Drug and Health Product Submissions Under Review (SUR): Supplemental submissions under review
This list is current as of: 2025-04-30.
An Excel version of the updated SUR List is available from the Overview page.
| 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) |
|---|---|---|---|---|
Acalabrutinib maleate |
Antineoplastic agents |
2024-10 |
AstraZeneca Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
Acalabrutinib maleate |
Antineoplastic agents |
2024-11 |
AstraZeneca Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
Adalimumab |
Immunosuppressants |
2024-09 |
Celltrion Healthcare Co Ltd |
Biosimilar |
Adalimumab |
Immunosuppressants |
2024-09 |
JAMP Pharma Corporation |
Biosimilar |
Aflibercept |
Ophthalmologicals |
2023-09 |
Bayer Inc |
Not applicable |
Alirocumab |
Lipid modifying agents |
2024-12 |
Sanofi-Aventis Canada Inc |
Not applicable |
Amifampridine phosphate |
Other nervous system drugs |
2024-08 |
Kye Pharmaceuticals Inc |
Not applicable |
Antihemophilic factor (recombinant, B-domain deleted, pegylated) |
Antihemorrhagics |
2024-12 |
Bayer Inc |
Not applicable |
Asciminib hydrochloride |
Antineoplastic agents |
2024-10 |
Novartis Pharmaceuticals Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
Belimumab |
Immunosuppressants |
2023-11 |
GlaxoSmithKline Inc |
Not applicable |
Benralizumab |
Drugs for obstructive airway diseases |
2024-04 |
AstraZeneca Canada Inc |
Not applicable |
Bimekizumab |
Immunosuppressants |
2024-06 |
UCB Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
Chikungunya virus live-attentuated |
Vaccines |
2024-10 |
Valneva Austria GmbH |
Not applicable |
Corynebacterium diphtheriae CRM-197 protein, pneumococcal polysaccharide serotypes 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, 35B, deOAc15B |
Vaccines |
2024-11 |
Merck Canada Inc |
Not applicable |
Daratumumab |
Antineoplastic agents |
2025-01 |
Janssen Inc |
Not applicable |
Darolutamide |
Endocrine therapy |
2024-11 |
Bayer Inc |
Part of an 'aligned review' with a health technology assessment organization |
Dupilumab |
Other dermatological preparations |
2024-06 |
Sanofi-Aventis Canada Inc |
Not applicable |
Dupilumab |
Other dermatological preparations |
2025-01 |
Sanofi-Aventis Canada Inc |
Not applicable |
Durvalumab |
Antineoplastic agents |
2024-01 |
AstraZeneca Canada Inc |
Not applicable |
Durvalumab |
Antineoplastic agents |
2025-01 |
AstraZeneca Canada Inc |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
Efgartigimod alfa |
Immunsuppressants |
2025-01 |
Argenx BV |
Not applicable |
Encorafenib |
Antineoplastic agents |
2024-12 |
Pfizer Canada ULC |
Being reviewed under the Notice of Compliance with Conditions Guidance |
Enoxaparin sodium |
Antithrombotic agents |
2024-12 |
Sanofi-Aventis Canada Inc |
Not applicable |
Evinacumab |
Lipid modifying agents |
2024-11 |
Ultragenyx Pharmaceutical Inc |
Being reviewed under the Priority Review Policy |
Finerenone |
Diuretics |
2025-03 |
Bayer Inc |
Part of an 'aligned review' with a health technology assessment organization |
Follitropin alfa, lutropin alfa |
Sex hormones and modulators of the genital system |
2024-11 |
EMD Serono a Division of EMD Inc. Canada |
Not applicable |
Fremanezumab |
Analgesics |
2025-04 |
Teva Canada Limited |
Not applicable |
Glofitamab |
Antineoplastic agents |
2024-10 |
Hoffmann-la Roche Limited |
Part of an 'aligned review' with a health technology assessment organization |
Guselkumab |
Immunosuppressants |
2024-06 |
Janssen Inc |
Not applicable |
Guselkumab |
Immunosuppressants |
2024-09 |
Janssen Inc |
Not applicable |
Guselkumab |
Immunosuppressants |
2025-01 |
Janssen Inc |
Not applicable |
Guselkumab |
Immunosuppressants |
2025-01 |
Janssen Inc |
Not applicable |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B |
Vaccines |
2025-04 |
BGP Pharma ULC |
Not applicable |
Inebilizumab |
Immunosuppressants |
2024-12 |
Horizon Therapeutics Ireland DAC |
Being reviewed under the Priority Review Policy |
Leuprolide acetate |
Endocrine therapy |
2025-01 |
Abbvie Corporation |
Not applicable |
Macitentan |
Antihypertensives |
2024-02 |
Janssen Inc |
Not applicable |
Maralixibat chloride |
Bile and liver therapy |
2025-04 |
Mirum Pharmaceuticals, Inc. |
Part of an 'aligned review' with a health technology assessment organization |
Mepolizumab |
Drugs for obstructive airway diseases |
2025-01 |
GlaxoSmithKline Inc |
Part of an 'aligned review' with a health technology assessment organization |
Mirikizumab |
Immunosuppressants |
2024-09 |
Eli Lilly Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
Nivolumab |
Antineoplastic agents |
2024-03 |
Bristol-Myers Squibb Canada |
Not applicable |
Nivolumab |
Antineoplastic agents |
2024-08 |
Bristol-Myers Squibb Canada |
Part of an 'aligned review' with a health technology assessment organization |
Nivolumab |
Antineoplastic agents |
2024-09 |
Bristol-Myers Squibb Canada |
Not applicable |
Obinutuzumab |
Antineoplastic agents |
2025-03 |
Hoffmann-la Roche Limited |
Not applicable |
Odevixibat |
Bile and liver therapy |
2024-09 |
Medison Pharma Canada Inc. |
Not applicable |
Pembrolizumab |
Antineoplastic agents |
2024-04 |
Merck Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
Pembrolizumab |
Antineoplastic agents |
2025-02 |
Merck Canada Inc |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
Ranolazine |
Cardiac therapy |
2022-08 |
KYE Pharmaceuticals Inc |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
Ribociclib succinate |
Antineoplastic agents |
2024-08 |
Novartis Pharmaceuticals Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
Roflumilast |
Antipsoriatics |
2025-01 |
Arcutis Canada, Inc. |
Not applicable |
RSV F-protein mRNA, 5'(m7G-5'-ppp-5'-Gm), 3' poly(A) |
Vaccines |
2025-03 |
Moderna Biopharma Canada Corporation |
Not applicable |
RSV subgroups A, B stabilized prefusion F protein |
Vaccines |
2024-12 |
Pfizer Canada ULC |
Not applicable |
Ruxolitinib phosphate |
Other dermatological preparations |
2024-12 |
Incyte Corporation |
Not applicable |
Sarilumab |
Immunosuppressants |
2024-07 |
Sanofi-Aventis Canada Inc |
Not applicable |
Semaglutide |
Drugs used in diabetes |
2024-02 |
Novo Nordisk Canada Inc |
Not applicable |
Semaglutide |
Drugs used in diabetes |
2024-07 |
Novo Nordisk Canada Inc |
Not applicable |
Semaglutide |
Drugs used in diabetes |
2025-03 |
Novo Nordisk Canada Inc |
Not applicable |
Semaglutide |
Drugs used in diabetes |
2025-04 |
Novo Nordisk Canada Inc |
Not applicable |
Semaglutide |
Drugs used in diabetes |
2025-04 |
Novo Nordisk Canada Inc |
Being reviewed under the Priority Review Policy |
Standardized allergen extract, white birch (Betula verrucosa) |
Allergens |
2024-07 |
ALK – Abello A/S |
Not applicable |
Sugammadex |
All other therapeutic products |
2024-10 |
Merck Canada Inc |
Not applicable |
Tenecteplase |
Antithrombotic agents |
2024-08 |
Hoffmann-la Roche Limited |
Not applicable |
Tezepelumab |
Drugs for obstructive airway diseases |
2025-04 |
AstraZeneca Canada Inc |
Not applicable |
Tirzepatide |
Drugs used in diabetes |
2025-02 |
Eli Lilly Canada Inc |
Not applicable |
Trastuzumab deruxtecan |
Antineoplastic agents |
2024-08 |
AstraZeneca Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
Trastuzumab deruxtecan |
Antineoplastic agents |
2024-12 |
AstraZeneca Canada Inc |
Part of an 'aligned review' with a health technology assessment organization |
Treosulfan |
Antineoplastic agents |
2024-03 |
Medexus Pharmaceuticals Inc. |
Not applicable |
Upadacitinib |
Immunosuppressants |
2024-10 |
Abbvie Corporation |
Not applicable |
Ustekinumab |
Immunosuppressants |
2024-12 |
Celltrion Inc |
Biosimilar |
Venetoclax |
Antineoplastic agents |
2024-10 |
Abbvie Corporation |
Part of an 'aligned review' with a health technology assessment organization |
Vutrisiran sodium |
Other nervous system drugs |
2025-02 |
Alnylam Netherlands B.V. |
Part of an 'aligned review' with a health technology assessment organization |
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