Drug and Health Product Submissions Under Review (SUR): Supplemental submissions completed
This list is current as of: 2025-02-28.
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 |
|---|---|---|---|---|---|
Abacavir sulfate, dolutegravir sodium, lamivudine |
Antivirals for systemic use |
208070 |
2017-08 |
2017-10 |
|
Abatacept |
Immunosuppressants |
204313 |
2017-05 |
2018-03 |
|
Abatacept |
Immunosuppressants |
255926 |
2021-09 |
2022-07 |
|
Abemaciclib |
Antineoplastic agents |
249557 |
2021-03 |
2022-01 |
Issued Notice of Compliance |
Abemaciclib |
Antineoplastic agents |
270898 |
2023-03 |
2023-12 |
|
Abiraterone acetate |
Endocrine therapy |
207915 |
2017-08 |
2018-02 |
|
AbobotulinumtoxinA |
Muscle relaxants |
202245 |
2017-03 |
2017-12 |
|
AbobotulinumtoxinA |
Muscle relaxants |
204299 |
2017-05 |
2018-03 |
|
AbobotulinumtoxinA |
Muscle relaxants |
206921 |
2017-08 |
2018-04 |
|
AbobotulinumtoxinA |
Muscle relaxants |
236999 |
2020-04 |
2021-02 |
|
Acalabrutinib |
Antineoplastic agents |
231228 |
2019-10 |
2019-11 |
Issued Notice of Compliance |
Ad26.COV2.S (recombinant) *For use in relation to COVID-19 |
Vaccines |
259715 |
2021-12 |
2022-05 |
|
Adalimumab |
Immunosuppressants |
197529 |
2016-09 |
2017-07 |
Issued Notice of Compliance |
Adalimumab |
Immunosuppressants |
201423 |
2017-02 |
2017-12 |
Issued Notice of Compliance |
Adalimumab |
Immunosuppressants |
212133 |
2018-02 |
2018-11 |
|
Adalimumab |
Immunosuppressants |
213550 |
2018-03 |
2019-01 |
|
Adalimumab |
Immunosuppressants |
219453 |
2018-10 |
2020-11 |
|
Adalimumab |
Immunosuppressants |
234183 |
2019-12 |
2020-11 |
|
Adalimumab |
Immunosuppressants |
234258 |
2020-01 |
2020-11 |
|
Adalimumab |
Immunosuppressants |
239280 |
2020-06 |
2021-04 |
|
Adalimumab |
Immunosuppressants |
244618 |
2020-11 |
2021-09 |
|
Adalimumab |
Immunosuppressants |
257327 |
2021-11 |
2022-08 |
|
Adalimumab |
Immunosuppressants |
256159 |
2021-10 |
2022-09 |
|
Adalimumab |
Immunsuppressants |
258125 |
2021-12 |
2022-10 |
|
Adalimumab |
Immunsuppressants |
259979 |
2022-02 |
2022-11 |
|
Adalimumab |
Immunosuppressants |
282461 |
2024-03 |
2025-01 |
Issued Notice of Compliance |
Afatinib dimaleate |
Antineoplastic agents |
209785 |
2017-12 |
2018-09 |
Issued Notice of Compliance |
Alectinib |
Antineoplastic agents |
210816 |
2017-12 |
2018-06 |
Issued Notice of Compliance |
Alectinib hydrochloride |
Antineoplastic agents |
282375 |
2024-01 |
2024-06 |
Issued Notice of Compliance |
Alemtuzumab |
Immunosuppressants |
239220 |
2020-07 |
2021-04 |
Issued Notice of Compliance |
Alirocumab |
Lipid modifying agents |
219669 |
2018-10 |
2019-07 |
|
Alpha 1-proteinase inhibitor (human) |
Antihemorrhagics |
205855 |
2017-06 |
2017-06 |
|
Amivantamab |
Antineoplastic agents |
282121 |
2024-01 |
2024-06 |
Issued Notice of Compliance |
Amivantamab |
Antineoplastic agents |
283969 |
2024-03 |
2025-01 |
Issued Notice of Compliance |
Anakinra |
Immunosuppressants |
195649 |
2016-07 |
2017-05 |
|
Anakinra |
Immunosuppressants |
237738 |
2020-05 |
2021-10 |
|
Anidulafungin |
Antimycotics for systemic use |
262044 |
2022-07 |
2023-05 |
|
Anthrax antigen filtrate |
Vaccines |
234257 |
2020-01 |
2020-11 |
|
Antihemophilic factor (recombinant) |
Antihemorrhagics |
250002 |
2021-03 |
2022-01 |
Issued Notice of Compliance |
Antihemophilic factor (recombinant), pegylated |
Antihemorrhagics |
211971 |
2018-01 |
2018-11 |
|
Antihemophilic factor (recombinant), pegylated |
Antihemorrhagics |
245031 |
2020-11 |
2021-11 |
Issued Notice of Compliance |
Antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated |
Antihemorrhagics |
268221 |
2022-11 |
2023-09 |
|
Apalutamide |
Endocrine therapy |
228077 |
2019-06 |
2019-12 |
Issued Notice of Compliance |
Apixaban |
Antithrombotic agents |
198842 |
2016-11 |
2018-10 |
Issued Notice of Compliance |
Apremilast |
Immunosuppressants |
233030 |
2019-12 |
2020-08 |
Issued Notice of Compliance |
Aripiprazole |
Psycholeptics |
200292 |
2017-01 |
2017-11 |
|
Aripiprazole |
Psycholeptics |
266917 |
2022-09 |
2025-01 |
Issued Notice of Compliance |
Atenolol |
Beta blocking agents |
278283 |
2023-09 |
2024-01 |
Issued Notice of Compliance |
Atenolol |
Beta blocking agents |
278032 |
2023-09 |
2024-02 |
Issued Notice of Compliance |
Atenolol |
Beta blocking agents |
279029 |
2023-10 |
2024-02 |
Issued Notice of Compliance |
Atezolizumab |
Antineoplastic agents |
205038 |
2017-06 |
2018-04 |
|
Atezolizumab |
Antineoplastic agents |
217324 |
2018-07 |
2019-05 |
|
Atezolizumab |
Antineoplastic agents |
223753 |
2019-02 |
2019-08 |
|
Atezolizumab |
Antineoplastic agents |
223911 |
2019-02 |
2019-09 |
Issued Notice of Compliance under the NOC/c Guidance |
Atezolizumab |
Antineoplastic agents |
226905 |
2019-06 |
2020-04 |
|
Atezolizumab |
Antineoplastic agents |
235450 |
2020-02 |
2020-08 |
|
Atezolizumab |
Antineoplastic agents |
237371 |
2020-05 |
2021-03 |
|
Atezolizumab |
Antineoplastic agents |
254361 |
2021-07 |
2022-01 |
|
Atezolizumab |
Antineoplastic agents |
254159 |
2021-08 |
2022-03 |
|
Atogepant |
Analgesics |
273484 |
2023-07 |
2024-05 |
|
Avelumab |
Antineoplastic agents |
225974 |
2019-04 |
2019-11 |
Issued Notice of Compliance under the NOC/c Guidance |
Avelumab |
Antineoplastic agents |
226954 |
2019-06 |
2020-06 |
|
Avelumab |
Antineoplastic agents |
240024 |
2020-06 |
2020-12 |
|
Axicabtagene ciloleucel |
Antineoplastic agents |
256106 |
2021-10 |
2022-09 |
Issued Notice of Compliance under the NOC/c Guidance |
Axicabtagene ciloleucel |
Antineoplastic agents |
259651 |
2022-02 |
2022-12 |
|
Axitinib |
Antineoplastic agents |
245813 |
2020-12 |
2021-10 |
Issued Notice of Compliance |
Azelastine hydrochloride, fluticasone propionate |
Nasal preparations |
221498 |
2018-12 |
2019-10 |
|
Azelastine hydrochloride, fluticasone propionate |
Nasal preparations |
254371 |
2021-08 |
2022-05 |
|
Baricitinib |
Immunosuppressants |
245874 |
2020-12 |
2022-01 |
|
Baricitinib *For use in relation to COVID-19 |
Immunosuppressants |
256724 |
2021-10 |
2023-06 |
|
Baricitinib |
Immunosuppressants |
270684 |
2023-04 |
2024-01 |
|
Bazedoxifene acetate, conjugated estrogens |
Sex hormones and modulators of the genital system |
210469 |
2017-11 |
2018-09 |
|
Belimumab |
Immunosuppressants |
243390 |
2020-10 |
2021-07 |
|
Belzutifan |
Antineoplastic agents |
270609 |
2023-01 |
2023-07 |
Issued Notice of Compliance |
Belzutifan |
Antineoplastic agents |
282593 |
2024-02 |
2024-12 |
Issued Notice of Compliance |
Betamethasone dipropionate, calcipotriol monohydrate |
Corticosteroids, dermatological preparations |
247673 |
2021-01 |
2021-10 |
Issued Notice of Compliance |
Bevacizumab |
Antineoplastic agents |
207259 |
2017-08 |
2018-06 |
|
Bevacizumab |
Antineoplastic agents |
218844 |
2018-09 |
2019-06 |
|
Bevacizumab |
Antineoplastic agents |
230254 |
2019-09 |
2020-02 |
|
Bevacizumab |
Antineoplastic agents |
232977 |
2019-11 |
2021-01 |
Issued Notice of Compliance |
Bevacizumab |
Antineoplastic agents |
257734 |
2021-12 |
2022-10 |
|
Bevacizumab |
Antineoplastic agents |
259936 |
2022-02 |
2022-11 |
Issued Notice of Compliance |
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
226658 |
2019-05 |
2020-03 |
|
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
240953 |
2020-07 |
2021-05 |
|
Bilastine |
Antihistamines for systemic use |
241318 |
2020-10 |
2021-08 |
|
Bimekizumab |
Immunosuppressants |
273184 |
2023-05 |
2024-02 |
Issued Notice of Compliance |
Bimekizumab |
Immunosuppressants |
273663 |
2023-05 |
2024-03 |
|
Bisoprolol fumarate |
Beta blocking agents |
243497 |
2021-01 |
2024-01 |
|
Blinatumomab |
Antineoplastic agents |
197615 |
2016-09 |
2017-04 |
Issued Notice of Compliance under the NOC/c Guidance |
Blinatumomab |
Antineoplastic agents |
204154 |
2017-05 |
2018-03 |
|
Blinatumomab |
Antineoplastic agents |
210780 |
2017-12 |
2019-12 |
Issued Notice of Compliance under the NOC/c Guidance |
Blinatumomab |
Antineoplastic agents |
283004 |
2024-02 |
2024-12 |
|
Bosutinib |
Antineoplastic agents |
211317 |
2018-02 |
2018-12 |
|
Brentuximab vedotin |
Antineoplastic agents |
213996 |
2018-04 |
2018-12 |
|
Brentuximab vedotin |
Antineoplastic agents |
216513 |
2018-07 |
2019-05 |
|
Brentuximab vedotin |
Antineoplastic agents |
227030 |
2019-05 |
2019-11 |
|
Brentuximab vedotin |
Antineoplastic agents |
268334 |
2022-12 |
2023-09 |
|
Brexpiprazole |
Psycholeptics |
205854 |
2017-07 |
2019-02 |
|
Brexpiprazole |
Psycholeptics |
257995 |
2021-12 |
2022-06 |
|
Brexpiprazole |
Psycholeptics |
272694 |
2023-04 |
2024-01 |
|
Brexucabtagene autoleucel |
Antineoplastic agents |
262249 |
2022-04 |
2022-11 |
Issued Notice of Compliance |
Brigatinib |
Antineoplastic agents |
237680 |
2020-05 |
2021-03 |
|
Brivaracetam |
Antiepileptics |
226734 |
2019-05 |
2020-03 |
Issued Notice of Compliance |
Brolucizumab |
Ophthalmologicals |
259754 |
2022-02 |
2022-11 |
|
Budesonide |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
218994 |
2018-09 |
2020-03 |
Cancelled by sponsor |
Budesonide |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
238101 |
2020-05 |
2021-03 |
Issued Notice of Compliance |
Budesonide, formoterol fumarate dihydrate |
Drugs for obstructive airway diseases |
220998 |
2018-11 |
2019-09 |
|
Burosumab |
Drugs for the treatment of bone diseases |
229313 |
2019-08 |
2020-06 |
|
Burosumab |
Drugs for treatment of bone diseases |
249112 |
2021-03 |
2021-08 |
|
C1 esterase inhibitor (human) |
Other hematological agents |
197440 |
2016-09 |
2017-03 |
|
Cabotegravir, rilpivirine |
Antivirals for systemic use |
254233 |
2021-08 |
2022-06 |
|
Cabotegravir, rilpivirine |
Antivirals for systemic use |
258574 |
2022-02 |
2022-12 |
|
Cabozantinib |
Antineoplastic agents |
221859 |
2018-12 |
2019-10 |
Issued Notice of Compliance |
Cabozantinib |
Antineoplastic agents |
222733 |
2019-01 |
2019-11 |
Issued Notice of Compliance |
Cabozantinib |
Antineoplastic agents |
245824 |
2020-12 |
2021-10 |
Issued Notice of Compliance |
Cabozantinib malate |
Antineoplastic agents |
257143 |
2021-11 |
2022-04 |
Issued Notice of Compliance |
Cabozantinib malate |
Antineoplastic agents |
280615 |
2023-11 |
2024-09 |
Issued Notice of Compliance |
Canagliflozin |
Drugs used in diabetes |
194762 |
2016-06 |
2017-04 |
|
Canagliflozin |
Drugs used in diabetes |
210676 |
2017-12 |
2018-10 |
|
Canagliflozin |
Drugs used in diabetes |
229188 |
2019-08 |
2020-01 |
Issued Notice of Compliance |
Canagliflozin, metformin hydrochloride |
Drugs used in diabetes |
210969 |
2017-12 |
2018-10 |
Issued Notice of Compliance |
Canagliflozin, metformin hydrochloride |
Drugs used in diabetes |
232307 |
2019-11 |
2020-08 |
Issued Notice of Compliance |
Canakinumab |
Immunosuppressants |
195617 |
2016-07 |
2017-01 |
|
Canakinumab |
Immunosuppressants |
237113 |
2020-04 |
2021-02 |
|
Carbetocin |
Pituitary and hypothalamic hormones and analogues |
225949 |
2019-05 |
2020-02 |
Issued Notice of Compliance |
Carfilzomib |
Antineoplastic agents |
237196 |
2020-04 |
2021-01 |
Issued Notice of Compliance |
Carfilzomib |
Antineoplastic agents |
267413 |
2022-10 |
2023-07 |
Issued Notice of Compliance |
Carglumic acid |
Other alimentary tract and metabolism products |
227936 |
2019-06 |
2020-11 |
|
Ceftolozane, tazobactam sodium |
Antibacterials for systemic use |
224729 |
2019-03 |
2019-08 |
|
Cemiplimab |
Antineoplastic agents |
246918 |
2020-12 |
2021-10 |
|
Cemiplimab |
Antineoplastic agents |
256178 |
2021-09 |
2022-03 |
|
Cemiplimab |
Antineoplastic agents |
263700 |
2022-05 |
2023-04 |
|
Certolizumab pegol |
Immunosuppressants |
209082 |
2017-10 |
2018-08 |
|
Certolizumab pegol |
Immunosuppressants |
222049 |
2019-01 |
2019-11 |
|
ChAdOx1-S (recombinant) *For use in relation to COVID-19 |
Vaccines |
259446 |
2021-12 |
2022-03 |
|
Cilgavimab, tixagevimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins |
265382 |
2022-06 |
2022-10 |
|
Ciltacabtagene autoleucel |
Antineoplastic agents |
277017 |
2023-08 |
2024-07 |
|
Coagulation factor VIII (human), human plasma proteins, von Willebrand factor (human) |
Antihemorrhagics |
274244 |
2023-05 |
2024-02 |
Issued Notice of Compliance |
Coagulation factor IX (recombinant), pegylated |
Antihemorrhagics |
258126 |
2021-12 |
2022-10 |
|
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
195789 |
2016-07 |
2017-05 |
Issued Notice of Compliance |
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
207251 |
2017-08 |
2018-06 |
|
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
219784 |
2018-10 |
2019-07 |
|
Collagenase clostridium histolyticum |
Other drugs for disorders of the musculo-skeletal system |
202488 |
2017-03 |
2018-01 |
|
Concizumab |
Antihemorrhagics |
285411 |
2024-05 |
2024-06 |
|
Corynebacterium diphtheriae CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F |
Vaccines |
259725 |
2022-01 |
2022-07 |
|
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 |
270922 |
2023-01 |
2023-07 |
|
Corynebacterium diphtheriae crm-197 protein, pneumococcal conjugate serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F |
Vaccines |
216208 |
2018-06 |
2019-04 |
|
Crisaborole |
Other dermatological preparations |
240171 |
2020-07 |
2021-05 |
|
Crizotinib |
Antineoplastic agents |
198322 |
2016-11 |
2017-08 |
|
Dabrafenib |
Antineoplastic agents |
199381 |
2016-11 |
2017-05 |
|
Dabrafenib |
Antineoplastic agents |
210753 |
2017-11 |
2018-05 |
|
Dabrafenib |
Antineoplastic agents |
213581 |
2018-03 |
2018-09 |
|
Dabrafenib mesylate |
Antineoplastic agents |
270381 |
2023-01 |
2023-07 |
Issued Notice of Compliance |
Dalbavancin |
Antibacterials for systemic use |
278103 |
2023-09 |
2024-07 |
Issued Notice of Compliance |
Dapagliflozin propanediol |
Drugs used in diabetes |
227213 |
2019-06 |
2020-04 |
Issued Notice of Compliance |
Dapagliflozin propanediol |
Drugs used in diabetes |
234304 |
2020-01 |
2020-06 |
|
Dapagliflozin propanediol |
Drugs used in diabetes |
248367 |
2021-02 |
2021-08 |
|
Dapagliflozin propanediol monohydrate |
Drugs used in diabetes |
268982 |
2022-12 |
2023-10 |
|
Dapagliflozin, metformin hydrochloride |
Drugs used in diabetes |
228055 |
2019-07 |
2020-04 |
Issued Notice of Compliance |
Daptomycin |
Antibacterials for systemic use |
214792 |
2018-05 |
2019-02 |
|
Daratumumab |
Antineoplastic agents |
198647 |
2016-10 |
2017-04 |
|
Daratumumab |
Antineoplastic agents |
212559 |
2018-01 |
2018-11 |
|
Daratumumab |
Antineoplastic agents |
226512 |
2019-05 |
2019-10 |
|
Daratumumab |
Antineoplastic agents |
234407 |
2020-01 |
2020-11 |
|
Daratumumab |
Antineoplastic agents |
244119 |
2020-11 |
2021-04 |
|
Daratumumab |
Antineoplastic agents |
249815 |
2021-03 |
2022-01 |
|
Daratumumab |
Antineoplastic agents |
259880 |
2022-02 |
2022-12 |
|
Daratumumab |
Antineoplastic agents |
286426 |
2024-05 |
2024-11 |
|
Darolutamide |
Endocrine therapy |
262749 |
2022-04 |
2022-09 |
|
Davesomeran, elasomeran *For use in relation to COVID-19 |
Vaccines |
273747 |
2023-03 |
2023-05 |
|
Davesomeran, elasomeran *For use in relation to COVID-19 |
Vaccines |
274717 |
2023-05 |
2023-10 |
|
Doravirine, lamivudine, tenofovir disoproxil fumarate |
Antivirals for systemic use |
266249 |
2022-09 |
2023-07 |
|
Dostarlimab |
Antineoplastic agents |
274515 |
2023-05 |
2023-11 |
|
Deferiprone |
All other therapeutic products |
244597 |
2020-12 |
2021-10 |
Issued Notice of Compliance |
Deferiprone |
All other therapeutic products |
261912 |
2022-06 |
2023-03 |
|
Denosumab |
Drugs for treatment of bone diseases |
203717 |
2017-04 |
2018-02 |
|
Denosumab |
Drugs for treatment of bone diseases |
205235 |
2017-06 |
2018-04 |
|
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract |
Allergens |
241617 |
2020-09 |
2022-12 |
|
Dexlansoprazole |
Drugs for acid related disorders |
215955 |
2018-06 |
2019-04 |
Issued Notice of Compliance |
Dimethyl fumarate |
Immunosuppressants |
259869 |
2022-04 |
2023-05 |
|
Diphtheria toxoid, filamentous haemagglutinin, fimbriae types 2 and 3 (FIM), inactivated poliomyelitis vaccine (D.C.O) Type 1 Mahoney, inactivated poliomyelitis vaccine (D.C.O) Type 2 M.E.F.1, inactivated poliomyelitis vaccine (D.C.O) Type 3 Saukett, pertactin, pertussis toxoid, tetanus toxoid |
Vaccines |
220233 |
2018-11 |
2020-09 |
|
Diphtheria toxoid, filamentous haemagglutinin, fimbriae types 2 and 3 (FIM), pertactin, pertussis toxoid, tetanus toxoid |
Vaccines |
220103 |
2018-11 |
2020-09 |
|
Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, inactivated poliovirus type I, inactivated poliovirus type II, inactivated poliovirus type III, pertactin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed |
Vaccines |
243463 |
2020-10 |
2021-08 |
|
Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed |
Vaccines |
243456 |
2020-10 |
2021-08 |
|
Dolutegravir |
Antivirals for systemic use |
207076 |
2017-08 |
2018-05 |
|
Dolutegravir |
Antivirals for systemic use |
235583 |
2020-04 |
2021-01 |
|
Doravirine |
Antivirals for systemic use |
264733 |
2022-07 |
2023-05 |
|
Dulaglutide |
Drugs used in diabetes |
201964 |
2017-03 |
2017-12 |
|
Dulaglutide |
Drugs used in diabetes |
232128 |
2019-11 |
2020-09 |
|
Dupilumab |
Other dermatological preparations |
221043 |
2018-11 |
2019-09 |
|
Dupilumab |
Other dermatological preparations |
231268 |
2019-10 |
2020-08 |
|
Dupilumab |
Other dermatological preparations |
234105 |
2020-01 |
2020-11 |
|
Dupilumab |
Other dermatological preparations |
237081 |
2020-04 |
2021-02 |
|
Dupilumab |
Other dermatological preparations |
252306 |
2021-05 |
2022-03 |
|
Dupilumab |
Other dermatological preparations |
264439 |
2022-06 |
2023-04 |
|
Dupilumab |
Other dermatological preparations |
268311 |
2022-11 |
2023-05 |
|
Dupilumab |
Other dermatological preparations |
266537 |
2022-09 |
2023-07 |
|
Dupilumab |
Other dermatological preparations |
283782 |
2024-03 |
2024-09 |
|
Durvalumab |
Antineoplastic agents |
233107 |
2019-11 |
2020-09 |
|
Durvalumab |
Antineoplastic agents |
262782 |
2022-04 |
2022-09 |
|
Durvalumab |
Endocrine therapy |
281318 |
2024-01 |
2024-10 |
|
Durvalumab |
Antineoplastic agents |
282097 |
2024-01 |
2025-01 |
|
Eculizumab |
Immunosuppressants |
212987 |
2018-02 |
2018-08 |
|
Eculizumab |
Immunosuppressants |
225847 |
2019-04 |
2019-09 |
|
Elasomeranb *For use in relation to COVID-19 |
Vaccines |
253430 |
2021-06 |
2021-08 |
|
Elasomeran *For use in relation to COVID-19 |
Vaccines |
257293 |
2021-10 |
2021-11 |
|
Elasomeran *For use in relation to COVID-19 |
Vaccines |
258658 |
2021-11 |
2022-03 |
|
Elasomeran *For use in relation to COVID-19 |
Vaccines |
263775 |
2022-04 |
2022-07 |
|
Elasomeran *For use in relation to COVID-19 |
Vaccines |
262952 |
2022-04 |
2022-09 |
|
Elasomeran *For use in relation to COVID-19 |
Vaccines |
262408 |
2022-03 |
2022-12 |
|
Elasomeran, imelasomeran *For use in relation to COVID-19 |
Vaccines |
269428 |
2022-11 |
2023-02 |
|
Elexacaftor, ivacaftor, tezacaftor |
Other respiratory system products |
255136 |
2021-10 |
2022-04 |
|
Elexacaftor, ivacaftor, tezacaftor |
Other respiratory system products |
271750 |
2023-04 |
2023-10 |
Issued Notice of Compliance |
Elexacaftor, ivacaftor, tezacaftor |
Other respiratory system products |
282009 |
2024-01 |
2024-07 |
|
Eltrombopag olamine |
Antihemorrhagics |
195798 |
2016-07 |
2017-05 |
|
Eltrombopag olamine |
Antihemorrhagics |
217802 |
2018-07 |
2019-05 |
|
Eltrombopag olamine |
Antihemorrhagics |
216004 |
2018-06 |
2019-06 |
Cancelled by sponsor |
Emicizumab |
Antihemorrhagics |
222209 |
2018-12 |
2019-06 |
|
Empagliflozin |
Drugs used in diabetes |
193840 |
2016-05 |
2018-04 |
Issued Notice of Compliance |
Empagliflozin |
Drugs used in diabetes |
221628 |
2019-01 |
2019-04 |
|
Empagliflozin |
Drugs used in diabetes |
246457 |
2021-01 |
2021-10 |
|
Empagliflozin |
Drugs used in diabetes |
256491 |
2021-10 |
2022-04 |
|
Empagliflozin |
Drugs used in diabetes |
270652 |
2023-03 |
2024-01 |
|
Empagliflozin, linagliptin |
Drugs used in diabetes |
204589 |
2017-06 |
2018-04 |
|
Emtricitabine, tenofovir alafenamide |
Antivirals for systemic use |
234525 |
2020-02 |
2020-11 |
|
Enfortumab vedotin |
Antineoplastic agents |
283003 |
2024-02 |
2024-08 |
|
Enoxaparin sodium |
Antithrombotic agents |
209807 |
2017-11 |
2018-09 |
|
Enzalutamide |
Endocrine therapy |
216719 |
2018-06 |
2018-12 |
Issued Notice of Compliance |
Enzalutamide |
Endocrine therapy |
233563 |
2019-12 |
2020-06 |
Issued Notice of Compliance |
Enzalutamide |
Endocrine therapy |
277282 |
2023-08 |
2024-01 |
Issued Notice of Compliance |
Eptacog alfa |
Antihemorrhagics |
200866 |
2017-01 |
2017-11 |
|
Eptacog alfa |
Antihemorrhagics |
267878 |
2022-11 |
2023-03 |
|
Eribulin mesylate |
Antineoplastic agents |
197739 |
2016-10 |
2017-08 |
|
Erlotinib hydrochloride |
Antineoplastic agents |
194018 |
2016-06 |
2017-03 |
|
Esketamine hydrochloride |
Psychoanaleptics |
244338 |
2020-11 |
2021-09 |
|
Eslicarbazepine acetate |
Antiepileptics |
208086 |
2017-09 |
2018-06 |
|
Eslicarbazepine acetate |
Antiepileptics |
209753 |
2017-11 |
2018-09 |
|
Etanercept |
Immunosuppressants |
193787 |
2016-05 |
2017-03 |
|
Etanercept |
Immunosuppressants |
213347 |
2018-03 |
2019-01 |
|
Etanercept |
Immunosuppressants |
231313 |
2019-10 |
2020-08 |
|
Etanercept |
Immunosuppressants |
226145 |
2019-05 |
2020-12 |
Issued Notice of Compliance |
Everolimus |
Antineoplastic agents |
200814 |
2017-01 |
2017-11 |
|
Evolocumab |
Lipid modifying agents |
207038 |
2017-08 |
2018-06 |
|
Evolocumab |
Lipid modifying agents |
208904 |
2017-10 |
2018-08 |
|
Evolocumab |
Lipid modifying agents |
247936 |
2021-02 |
2021-12 |
Issued Notice of Compliance |
Exenatide |
Drugs used in diabetes |
208034 |
2017-09 |
2018-07 |
|
Famtozinameran, tozinameran *For use in relation to COVID-19 |
Vaccines |
268826 |
2022-10 |
2022-12 |
|
Famtozinameran, tozinameran *For use in relation to COVID-19 |
Vaccines |
274152 |
2023-03 |
2023-07 |
|
Famtozinameran, tozinameran *For use in relation to COVID-19 |
Vaccines |
275559 |
2023-06 |
2023-08 |
|
Faricimab |
Ophthalmologicals |
278042 |
2023-09 |
2024-07 |
|
Fibrinogen (human) |
Antihemorrhagics |
230407 |
2019-09 |
2020-07 |
|
Fibrinogen (human) |
Antihemorrhagics |
227551 |
2019-06 |
2020-11 |
|
Fibrinogen (human), thrombin (human) |
Antihemorrhagics |
281380 |
2024-01 |
2024-11 |
|
Fingolimod hydrochloride |
Immunosuppressants |
215423 |
2018-05 |
2018-11 |
|
Flibanserin |
Other gynecologicals |
229727 |
2019-07 |
2021-01 |
Issued Notice of Compliance |
Fluticasone furoate |
Drugs for obstructive airway diseases |
208727 |
2017-10 |
2018-10 |
|
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate |
Drugs for obstructive airway diseases |
215148 |
2018-05 |
2019-03 |
|
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate |
Drugs for obstructive airway diseases |
240101 |
2020-07 |
2021-05 |
|
Formoterol fumarate dihydrate, mometasone furoate |
Drugs for obstructive airway diseases |
239493 |
2020-06 |
2021-04 |
|
Fosfomycin sodium |
Antibacterials for systemic use |
256308 |
2021-12 |
2022-10 |
|
Fulvestrant |
Endocrine therapy |
201150 |
2017-01 |
2017-11 |
|
Gadoterate meglumine |
Contrast media |
205610 |
2017-06 |
2018-04 |
|
Gadoteridol |
Contrast media |
252254 |
2021-07 |
2022-05 |
|
Galcanezumab |
Analgesics |
232324 |
2019-11 |
2020-09 |
|
Gallium (68Ga) gozetotide |
Diagnostic radiopharmaceuticals |
279567 |
2023-11 |
2024-09 |
|
Glecaprevir, pibrentasvir |
Antivirals for systemic use |
222816 |
2018-12 |
2019-06 |
|
Glecaprevir, pibrentasvir |
Antivirals for systemic use |
247707 |
2021-02 |
2021-11 |
|
Glycerol phenylbutyrate |
Other alimentary tract and metabolism products |
259175 |
2022-02 |
2022-11 |
|
Glycopyrronium bromide, indacaterol maleate |
Drugs for obstructive airway diseases |
198552 |
2016-11 |
2017-08 |
|
Golimumab |
Immunosuppressants |
197362 |
2016-09 |
2017-06 |
Issued Notice of Compliance |
Golimumab |
Immunosuppressants |
205724 |
2017-06 |
2018-04 |
|
Golimumab |
Immunosuppressants |
255908 |
2021-10 |
2022-07 |
|
Goserelin acetate |
Endocrine therapy |
275599 |
2023-07 |
2024-05 |
Issued Notice of Compliance |
Guselkumab |
Immunosuppressants |
232124 |
2019-11 |
2020-09 |
|
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B |
Vaccines |
199807 |
2016-11 |
2017-05 |
Issued Notice of Compliance |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
225528 |
2019-04 |
2020-02 |
|
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
229325 |
2019-08 |
2020-06 |
Issued Notice of Compliance |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
238479 |
2020-05 |
2021-03 |
Issued Notice of Compliance |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
246936 |
2021-01 |
2021-11 |
|
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
251147 |
2021-05 |
2022-03 |
|
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Yamagata) |
Vaccines |
218188 |
2018-08 |
2019-06 |
|
Hexaminolevulinate hydrochloride |
Diagnostic agents |
273436 |
2023-05 |
2024-03 |
|
Human immunoglobulin |
Immune sera and immunoglobulins |
208033 |
2017-09 |
2018-07 |
|
Hyaluronidase (human recombinant), immunoglobulin (human) |
Immune sera and immunoglobulins |
276884 |
2023-08 |
2024-06 |
|
Hydromorphone hydrochloride |
Analgesics |
223245 |
2019-01 |
2019-05 |
|
Hydroxyethyl starch |
Blood substitutes and perfusion solutions |
222938 |
2019-04 |
2020-02 |
Issued Notice of Compliance |
Hydroxyethyl starch |
Blood substitutes and perfusion solutions |
223031 |
2019-04 |
2020-02 |
Issued Notice of Compliance |
Hydroxyurea |
Antineoplastic agents |
226144 |
2019-04 |
2020-02 |
Issued Notice of Compliance |
Ibrutinib |
Immunosuppressants |
204436 |
2017-05 |
2017-10 |
|
Ibrutinib |
Antineoplastic agents |
212632 |
2018-02 |
2018-07 |
|
Ibrutinib |
Antineoplastic agents |
218457 |
2018-08 |
2019-02 |
Issued Notice of Compliance |
Ibrutinib |
Antineoplastic agents |
222804 |
2019-01 |
2019-11 |
Issued Notice of Compliance |
Ibrutinib |
Antineoplastic agents |
235706 |
2020-02 |
2020-12 |
Issued Notice of Compliance |
Ibrutinib |
Antineoplastic agents |
263702 |
2022-05 |
2023-03 |
|
Ibrutinib |
Antineoplastic agents |
266710 |
2022-10 |
2023-08 |
Issued Notice of Compliance |
Icatibant acetate |
Other hematological agents |
217805 |
2018-09 |
2019-06 |
|
Idelalisib |
Antineoplastic agents |
203513 |
2017-04 |
2017-12 |
Cancelled by sponsor |
Immunoglobulin (human) |
Immune sera and immunoglobulins |
201326 |
2017-01 |
2017-10 |
|
Immunoglobulin (human) |
Immune sera and immunoglobulins |
223557 |
2019-02 |
2019-11 |
|
Immunoglobulin (human) |
Immune sera and immunoglobulins |
240691 |
2020-07 |
2021-05 |
|
Immunoglobulin (human) |
Immune sera and immunoglobulins |
253256 |
2021-07 |
2022-05 |
|
IncobotulinumtoxinA |
Muscle relaxants |
208713 |
2017-10 |
2019-06 |
|
IncobotulinumtoxinA |
Muscle relaxants |
234438 |
2020-01 |
2020-11 |
|
IncobotulinumtoxinA |
Muscle relaxants |
251521 |
2021-05 |
2022-03 |
Issued Notice of Compliance |
IncobotulinumtoxinA |
Muscle relaxants |
257192 |
2021-11 |
2022-09 |
|
IncobotulinumtoxinA |
Muscle relaxants |
268590 |
2022-11 |
2023-10 |
|
IncobotulinumtoxinA |
Muscle relaxants |
278522 |
2023-10 |
2024-12 |
|
Infliximab |
Immunosuppressants |
220321 |
2018-11 |
2019-08 |
|
Infliximab |
Immunosuppressants |
262141 |
2022-04 |
2023-03 |
|
Infliximab |
Immunosuppressants |
272981 |
2023-04 |
2024-02 |
Issued Notice of Compliance |
Insulin aspart |
Drugs used in diabetes |
226586 |
2019-05 |
2020-02 |
|
Insulin aspart |
Drugs used in diabetes |
254352 |
2021-10 |
2022-07 |
|
Insulin degludec |
Drugs used in diabetes |
208917 |
2017-10 |
2018-07 |
|
Insulin degludec, liraglutide |
Drugs used in diabetes |
234406 |
2020-01 |
2020-11 |
|
Insulin glargine |
Drugs used in diabetes |
228382 |
2019-07 |
2020-05 |
Issued Notice of Compliance |
Insulin glargine, lixisenatide |
Drugs used in diabetes |
232504 |
2019-11 |
2020-09 |
Issued Notice of Compliance |
Iohexol |
Contrast media |
268527 |
2023-03 |
2023-12 |
Issued Notice of Compliance |
Ipilimumab |
Antineoplastic agents |
202533 |
2017-02 |
2017-04 |
|
Ipilimumab |
Antineoplastic agents |
255450 |
2021-09 |
2022-03 |
|
Ipilimumab |
Antineoplastic agents |
270801 |
2023-02 |
2023-12 |
Issued Notice of Compliance |
Isatuximab |
Antineoplastic agents |
244601 |
2020-10 |
2021-09 |
|
Isavuconazonium sulfate |
Antimycotics for systemic use |
280928 |
2023-12 |
2024-11 |
Issued Notice of Compliance |
Ivacaftor |
Other respiratory system products |
218044 |
2018-08 |
2019-01 |
|
Ivacaftor |
Other respiratory system products |
247481 |
2021-02 |
2021-08 |
|
Ivacaftor |
Other respiratory system products |
255781 |
2021-09 |
2022-03 |
|
Ivacaftor |
Other respiratory system products |
273575 |
2023-06 |
2023-11 |
Issued Notice of Compliance |
Ivacaftor, lumacaftor |
Other respiratory system products |
198036 |
2016-10 |
2017-04 |
|
Ivacaftor, lumacaftor |
Other respiratory system products |
215032 |
2018-06 |
2018-12 |
|
Ivacaftor, lumacaftor |
Other respiratory system products |
264825 |
2022-07 |
2023-04 |
|
Ixekizumab |
Immunosuppressants |
204690 |
2017-06 |
2018-03 |
|
Ixekizumab |
Immunosuppressants |
225178 |
2019-04 |
2020-02 |
|
Ixekizumab |
Immunosuppressants |
233071 |
2019-12 |
2020-10 |
|
Ixekizumab |
Immunosuppressants |
238580 |
2020-06 |
2021-03 |
|
Japanese encephalitis virus vaccine inactivated |
Vaccines |
203520 |
2017-05 |
2018-03 |
|
Lacosamide |
Antiepileptics |
193732 |
2016-05 |
2017-02 |
|
Lanreotide acetate |
Pituitary and hypothalamic hormones and analogues |
203094 |
2017-04 |
2018-02 |
|
Ledipasvir, sofosbuvir |
Antivirals for systemic use |
199607 |
2016-11 |
2017-05 |
|
Lenvatinib mesylate |
Antineoplastic agents |
197794 |
2016-11 |
2017-09 |
|
Lenvatinib mesylate |
Antineoplastic agents |
212989 |
2018-02 |
2018-12 |
Issued Notice of Compliance |
Lenvatinib mesylate |
Antineoplastic agents |
228723 |
2019-07 |
2019-09 |
Issued Notice of Compliance under the NOC/c Guidance |
Lenvatinib mesylate |
Antineoplastic agents |
252195 |
2021-06 |
2022-02 |
|
Lenvatinib mesylate |
Antineoplastic agents |
253057 |
2021-07 |
2022-05 |
|
Letermovir |
Antivirals for systemic use |
272553 |
2023-03 |
2023-09 |
|
Lutetium (177Lu) oxodotreotide |
Therapeutic radiopharmaceuticals |
282347 |
2024-02 |
2024-12 |
|
Leucovorin calcium |
All other therapeutic products |
276242 |
2023-08 |
2023-12 |
Issued Notice of Compliance |
Leuprolide acetate |
Endocrine therapy |
193372 |
2016-05 |
2017-02 |
|
Leuprolide acetate |
Endocrine therapy |
269016 |
2022-12 |
2023-09 |
Issued Notice of Compliance |
Leuprolide acetate |
Endocrine therapy |
254192 |
2021-10 |
2024-01 |
Issued Notice of Compliance |
Levomilnacipran |
Psychoanaleptics |
222857 |
2019-01 |
2019-11 |
Issued Notice of Compliance |
Levonorgestrel |
Sex hormones and modulators of the genital system |
204355 |
2017-05 |
2018-03 |
|
Levonorgestrel |
Other gynecologicals |
273103 |
2023-04 |
2024-02 |
|
Linaclotide |
Drugs for constipation |
279169 |
2023-11 |
2024-09 |
Issued Notice of Compliance |
Linagliptin |
Drugs used in diabetes |
194075 |
2016-06 |
2018-10 |
|
Linagliptin |
Drugs used in diabetes |
222572 |
2019-01 |
2019-11 |
Issued Notice of Compliance |
Linagliptin, metformin hydrochloride |
Drugs used in diabetes |
194067 |
2016-06 |
2017-05 |
|
Linagliptin, metformin hydrochloride |
Drugs used in diabetes |
229225 |
2019-08 |
2020-06 |
Issued Notice of Compliance |
Liraglutide |
Drugs used in diabetes |
196457 |
2016-08 |
2017-06 |
|
Liraglutide |
Drugs used in diabetes |
200821 |
2017-01 |
2017-11 |
|
Liraglutide |
Drugs used in diabetes |
225809 |
2019-05 |
2020-02 |
Issued Notice of Compliance |
Liraglutide |
Drugs used in diabetes |
237880 |
2020-05 |
2021-02 |
|
Lisocabtagene maraleucel |
Antineoplastic agents |
279827 |
2023-11 |
2024-09 |
|
Lorlatinib |
Antineoplastic agents |
247174 |
2021-01 |
2021-06 |
Issued Notice of Compliance |
Lumasiran sodium |
Other alimentary tract and metabolism products |
265088 |
2022-07 |
2023-05 |
|
Lurasidone hydrochloride |
Psycholeptics |
197342 |
2016-09 |
2017-07 |
|
Lurasidone hydrochloride |
Psycholeptics |
205325 |
2017-06 |
2018-04 |
|
Luspatercept |
Antianemic preparations |
279552 |
2023-11 |
2024-09 |
|
Macitentan |
Antihypertensives |
219599 |
2018-11 |
2019-11 |
Cancelled by sponsor |
Macitentan |
Antihypertensives |
221389 |
2019-01 |
2020-07 |
Issued Notice of Compliance |
Mavacamten |
Cardiac therapy |
272517 |
2023-04 |
2024-02 |
|
Meningococcal polysaccharide antigen groups A, C, W-135, and Y, tetanus toxoid |
Vaccines |
203844 |
2017-04 |
2018-02 |
|
Mepolizumab |
Drugs for obstructive airway diseases |
208467 |
2017-09 |
2018-07 |
|
Mepolizumab |
Drugs for obstructive airway diseases |
212242 |
2018-02 |
2018-10 |
|
Mepolizumab |
Drugs for obstructive airway diseases |
221528 |
2018-12 |
2019-10 |
|
Mepolizumab |
Drugs for obstructive airway diseases |
226197 |
2019-05 |
2020-03 |
|
Mepolizumab |
Drugs for obstructive airway diseases |
247542 |
2021-01 |
2021-11 |
|
Mesalazine |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
255153 |
2021-09 |
2022-08 |
|
Methyl aminolevulinate hydrochloride |
Antineoplastic agents |
262828 |
2022-04 |
2023-02 |
Issued Notice of Compliance |
Methylphenidate hydrochloride |
Psychoanaleptics |
214860 |
2018-05 |
2019-03 |
Issued Notice of Compliance |
Methylphenidate hydrochloride |
Psychoanaleptics |
224342 |
2019-03 |
2020-01 |
Issued Notice of Compliance |
Midostaurin |
Antineoplastic agents |
210496 |
2017-12 |
2018-10 |
|
Mifepristone, misoprostol |
Sex hormones and modulators of the genital system |
200856 |
2017-01 |
2017-11 |
|
Migalastat hydrochloride |
Other alimentary tract and metabolism products |
262810 |
2022-05 |
2023-03 |
|
Nadroparin calcium |
Antithrombotic agents |
195973 |
2016-08 |
2017-07 |
|
Naloxegol oxalate |
Drugs for constipation |
221031 |
2018-11 |
2019-09 |
Cancelled by sponsor |
Neratinib maleate |
Antineoplastic agents |
242449 |
2020-09 |
2021-06 |
Issued Notice of Compliance |
Nilotinib |
Antineoplastic agents |
211052 |
2017-12 |
2018-10 |
Issued Notice of Compliance |
Nintedanib |
Antineoplastic agents |
227166 |
2019-05 |
2019-11 |
|
Nintedanib |
Antineoplastic agents |
232923 |
2019-11 |
2020-05 |
|
Nintedanib |
Antineoplastic agents |
241747 |
2020-08 |
2021-06 |
|
Niraparib |
Antineoplastic agents |
237670 |
2020-04 |
2020-10 |
Issued Notice of Compliance |
Nivolumab |
Antineoplastic agents |
199379 |
2016-11 |
2017-05 |
|
Nivolumab |
Antineoplastic agents |
203286 |
2017-03 |
2017-11 |
|
Nivolumab |
Antineoplastic agents |
203593 |
2017-04 |
2018-01 |
|
Nivolumab |
Antineoplastic agents |
206974 |
2017-07 |
2018-03 |
Issued Notice of Compliance under the NOC/c Guidance |
Nivolumab |
Antineoplastic agents |
212067 |
2018-01 |
2018-07 |
|
Nivolumab |
Antineoplastic agents |
211838 |
2018-01 |
2018-11 |
|
Nivolumab |
Antineoplastic agents |
215535 |
2018-06 |
2019-11 |
|
Nivolumab |
Antineoplastic agents |
236255 |
2020-03 |
2020-08 |
|
Nivolumab |
Antineoplastic agents |
234228 |
2020-01 |
2020-11 |
|
Nivolumab |
Antineoplastic agents |
239474 |
2020-06 |
2021-02 |
Issued Notice of Compliance under the NOC/c Guidance |
Nivolumab |
Antineoplastic agents |
243600 |
2020-09 |
2021-05 |
|
Nivolumab |
Antineoplastic agents |
247045 |
2021-01 |
2021-07 |
|
Nivolumab |
Antineoplastic agents |
245851 |
2020-12 |
2021-10 |
|
Nivolumab |
Antineoplastic agents |
247339 |
2021-01 |
2021-10 |
|
Nivolumab |
Antineoplastic agents |
253652 |
2021-07 |
2022-06 |
Issued Notice of Compliance under the NOC/c Guidance |
Nivolumab |
Antineoplastic agents |
257103 |
2021-11 |
2022-07 |
|
Nivolumab |
Antineoplastic agents |
261300 |
2022-03 |
2022-08 |
|
Nivolumab |
Antineoplastic agents |
272504 |
2023-03 |
2023-12 |
Issued Notice of Compliance |
Nivolumab |
Antineoplastic agents |
282374 |
2024-01 |
2024-06 |
|
Norfloxacin |
Antibacterials for systemic use |
208906 |
2017-10 |
2017-12 |
Issued Notice of Compliance |
Obinutuzumab |
Antineoplastic agents |
208089 |
2017-09 |
2018-07 |
|
Olaparib |
Antineoplastic agents |
210204 |
2017-11 |
2018-05 |
|
Olaparib |
Antineoplastic agents |
219799 |
2018-11 |
2019-05 |
Issued Notice of Compliance |
Olaparib |
Antineoplastic agents |
230309 |
2019-08 |
2020-02 |
Issued Notice of Compliance |
Olaparib |
Antineoplastic agents |
235698 |
2020-02 |
2020-08 |
Issued Notice of Compliance |
Olaparib |
Antineoplastic agents |
259417 |
2022-01 |
2022-07 |
Issued Notice of Compliance under the NOC/c Guidance |
Olaparib |
Antineoplastic agents |
265427 |
2022-08 |
2023-07 |
Issued Notice of Compliance under the NOC/c Guidance |
Olodaterol hydrochloride, tiotropium bromide monohydrate |
Drugs for obstructive airway diseases |
223910 |
2019-03 |
2019-12 |
Issued Notice of Compliance |
Omalizumab |
Drugs for obstructive airway diseases |
194542 |
2016-06 |
2017-04 |
|
Omalizumab |
Drugs for obstructive airway diseases |
241064 |
2020-08 |
2021-07 |
|
Ombitasvir, paritaprevir, ritonavir |
Antivirals for systemic use |
195504 |
2016-07 |
2017-05 |
Issued Notice of Compliance |
OnabotulinumtoxinA |
Muscle relaxants |
211053 |
2017-12 |
2018-10 |
Issued Notice of Compliance |
OnabotulinumtoxinA |
Muscle relaxants |
237685 |
2020-05 |
2021-03 |
|
OnabotulinumtoxinA |
Muscle relaxants |
273166 |
2023-04 |
2024-02 |
Issued Notice of Compliance |
OnabotulinumtoxinA |
Muscle relaxants |
275576 |
2023-06 |
2024-04 |
|
Osimertinib mesylate |
Antineoplastic agents |
211762 |
2018-01 |
2018-07 |
|
Osimertinib mesylate |
Antineoplastic agents |
243288 |
2020-09 |
2021-01 |
|
Osimertinib mesylate |
Antineoplastic agents |
279138 |
2023-10 |
2024-07 |
Issued Notice of Compliance |
Outer membrane vesicles (Neisseria meningitidis group B NZ98/254 strain), recombinant Neisseria meningitidis group B NHBA fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B fHBP fusion protein |
Vaccines |
209413 |
2017-11 |
2018-08 |
|
Ozanimod |
Immunosuppressants |
248992 |
2021-05 |
2022-04 |
|
Palbociclib |
Antineoplastic agents |
195948 |
2016-07 |
2017-05 |
|
Palbociclib |
Antineoplastic agents |
219500 |
2018-10 |
2019-08 |
|
Palbociclib |
Antineoplastic agents |
273901 |
2023-05 |
2024-03 |
Issued Notice of Compliance |
Palonosetron hydrochloride |
Antiemetics and antinauseants |
215829 |
2018-06 |
2019-04 |
|
Panitumumab |
Antineoplastic agents |
193962 |
2016-06 |
2017-04 |
|
Pasireotide |
Pituitary and hypothalamic hormones and analogues |
209345 |
2017-11 |
2018-08 |
|
Pembrolizumab |
Antineoplastic agents |
201200 |
2017-01 |
2017-09 |
Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab |
Antineoplastic agents |
203157 |
2017-03 |
2017-09 |
|
Pembrolizumab |
Antineoplastic agents |
212388 |
2018-01 |
2018-09 |
Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab |
Antineoplastic agents |
215699 |
2018-05 |
2019-03 |
|
Pembrolizumab |
Antineoplastic agents |
209011 |
2017-09 |
2019-04 |
|
Pembrolizumab |
Antineoplastic agents |
216451 |
2018-06 |
2019-04 |
|
Pembrolizumab |
Antineoplastic agents |
218779 |
2018-08 |
2019-04 |
Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab |
Antineoplastic agents |
219700 |
2018-10 |
2019-07 |
|
Pembrolizumab |
Antineoplastic agents |
228721 |
2019-07 |
2019-09 |
Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab |
Antineoplastic agents |
223819 |
2019-02 |
2019-12 |
|
Pembrolizumab |
Antineoplastic agents |
219213 |
2018-09 |
2020-03 |
|
Pembrolizumab |
Antineoplastic agents |
232775 |
2019-12 |
2020-10 |
|
Pembrolizumab |
Antineoplastic agents |
236910 |
2020-04 |
2020-12 |
Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab |
Antineoplastic agents |
239505 |
2020-06 |
2021-02 |
Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab |
Antineoplastic agents |
240864 |
2020-07 |
2021-03 |
|
Pembrolizumab |
Antineoplastic agents |
246922 |
2020-12 |
2021-06 |
|
Pembrolizumab |
Antineoplastic agents |
246373 |
2020-12 |
2021-11 |
Issued Notice of Compliance under the NOC/c Guidance |
Pembrolizumab |
Antineoplastic agents |
252263 |
2021-06 |
2022-02 |
|
Pembrolizumab |
Antineoplastic agents |
256659 |
2021-10 |
2022-04 |
|
Pembrolizumab |
Antineoplastic agents |
257236 |
2021-11 |
2022-04 |
|
Pembrolizumab |
Antineoplastic agents |
253060 |
2021-07 |
2022-05 |
|
Pembrolizumab |
Antineoplastic agents |
259703 |
2022-01 |
2022-07 |
|
Pembrolizumab |
Antineoplastic agents |
256537 |
2021-10 |
2022-08 |
|
Pembrolizumab |
Antineoplastic agents |
264318 |
2022-06 |
2023-04 |
|
Pembrolizumab |
Antineoplastic agents |
272409 |
2023-03 |
2024-02 |
Issued Notice of Compliance |
Pembrolizumab |
Antineoplastic agents |
273487 |
2023-05 |
2024-03 |
|
Pembrolizumab |
Antineoplastic agents |
275053 |
2023-06 |
2024-04 |
|
Pembrolizumab |
Antineoplastic agents |
276501 |
2023-08 |
2024-05 |
|
Pembrolizumab |
Antineoplastic agents |
278399 |
2023-10 |
2024-08 |
|
Pembrolizumab |
Antineoplastic agents |
282981 |
2024-02 |
2024-08 |
|
Pembrolizumab |
Antineoplastic agents |
274453 |
2023-06 |
2025-02 |
Issued Notice of Compliance |
Perampanel |
Antiepileptics |
204327 |
2017-05 |
2018-03 |
|
Perampanel |
Antiepileptics |
225719 |
2019-05 |
2020-02 |
Issued Notice of Compliance |
Pertuzumab |
Antineoplastic agents |
209467 |
2017-11 |
2018-08 |
|
Pertuzumab, trastuzumab |
Antineoplastic agents |
222022 |
2018-12 |
2020-07 |
Issued Notice of Compliance |
Pertuzumab, trastuzumab |
Antineoplastic agents |
230602 |
2019-09 |
2021-02 |
|
Pertuzumab, trastuzumab |
Antineoplastic agents |
254251 |
2021-07 |
2022-01 |
|
Pimecrolimus |
Other dermatological preparations |
220947 |
2018-11 |
2019-09 |
|
Pimecrolimus |
Other dermatological preparations |
247851 |
2021-01 |
2023-09 |
|
Pitolisant hydrochloride |
Other nervous system drugs |
270856 |
2023-02 |
2024-01 |
|
Pitolisant hydrochloride |
Other nervous system drugs |
284477 |
2024-04 |
2025-02 |
Issued Notice of Compliance |
Plecanatide |
Drugs for constipation |
279583 |
2024-01 |
2024-12 |
Issued Notice of Compliance |
Plerixafor |
Immunostimulants |
213345 |
2018-03 |
2019-01 |
Issued Notice of Compliance |
Polatuzumab vedotin |
Antineoplastic agents |
259726 |
2022-01 |
2022-11 |
|
Pomalidomide |
Immunosuppressants |
218459 |
2018-09 |
2019-07 |
Issued Notice of Compliance |
Ranibizumab |
Ophthalmologicals |
201272 |
2017-01 |
2017-11 |
|
Ranibizumab |
Opthalmologicals |
233361 |
2019-11 |
2021-11 |
Issued Notice of Compliance under the NOC/c Guidance |
Ravulizumab |
Immunosuppressants |
259173 |
2022-01 |
2022-11 |
Issued Notice of Compliance |
Ravulizumab |
Immunosuppressants |
261864 |
2022-03 |
2023-01 |
Issued Notice of Compliance |
Ravulizumab |
Immunosuppressants |
269852 |
2023-01 |
2023-10 |
|
Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein |
Vaccines |
223244 |
2019-02 |
2020-08 |
|
Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein |
Vaccines |
251509 |
2021-05 |
2022-04 |
Issued Notice of Compliance under the NOC/c Guidance |
Regorafenib |
Antineoplastic agents |
203322 |
2017-04 |
2017-09 |
|
Remdesivir *For use in relation to COVID-19 |
Antivirals for systemic use |
250151 |
2021-04 |
2022-04 |
|
Remdesivir *For use in relation to COVID-19 |
Antivirals for systemic use |
266313 |
2022-08 |
2023-06 |
|
Respiratory syncytial virus prefusion F protein (RSVPreF3) |
Vaccines |
282013 |
2024-01 |
2024-11 |
Issued Notice of Compliance |
Ribociclib succinate |
Antineoplastic agents |
225074 |
2019-04 |
2020-02 |
Issued Notice of Compliance |
Ribociclib succinate |
Antineoplastic agents |
233623 |
2019-12 |
2020-10 |
Issued Notice of Compliance |
Ribociclib succinate |
Antineoplastic agents |
262779 |
2022-04 |
2023-02 |
Issued Notice of Compliance |
Rifaximin |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
209230 |
2018-02 |
2018-12 |
Issued Notice of Compliance |
Risankizumab |
Immunosuppressants |
251455 |
2021-05 |
2022-03 |
|
Risankizumab |
Immunosuppressants |
258394 |
2021-12 |
2022-10 |
|
Risankizumab |
Immunosuppressants |
280386 |
2023-12 |
2024-10 |
|
Risdiplam |
Other drugs for disorders of the musculo-skeletal system |
284770 |
2024-04 |
2024-10 |
Issued Notice of Compliance |
Rituximab |
Antineoplastic agents |
204718 |
2017-05 |
2018-03 |
|
Rituximab |
Antineoplastic agents |
228130 |
2019-07 |
2020-05 |
Issued Notice of Compliance |
Rituximab |
Antineoplastic agents |
242572 |
2020-09 |
2021-06 |
|
Rivaroxaban |
Antithrombotic agents |
211611 |
2018-01 |
2018-09 |
|
Rivaroxaban |
Antithrombotic agents |
233166 |
2020-02 |
2020-11 |
|
Rivaroxaban |
Antithrombotic agents |
234756 |
2020-03 |
2021-01 |
|
Roflumilast |
Antipsoriatics |
280534 |
2023-12 |
2024-10 |
Issued Notice of Compliance |
Romiplostim |
Antihemorrhagics |
243699 |
2020-10 |
2021-08 |
|
Romosozumab |
Drugs for treatment of bone diseases |
262756 |
2022-05 |
2023-03 |
|
Rufinamide |
Antiepileptics |
194343 |
2016-06 |
2017-04 |
|
Ruxolitinib phosphate |
Antineoplastic agents |
250022 |
2021-03 |
2022-05 |
Issued Notice of Compliance |
SARS‑CoV‑2 recombinant spike protein *For use in relation to COVID-19 |
Vaccines |
266285 |
2022-07 |
2022-11 |
|
SARS‑CoV‑2 recombinant spike protein *For use in relation to COVID-19 |
Vaccines |
265342 |
2022-06 |
2022-12 |
|
SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 |
Vaccines |
273313 |
2023-03 |
2023-11 |
|
Sacituzumab govitecan |
Antineoplastic agents |
270849 |
2023-01 |
2023-07 |
|
Sarilumab |
Immunosuppressants |
211993 |
2018-01 |
2019-08 |
|
Secukinumab |
Immunosuppressants |
219231 |
2018-09 |
2019-07 |
Issued Notice of Compliance |
Secukinumab |
Immunosuppressants |
235994 |
2020-03 |
2021-01 |
|
Secukinumab |
Immunosuppressants |
240496 |
2020-07 |
2021-05 |
|
Secukinumab |
Immunosuppressants |
250272 |
2021-05 |
2022-03 |
|
Secukinumab |
Immunosuppressants |
257230 |
2021-11 |
2022-09 |
|
Secukinumab |
Immunosuppressants |
269287 |
2022-12 |
2024-05 |
|
Semaglutide |
Drugs used in diabetes |
227387 |
2019-06 |
2020-03 |
|
Semaglutide |
Drugs used in diabetes |
231580 |
2019-10 |
2020-08 |
|
Semaglutide |
Drugs used in diabetes |
245932 |
2020-12 |
2021-10 |
Issued Notice of Compliance |
Semaglutide |
Drugs used in diabetes |
266244 |
2022-09 |
2023-06 |
|
Semaglutide |
Drugs used in diabetes |
279915 |
2023-12 |
2024-11 |
Issued Notice of Compliance |
Sevelamer carbonate |
All other therapeutic products |
211598 |
2018-04 |
2019-02 |
|
Simeprevir |
Antivirals for systemic use |
197253 |
2016-09 |
2017-07 |
|
Sofosbuvir, velpatasvir |
Antivirals for systemic use |
199753 |
2016-12 |
2017-09 |
|
Sofosbuvir, velpatasvir |
Antivirals for systemic use |
233923 |
2020-01 |
2020-11 |
|
Somatropin |
Pituitary and hypothalamic hormones and analogues |
205985 |
2017-06 |
2018-04 |
|
Somatropin |
Pituitary and hypothalamic hormones and analogues |
241147 |
2020-08 |
2021-06 |
|
Somatropin R-DNA origin |
Pituitary and hypothalamic hormones and analogues |
229726 |
2019-08 |
2020-06 |
|
Spesolimab |
Immunosuppressants |
278317 |
2023-10 |
2024-07 |
Issued Notice of Compliance |
Standardized short ragweed pollen allergenic extract |
Allergens |
234565 |
2020-02 |
2020-12 |
Issued Notice of Compliance |
Sugammadex |
All other therapeutic products |
234372 |
2020-01 |
2021-10 |
|
Sulfur hexafluoride |
Contrast media |
231944 |
2019-11 |
2020-08 |
|
Sunitinib malate |
Antineoplastic agents |
208710 |
2017-10 |
2019-04 |
|
Talazoparib |
Antineoplastic agents |
271537 |
2023-05 |
2025-01 |
Issued Notice of Compliance |
Teduglutide |
Other alimentary tract and metabolism products |
223862 |
2019-02 |
2019-08 |
|
Teriflunomide |
Immunosuppressants |
231739 |
2019-11 |
2020-09 |
Issued Notice of Compliance |
Thioguanine |
Antineoplastic agents |
199259 |
2016-11 |
2017-09 |
|
Ticagrelor |
Antithrombotic agents |
231818 |
2019-10 |
2020-08 |
|
Tinzaparin sodium |
Antithrombotic agents |
199839 |
2016-12 |
2018-11 |
|
Tipiracil hydrochloride, trifluridine |
Antineoplastic agents |
227070 |
2019-05 |
2019-11 |
|
Tisagenlecleucel |
Antineoplastic agents |
263500 |
2022-05 |
2022-12 |
Issued Notice of Compliance under the NOC/c Guidance |
Tocilizumab |
Immunosuppressants |
204251 |
2017-05 |
2017-10 |
|
Tocilizumab |
Immunosuppressants |
219690 |
2018-10 |
2019-07 |
Issued Notice of Compliance |
Tocilizumab |
Immunosuppressants |
220039 |
2018-10 |
2019-08 |
|
Tocilizumab *For use in relation to COVID-19 |
Immunosuppressants |
261220 |
2022-02 |
2022-10 |
|
Tofacitinib |
Immunosuppressants |
209522 |
2017-11 |
2018-09 |
Issued Notice of Compliance |
Tofacitinib |
Immunosuppressants |
209643 |
2017-12 |
2018-10 |
|
Tofacitinib |
Immunosuppressants |
213578 |
2018-04 |
2019-01 |
Issued Notice of Compliance |
Tofacitinib citrate |
Immunosuppressants |
264582 |
2022-07 |
2023-05 |
|
Tofacitinib citrate |
Immunosuppressants |
271059 |
2023-03 |
2024-04 |
Issued Notice of Compliance |
Tolvaptan |
Diuretics |
213262 |
2018-03 |
2019-01 |
Issued Notice of Compliance |
Tozinameranb *For use in relation to COVID-19 |
Vaccines |
251730 |
2021-04 |
2021-05 |
|
Tozinameran *For use in relation to COVID-19 |
Vaccines |
257162 |
2021-10 |
2021-11 |
|
Tozinameran *For use in relation to COVID-19 |
Vaccines |
257698 |
2021-10 |
2021-11 |
|
Tozinameran *For use in relation to COVID-19 |
Vaccines |
261729 |
2022-02 |
2022-06 |
|
Tozinameran *For use in relation to COVID-19 |
Vaccines |
264621 |
2022-05 |
2022-08 |
|
Tozinameran *For use in relation to COVID-19 |
Vaccines |
265483 |
2022-06 |
2022-09 |
|
Tralokinumab |
Other dermatological preparations |
261661 |
2022-04 |
2023-02 |
|
Trametinib |
Antineoplastic agents |
199382 |
2016-11 |
2017-05 |
|
Trametinib |
Antineoplastic agents |
210760 |
2017-11 |
2018-05 |
|
Trametinib |
Antineoplastic agents |
213580 |
2018-03 |
2018-09 |
|
Trametinib |
Antineoplastic agents |
270386 |
2023-01 |
2023-07 |
Issued Notice of Compliance |
Trastuzumab |
Antineoplastic agents |
239083 |
2020-06 |
2021-04 |
|
Trastuzumab |
Antineoplastic agents |
237674 |
2020-05 |
2021-04 |
|
Trastuzumab |
Antineoplastic agents |
242479 |
2020-09 |
2021-04 |
Issued Notice of Compliance |
Trastuzumab |
Antineoplastic agents |
247842 |
2021-02 |
2021-12 |
|
Trastuzumab deruxtecan |
Antineoplastic agents |
259440 |
2022-01 |
2022-06 |
|
Trastuzumab deruxtecan |
Antineoplastic agents |
265333 |
2022-07 |
2023-01 |
|
Trastuzumab deruxtecan |
Antineoplastic agents |
285834 |
2024-05 |
2025-01 |
Issued Notice of Compliance |
Trastuzumab emtansine |
Antineoplastic agents |
227372 |
2019-05 |
2019-11 |
|
Tretinoin |
Anti-acne preparations |
235656 |
2020-03 |
2021-01 |
|
Umeclidinium bromide |
Drugs for obstructive airway diseases |
222505 |
2019-01 |
2020-09 |
|
Upadacitinib |
Immunosuppressants |
241253 |
2020-08 |
2021-06 |
Issued Notice of Compliance |
Upadacitinib |
Immunosuppressants |
245530 |
2020-12 |
2021-10 |
|
Upadacitinib |
Immunosuppressants |
247702 |
2021-02 |
2022-07 |
Issued Notice of Compliance |
Upadacitinib |
Immunosuppressants |
264612 |
2022-07 |
2023-05 |
|
Upadacitinib |
Immunosuppressants |
257284 |
2021-12 |
2023-07 |
Issued Notice of Compliance |
Upadacitinib |
Immunosuppressants |
267554 |
2022-12 |
2023-10 |
|
Ustekinumab |
Immunosuppressants |
224739 |
2019-03 |
2020-01 |
|
Ustekinumab |
Immunosuppressants |
230279 |
2019-08 |
2020-06 |
|
Ustekinumab |
Immunosuppressants |
285419 |
2024-05 |
2024-11 |
|
Varicella-zoster virus glycoprotein E (GE) |
Vaccines |
246933 |
2021-01 |
2021-11 |
|
Venetoclax |
Antineoplastic agents |
214078 |
2018-03 |
2018-09 |
|
Venetoclax |
Antineoplastic agents |
228475 |
2019-07 |
2020-04 |
Issued Notice of Compliance |
Venetoclax |
Antineoplastic agents |
240541 |
2020-06 |
2021-01 |
Issued Notice of Compliance |
Vilazodone hydrochloride |
Psychoanaleptics |
210066 |
2017-11 |
2018-10 |
|
Virus-like particles (VLP) of SARS-CoV-2 spike protein *For use in relation to COVID-19 |
Vaccines |
267448 |
2022-08 |
2023-03 |
|
Zanubrutinib |
Antineoplastic agents |
254556 |
2021-09 |
2022-02 |
|
Zanubrutinib |
Antineoplastic agents |
264963 |
2022-07 |
2023-05 |
|
Zanubrutinib |
Antineoplastic agents |
273215 |
2023-04 |
2024-02 |
|
|
|||||
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