Drug and Health Product Submissions Under Review (SUR): Supplemental submissions under review
Medicinal Ingredient(s) | Therapeutic Area | Year, Month Submission was Accepted into Review | Company Name (available for submissions accepted into review on or after October 1, 2018) | Submission 'Class' (if applicable) (available for submissions accepted into review on or after October 1, 2018) |
---|---|---|---|---|
Abemaciclib | Antineoplastic agents | 2023-03 | Eli Lilly Canada Inc | Not applicable |
Anidulafungin | Antimycotics for systemic use | 2022-07 | Pfizer Canada ULC | Not applicable |
Antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated | Antihemorrhagics | 2022-11 | Novo Nordisk Canada Inc | Not applicable |
Aripiprazole | Psycholeptics | 2022-09 | Otsuka Pharmaceutical Co Ltd | Not applicable |
Baricitinib | Immunosuppressants | 2021-09Footnote * | Eli Lilly Canada Inc | For use in relation to COVID-19 |
Belzutifan | Antineoplastic agents | 2023-01 | Merck Canada Inc | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
Bisoprolol fumarate | Beta blocking agents | 2021-01 | Sandoz Canada Incorporated | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Brentuximab vedotin | Antineoplastic agents | 2022-12 | Seagen Inc. | Part of an 'aligned review' with a health technology assessment organization |
Carfilzomib | Antineoplastic agents | 2022-10 | Amgen Canada Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Cemiplimab | Antineoplastic agents | 2022-05 | Sanofi-Aventis Canada Inc | Not applicable |
Corynebacterium diphtheriae CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F | Vaccines | 2023-01 | Pfizer Canada ULC | Being reviewed under the Priority Review Policy |
Dabrafenib mesylate | Antineoplastic agents | 2023-01 | Novartis Pharmaceuticals Canada Inc | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
Dapagliflozin propanediol monohydrate | Drugs used in diabetes | 2022-12 | AstraZeneca Canada Inc | Not applicable |
Davesomeran, elasomeran | Vaccines | 2023-03Footnote * | ModernaTX, Inc. | For use in relation to COVID-19 |
Dimethyl fumarate | Immunosuppressants | 2022-04 | Biogen Canada Inc | Not applicable |
Doravirine | Antivirals for systemic use | 2022-07 | Merck Canada Inc | Not applicable |
Doravirine, lamivudine, tenofovir disoproxil fumarate | Antivirals for systemic use | 2022-09 | Merck Canada Inc | Not applicable |
Dupilumab | Other dermatological preparations | 2022-06 | Sanofi-Aventis Canada Inc | Not applicable |
Dupilumab | Other dermatological preparations | 2022-09 | Sanofi-Aventis Canada Inc | Not applicable |
Dupilumab | Other dermatological preparations | 2022-11 | Sanofi-Aventis Canada Inc | Being reviewed under the Priority Review Policy |
Empagliflozin | Drugs used in diabetes | 2023-03 | Boehringer Ingelheim (Canada) Ltd Ltee | Not applicable |
Famtozinameran, tozinameran | Vaccines | 2023-03Footnote * | BioNTech Manufacturing GmbH | For use in relation to COVID-19 |
Ibrutinib | Antineoplastic agents | 2022-10 | Janssen Inc | Not applicable |
IncobotulinumtoxinA | Muscle relaxants | 2022-11 | Merz Pharmaceuticals GmbH | Not applicable |
Ipilimumab | Antineoplastic agents | 2023-02 | Bristol-Myers Squibb Canada | Not applicable |
Ivacaftor, lumacaftor | Other respiratory system products | 2022-07 | Vertex Pharmaceuticals (Canada) Incorporated | Not applicable |
Letermovir | Antivirals for systemic use | 2023-03 | Merck Canada Inc | Being reviewed under the Priority Review Policy |
Leuprolide acetate | Endocrine therapy | 2021-10 | Verity Pharmaceuticals Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Leuprolide acetate | Endocrine therapy | 2022-12 | AbbVie Corporation | Not applicable |
Leuprolide acetate | Endocrine therapy | 2022-12 | Tolmar International Ltd. | Not applicable |
Lumasiran sodium | Other alimentary tract and metabolism products | 2022-07 | Alnylam Netherlands B.V. | Not applicable |
Nivolumab | Antineoplastic agents | 2023-03 | Bristol-Myers Squibb Canada | Not applicable |
Olaparib | Antineoplastic agents | 2022-08 | AstraZeneca Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
Pembrolizumab | Antineoplastic agents | 2022-06 | Merck Canada Inc | Not applicable |
Pembrolizumab | Antineoplastic agents | 2023-03 | Merck Canada Inc | Not applicable |
Pimecrolimus | Other dermatological preparations | 2021-01 | Bausch Health, Canada Inc. | Not applicable |
Pitolisant hydrochloride | Other nervous system drugs | 2023-02 | Endo Ventures Ltd | Not applicable |
Ranolazine | Cardiac therapy | 2022-08 | KYE Pharmaceuticals Inc | Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Ravulizumab | Immunosuppressants | 2023-01 | Alexion Pharma GmbH | Not applicable |
Remdesivir | Antivirals for systemic use | 2022-07Footnote * | Gilead Sciences Canada Inc | For use in relation to COVID-19 |
Sacituzumab govitecan | Antineoplastic agents | 2023-01 | Gilead Sciences Canada Inc | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
SARS-CoV-2 recombinant spike protein | Vaccines | 2023-03Footnote * | Novavax Inc. | For use in relation to COVID-19 |
Secukinumab | Immunosuppressants | 2022-12 | Novartis Pharmaceuticals Canada Inc | Part of an 'aligned review' with a health technology assessment organization |
Semaglutide | Drugs used in diabetes | 2022-09 | Novo Nordisk Canada Inc | Not applicable |
Tofacitinib citrate | Immunosuppressants | 2022-07 | Pfizer Canada ULC | Not applicable |
Tofacitinib citrate | Immunosuppressants | 2023-03 | Pfizer Canada ULC | Not applicable |
Trametinib | Antineoplastic agents | 2023-01 | Novartis Pharmaceuticals Canada Inc | Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
Upadacitinib | Immunosuppressants | 2021-12 | AbbVie Corporation | Part of an 'aligned review' with a health technology assessment organization |
Upadacitinib | Immunosuppressants | 2022-07 | AbbVie Corporation | Not applicable |
Upadacitinib | Immunosuppressants | 2022-12 | AbbVie Corporation | Not applicable |
Zanubrutinib | Antineoplastic agents | 2022-07 | Beigene Switzerland GmbH | Part of an 'aligned review' with a health technology assessment organization |
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