Drug and Health Product Submissions Under Review (SUR): New drug submissions completed
This list is current as of: 2024-09-30.
An Excel version of the updated SUR List is available from the Overview page.
| Medicinal Ingredient(s) | Therapeutic Area | Submission Control Number | Year, Month Submission was Accepted into Review | Year, Month Submission Concluded | Outcome of SubmissionFootnote a |
|---|---|---|---|---|---|
| 5-Aminolevulinic acid | Antineoplastic agents | 234673 | 2020-03 | 2020-09 | Issued Notice of Compliance |
| Abaloparatide | Calcium homeostasis | 259301 | 2022-03 | 2023-01 | Cancelled by sponsor |
| Abemaciclib | Antineoplastic agents | 215268 | 2018-06 | 2019-04 | Issued Notice of Compliance |
| Abiraterone acetate, niraparib | Endocrine therapy | 265223 | 2022-08 | 2023-06 | Issued Notice of Compliance under the NOC/c Guidance |
| Abrocitinib | Other dermatological preparations | 245854 | 2020-12 | 2022-06 | Issued Notice of Compliance |
| Acalabrutinib | Antineoplastic agents | 214504 | 2018-04 | 2019-08 | Issued Notice of Compliance |
| Acalabrutinib | Antineoplastic agents | 259246 | 2022-05 | 2023-02 | Issued Notice of Compliance |
| Acetaminophen | Analgesics | 209478 | 2018-02 | 2018-11 | Issued Notice of Compliance |
| Acetaminophen | Analgesics | 244695 | 2021-04 | 2023-02 | Issued Notice of Compliance |
| Acetaminophen, ibuprofen sodium dihydrate | Analgesics | 260262 | 2022-06 | 2024-02 | Issued Notice of Compliance |
| Acetylsalicylic acid, atorvastatin calcium, ramipril | Cardiac therapy | 234460 | 2020-02 | 2021-03 | Cancelled by sponsor |
| Ad26.COV2.S (recombinant)Table 3 footnote b *For use in relation to COVID-19 |
Vaccines | 246758 | 2020-11 | 2021-03 | Authorized under Interim Order |
| Ad26.COV2.S (recombinant) *For use in relation to COVID-19 |
Vaccines | 253702 | 2021-07 | 2021-11 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 203250 | 2017-04 | 2018-05 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 203292 | 2017-04 | 2018-05 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 230637 | 2019-10 | 2020-10 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 217314 | 2018-11 | 2020-11 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 229124 | 2019-09 | 2020-11 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 235685 | 2020-03 | 2021-01 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 247265 | 2021-03 | 2021-12 | Issued Notice of Compliance |
| Adalimumab | Immunosuppressants | 244990 | 2021-02 | 2022-01 | Issued Notice of Compliance |
| Adapalene, benzoyl peroxide, clindamycin phosphate | Anti-acne preparations | 271199 | 2023-10 | 2024-08 | Issued Notice of Compliance |
| Aducanumab | Other nervous system drugs | 251005 | 2021-06 | 2022-05 | Cancelled by sponsor |
| Alectinib | Antineoplastic agents | 189442 | 2016-02 | 2016-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Alfa 1-proteinase inhibitor (human) | Antihemorrhagics | 246730 | 2021-01 | 2021-11 | Issued Notice of Compliance |
| Alirocumab | Lipid modifying agents | 183116 | 2015-06 | 2016-04 | Issued Notice of Compliance |
| Alpelisib | Antineoplastic agents | 226941 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Alvimopan | Drugs for constipation | 189825 | 2016-03 | 2017-03 | Cancelled by sponsor |
| Alpha1-proteinase inhibitor (human) | Antihemorrhagics | 273683 | 2023-05 | 2023-11 | Issued Notice of Compliance |
| Amifampridine | Other nervous system drugs | 234655 | 2020-02 | 2023-01 | Issued Notice of Compliance |
| Amifampridine phosphate | Other nervous system drugs | 232685 | 2020-02 | 2020-07 | Issued Notice of Compliance |
| Amisulpride | Psycholeptics | 235705 | 2020-03 | 2021-01 | Cancelled by sponsor |
| Amivantamab | Antineoplastic agents | 254440 | 2021-07 | 2022-03 | Issued Notice of Compliance under the NOC/c Guidance |
| Amlodipine besylate | Calcium channel blockers | 211854 | 2018-07 | 2019-01 | Issued Notice of Compliance |
| Amoxicillin sodium, clavulanic acid | Antibacterials for systemic use | 221964 | 2019-04 | 2020-01 | Issued Notice of Compliance |
| Andexanet alfa | All other therapeutic products | 266464 | 2022-10 | 2023-06 | Issued Notice of Compliance under the NOC/c Guidance |
| Andusomeran *For use in relation to COVID-19 |
Vaccines | 275936 | 2023-06 | 2023-09 | Issued Notice of Compliance |
| Anifrolumab | Immunosuppressants | 246187 | 2020-12 | 2021-11 | Issued Notice of Compliance |
| Anthrax antigen filtrate | Vaccines | 212387 | 2018-02 | 2018-12 | Issued Notice of Compliance |
| Anthrax immunoglobulin (human) | Immune sera and immunoglobulins | 200446 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Antihemophilic factor (human), Von Willebrand factor (human) | Antihemorrhagics | 194071 | 2017-06 | 2018-05 | Issued Notice of Compliance |
| Antihemophilic factor (recombinant), pegylated | Antihemorrhagics | 189709 | 2016-01 | 2016-11 | Issued Notice of Compliance |
| Antihemophilic factor (recombinant, B-domain deleted, pegylated) | Antihemorrhagics | 210935 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Antihemophilic factor VIII (Recombinant, B-domain truncated), pegylated | Antihemorrhagics | 218531 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Apalutamide | Endocrine therapy | 211942 | 2018-01 | 2018-07 | Issued Notice of Compliance |
| Apomorphine hydrochloride | Anti-parkinson drugs | 217320 | 2018-08 | 2020-06 | Issued Notice of Compliance |
| Aprotinin | Antihemorrhagics | 247924 | 2021-02 | 2022-02 | Cancelled by sponsor |
| Ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium chloride, sodium sulfate | Drugs for constipation | 273065 | 2023-07 | 2024-08 | Issued Notice of Compliance |
| Asciminib hydrochloride | Antineoplastic agents | 255700 | 2021-08 | 2022-06 | Issued Notice of Compliance |
| Ataluren | Other drugs for disorders of the musculo-skeletal system | 186992 | 2015-09 | 2016-03 | Cancelled by sponsor |
| Ataluren | Other drugs for disorders of the musculo-skeletal system | 217349 | 2018-09 | 2019-10 | Cancelled by sponsor |
| Atezolizumab | Antineoplastic agents | 196843 | 2016-08 | 2017-04 | Issued Notice of Compliance under the NOC/c Guidance |
| Atogepant | Analgesics | 253186 | 2021-07 | 2022-12 | Issued Notice of Compliance |
| Atropine sulfate | Ophthalmologicals | 262121 | 2023-04 | 2024-07 | Cancelled by sponsor |
| Avacopan | Immunosuppressants | 248255 | 2021-05 | 2022-04 | Issued Notice of Compliance |
| Avalglucosidase alfa | Other alimentary tract and metabolism | 245680 | 2020-11 | 2021-11 | Issued Notice of Compliance |
| Avanafil | Urologicals | 220887 | 2019-06 | 2021-10 | Issued Notice of Non-compliance - Withdrawal |
| Avapritinib | Antineoplastic agents | 278913 | 2023-11 | 2024-09 | Issued Notice of Compliance |
| Avatrombopag maleate | Antihemorrhagics | 251688 | 2021-06 | 2023-11 | Issued Notice of Compliance |
| Avelumab | Antineoplastic agents | 204052 | 2017-04 | 2017-12 | Issued Notice of Compliance under the NOC/c Guidance |
| Avelumab | Antineoplastic agents | 208742 | 2017-09 | 2018-05 | Issued Notice of Compliance under the NOC/c Guidance |
| Axicabtagene ciloleucel | Antineoplastic agents | 218389 | 2018-08 | 2019-02 | Issued Notice of Compliance |
| Azacitidine | Antineoplastic agents | 240668 | 2020-07 | 2021-01 | Issued Notice of Compliance |
| Bacillus Calmette-Guerin BCG – Strain Russian BCG-I | Immunostimulants | 221579 | 2018-12 | 2020-12 | Issued Notice of Compliance under the NOC/c Guidance |
| Baloxavir marboxil | Antivirals for systemic use | 227361 | 2019-05 | 2020-02 | Issued Notice of Compliance |
| BamlanivimabTable 3 footnote b *For use in relation to COVID-19 |
Immune sera and immunoglobulins | 244947 | 2020-10 | 2020-11 | Authorized under Interim Order |
| Bamlanivimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins | 253646 | 2021-07 | 2023-02 | Cancelled by sponsor |
| Baricitinib | Antiinflammatory and antirheumatic products | 193687 | 2016-05 | 2018-08 | Issued Notice of Compliance |
| Belinostat | Antineoplastic agents | 208886 | 2017-12 | 2019-11 | Cancelled by sponsor |
| Belumosudil mesylate | Immunosuppressants | 245791 | 2021-01 | 2022-03 | Issued Notice of Compliance |
| Belzutifan | Antineoplastic agents | 254495 | 2021-09 | 2022-07 | Issued Notice of Compliance |
| Bendamustine hydrochloride | Antineoplastic agents | 248962 | 2021-03 | 2022-01 | Issued Notice of Compliance |
| Bendamustine hydrochloride | Antineoplastic agents | 249957 | 2021-07 | 2022-05 | Issued Notice of Compliance |
| Benralizumab | Immunosuppressants | 204008 | 2017-04 | 2018-02 | Issued Notice of Compliance |
| Bepotastine besilate | Ophthalmologicals | 179294 | 2015-10 | 2016-07 | Issued Notice of Compliance |
| Berotralstat hydrochloride | Other hematological agents | 252301 | 2021-08 | 2022-06 | Issued Notice of Compliance |
| Betamethasone valerate, fusidic acid | Corticosteroids, dermatological preparations | 203765 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Betula verrucosa extract | Nasal preparations | 227270 | 2019-06 | 2020-04 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 201427 | 2017-02 | 2018-04 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 218183 | 2018-08 | 2019-06 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 217524 | 2018-08 | 2021-01 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 242395 | 2020-10 | 2021-09 | Cancelled by sponsor |
| Bevacizumab | Antineoplastic agents | 244450 | 2020-11 | 2021-09 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 237499 | 2020-07 | 2021-11 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 247369 | 2021-02 | 2021-11 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 247724 | 2021-02 | 2021-11 | Issued Notice of Compliance |
| Bevacizumab | Antineoplastic agents | 258973 | 2022-03 | 2023-01 | Issued Notice of Compliance |
| Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 203718 | 2017-09 | 2018-07 | Issued Notice of Compliance |
| Bilastine | Antihistamines for systemic use | 184231 | 2015-06 | 2016-04 | Issued Notice of Compliance |
| Bimatoprost | Ophthalmologicals | 259843 | 2022-02 | 2022-12 | Issued Notice of Compliance |
| Bimekizumab | Immunosuppressants | 238499 | 2021-04 | 2022-02 | Issued Notice of Compliance |
| Binimetinib | Antineoplastic agents | 237410 | 2020-05 | 2021-03 | Issued Notice of Compliance |
| Bisoprolol fumarate | Beta blocking agents | 203050 | 2017-07 | 2019-11 | Issued Notice of Compliance |
| Bisoprolol fumarate | Beta blocking agents | 231842 | 2020-05 | 2020-09 | Cancelled by sponsor |
| Bivalirudin | Antithrombotic agents | 232423 | 2019-11 | 2020-09 | Issued Notice of Compliance |
| Blinatumomab | Antineoplastic agents | 181723 | 2015-04 | 2015-12 | Issued Notice of Compliance under the NOC/c Guidance |
| Bortezomib | Antineoplastic agents | 273611 | 2023-07 | 2024-07 | Issued Notice of Compliance |
| Botulinum antitoxin, serotypes A, B, C, D, E, F, G | Immune sera and immunoglobulins | 190645 | 2016-02 | 2016-12 | Issued Notice of Compliance |
| Brexpiprazole | Psycholeptics | 192684 | 2016-04 | 2017-02 | Issued Notice of Compliance |
| Brexucabtagene autoleucel | Antineoplastic agents | 246355 | 2020-12 | 2021-06 | Issued Notice of Compliance |
| Brigatinib | Antineoplastic agents | 210369 | 2017-11 | 2018-07 | Issued Notice of Compliance under the NOC/c Guidance |
| Brilliant blue G | Ophthalmologicals | 232449 | 2020-03 | 2021-01 | Issued Notice of Compliance |
| Brincidofovir | Antivirals for systemic use | 262030 | 2022-05 | 2023-12 | Issued Notice of Compliance |
| Brivaracetam | Antiepileptics | 183355 | 2015-05 | 2016-03 | Issued Notice of Compliance |
| Brodalumab | Immunosuppressants | 195317 | 2016-07 | 2018-03 | Issued Notice of Compliance |
| Brolucizumab | Ophthalmologicals | 226224 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 227232 | 2019-05 | 2019-11 | Issued Notice of Compliance |
| Budesonide | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 220876 | 2019-06 | 2020-04 | Issued Notice of Compliance |
| Budesonide, formoterol fumarate dihydrate, glycopyrronium bromide | Drugs for obstructive airway diseases | 242357 | 2020-09 | 2021-07 | Issued Notice of Compliance |
| Bupivacaine | Anesthetics | 231224 | 2019-12 | 2021-08 | Cancelled by sponsor |
| Bupivacaine, meloxicam | Antiinflammatory and antirheumatic products | 233561 | 2020-01 | 2022-03 | Issued Notice of Compliance |
| Buprenorphine | Other nervous system drugs | 215660 | 2018-05 | 2018-11 | Issued Notice of Compliance |
| Buprenorphine hydrochloride | Other nervous system drugs | 196428 | 2016-08 | 2017-06 | Issued Notice of Compliance |
| Buprenorphine hydrochloride | Other nervous system drugs | 204746 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Bupropion hydrochloride, naltrexone hydrochloride | Antiobesity preparations, excluding diet products | 202774 | 2017-04 | 2018-02 | Issued Notice of Compliance |
| Burosumab | Drugs for treatment of bone diseases | 216239 | 2018-06 | 2018-12 | Issued Notice of Compliance |
| C1 esterase inhibitor (human) | Other hematological agents | 198308 | 2016-11 | 2017-09 | Issued Notice of Compliance |
| Cabotegravir, cabotegravir sodium | Antivirals for systemic use | 280033 | 2023-11 | 2024-05 | Issued Notice of Compliance |
| Cabotegravir, rilpivirine | Antivirals for systemic use | 227315 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Cabozantinib | Antineoplastic agents | 206230 | 2017-07 | 2018-09 | Issued Notice of Compliance |
| Caffeine citrate | Psychoanaleptics | 225810 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Calaspargase pegol | Antineoplastic agents | 268282 | 2022-11 | 2023-11 | Issued Notice of Compliance |
| Calcifediol | Vitamins | 205392 | 2017-09 | 2018-07 | Issued Notice of Compliance |
| Calcium oxybate, magnesium oxybate, potassium oxybate, sodium oxybate | Other nervous system drugs | 262870 | 2022-07 | 2023-05 | Issued Notice of Compliance |
| Canakinumab | Immunosuppressants | 213303 | 2018-06 | 2018-12 | Cancelled by sponsor |
| Cangrelor tetrasodium | Antithrombotic agents | 255032 | 2021-11 | 2023-01 | Issued Notice of Compliance |
| Cannabidiol | Antiepileptics | 268559 | 2023-01 | 2023-11 | Issued Notice of Compliance |
| Capivastertib | Antineoplastic agents | 274859 | 2023-06 | 2024-01 | Issued Notice of Compliance |
| Caplacizumab | Antithrombotic agents | 230001 | 2019-08 | 2020-02 | Issued Notice of Compliance |
| Capmatinib dihydrochloride | Antineoplastic agents | 255972 | 2021-09 | 2022-05 | Issued Notice of Compliance under the NOC/c Guidance |
| Captopril | Agents acting on the renin-angiotensin system | 248574 | 2021-04 | 2023-12 | Issued Notice of Compliance |
| Carbidopa, levodopa | Anti-parkinson drugs | 257242 | 2022-04 | 2022-10 | Issued Notice of Compliance |
| Carfilzomib | Antineoplastic agents | 184479 | 2015-07 | 2016-01 | Issued Notice of Compliance |
| Cariprazine hydrochloride | Psycholeptics | 249774 | 2021-06 | 2022-04 | Issued Notice of Compliance |
| Casirivimab, imdevimabTable 3 footnote b *For use in relation to COVID-19 |
Immune sera and immunoglobulins | 249830 | 2021-02 | 2021-06 | Authorized under Interim Order |
| Casirivimab, imdevimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins | 256264 | 2021-09 | 2024-06 | Cancelled by sponsor |
| Cedazuridine, decitabine | Antineoplastic agents | 234610 | 2020-01 | 2020-07 | Issued Notice of Compliance |
| Cefditoren pivoxil | Antibacterials for systemic use | 261973 | 2022-07 | 2024-03 | Cancelled by sponsor |
| Cefixime | Antibacterials for systemic use | 189720 | 2016-05 | 2017-10 | Issued Notice of Compliance |
| Cemiplimab | Antineoplastic agents | 218718 | 2018-08 | 2019-04 | Issued Notice of Compliance under the NOC/c Guidance |
| Cenegermin | Ophthalmologicals | 218145 | 2018-08 | 2019-02 | Issued Notice of Compliance |
| Cenobamate | Antiepileptics | 261689 | 2022-07 | 2023-06 | Issued Notice of Compliance |
| Cerliponase alfa | Other alimentary tract and metabolism products | 216539 | 2018-06 | 2018-12 | Issued Notice of Compliance |
| Cevimeline hydrochloride | Other nervous system drugs | 240337 | 2020-09 | 2022-04 | Issued Notice of Non-compliance - Withdrawal |
| ChAdOx1-S (recombinant)Table 3 footnote b *For use in relation to COVID-19 |
Vaccines | 244627 | 2020-10 | 2021-02 | Authorized under Interim Order |
| ChAdOx1-S (recombinant)Table 3 footnote b *For use in relation to COVID-19 |
Vaccines | 248651 | 2021-01 | 2021-02 | Authorized under Interim Order |
| ChAdOx1-S (recombinant) *For use in relation to COVID-19 |
Vaccines | 253700 | 2021-07 | 2021-11 | Issued Notice of Compliance |
| Chikungunya virus live-attenuated | Vaccines | 275762 | 2023-08 | 2024-06 | Issued Notice of Compliance |
| Chlormethine | Antineoplastic agents | 238994 | 2020-08 | 2021-06 | Issued Notice of Compliance |
| Chloroprocaine hydrochloride | Anesthetics | 270862 | 2023-05 | 2024-08 | Issued Notice of Compliance |
| Chromic chloride, cupric chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate, sodium selenite, zinc chloride | Blood substitutes and perfusion solutions | 223801 | 2019-06 | 2020-04 | Issued Notice of Compliance |
| Cidofovir | Antivirals for systemic use | 200865 | 2017-04 | 2018-03 | Issued Notice of Compliance |
| Cilgavimab, tixagevimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins | 258295 | 2021-11 | 2022-04 | Issued Notice of Compliance |
| Cilostazol | Antithrombotic agents | 240368 | 2021-02 | 2022-07 | Cancelled by sponsor |
| Ciltacabtagene autoleucel | Antineoplastic agents | 262122 | 2022-04 | 2023-02 | Issued Notice of Compliance under the NOC/c Guidance |
| Cinnarizine, dimenhydrinate | Other nervous system drugs | 195151 | 2016-09 | 2018-11 | Issued Notice of Non-compliance - Withdrawal |
| Cladribine | Immunosuppressants | 200943 | 2017-02 | 2017-11 | Issued Notice of Compliance |
| Clascoterone | Anti-acne preparations | 265619 | 2022-08 | 2023-06 | Issued Notice of Compliance |
| Clozapine | Psycholeptics | 193638 | 2016-05 | 2016-11 | Issued Notice of Compliance |
| Coagulation factor IX (recombinant), pegylated | Antihemorrhagics | 201114 | 2017-02 | 2017-11 | Issued Notice of Compliance |
| Cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide hemifumarate | Antivirals for systemic use | 199705 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Cobimetinib fumarate | Antineoplastic agents | 182788 | 2015-04 | 2016-02 | Issued Notice of Compliance |
| ColchicineTable 3 footnote b *For use in relation to COVID-19 | Antigout preparations | 248711 | 2021-01 | 2021-06 | Cancelled by sponsor |
| Colchicine | Antigout preparations | 248423 | 2021-02 | 2021-08 | Issued Notice of Compliance |
| Concizumab | Antihemorrhagics | 267120 | 2022-09 | 2023-03 | Issued Notice of Compliance |
| Concizumab | Antihemorrhagics | 267314 | 2022-09 | 2023-07 | Issued Notice of Compliance |
| Copanlisib dihydrochloride | Antineoplastic agents | 255077 | 2021-08 | 2021-12 | Cancelled by sponsor |
| Copper, manganese sulfate, selenious acid, sodium iodide, zinc sulfate | Blood substitutes and perfusion solutions | 246125 | 2021-03 | 2023-03 | Issued Notice of Compliance |
| Corynebacterium diphtheriae CRM-197 protein, pneumococcal conjugate serotype 33F, pneumococcal polysaccharide serotypes 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, deOAc15B, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 35B | Vaccines | 281914 | 2024-01 | 2024-07 | Issued Notice of Compliance |
| Corynebacterium diphtheria 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 | 253111 | 2021-07 | 2022-05 | Issued Notice of Compliance |
| Corynebacterium diphtheria CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F | Vaccines | 247042 | 2021-01 | 2021-11 | Issued Notice of Compliance |
| Crisaborole | Other dermatological preparations | 206906 | 2017-08 | 2018-06 | Issued Notice of Compliance |
| Crisantaspase, recombinant | Antineoplastic drugs | 257092 | 2021-11 | 2022-09 | Issued Notice of Compliance |
| Cyclosporine | Ophthalmologicals | 194580 | 2016-08 | 2018-04 | Issued Notice of Non-compliance - Withdrawal |
| Cyclosporine | Ophthalmologicals | 215813 | 2018-07 | 2018-12 | Issued Notice of Compliance |
| Cyclosporine | Ophthalmologicals | 234677 | 2020-04 | 2021-02 | Issued Notice of Compliance |
| Cysteamine hydrochloride | Ophthalmologicals | 211635 | 2018-02 | 2019-02 | Issued Notice of Compliance |
| Cytarabine, daunorubicin hydrochloride | Antineoplastic agents | 242743 | 2020-11 | 2021-04 | Issued Notice of Compliance |
| Daclizumab | Immunosuppressants | 190458 | 2016-02 | 2016-12 | Issued Notice of Compliance |
| Dacomitinib | Antineoplastic agents | 214572 | 2018-05 | 2019-02 | Issued Notice of Compliance |
| Dalbavancin | Antibacterials for systemic use | 212390 | 2018-03 | 2018-09 | Issued Notice of Compliance |
| Danicopan | Other hematological agents | 274338 | 2023-09 | 2024-07 | Issued Notice of Compliance |
| Daprodustat | Antianemic preparations | 263001 | 2022-05 | 2023-07 | Cancelled by sponsor |
| Daratumumab | Antineoplastic agents | 187648 | 2015-11 | 2016-06 | Issued Notice of Compliance under the NOC/c Guidance |
| Daridorexant hydrochloride | Other nervous system drugs | 255507 | 2021-10 | 2023-04 | Issued Notice of Compliance |
| Darolutamide | Endocrine therapy | 226146 | 2019-04 | 2020-02 | Issued Notice of Compliance |
| Darvadstrocel | Unassigned | 217347 | 2018-08 | 2019-06 | Cancelled by sponsor |
| Davesomeran, elasomeran *For use in relation to COVID-19 |
Vaccines | 267589 | 2022-09 | 2022-11 | Issued Notice of Compliance |
| Decitabine | Antineoplastic agents | 207372 | 2018-03 | 2019-01 | Issued Notice of Compliance |
| Decitabine | Antineoplastic agents | 217663 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Defibrotide | Antithrombotic agents | 200808 | 2017-01 | 2017-07 | Issued Notice of Compliance |
| Denosumab | Drugs for treatment of bone diseases | 271806 | 2023-03 | 2024-02 | Issued Notice of Compliance |
| Denosumab | Drugs for treatment of bone diseases | 267788 | 2023-03 | 2024-03 | Issued Notice of Compliance |
| Dequalinium chloride | Gynecological antiinfectives and antiseptics | 227886 | 2019-07 | 2021-07 | Issued Notice of Compliance |
| Dermatophagoides farinae, dermatophagoides pteronyssinus | Allergens | 208152 | 2017-09 | 2020-07 | Cancelled by sponsor |
| Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract | Allergens | 195186 | 2016-07 | 2017-05 | Issued Notice of Compliance |
| Desvenlafaxine | Psychoanaleptics | 199626 | 2017-02 | 2017-08 | Issued Notice of Compliance |
| Deucravacitinib | Immunosuppressants | 259397 | 2022-01 | 2022-11 | Issued Notice of Compliance |
| Dexamethasone, levofloxacin | Ophthalmologicals | 258157 | 2021-12 | 2023-12 | Issued Notice of Compliance |
| Dexamethasone sodium phosphate, netilmicin sulfate | Ophthalmologicals | 212391 | 2018-02 | 2019-10 | Issued Notice of Compliance |
| Diamorphine hydrochloride | Other nervous system drugs | 254850 | 2021-08 | 2022-02 | Issued Notice of Compliance |
| Difelikefalin | All other therapeutic products | 254548 | 2021-10 | 2022-08 | Issued Notice of Compliance |
| Dinutuximab | Antineoplastic agents | 212066 | 2018-02 | 2018-11 | Issued Notice of Compliance |
| Diroximel fumarate | Immunosuppressants | 240071 | 2020-07 | 2023-02 | Cancelled by sponsor |
| Disodium phosphate, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate, sodium phosphate monobasic | All other non-therapeutic products | 220402 | 2018-11 | 2019-09 | Issued Notice of Compliance |
| Dolutegravir, lamivudine | Antivirals for systemic use | 220275 | 2018-10 | 2019-08 | Issued Notice of Compliance |
| Dolutegravir sodium, rilpivirine hydrochloride | Antivirals for systemic use | 206402 | 2017-07 | 2018-05 | Issued Notice of Compliance |
| Doravirine | Antivirals for systemic use | 211293 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Doravirine, lamivudine, tenofovir disoproxil fumarate | Antivirals for systemic use | 211708 | 2018-01 | 2018-11 | Issued Notice of Compliance |
| Dostarlimab | Antineoplastic agents | 251105 | 2021-04 | 2021-12 | Issued Notice of Compliance under the NOC/c Guidance |
| Dotatate | Diagnostic radiopharmaceuticals | 218346 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Dronabinol | Antiemetics and antinauseants | 240372 | 2021-05 | 2023-05 | Cancelled by sponsor |
| Drospirenone | Sex hormones and modulators of the genital system | 242176 | 2021-02 | 2021-11 | Issued Notice of Compliance |
| Drospirenone, estetrol monohydrate | Sex hormones and modulators of the genital system | 236197 | 2020-05 | 2021-03 | Issued Notice of Compliance |
| Dupilumab | Immunosuppressants | 201285 | 2017-02 | 2017-11 | Issued Notice of Compliance |
| Durvalumab | Antineoplastic agents | 202953 | 2017-03 | 2017-11 | Issued Notice of Compliance under the NOC/c Guidance |
| Durvalumab | Antineoplastic agents | 208834 | 2017-09 | 2018-05 | Issued Notice of Compliance under the NOC/c Guidance |
| Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live, attenuated) | Vaccines | 256568 | 2021-10 | 2022-11 | Issued Notice of Compliance |
| Edaravone | Other nervous system drugs | 214391 | 2018-04 | 2018-10 | Issued Notice of Compliance |
| Edoxaban | Antithrombotic agents | 187363 | 2015-12 | 2016-11 | Issued Notice of Compliance |
| Efgartigimod alfa | Immunosuppressants | 267438 | 2022-11 | 2023-09 | Issued Notice of Compliance |
| Elagolix | Sex hormones and modulators of the genital system | 209513 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| ElasomeranTable 3 footnote b *For use in relation to COVID-19 |
Vaccines | 244946 | 2020-10 | 2020-12 | Authorized under Interim Order |
| Elasomeran *For use in relation to COVID-19 |
Vaccines | 252733 | 2021-06 | 2021-09 | Issued Notice of Compliance |
| Elasomeran, imelasomeran *For use in relation to COVID-19 |
Vaccines | 265656 | 2022-06 | 2022-09 | Issued Notice of Compliance |
| Elbasvir, grazoprevir | Antivirals for systemic use | 185866 | 2015-07 | 2016-01 | Issued Notice of Compliance |
| Elexacaftor, ivacaftor, tezacaftor | Other respiratory system products | 246955 | 2020-12 | 2021-06 | Issued Notice of Compliance |
| Eliglustat tartrate | Other alimentary tract and metabolism products | 183050 | 2015-05 | 2017-04 | Issued Notice of Compliance |
| Elotuzumab | Antineoplastic agents | 188144 | 2015-12 | 2016-06 | Issued Notice of Compliance |
| Elranatamab | Antineoplastic agents | 273519 | 2023-04 | 2023-12 | Issued Notice of Compliance under the NOC/c Guidance |
| Eluxadoline | Drugs for functional gastrointestinal disorders | 190162 | 2016-04 | 2017-01 | Issued Notice of Compliance |
| Emapalumab | Immunosuppressants | 237121 | 2020-05 | 2021-01 | Cancelled by sponsor |
| Emicizumab | Antihemorrhagics | 212635 | 2018-02 | 2018-08 | Issued Notice of Compliance |
| Enasidenib mesylate | Antineoplastic agents | 217033 | 2018-07 | 2019-02 | Issued Notice of Compliance under the NOC/c Guidance |
| Encorafenib | Antineoplastic agents | 237413 | 2020-05 | 2021-03 | Issued Notice of Compliance |
| Encorafenib | Antineoplastic agents | 238571 | 2020-06 | 2021-03 | Issued Notice of Compliance |
| Enfortumab vedotin | Antineoplastic agents | 251438 | 2021-05 | 2021-10 | Issued Notice of Compliance |
| Enoxaparin sodium | Antithrombotic agents | 233058 | 2019-12 | 2020-10 | Issued Notice of Compliance |
| Enoxaparin sodium | Antithrombotic agents | 233987 | 2020-01 | 2020-11 | Issued Notice of Compliance |
| Enoxaparin sodium | Antithrombotic agents | 231767 | 2019-11 | 2020-12 | Issued Notice of Compliance |
| Enoxaparin sodium | Antithrombotic agents | 243026 | 2021-12 | 2022-10 | Issued Notice of Compliance |
| Enoxaparin sodium | Antithrombotic agents | 266545 | 2022-09 | 2023-07 | Issued Notice of Compliance |
| Enterococcus faecalis inactivated, Escherichia coli inactivated, Klebsiella pneumoniae inactivated, Proteus vulgaris inactivated | Vaccines | 262815 | 2022-05 | 2023-05 | Cancelled by sponsor |
| Entrectinib | Antineoplastic agents | 227517 | 2019-06 | 2020-02 | Issued Notice of Compliance under the NOC/c Guidance |
| Entrectinib | Antineoplastic agents | 228159 | 2019-07 | 2020-05 | Issued Notice of Compliance |
| Epcoritamab | Antineoplastic agents | 271331 | 2023-02 | 2023-10 | Issued Notice of Compliance under the NOC/c Guidance |
| Eplontersen | Other nervous system drugs | 274598 | 2023-08 | 2024-06 | Issued Notice of Compliance |
| Eptinezumab | Analgesics | 233288 | 2020-03 | 2021-01 | Issued Notice of Compliance |
| Erdafitinib | Antineoplastic agents | 224529 | 2019-03 | 2019-10 | Issued Notice of Compliance under the NOC/c Guidance |
| Erenumab | Analgesics | 208607 | 2017-10 | 2018-08 | Issued Notice of Compliance |
| Ertugliflozin pidolate | Drugs used in diabetes | 204724 | 2017-07 | 2018-05 | Issued Notice of Compliance |
| Ertugliflozin pidolate, metformin hydrochloride | Drugs used in diabetes | 201005 | 2017-08 | 2018-05 | Issued Notice of Compliance |
| Ertugliflozin pidolate, sitagliptin phosphate monohydrate | Drugs used in diabetes | 201006 | 2017-07 | 2018-05 | Issued Notice of Compliance |
| Erwinia L-asparaginase | Antineoplastic agents | 255132 | 2021-09 | 2023-07 | Cancelled by sponsor |
| Esketamine hydrochloride | Psychoanaleptics | 222855 | 2019-01 | 2020-05 | Issued Notice of Compliance |
| Estradiol, norethindrone acetate, relugolix | Pituitary, hypothalamic hormones and analogues | 267148 | 2022-11 | 2023-09 | Issued Notice of Compliance |
| Estradiol, norethindrone acetate, relugolix | Pituitary, hypothalamic hormones and analogues | 268111 | 2022-12 | 2023-10 | Issued Notice of Compliance |
| Estradiol hemihydrate | Sex hormones and modulators of the genital system | 223938 | 2019-10 | 2020-08 | Issued Notice of Compliance |
| Estradiol hemihydrate, progesterone | Sex hormones and modulators of the genital system | 224010 | 2019-11 | 2020-09 | Issued Notice of Compliance |
| Estriol, lactobacillus acidophilus | Sex hormones and modulators of the genital system | 203472 | 2017-06 | 2019-01 | Issued a Notice of Deficiency - Withdrawal |
| Etanercept | Immunosuppressants | 193864 | 2016-06 | 2017-04 | Issued Notice of Compliance |
| Etanercept | Immunosuppressants | 234562 | 2020-02 | 2022-08 | Issued Notice of Compliance |
| Etesevimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins | 256653 | 2021-09 | 2023-02 | Cancelled by sponsor |
| Etomidate | Anesthetics | 231245 | 2019-12 | 2020-07 | Issued Notice of Compliance |
| Etonogestrel | Sex hormones and modulators of the genital system | 226314 | 2019-05 | 2020-05 | Issued Notice of Compliance |
| Etranacogene dezaparvovec | Other hematological agents | 273721 | 2023-04 | 2023-10 | Issued Notice of Compliance |
| Etrasimod L-arginine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 271038 | 2023-03 | 2024-01 | Issued Notice of Compliance |
| Evinacumab | Lipid modifying agents | 272688 | 2023-03 | 2023-09 | Issued Notice of Compliance |
| Exagamglogene autotemcel | Other hematological agents | 284351 | 2024-03 | 2024-09 | Issued Notice of Compliance |
| Famtozinameran, tozinameran *For use in relation to COVID-19 |
Vaccines | 267502 | 2022-09 | 2022-10 | Issued Notice of Compliance |
| Faricimab | Ophthalmologicals | 253904 | 2021-08 | 2022-05 | Issued Notice of Compliance |
| Favipiravir *For use in relation to COVID-19 |
Antivirals for systemic use | 256417 | 2020-12 | 2022-02 | Cancelled by sponsor |
| Fedratinib dihydrochloride monohydrate | Antineoplastic agents | 229866 | 2019-10 | 2020-07 | Issued Notice of Compliance |
| Ferric carboxymaltose | Antianemic preparations | 272960 | 2023-04 | 2024-03 | Issued Notice of Compliance |
| Ferric maltol | Antianemic preparations | 260666 | 2022-06 | 2024-08 | Issued Notice of Compliance |
| Ferric pyrophosphate citrate | Antianemic preparations | 239850 | 2020-06 | 2021-04 | Issued Notice of Compliance |
| Ferumoxytol | Antianemic preparations | 258248 | 2022-03 | 2023-02 | Cancelled by sponsor |
| Fibrinogen (human) | Antihemorrhagics | 195870 | 2016-08 | 2017-06 | Issued Notice of Compliance |
| Fibrinogen (human), thrombin (human) | Antihemorrhagics | 239016 | 2020-05 | 2021-03 | Issued Notice of Compliance |
| Fidanacogene elaparvovec | Antihemorrhagics | 275853 | 2023-06 | 2023-12 | Issued Notice of Compliance |
| Filgotinib | Immunosuppressants | 235219 | 2020-04 | 2021-01 | Cancelled by sponsor |
| Filgrastim (r-metHuG-CSF) | Immunostimulants | 212016 | 2018-02 | 2019-08 | Cancelled by sponsor |
| Filgrastim (r-metHuG-CSF) | Immunostimulants | 214080 | 2018-04 | 2020-04 | Issued Notice of Compliance |
| Filgrastim (r-metHuG-CSF) | Immunostimulants | 220512 | 2019-03 | 2021-10 | Issued Notice of Compliance |
| Filgrastim (r-metHuG-CSF) | Immunostimulants | 267597 | 2023-01 | 2024-07 | Cancelled by sponsor |
| Finerenone | Diuretics | 249486 | 2021-04 | 2021-10 | Cancelled by sponsor |
| Finerenone | Diuretics | 258231 | 2021-12 | 2022-10 | Issued Notice of Compliance |
| Flibanserin | Other gynecologicals | 189352 | 2016-04 | 2018-02 | Issued Notice of Compliance |
| Florbetaben (18F) | Diagnostic radiopharmaceuticals | 193105 | 2016-04 | 2017-02 | Issued Notice of Compliance |
| Fluocinolone acetonide | Ophthalmologicals | 201510 | 2017-02 | 2018-11 | Issued Notice of Compliance |
| Fluorouracil | Antineoplastic agents | 211768 | 2018-04 | 2019-02 | Issued Notice of Compliance |
| Fluoxetine hydrochloride | Psychoanaleptics | 198520 | 2016-12 | 2017-06 | Issued Notice of Compliance |
| Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate | Drugs for obstructive airway diseases | 204880 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Fluticasone propionate | Drugs for obstructive airway diseases | 197873 | 2016-10 | 2017-08 | Issued Notice of Compliance |
| Fluticasone proprionate, salmeterol xinafoate | Drugs for obstructive airway diseases | 197974 | 2016-11 | 2018-04 | Issued Notice of Compliance |
| Follitropin delta | Sex hormones and modulators of the genital system | 188743 | 2016-01 | 2018-03 | Issued Notice of Compliance |
| Formoterol fumarate dihydrate, glycopyrronium bromide | Drugs for obstructive airway diseases | 201306 | 2017-02 | 2018-03 | Issued Notice of Compliance |
| Foscarbidopa, foslevodopa | Anti-parkinson drugs | 263826 | 2022-07 | 2023-05 | Issued Notice of Compliance |
| Foscarnet sodium | Antivirals for systemic use | 233046 | 2019-12 | 2020-10 | Issued Notice of Compliance |
| Fosfomycin sodium | Antibacterials for systemic use | 219662 | 2018-11 | 2019-05 | Issued Notice of Compliance |
| Fostamatinib disodium | Antihemorrhagics | 232078 | 2020-01 | 2020-11 | Issued Notice of Compliance |
| Fostemsavir tromethamine | Antivirals for systemic use | 250213 | 2021-04 | 2021-10 | Issued Notice of Compliance |
| Fremanezumab | Analgesics | 226828 | 2019-06 | 2020-04 | Issued Notice of Compliance |
| Fruquintinib | Antineoplastic agents | 275803 | 2023-11 | 2024-09 | Issued Notice of Compliance |
| Gadoteric acid | Contrast media | 186333 | 2015-12 | 2016-11 | Issued Notice of Compliance |
| Galcanezumab | Analgesics | 219521 | 2018-10 | 2019-07 | Issued Notice of Compliance |
| Gallium (68Ga) chloride | Diagnostic radiopharmaceuticals | 221824 | 2019-04 | 2019-11 | Issued Notice of Compliance |
| Gallium (68Ga) chloride, germanium (68Ge) chloride | Diagnostic radiopharmaceuticals | 227804 | 2019-10 | 2020-08 | Issued Notice of Compliance |
| Gallium (68Ga) gozetotide | Diagnostic radiopharmaceuticals | 242332 | 2021-02 | 2022-10 | Issued Notice of Compliance |
| Gallium (68Ga) gozetotide | Diagnostic radiopharmaceuticals | 263638 | 2022-06 | 2023-04 | Issued Notice of Compliance |
| Gallium oxodotreotide | Diagnostic radiopharmaceuticals | 248874 | 2021-05 | 2022-02 | Issued Notice of Compliance |
| Ganciclovir | Ophthalmologicals | 221456 | 2019-02 | 2022-09 | Issued Notice of Compliance |
| Gefapixant | Cough and cold preparations | 255697 | 2021-12 | 2024-06 | Cancelled by sponsor |
| Gemtuzumab ozogamicin | Antineoplastic agents | 223091 | 2019-02 | 2019-11 | Issued Notice of Compliance |
| Gilteritinib fumarate | Antineoplastic agents | 227918 | 2019-06 | 2019-12 | Issued Notice of Compliance |
| Givosiran | Bile and liver therapy | 237194 | 2020-04 | 2020-10 | Issued Notice of Compliance |
| Glasdegib | Antineoplastic agents | 225793 | 2019-07 | 2020-04 | Issued Notice of Compliance |
| Glecaprevir, pibrentasvir | Antivirals for systemic use | 202233 | 2017-02 | 2017-08 | Issued Notice of Compliance |
| Glofitamab | Antineoplastic agents | 265517 | 2022-07 | 2023-03 | Issued Notice of Compliance under the NOC/c Guidance |
| Glucagon | Pancreatic hormones | 220839 | 2018-11 | 2019-09 | Issued Notice of Compliance |
| Glycine, histidine, L-alanine, L-arginine, L-isoleucine, L-leucine, L-lysine acetate, L-methionine, L-phenylalanine, L-proline, L-threonine, L-tryptophan, L-tyrosine, L-valine, serine, taurine | Blood substitutes and perfusion solutions | 231585 | 2020-03 | 2020-12 | Issued Notice of Compliance |
| Glycopyrrolate | Drugs for functional gastrointestinal disorders | 197038 | 2017-01 | 2017-10 | Issued Notice of Compliance |
| Glycopyrronium bromide, indacaterol acetate, mometasone furoate | Drugs for obstructive airway diseases | 228353 | 2019-09 | 2020-07 | Issued Notice of Compliance |
| Goserelin acetate | Endocrine therapy | 232286 | 2020-07 | 2021-10 | Cancelled by sponsor |
| Guselkumab | Immunosuppressants | 200590 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B | Vaccines | 200726 | 2017-05 | 2019-03 | Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 203436 | 2017-04 | 2018-02 | Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 222669 | 2019-01 | 2019-11 | Issued Notice of Compliance |
| Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) | Vaccines | 234113 | 2020-01 | 2020-11 | Cancelled by sponsor |
| Haemagglutinin, neuraminidase antigen | Vaccines | 235556 | 2020-03 | 2021-01 | Issued Notice of Compliance |
| Halobetasol propionate, tazarotene | Corticosteroids, dermatological preparations | 212718 | 2018-05 | 2020-06 | Issued Notice of Compliance |
| Hemin | Other alimentary tract and metabolism | 212276 | 2018-01 | 2018-07 | Issued Notice of Compliance |
| Hepatitis B surface antigen (recombinant) | Vaccines | 259302 | 2022-02 | 2022-12 | Issued Notice of Compliance |
| Human heterologous liver cells | Other alimentary tract and metabolism products | 205160 | 2017-06 | 2018-07 | Cancelled by sponsor |
| Human insulin (recombinant) | Drugs used in diabetes | 251360 | 2021-05 | 2022-08 | Issued Notice of Compliance |
| Hyaluronidase (human recombinant), immunoglobulin (human), | Immune sera and immunoglobulins | 247727 | 2021-02 | 2022-01 | Issued Notice of Compliance |
| Hydrochlorothiazide, zofenopril calcium | Agents acting on the renin-angiotensin system | 212396 | 2018-06 | 2019-06 | Cancelled by sponsor |
| Hydrogen peroxide | Other dermatological preparations | 216854 | 2018-12 | 2019-08 | Cancelled by sponsor |
| Icosapent ethyl | Lipid modifying agents | 227235 | 2019-07 | 2019-12 | Issued Notice of Compliance |
| Idarucizumab | All other therapeutic products | 182503 | 2015-05 | 2016-04 | Issued Notice of Compliance under the NOC/c Guidance |
| Idecabtagene vicleucel | Antineoplastic agents | 244266 | 2020-10 | 2021-05 | Issued Notice of Compliance under the NOC/c Guidance |
| Immunoglobulin (human) | Immune sera and immunoglobulins | 194291 | 2016-10 | 2017-08 | Issued Notice of Compliance |
| Immunoglobulin (human) | Immune sera and immunoglobulins | 226576 | 2019-06 | 2019-12 | Issued Notice of Compliance |
| Immunoglobulin G (human) | Immune sera and immunoglobulins | 202924 | 2017-04 | 2018-02 | Issued Notice of Compliance |
| Inclisiran sodium | Lipid modifying agents | 243470 | 2020-09 | 2021-07 | Issued Notice of Compliance |
| Indacaterol acetate, mometasone furoate | Drugs for obstructive airway diseases | 227987 | 2019-07 | 2020-05 | Issued Notice of Compliance |
| Inebilizumab | Immunosuppressants | 271065 | 2023-02 | 2023-12 | Issued Notice of Compliance |
| Infigratinib phosphate | Antineoplastic agents | 246904 | 2021-01 | 2021-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Infliximab | Immunosuppressants | 226189 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Infliximab | Immunosuppressants | 248134 | 2021-02 | 2021-12 | Issued Notice of Compliance |
| Influenza virus type A (H1N1) | Vaccines | 267444 | 2022-10 | 2023-10 | Issued Notice of Compliance |
| Inotersen sodium | Other nervous system drugs | 214274 | 2018-04 | 2018-10 | Issued Notice of Compliance |
| Inotuzumab ozogamicin | Antineoplastic agents | 204077 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Insulin aspart | Drugs used in diabetes | 226573 | 2019-12 | 2020-10 | Issued Notice of Compliance |
| Insulin aspart | Drugs used in diabetes | 243229 | 2020-12 | 2021-10 | Issued Notice of Compliance |
| Insulin degludec | Drugs used in diabetes | 198124 | 2016-10 | 2017-08 | Issued Notice of Compliance |
| Insulin degludec, liraglutide | Drugs used in diabetes | 194513 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Insulin glargine | Drugs used in diabetes | 202772 | 2017-04 | 2019-02 | Cancelled by sponsor |
| Insulin glargine | Drugs used in diabetes | 252068 | 2021-06 | 2022-04 | Issued Notice of Compliance |
| Insulin glargine, lixisenatide | Drugs used in diabetes | 207006 | 2017-09 | 2018-07 | Issued Notice of Compliance |
| Insulin icodec | Drugs used in diabetes | 273850 | 2023-05 | 2024-03 | Issued Notice of Compliance |
| Insulin injection human biosynthetic | Drugs used in diabetes | 189076 | 2016-09 | 2017-07 | Issued Notice of Compliance |
| Insulin lispro | Drugs used in diabetes | 200792 | 2017-01 | 2017-11 | Issued Notice of Compliance |
| Insulin lispro | Drugs used in diabetes | 244611 | 2020-11 | 2021-09 | Issued Notice of Compliance |
| Iodine | Contrast media | 196107 | 2016-09 | 2017-07 | Issued Notice of Compliance |
| Ioflupane (123I) | Diagnostic radiopharmaceuticals | 201481 | 2017-02 | 2017-12 | Issued Notice of Compliance |
| Iron dextran | Antianemic preparations | 189897 | 2016-05 | 2017-06 | Cancelled by sponsor |
| Iron isomaltoside 1000 | Antianemic preparations | 193890 | 2016-07 | 2018-06 | Issued Notice of Compliance |
| Isatuximab | Antineoplastic agents | 229245 | 2019-07 | 2020-04 | Issued Notice of Compliance |
| Isavuconazonium sulfate | Antimycotics for systemic use | 208919 | 2018-02 | 2018-12 | Issued Notice of Compliance |
| Isotretinoin | Anti-acne preparations | 263460 | 2022-08 | 2023-06 | Issued Notice of Compliance |
| Ivacaftor, tezacaftor | Other respiratory system products | 211292 | 2017-12 | 2018-06 | Issued Notice of Compliance |
| Ivermectin | Anthelmintics | 211000 | 2017-12 | 2018-09 | Issued Notice of Compliance |
| Ivosidenib | Antineoplastic agents | 277139 | 2023-09 | 2024-07 | Issued Notice of Compliance |
| Ixazomib citrate | Antineoplastic agents | 190498 | 2016-02 | 2016-08 | Issued Notice of Compliance |
| Ixekizumab | Immunosuppressants | 184993 | 2015-07 | 2016-05 | Issued Notice of Compliance |
| Lanadelumab | Other hematological agents | 213920 | 2018-03 | 2018-09 | Issued Notice of Compliance |
| Landiolol hydrochloride | Beta blocking agents | 259953 | 2022-02 | 2023-11 | Issued Notice of Compliance |
| Larotrectinib | Antineoplastic agents | 219998 | 2018-11 | 2019-07 | Issued Notice of Compliance under the NOC/c Guidance |
| Lasmiditan | Analgesics | 236369 | 2020-04 | 2021-01 | Cancelled by sponsor |
| Latanoprostene bunod | Ophthalmologicals | 211732 | 2018-03 | 2018-12 | Issued Notice of Compliance |
| Lebrikizumab | Immunosuppressants | 272660 | 2023-05 | 2024-06 | Issued Notice of Compliance |
| Lefamulin acetate | Antibacterials for systemic use | 233292 | 2020-01 | 2020-07 | Issued Notice of Compliance |
| Lemborexant | Psycholeptics | 231286 | 2020-01 | 2020-11 | Issued Notice of Compliance |
| Lenacapavir sodium | Antivirals for systemic use | 262999 | 2022-05 | 2022-11 | Issued Notice of Compliance |
| LeronlimabTable 3 footnote b *For use in relation to COVID-19 |
Immune sera and immunoglobulins | 250805 | 2021-03 | 2021-09 | Interim Order expired |
| Letermovir | Antivirals for systemic use | 204165 | 2017-05 | 2017-11 | Issued Notice of Compliance |
| LetibotulinumtoxinA | Muscle relaxants | 251157 | 2021-08 | 2022-06 | Issued Notice of Compliance |
| Leuprolide mesylate | Endocrine therapy | 246800 | 2021-01 | 2021-11 | Issued Notice of Compliance |
| Levetiracetam | Antiepileptics | 213656 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Levothyroxine sodium | Thyroid therapy | 232047 | 2020-01 | 2020-11 | Issued Notice of Compliance |
| Lidocaine hydrochloride, nifedipine | Vasoprotectives | 265823 | 2022-11 | 2024-05 | Issued Notice of Compliance |
| Lifitegrast | Ophthalmologicals | 199810 | 2016-12 | 2017-12 | Issued Notice of Compliance |
| Lisocabtagene maraleucel | Antineoplastic agents | 247562 | 2021-02 | 2022-05 | Issued Notice of Compliance |
| Lixisenatide | Drugs used in diabetes | 193862 | 2016-06 | 2017-05 | Issued Notice of Compliance |
| Lonoctocog alfa | Antihemorrhagics | 190891 | 2016-02 | 2016-12 | Issued Notice of Compliance |
| Lorcaserin hydrochloride | Antiobesity preparations, excluding diet products | 198689 | 2016-11 | 2018-02 | Cancelled by sponsor |
| Lorlatinib | Antineoplastic agents | 215733 | 2018-06 | 2019-02 | Issued Notice of Compliance under the NOC/c Guidance |
| Lurbinectedin | Antineoplastic agents | 247485 | 2021-01 | 2021-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Lumasiran | Other alimentary tract and metabolism products | 254883 | 2021-08 | 2022-03 | Issued Notice of Compliance |
| Luspatercept | Antianemic preparations | 236441 | 2020-03 | 2020-09 | Issued Notice of Compliance |
| Luspatercept | Antianemic preparations | 236625 | 2020-04 | 2021-02 | Issued Notice of Compliance |
| Lutetium (177Lu) oxodotretotide | Therapeutic radiopharmaceuticals | 217184 | 2018-07 | 2019-01 | Issued Notice of Compliance |
| Lutetium (177Lu) vipivotide tetraxetan | Therapeutic radiopharmaceuticals | 260951 | 2022-02 | 2022-08 | Issued Notice of Compliance |
| Macitentan, tadalafil | Antihypertensives | 245848 | 2020-12 | 2021-10 | Issued Notice of Compliance |
| Mannitol | Diagnostic agents | 217446 | 2018-08 | 2019-06 | Issued Notice of Compliance |
| Maralixibat chloride | Bile and liver therapy | 271030 | 2023-01 | 2023-07 | Issued Notice of Compliance |
| Maribavir | Antivirals for systemic use | 259676 | 2022-03 | 2022-09 | Issued Notice of Compliance |
| Mavacamten | Cardiac therapy | 258772 | 2022-01 | 2022-11 | Issued Notice of Compliance |
| Mecasermin | Pituitary, hypothalamic hormones and analogues | 235023 | 2020-02 | 2020-12 | Issued Notice of Compliance |
| Meningococcal group A polysaccharide-tetanus toxoid conjugate, meningococcal group C polysaccharide-tetanus toxoid conjugate, meningococcal group W polysaccharide-tetanus toxoid conjugate, meningococcal group Y polysaccharide-tetanus toxoid conjugate | Vaccines | 233632 | 2020-01 | 2020-10 | Issued Notice of Compliance |
| Mercaptamine bitartrate | Other alimentary tract and metabolism products | 191347 | 2016-03 | 2017-06 | Issued Notice of Compliance |
| Meropenem trihydrate | Antibacterials for systemic use | 266553 | 2023-03 | 2024-01 | Issued Notice of Compliance |
| Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 204605 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 198475 | 2017-02 | 2020-08 | Cancelled by sponsor |
| Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 194646 | 2016-09 | 2021-05 | Issued Notice of Compliance |
| Mesalazine | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 247241 | 2021-03 | 2022-01 | Issued Notice of Compliance |
| Metformin hydrochloride | Drugs used in diabetes | 263913 | 2022-07 | 2023-01 | Issued Notice of Compliance |
| Methotrexate | Immunosuppressants | 262108 | 2022-05 | 2024-03 | Issued Notice of Compliance |
| Methotrexate sodium | Immunosuppressants | 254599 | 2021-11 | 2022-09 | Issued Notice of Compliance |
| Methoxyflurane | Analgesics | 204879 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Methylene blue | Diagnostic agents | 219788 | 2018-10 | 2021-05 | Issued Notice of Non-compliance - Withdrawal |
| Methylphenidate hydrochloride | Psychoanaleptics | 243224 | 2021-01 | 2023-09 | Issued Notice of Compliance |
| Metreleptin | Other alimentary tract and metabolism products | 273908 | 2023-04 | 2024-01 | Issued Notice of Compliance |
| Midostaurin | Antineoplastic agents | 201101 | 2017-01 | 2017-07 | Issued Notice of Compliance |
| Migalastat hydrochloride | Other alimentary tract and metabolism products | 196956 | 2016-11 | 2017-09 | Issued Notice of Compliance |
| Mirikizumab | Immunosuppressants | 266471 | 2022-09 | 2023-07 | Issued Notice of Compliance |
| Mogamulizumab | Antineoplastic agents | 251277 | 2021-05 | 2022-06 | Issued Notice of Compliance |
| Molnupiravir *For use in relation to COVID-19 |
Antivirals for systemic use | 255584 | 2021-08 | 2023-04 | Cancelled by sponsor |
| Mometasone furoate | Corticosteroids, dermatological preparations | 199704 | 2017-09 | 2019-10 | Cancelled by sponsor |
| Mometasone furoate monohydrate, olopatadine hydrochloride | Nasal preparations | 238027 | 2020-07 | 2022-09 | Issued Notice of Compliance |
| Naloxone hydrochloride | All other therapeutic products | 193199 | 2016-04 | 2016-10 | Issued Notice of Compliance |
| Naloxone hydrochloride dihydrate | All other therapeutic products | 211970 | 2018-01 | 2019-06 | Cancelled by sponsor |
| Naproxen sodium, sumatriptan succinate | Analgesics | 225848 | 2019-05 | 2020-02 | Issued Notice of Compliance |
| Necitumumab | Antineoplastic agents | 193689 | 2016-05 | 2017-03 | Issued Notice of Compliance |
| Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B | Vaccines | 195550 | 2016-07 | 2017-10 | Issued Notice of Compliance |
| Neratinib maleate | Antineoplastic agents | 218224 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Netupitant, palonosetron hydrochloride | Antiemetics and antinauseants | 196495 | 2016-12 | 2017-09 | Issued Notice of Compliance |
| Nicardipine hydrochloride | Calcium channel blockers | 216257 | 2018-07 | 2020-04 | Issued Notice of Non-compliance - Withdrawal |
| Niraparib | Antineoplastic agents | 216792 | 2018-09 | 2019-06 | Issued Notice of Compliance |
| Nirmatrelvir, ritonavir *For use in relation to COVID-19 |
Antivirals for systemic use | 259186 | 2021-12 | 2022-01 | Issued Notice of Compliance |
| Nirsevimab | Immune sera and immunoglobulins | 269388 | 2022-12 | 2023-04 | Issued Notice of Compliance |
| Nitisinone | Other alimentary tract and metabolism products | 190564 | 2016-03 | 2016-09 | Issued Notice of Compliance |
| Nitisinone | Other alimentary tract and metabolism products | 193226 | 2016-07 | 2016-12 | Issued Notice of Compliance |
| Nitisinone | Other alimentary tract and metabolism products | 193770 | 2016-05 | 2016-11 | Issued Notice of Compliance |
|
Nitric oxideTable 3 footnote b |
Other nervous system drugs | 253630 | 2021-06 | 2021-09 | Cancelled by sponsor |
| Nivolumab, relatlimab | Antineoplastic agents | 256629 | 2022-09 | 2023-09 | Issued Notice of Compliance |
| Nusinersen | Other drugs for disorders of the musculo-skeletal systemOther | 200070 | 2016-12 | 2017-06 | Issued Notice of Compliance |
| Obeticholic acid | Bile and liver therapy | 198418 | 2016-10 | 2017-05 | Issued Notice of Compliance under the NOC/c Guidance |
| Obiltoxaximab | Immune sera and immunoglobulins | 230825 | 2019-10 | 2020-07 | Issued Notice of Compliance |
| Ocrelizumab | Immunosuppressants | 198094 | 2016-10 | 2017-08 | Issued Notice of Compliance |
| Ocrelizumab | Immunosuppressants | 197969 | 2016-10 | 2018-02 | Issued Notice of Compliance under the NOC/c Guidance |
| Odevixibat | Bile and liver therapy | 273741 | 2023-05 | 2023-10 | Issued Notice of Compliance |
| Ofatumumab | Antineoplastic agents | 237346 | 2020-05 | 2021-01 | Issued Notice of Compliance |
| Olaparib | Antineoplastic agents | 182823 | 2015-06 | 2016-04 | Issued Notice of Compliance under the NOC/c Guidance |
| Olaratumab | Antineoplastic agents | 203478 | 2017-04 | 2017-11 | Issued Notice of Compliance under the NOC/c Guidance |
| Olipudase alfa | Other alimentary tract and metabolism products | 275236 | 2023-06 | 2024-02 | Issued Notice of Compliance |
| Onasemnogene abeparvovec | Other drugs for disorders of the musculo-skeletal system | 239719 | 2020-06 | 2020-12 | Issued Notice of Compliance |
| Osimertinib | Antineoplastic agents | 188171 | 2015-11 | 2016-07 | Issued Notice of Compliance under the NOC/c Guidance |
| Ospemifene | Sex hormones and modulators of the genital system | 222001 | 2019-03 | 2021-07 | Issued Notice of Compliance |
| Oxycodone | Analgesics | 198865 | 2016-11 | 2018-07 | Cancelled by sponsor |
| Ozanimod hydrochloride | Immunosuppressants | 232761 | 2019-12 | 2020-10 | Issued Notice of Compliance |
| Ozenoxacin | Antibiotics and chemotherapy for dermatological use | 192925 | 2016-07 | 2017-05 | Issued Notice of Compliance |
| Palovarotene | Other drugs for disorders of the musculo-skeletal system | 252065 | 2021-07 | 2022-01 | Issued Notice of Compliance |
| Panobinostat | Antineoplastic agents | 187504 | 2015-11 | 2016-06 | Cancelled by sponsor |
| Patiromer sorbitex calcium | All other therapeutic products | 210368 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Patisiran | Other nervous system drugs | 221896 | 2018-12 | 2019-06 | Issued Notice of Compliance |
| Pegaspargase | Antineoplastic agents | 189795 | 2016-05 | 2017-02 | Issued Notice of Compliance |
| Pegcetaclopan | Immunosuppressants | 263432 | 2022-06 | 2022-12 | Issued Notice of Compliance |
| Pegfilgrastim | Immunostimulants | 204841 | 2017-06 | 2018-04 | Issued Notice of Compliance |
| Pegfilgrastim | Immunostimulants | 200807 | 2017-01 | 2018-12 | Issued Notice of Compliance |
| Pegfilgrastim | Immunostimulants | 220445 | 2019-05 | 2020-04 | Issued Notice of Compliance |
| Pegfilgrastim | Immunostimulants | 233373 | 2020-01 | 2020-10 | Issued Notice of Compliance |
| Pegfilgrastim | Immunostimulants | 232048 | 2019-11 | 2021-07 | Cancelled by sponsor |
| Pegfilgrastim | Immunostimulants | 262438 | 2022-05 | 2024-04 | Issued Notice of Compliance |
| Pegfilgrastim | Immunostimulants | 271699 | 2023-06 | 2024-07 | Cancelled by sponsor |
| Pegfilgrastim | Immunostimulants | 262990 | 2022-05 | 2024-08 | Issued Notice of Compliance |
| Pegvaliase | Other alimentary tract and metabolism products | 251687 | 2021-06 | 2022-03 | Issued Notice of Compliance |
| Pemigatinib | Antineoplastic agents | 242569 | 2020-10 | 2021-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Peramivir | Antivirals for systemic use | 191280 | 2016-03 | 2017-01 | Issued Notice of Compliance |
| Perfluorohexyloctane | Ophthalmologicals | 272066 | 2023-08 | 2024-09 | Issued Notice of Compliance |
| Perindopril arginine | Agents acting on the renin-angiotensin system | 201189 | 2017-08 | 2018-03 | Issued Notice of Compliance |
| Pertuzumab, trastuzumab | Antineoplastic agents | 237402 | 2020-05 | 2021-03 | Issued Notice of Compliance |
| Pitolisant | Other nervous system drugs | 238175 | 2020-05 | 2021-05 | Issued Notice of Compliance |
| Plecanatide | Drugs for constipation | 215288 | 2018-12 | 2019-10 | Issued Notice of Compliance |
| Polatuzumab vedotin | Antineoplastic agents | 232303 | 2019-11 | 2020-07 | Issued Notice of Compliance under the NOC/c Guidance |
| Ponesimod | Immunosuppressants | 239537 | 2020-07 | 2021-04 | Issued Notice of Compliance |
| PrabotulinumtoxinA | Muscle relaxants | 208364 | 2017-10 | 2018-08 | Issued Notice of Compliance |
| Pralatrexate | Antineoplastic agents | 207545 | 2017-11 | 2018-10 | Issued Notice of Compliance under the NOC/c Guidance |
| Pralsetinib | Antineoplastic agents | 243731 | 2020-11 | 2021-06 | Issued Notice of Compliance under the NOC/c Guidance |
| Pralsetinib | Antineoplastic agents | 252270 | 2021-06 | 2022-04 | Cancelled by sponsor |
| Prasterone | Anabolic agents for systemic use | 198822 | 2016-12 | 2019-11 | Issued Notice of Compliance |
| Progesterone | Sex hormones and modulators of the genital system | 211548 | 2018-02 | 2018-08 | Issued Notice of Compliance |
| Progesterone | Sex hormones and modulators of the genital system | 239820 | 2020-07 | 2021-04 | Issued Notice of Compliance |
| Propiverine hydrochloride | Urologicals | 188323 | 2016-03 | 2017-01 | Issued Notice of Compliance |
| Rabies immunoglobulin, human | Immune sera and immunoglobulins | 211541 | 2018-01 | 2018-11 | Issued Notice of Compliance |
| Ranibizumab | Ophthalmologicals | 251162 | 2021-05 | 2022-03 | Issued Notice of Compliance |
| Ranibizumab | Ophthalmologicals | 254848 | 2021-09 | 2022-09 | Issued Notice of Compliance |
| Ranibizumab | Ophthalmologicals | 268288 | 2022-12 | 2023-10 | Issued Notice of Compliance |
| Ranolazine | Cardiac therapy | 239943 | 2020-07 | 2020-12 | Issued Notice of Compliance |
| Ravulizumab | Immunosuppressants | 217955 | 2018-11 | 2019-08 | Issued Notice of Compliance |
| Raxtozinameran *For use in relation to COVID-19 |
Vaccines | 276302 | 2023-06 | 2023-09 | Issued Notice of Compliance |
| Recombinant fusion protein linking factor IX with recombinant albumin (RIX-FP) | Antihemorrhagics | 180793 | 2015-04 | 2016-01 | Issued Notice of Compliance |
| Recombinant haemagglutinin-strain A (H1N1) virus-like particles, Recombinant haemagglutinin-strain A (H3N2) virus-like particles, Recombinant haemagglutinin-strain B (Victoria lineage) virus-like particles, Recombinant haemagglutinin-strain B (Yamagata lineage) virus-like particles | Vaccines | 230211 | 2019-09 | 2021-09 | Cancelled by sponsor |
| Recombinant influenza strain A H1N1 HA protein, recombinant influenza strain A H3N2 HA protein, recombinant influenza strain B (Victoria lineage) HA protein, recombinant influenza strain B (Yamagata lineage) HA protein | Vaccines | 235672 | 2020-03 | 2021-01 | Issued Notice of Compliance |
| RelabotulinumtoxinA | Muscle relaxants | 271756 | 2023-03 | 2024-01 | Cancelled by sponsor |
| Relugolix | Endocrine therapy | 269372 | 2022-12 | 2023-10 | Issued Notice of Compliance |
| Remdesivir | Antivirals for systemic use | 240551 | 2020-07 | 2020-07 | Issued Notice of Compliance under the NOC/c Guidance |
| Reslizumab | Immunosuppressants | 185873 | 2015-09 | 2016-07 | Issued Notice of Compliance |
| Respiratory syncytial virus prefusion F protein (RSVPreF3) | Vaccines | 269021 | 2022-11 | 2023-08 | Issued Notice of Compliance |
| Ribociclib | Antineoplastic agents | 203884 | 2017-05 | 2018-03 | Issued Notice of Compliance |
| Riltozinameran, tozinameran *For use in relation to COVID-19 |
Vaccines | 266189 | 2022-07 | 2022-10 | Issued Notice of Compliance |
| Rimegepant | Analgesics | 268384 | 2023-01 | 2023-12 | Issued Notice of Compliance |
| Ripretinib | Antineoplastic agents | 234688 | 2020-03 | 2020-06 | Issued Notice of Compliance |
| Risankizumab | Immunosuppressants | 215753 | 2018-06 | 2019-04 | Issued Notice of Compliance |
| Risdiplam | Other drugs for disorders of the musculo-skeletal system | 242373 | 2020-10 | 2021-04 | Issued Notice of Compliance |
| Risperidone | Psycholeptics | 233331 | 2020-01 | 2020-11 | Issued Notice of Compliance |
| Risperidone | Psycholeptics | 264840 | 2022-12 | 2024-03 | Issued Notice of Compliance |
| Ritlecitinib | Immunosuppressants | 268723 | 2023-02 | 2023-11 | Issued Notice of Compliance |
| Rituximab | Antineoplastic agents | 207702 | 2017-09 | 2019-03 | Cancelled by sponsor |
| Rituximab | Antineoplastic agents | 208107 | 2017-09 | 2019-03 | Cancelled by sponsor |
| Rituximab | Antineoplastic agents | 208204 | 2017-09 | 2019-04 | Issued Notice of Compliance |
| Rituximab | Antineoplastic agents | 224672 | 2019-03 | 2019-04 | Cancelled by sponsor |
| Rituximab | Antineoplastic agents | 214058 | 2018-04 | 2020-04 | Issued Notice of Compliance |
| Rituximab | Antineoplastic agents | 224164 | 2019-03 | 2020-05 | Issued Notice of Compliance |
| Rituximab | Antineoplastic agents | 237814 | 2020-05 | 2021-03 | Issued Notice of Compliance |
| Roflumilast | Other dermatological preparations | 264296 | 2022-07 | 2023-04 | Issued Notice of Compliance |
| Romosozumab | Drugs for treatment of bone diseases | 197713 | 2016-10 | 2019-06 | Issued Notice of Compliance |
| Roxadustat | Antianemic preparations | 236566 | 2020-03 | 2021-10 | Cancelled by sponsor |
| RSV F antigen 847A, recombinant, RSV F antigen 847B, recombinant | Vaccines | 272785 | 2023-03 | 2023-12 | Issued Notice of Compliance |
| Rupatadine fumarate | Antihistamines for systemic use | 186488 | 2015-09 | 2016-07 | Issued Notice of Compliance |
| Sabizabulin *For use in relation to COVID-19 |
Antivirals for systemic use | 270055 | 2022-11 | 2023-06 | Cancelled by sponsor |
| Sacituzumab govitecan | Antineoplastic agents | 248753 | 2021-03 | 2021-09 | Issued Notice of Compliance |
| Safinamide | Anti-parkinson drugs | 207115 | 2018-03 | 2019-01 | Issued Notice of Compliance |
| Salbutamol sulfate | Drugs for obstructive airway diseases | 189577 | 2016-11 | 2017-11 | Issued Notice of Compliance |
| Sarilumab | Immunosuppressants | 191745 | 2016-03 | 2017-01 | Issued Notice of Compliance |
| SARS-CoV-2 prefusion spike delta TM protein, recombinant *For use in relation to COVID-19 |
Vaccines | 254715 | 2021-07 | 2023-02 | Cancelled by sponsor |
| SARS-CoV-2 prefusion spike delta TM protein, recombinant *For use in relation to COVID-19 |
Vaccines | 269939 | 2022-12 | 2023-02 | Cancelled by sponsor |
| SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 |
Vaccines | 255370 | 2021-10 | 2022-02 | Issued Notice of Compliance |
| SARS-CoV-2 recombinant spike protein (Omicron XBB.1.5) *For use in relation to COVID-19 |
Vaccines | 278519 | 2023-09 | 2023-12 | Issued Notice of Compliance |
| Satralizumab | Immunosuppressants | 233642 | 2019-12 | 2020-06 | Issued Notice of Compliance |
| Sebelipase alfa | Other alimentary tract and metabolism products | 204085 | 2017-04 | 2017-12 | Issued Notice of Compliance under the NOC/c Guidance |
| Selinexor | Antineoplastic agents | 253182 | 2021-08 | 2022-05 | Issued Notice of Compliance |
| Selpercatinib | Antineoplastic agents | 243748 | 2020-10 | 2021-06 | Issued Notice of Compliance under the NOC/c Guidance |
| Selumetinib | Antineoplastic agents | 243733 | 2020-11 | 2022-08 | Issued Notice of Compliance |
| Semaglutide | Drugs used in diabetes | 202059 | 2017-03 | 2018-01 | Issued Notice of Compliance |
| Semaglutide | Drugs used in diabetes | 226906 | 2019-06 | 2020-03 | Issued Notice of Compliance |
| Semaglutide | Drugs used in diabetes | 247235 | 2021-01 | 2021-11 | Issued Notice of Compliance |
| Setmelanotide acetate | Antiobesity preparations, excluding diet products | 268412 | 2022-11 | 2023-05 | Issued Notice of Compliance |
| Siponimod | Immunosuppressants | 223225 | 2019-02 | 2020-02 | Issued Notice of Compliance |
| Sirukumab | Immunosuppressants | 205568 | 2017-06 | 2017-10 | Cancelled by sponsor |
| Smallpox vaccine dried | Vaccines | 270800 | 2023-02 | 2023-12 | Issued Notice of Compliance |
| Sodium chloride, sodium citrate | Blood substitutes and perfusion solutions | 225953 | 2019-05 | 2020-03 | Issued Notice of Compliance |
| Sodium pertechnetate Tc-99m | Diagnostic radiopharmaceuticals | 231915 | 2020-01 | 2020-11 | Issued Notice of Compliance |
| Sodium phenylbutyrate, ursodoxicoltaurine | Other nervous system drugs | 253502 | 2021-08 | 2022-06 | Issued Notice of Compliance under the NOC/c Guidance |
| Sodium zirconium cyclosilicate | All other therapeutic products | 218799 | 2018-09 | 2019-07 | Issued Notice of Compliance |
| Sofosbuvir, velpatasvir | Antivirals for systemic use | 190521 | 2016-01 | 2016-07 | Issued Notice of Compliance |
| Sofosbuvir, velpatasvir, voxilaprevir | Antivirals for systemic use | 202324 | 2017-02 | 2017-08 | Issued Notice of Compliance |
| Solriamfetol hydrochloride | Psychoanaleptics | 237511 | 2020-07 | 2021-05 | Issued Notice of Compliance |
| Somapacitan | Pituitary, hypothalamic hormones and analogues | 267443 | 2022-09 | 2023-07 | Issued Notice of Compliance |
| Somatrogon | Pituitary, hypothalamic hormones and analogues | 246729 | 2020-12 | 2021-10 | Issued Notice of Compliance |
| Sonidegib | Antineoplastic agents | 229407 | 2019-08 | 2020-06 | Issued Notice of Compliance |
| Sotagliflozin | Drugs used in diabetes | 217853 | 2018-08 | 2019-06 | Cancelled by sponsor |
| Sotorasib | Antineoplastic agents | 248435 | 2021-02 | 2021-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Sotatercept | Antihypertensives | 283307 | 2024-03 | 2024-08 | Issued Notice of Compliance |
| SotrovimabTable 3 footnote b *For use in relation to COVID-19 |
Immune sera and immunoglobulins | 251285 | 2021-04 | 2021-07 | Authorized under Interim Order |
| Sotrovimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins | 257895 | 2021-10 | 2024-04 | Cancelled by sponsor |
| Spesolimab | Immunosuppressants | 267362 | 2022-09 | 2023-03 | Issued Notice of Compliance |
| Sucroferric oxyhydroxide | All other therapeutic products | 201492 | 2017-02 | 2018-01 | Issued Notice of Compliance |
| Sugammadex | All other therapeutic products | 180385 | 2015-04 | 2016-02 | Issued Notice of Compliance |
| Suvorexant | Psycholeptics | 196367 | 2016-08 | 2018-11 | Issued Notice of Compliance |
| Tacrolimus | Immunosuppressants | 209210 | 2018-04 | 2019-02 | Issued Notice of Compliance |
| Tafamidis | Other nervous system drugs | 240239 | 2020-09 | 2021-07 | Issued Notice of Compliance |
| Tafamidis meglumine | Other nervous system drugs | 228368 | 2019-07 | 2020-01 | Issued Notice of Compliance |
| Tafasitamab | Antineoplastic agents | 247025 | 2020-12 | 2021-08 | Issued Notice of Compliance |
| Talazoparib | Antineoplastic agents | 220584 | 2018-11 | 2019-09 | Issued Notice of Compliance |
| Talquetamab | Antineoplastic agents | 278277 | 2023-09 | 2024-04 | Issued Notice of Compliance under the NOC/c Guidance |
| Tarlatamab | Antineoplastic agents | 281963 | 2024-01 | 2024-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Tazarotene | Antipsoriatics | 236286 | 2020-09 | 2021-07 | Issued Notice of Compliance |
| Tebentafusp | Antineoplastic agents | 258717 | 2021-12 | 2022-06 | Issued Notice of Compliance |
| Teclistamab | Antineoplastic agents | 269369 | 2022-12 | 2023-07 | Issued Notice of Compliance under the NOC/c Guidance |
| Tecovirimat monohydrate | Antivirals for systemic use | 247561 | 2021-02 | 2021-11 | Issued Notice of Compliance |
| Telotristat etiprate | Antidiarrheals, intestinal anti-inflammatory/anti-infective agents | 208730 | 2017-12 | 2018-10 | Issued Notice of Compliance |
| Tenapanor | Drugs for constipation | 224850 | 2019-06 | 2020-04 | Issued Notice of Compliance |
| Tenofovir alafenamide hemifumarate | Antivirals for systemic use | 193066 | 2016-07 | 2017-05 | Issued Notice of Compliance |
| Tepotinib | Antineoplastic agents | 242300 | 2020-10 | 2021-05 | Issued Notice of Compliance under the NOC/c Guidance |
| Teriparatide | Calcium homeostasis | 215409 | 2018-06 | 2020-01 | Issued Notice of Compliance |
| Tezepelumab | Drugs for obstructive airway diseases | 256188 | 2021-10 | 2022-07 | Issued Notice of Compliance |
| Tibolone | Sex hormones and modulators of the genital system | 206099 | 2017-10 | 2019-05 | Issued Notice of Compliance |
| Tildrakizumab | Immunosuppressants | 224036 | 2019-02 | 2021-05 | Issued Notice of Compliance |
| Tipiracil hydrochloride, trifluridine | Antineoplastic agents | 205852 | 2017-07 | 2018-01 | Issued Notice of Compliance |
| Tirbanibulin | Antibiotics and chemotherapy for dermatological use | 262080 | 2022-07 | 2023-05 | Issued Notice of Compliance |
| Tirzepatide | Drugs used in diabetes | 259103 | 2022-02 | 2022-11 | Issued Notice of Compliance |
| Tisagenlecleucel-T | Antineoplastic agents | 213547 | 2018-03 | 2018-09 | Issued Notice of Compliance |
| Tisagenlecleucel-T | Antineoplastic agents | 213698 | 2018-03 | 2018-09 | Issued Notice of Compliance |
| TozinameranTable 3 footnote b *For use in relation to COVID-19 |
Vaccines | 244906 | 2020-10 | 2020-12 | Authorized under Interim Order |
| Tozinameran *For use in relation to COVID-19 |
Vaccines | 252736 | 2021-06 | 2021-09 | Issued Notice of Compliance |
| Tralokinumab | Other dermatological preparations | 245877 | 2020-12 | 2021-10 | Issued Notice of Compliance |
| Trastuzumab | Antineoplastic agents | 204579 | 2017-06 | 2019-05 | Issued Notice of Compliance |
| Trastuzumab | Antineoplastic agents | 212140 | 2018-02 | 2019-08 | Issued Notice of Compliance |
| Trastuzumab | Antineoplastic agents | 210238 | 2017-11 | 2019-09 | Issued Notice of Compliance |
| Trastuzumab | Antineoplastic agents | 208836 | 2017-10 | 2020-02 | Issued Notice of Compliance |
| Trastuzumab | Antineoplastic agents | 235995 | 2020-04 | 2022-01 | Issued Notice of Compliance |
| Trastuzumab | Antineoplastic agents | 253850 | 2021-08 | 2023-06 | Cancelled by sponsor |
| Trastuzumab | Antineoplastic agents | 275910 | 2023-07 | 2024-08 | Issued Notice of Compliance |
| Trastuzumab deruxtecan | Antineoplastic agents | 242104 | 2020-08 | 2021-04 | Issued Notice of Compliance under the NOC/c Guidance |
| Tremelimumab | Antineoplastic agents | 262740 | 2022-05 | 2023-08 | Issued Notice of Compliance |
| Treosulfan | Antineoplastic agents | 244137 | 2020-12 | 2021-06 | Issued Notice of Compliance |
| Treosulfan | Antineoplastic agents | 231223 | 2020-01 | 2021-06 | Issued a Notice of Deficiency - Withdrawal |
| Triamcinolone hexacetonide | Corticosteroids for systemic use | 201546 | 2017-02 | 2017-12 | Issued Notice of Compliance |
| Trientine hydrochloride | Other alimentary tract and metabolism products | 228708 | 2019-11 | 2020-09 | Issued Notice of Compliance |
| Trientine hydrochloride | All other therapeutic products | 237287 | 2020-06 | 2021-04 | Issued Notice of Compliance |
| Trifarotene | Anti-acne preparations | 221945 | 2019-01 | 2019-11 | Issued Notice of Compliance |
| Triheptanoin | Other alimentary tract and metabolism | 242196 | 2020-08 | 2021-02 | Issued Notice of Compliance |
| Tucatinib | Antineoplastic agents | 235295 | 2020-02 | 2020-06 | Issued Notice of Compliance |
| Ubrogepant | Analgesics | 256191 | 2021-10 | 2022-11 | Issued Notice of Compliance |
| Upadacitinib | Immunosuppressants | 223734 | 2019-03 | 2019-12 | Issued Notice of Compliance |
| Ustekinumab | Immunosuppressants | 268742 | 2023-01 | 2023-11 | Issued Notice of Compliance |
| Ustekinumab | Immunosuppressants | 269097 | 2023-03 | 2023-12 | Issued Notice of Compliance |
| Ustekinumab | Immunosuppressants | 274939 | 2023-08 | 2024-07 | Issued Notice of Compliance |
| Ustekinumab | Immunosuppressants | 277532 | 2023-10 | 2024-08 | Issued Notice of Compliance |
| Ustekinumab | Immunosuppressants | 278712 | 2023-10 | 2024-08 | Issued Notice of Compliance |
| Varicella-zoster virus glycoprotein E (GE) | Vaccines | 200244 | 2016-12 | 2017-10 | Issued Notice of Compliance |
| Venetoclax | Antineoplastic agents | 190761 | 2016-02 | 2016-09 | Issued Notice of Compliance under the NOC/c Guidance |
| Vericiguat | Cardiac therapy | 240862 | 2021-01 | 2023-04 | Issued Notice of Compliance |
| Vernakalant hydrochloride | Cardiac therapy | 190817 | 2016-05 | 2017-03 | Issued Notice of Compliance |
| Vibrio cholerae, strain CVD 103-HgR, live | Vaccines | 264995 | 2022-07 | 2023-05 | Issued Notice of Compliance |
| Virus-like particles (VLP) of SARS-CoV-2 spike protein *For use in relation to COVID-19 |
Vaccines | 254598 | 2021-09 | 2022-02 | Issued Notice of Compliance |
| Vitamin D3 | Vitamins | 219321 | 2019-01 | 2021-02 | Issued Notice of Compliance |
| Vitamin K1 | Antihemorrhagics | 225983 | 2019-08 | 2021-06 | Issued a Notice of Deficiency - Withdrawal |
| Volanesorsen | Lipid modifying agents | 209280 | 2017-11 | 2018-11 | Issued Notice of Non-compliance - Withdrawal |
| Vonicog alfa | Antihemorrhagics | 213188 | 2018-03 | 2019-01 | Issued Notice of Compliance |
| Vorasidenib citrate | Antineoplastic agents | 282910 | 2024-03 | 2024-08 | Issued Notice of Compliance |
| Voretigene neparvovec | Ophthalmologicals | 233097 | 2019-12 | 2020-10 | Issued Notice of Compliance |
| Vutrisiran | Other nervous system drugs | 267923 | 2022-12 | 2023-10 | Issued Notice of Compliance |
| Whole virion inactivated coronavirus *For use in relation to COVID-19 |
Vaccines | 254518 | 2021-07 | 2022-08 | Cancelled by sponsor |
| Zanubrutinib | Antineoplastic agents | 242748 | 2020-09 | 2021-03 | Issued Notice of Compliance |
| Zanubrutinib | Antineoplastic agents | 242885 | 2020-09 | 2021-07 | Issued Notice of Compliance |
| Zilucoplan | Immunosuppressants | 276757 | 2023-08 | 2024-07 | Issued Notice of Compliance |
| Zofenopril calcium | Agents acting on the renin-angiotensin system | 212392 | 2018-06 | 2019-06 | Cancelled by sponsor |
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