported by efficacy and safety data of two pivotal studies in which Rinvoq demonstrated improvements ...

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Health Canada authorises use of Moderna COVID-19 vaccine in children 6 months to 5 years of age

14 July 2022 - Today, Health Canada authorised the use of the Moderna Spikevax COVID-19 vaccine in children 6 months to ...

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Arcutis Biotherapeutics announces Health Canada accepts for review the new drug submission for roflumilast cream for adults and adolescents with plaque psoriasis

11 July 2022 - Submission supported by positive clinical data from the pivotal Phase 3 DERMIS-1 and DERMIS-2 clinical studies, as ...

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Regulatory submission for GSK's daprodustat accepted into Health Canada review

6 July 2022 - Canadian regulatory submission acceptance follows that of the US FDA and the EMA as well as ...

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Health Canada approves HyQvia, a new treatment for Canadians with immune deficiencies

 6 July 2022 - New immunoglobulin treatment offers Canadian patients option of subcutaneous once-monthly (every three or four weeks) dosing. ...

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Sandoz Canada expands its generics portfolio with three new products

5 July 2022 - Generic medicines like these three products help make effective medicine more affordable and accessible for Canadians and ...

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Health Canada approves the use of Cibinqo (abrocitinib) for the treatment of patients 12 years of age and older with moderate-to-severe atopic dermatitis

4 July 2022 - Pfizer Canada announces today that Health Canada has approved Cibinqo (abrocitinib) for the treatment of patients 12 ...

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Health Canada approves Opdivo (nivolumab) as monotherapy for the adjuvant treatment of adults with urothelial carcinoma at high risk of recurrence after undergoing radical resection of urothelial carcinoma

28 June 2022 - First adjuvant Immunotherapy for patients at high risk of disease recurrence. ...

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Health Canada expands approval of Enhertu for adults with HER2 positive metastatic breast cancer

23 June 2022 - Approval based on the ground-breaking DESTINY-Breast03 Phase 3 trial, showing Enhertu reduced the risk of disease ...

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Maviret (glecaprevir/pibrentasvir) approved by Health Canada for paediatric patients with chronic hepatitis C

22 June 2022 - This approval is supported by 98.4 per cent cure rate across this group of patients who ...

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Canadian regulator OKs Hugel's botulinum toxin product

16 June 2022 - Hugel said Thursday that it has obtained product approval from Health Canada for its botulinum toxin ...

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