Drug and Health Product Submissions Under Review (SUR): Supplemental submissions completed
This list is current as of: 2026-02-28.
An Excel version of the updated SUR List is available from the Overview page.
| Submission Control Number | Medicinal Ingredient(s) | Therapeutic Area | Submission 'class' (if applicable) |
Date submission was accepted into review | Outcome of submission (hyperlinked if applicable) | Date submission concluded |
|---|---|---|---|---|---|---|
208070 |
Abacavir sulfate, dolutegravir sodium, lamivudine |
Antivirals for systemic use |
Not applicable |
2017-08-11 |
2017-10-11 |
|
204313 |
Abatacept |
Immunosuppressants |
Not applicable |
2017-05-19 |
2018-03-15 |
|
255926 |
Abatacept |
Immunosuppressants |
Reviewed under Project Orbis Type B |
2021-09-16 |
2022-07-21 |
|
249557 |
Abemaciclib |
Antineoplastic agents |
Not applicable |
2021-03-24 |
2022-01-12 |
|
270898 |
Abemaciclib |
Antineoplastic agents |
Not applicable |
2023-03-03 |
2023-12-06 |
|
207915 |
Abiraterone acetate |
Endocrine therapy |
Not applicable |
2017-08-22 |
2018-02-13 |
|
202245 |
Abobotulinumtoxina |
Muscle relaxants |
Not applicable |
2017-03-10 |
2017-12-21 |
|
204299 |
Abobotulinumtoxina |
Muscle relaxants |
Not applicable |
2017-05-15 |
2018-03-09 |
|
206921 |
Abobotulinumtoxina |
Muscle relaxants |
Not applicable |
2017-08-10 |
2018-04-24 |
|
236999 |
Abobotulinumtoxina |
Muscle relaxants |
Not applicable |
2020-04-27 |
2021-02-19 |
|
231228 |
Acalabrutinib |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2019-10-01 |
Issued Notice of Compliance |
2019-11-28 |
289986 |
Acalabrutinib maleate |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2024-10-08 |
Issued Notice of Compliance |
2025-06-24 |
291668 |
Acalabrutinib maleate |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-11-28 |
Issued Notice of Compliance |
2025-09-11 |
259715 |
Ad26.COV2.S (recombinant) *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2021-12-17 |
2022-05-12 |
|
197529 |
Adalimumab |
Immunosuppressants |
Not applicable |
2016-09-19 |
Issued Notice of Compliance |
2017-07-14 |
201423 |
Adalimumab |
Immunosuppressants |
Not applicable |
2017-02-08 |
Issued Notice of Compliance |
2017-12-05 |
212133 |
Adalimumab |
Immunosuppressants |
Not applicable |
2018-02-05 |
2018-11-30 |
|
213550 |
Adalimumab |
Immunosuppressants |
Not applicable |
2018-03-29 |
2019-01-23 |
|
219453 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2018-10-04 |
2020-11-04 |
|
234183 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2019-12-19 |
2020-11-04 |
|
234258 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2020-01-31 |
2020-11-26 |
|
239280 |
Adalimumab |
Immunosuppressants |
Not applicable |
2020-06-25 |
2021-04-21 |
|
244618 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2020-11-19 |
2021-09-10 |
|
257327 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2021-11-22 |
2022-08-12 |
|
256159 |
Adalimumab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2021-10-19 |
2022-09-09 |
|
258125 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2021-12-13 |
2022-10-11 |
|
259979 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2022-02-18 |
2022-11-14 |
|
282461 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2024-03-13 |
Issued Notice of Compliance |
2025-01-15 |
281626 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2024-09-23 |
2025-06-19 |
|
209785 |
Afatinib dimaleate |
Antineoplastic agents |
Not applicable |
2017-12-19 |
Issued Notice of Compliance |
2018-09-20 |
278211 |
Aflibercept |
Ophthalmologicals |
Not applicable |
2023-09-26 |
2025-05-02 |
|
210816 |
Alectinib |
Antineoplastic agents |
Not applicable |
2017-12-21 |
Issued Notice of Compliance |
2018-06-11 |
282375 |
Alectinib hydrochloride |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2024-01-04 |
2024-06-27 |
|
239220 |
Alemtuzumab |
Immunosuppressants |
Not applicable |
2020-07-03 |
Issued Notice of Compliance |
2021-04-28 |
219669 |
Alirocumab |
Lipid modifying agents |
Not applicable |
2018-10-05 |
2019-07-31 |
|
205855 |
Alpha 1-proteinase inhibitor (human) |
Antihemorrhagics |
Not applicable |
2017-06-08 |
2017-06-30 |
|
288056 |
Amifampridine phosphate |
Other nervous system drugs |
Not applicable |
2024-08-14 |
2025-06-10 |
|
282121 |
Amivantamab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2024-01-02 |
2024-06-28 |
|
283969 |
Amivantamab |
Antineoplastic agents |
Reviewed under Project Orbis Type B |
2024-03-19 |
Issued Notice of Compliance |
2025-01-13 |
195649 |
Anakinra |
Immunosuppressants |
Not applicable |
2016-07-25 |
2017-05-18 |
|
237738 |
Anakinra |
Immunosuppressants |
Being reviewed under the Submissions Relying on Third-Party Data Guidance Part of an 'aligned review' with a health technology assessment organization |
2020-05-08 |
2021-10-29 |
|
262044 |
Anidulafungin |
Antimycotics for systemic use |
Not applicable |
2022-07-13 |
2023-05-08 |
|
234257 |
Anthrax antigen filtrate |
Vaccines |
Extraordinary use submission |
2020-01-27 |
2020-11-19 |
|
250002 |
Antihemophilic factor (recombinant) |
Antihemorrhagics |
Not applicable |
2021-03-29 |
Issued Notice of Compliance |
2022-01-19 |
211971 |
Antihemophilic factor (recombinant), pegylated |
Antihemorrhagics |
Not applicable |
2018-01-25 |
2018-11-21 |
|
245031 |
Antihemophilic factor (recombinant), pegylated |
Antihemorrhagics |
Not applicable |
2020-11-30 |
Issued Notice of Compliance |
2021-11-05 |
291800 |
Antihemophilic factor (recombinant, B-domain deleted, pegylated) |
Antihemorrhagics |
Not applicable |
2024-12-23 |
Issued Notice of Compliance |
2025-10-20 |
268221 |
Antihemophilic factor VIII (recombinant, B-domain truncated), pegylated |
Antihemorrhagics |
Not applicable |
2022-11-17 |
2023-09-11 |
|
228077 |
Apalutamide |
Endocrine therapy |
Being reviewed under the Priority Review Policy |
2019-06-17 |
Issued Notice of Compliance |
2019-12-12 |
198842 |
Apixaban |
Antithrombotic agents |
Not applicable |
2016-11-18 |
Issued Notice of Compliance |
2018-10-17 |
233030 |
Apremilast |
Immunosuppressants |
Not applicable |
2019-12-19 |
Issued Notice of Compliance |
2020-08-10 |
200292 |
Aripiprazole |
Psycholeptics |
Not applicable |
2017-01-06 |
2017-11-02 |
|
266917 |
Aripiprazole |
Psycholeptics |
Part of an 'aligned review' with a health technology assessment organization |
2022-09-29 |
2025-01-17 |
|
290676 |
Asciminib hydrochloride |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-10-15 |
Issued Notice of Compliance |
2025-07-25 |
205038 |
Atezolizumab |
Antineoplastic agents |
Not applicable |
2017-06-12 |
2018-04-06 |
|
217324 |
Atezolizumab |
Antineoplastic agents |
Not applicable |
2018-07-30 |
2019-05-24 |
|
223753 |
Atezolizumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy |
2019-02-11 |
2019-08-08 |
|
223911 |
Atezolizumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy |
2019-02-22 |
2019-09-19 |
|
226905 |
Atezolizumab |
Antineoplastic agents |
Not applicable |
2019-06-07 |
2020-04-02 |
|
235450 |
Atezolizumab |
Antineoplastic agents |
Reviewed under Project Orbis Type A |
2020-02-20 |
2020-08-10 |
|
237371 |
Atezolizumab |
Antineoplastic agents |
Not applicable |
2020-05-08 |
2021-03-01 |
|
254361 |
Atezolizumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2021-07-23 |
2022-01-14 |
|
254159 |
Atezolizumab |
Antineoplastic agents |
Not applicable |
2021-08-10 |
2022-03-29 |
|
273484 |
Atogepant |
Analgesics |
Not applicable |
2023-07-07 |
2024-05-02 |
|
225974 |
Avelumab |
Antineoplastic agents |
Being reviewed under the Notice of Compliance with Conditions Guidance |
2019-04-05 |
2019-11-06 |
|
226954 |
Avelumab |
Antineoplastic agents |
Not applicable |
2019-06-07 |
2020-06-30 |
|
240024 |
Avelumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy |
2020-06-15 |
2020-12-10 |
|
256106 |
Axicabtagene ciloleucel |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2021-10-14 |
2022-09-29 |
|
259651 |
Axicabtagene ciloleucel |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2022-02-04 |
2022-12-06 |
|
245813 |
Axitinib |
Antineoplastic agents |
Not applicable |
2020-12-09 |
Issued Notice of Compliance |
2021-10-04 |
221498 |
Azelastine hydrochloride, fluticasone propionate |
Nasal preparations |
Not applicable |
2018-12-14 |
2019-10-04 |
|
254371 |
Azelastine hydrochloride, fluticasone propionate |
Nasal preparations |
Not applicable |
2021-08-20 |
2022-05-18 |
|
245874 |
Baricitinib |
Immunosuppressants |
Not applicable |
2020-12-18 |
2022-01-28 |
|
270684 |
Baricitinib |
Immunosuppressants |
Not applicable |
2023-04-03 |
2024-01-26 |
|
256724 |
Baricitinib *For use in relation to COVID-19 |
Immunosuppressants |
For use in relation to COVID-19 |
2021-10-15 |
2023-06-13 |
|
210469 |
Bazedoxifene acetate, conjugated estrogens |
Sex hormones and modulators of the genital system |
Not applicable |
2017-11-30 |
2018-09-14 |
|
243390 |
Belimumab |
Immunosuppressants |
Not applicable |
2020-10-02 |
2021-07-29 |
|
279522 |
Belimumab |
Immunosuppressants |
Not applicable |
2023-11-15 |
2025-12-23 |
|
270609 |
Belzutifan |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-01-16 |
2023-07-11 |
|
282593 |
Belzutifan |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-02-15 |
2024-12-17 |
|
284185 |
Benralizumab |
Drugs for obstructive airway diseases |
Not applicable |
2024-04-12 |
2025-07-18 |
|
247673 |
Betamethasone dipropionate, calcipotriol monohydrate |
Corticosteroids, dermatological preparations |
Not applicable |
2021-01-29 |
Issued Notice of Compliance |
2021-10-25 |
207259 |
Bevacizumab |
Antineoplastic agents |
Not applicable |
2017-08-10 |
2018-06-06 |
|
218844 |
Bevacizumab |
Antineoplastic agents |
Not applicable |
2018-09-12 |
2019-06-05 |
|
230254 |
Bevacizumab |
Antineoplastic agents |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2019-09-19 |
2020-02-21 |
|
232977 |
Bevacizumab |
Antineoplastic agents |
Biosimilar |
2019-11-20 |
Issued Notice of Compliance |
2021-01-05 |
257734 |
Bevacizumab |
Antineoplastic agents |
Biosimilar |
2021-12-13 |
2022-10-06 |
|
259936 |
Bevacizumab |
Antineoplastic agents |
Biosimilar |
2022-02-01 |
Issued Notice of Compliance |
2022-11-23 |
226658 |
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
Not applicable |
2019-05-08 |
2020-03-02 |
|
240953 |
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
Not applicable |
2020-07-29 |
2021-05-21 |
|
288709 |
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
Not applicable |
2024-08-14 |
2025-06-10 |
|
241318 |
Bilastine |
Antihistamines for systemic use |
Not applicable |
2020-10-15 |
2021-08-11 |
|
273184 |
Bimekizumab |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization |
2023-05-01 |
2024-02-23 |
|
273663 |
Bimekizumab |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization |
2023-05-16 |
2024-03-11 |
|
286289 |
Bimekizumab |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization |
2024-06-17 |
2025-12-12 |
|
243497 |
Bisoprolol fumarate |
Beta blocking agents |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-01-11 |
2024-01-04 |
|
197615 |
Blinatumomab |
Antineoplastic agents |
Not applicable |
2016-09-16 |
2017-04-28 |
|
204154 |
Blinatumomab |
Antineoplastic agents |
Not applicable |
2017-05-09 |
2018-03-05 |
|
210780 |
Blinatumomab |
Antineoplastic agents |
Not applicable |
2017-12-15 |
2019-12-19 |
|
283004 |
Blinatumomab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2024-02-26 |
2024-12-27 |
|
211317 |
Bosutinib |
Antineoplastic agents |
Not applicable |
2018-02-15 |
2018-12-10 |
|
213996 |
Brentuximab vedotin |
Antineoplastic agents |
Not applicable |
2018-04-19 |
2018-12-21 |
|
216513 |
Brentuximab vedotin |
Antineoplastic agents |
Not applicable |
2018-07-06 |
2019-05-02 |
|
227030 |
Brentuximab vedotin |
Antineoplastic agents |
Being reviewed under the Priority Review Policy |
2019-05-27 |
2019-11-22 |
|
268334 |
Brentuximab vedotin |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2022-12-01 |
2023-09-13 |
|
205854 |
Brexpiprazole |
Psycholeptics |
Not applicable |
2017-07-07 |
2019-02-22 |
|
257995 |
Brexpiprazole |
Psycholeptics |
Not applicable |
2021-12-17 |
2022-06-17 |
|
272694 |
Brexpiprazole |
Psycholeptics |
Not applicable |
2023-04-12 |
2024-01-23 |
|
262249 |
Brexucabtagene autoleucel |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2022-04-12 |
Issued Notice of Compliance |
2022-11-16 |
237680 |
Brigatinib |
Antineoplastic agents |
Not applicable |
2020-05-11 |
2021-03-03 |
|
226734 |
Brivaracetam |
Antiepileptics |
Not applicable |
2019-05-29 |
Issued Notice of Compliance |
2020-03-24 |
259754 |
Brolucizumab |
Ophthalmologicals |
Part of an 'aligned review' with a health technology assessment organization |
2022-02-04 |
2022-11-30 |
|
218994 |
Budesonide |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
Not applicable |
2018-09-18 |
Cancelled by sponsor |
2020-03-18 |
238101 |
Budesonide |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
Part of an 'aligned review' with a health technology assessment organization |
2020-05-20 |
Issued Notice of Compliance |
2021-03-16 |
220998 |
Budesonide, formoterol fumarate dihydrate |
Drugs for obstructive airway diseases |
Not applicable |
2018-11-29 |
2019-09-25 |
|
292450 |
Buprenorphine |
Other nervous system drugs |
Not applicable |
2025-01-10 |
2025-12-02 |
|
229313 |
Burosumab |
Drugs for treatment of bone diseases |
Not applicable |
2019-08-22 |
2020-06-16 |
|
249112 |
Burosumab |
Drugs for treatment of bone diseases |
Being reviewed under the Priority Review Policy |
2021-03-05 |
2021-08-26 |
|
197440 |
C1 esterase inhibitor (human) |
Other hematological agents |
Not applicable |
2016-09-15 |
2017-03-31 |
|
254233 |
Cabotegravir, rilpivirine |
Antivirals for systemic use |
Not applicable |
2021-08-19 |
2022-06-15 |
|
258574 |
Cabotegravir, rilpivirine |
Antivirals for systemic use |
Not applicable |
2022-02-14 |
2022-12-09 |
|
221859 |
Cabozantinib |
Antineoplastic agents |
Not applicable |
2018-12-19 |
Issued Notice of Compliance |
2019-10-10 |
222733 |
Cabozantinib |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2019-01-14 |
Issued Notice of Compliance |
2019-11-08 |
245824 |
Cabozantinib |
Antineoplastic agents |
Not applicable |
2020-12-18 |
Issued Notice of Compliance |
2021-10-12 |
257143 |
Cabozantinib malate |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2021-11-04 |
2022-04-28 |
|
280615 |
Cabozantinib malate |
Antineoplastic agents |
Not applicable |
2023-11-23 |
2024-09-12 |
|
194762 |
Canagliflozin |
Drugs used in diabetes |
Not applicable |
2016-06-24 |
2017-04-13 |
|
210676 |
Canagliflozin |
Drugs used in diabetes |
Not applicable |
2017-12-20 |
2018-10-15 |
|
229188 |
Canagliflozin |
Drugs used in diabetes |
Being reviewed under the Priority Review Policy |
2019-08-02 |
Issued Notice of Compliance |
2020-01-24 |
210969 |
Canagliflozin, metformin hydrochloride |
Drugs used in diabetes |
Not applicable |
2017-12-21 |
Issued Notice of Compliance |
2018-10-16 |
232307 |
Canagliflozin, metformin hydrochloride |
Drugs used in diabetes |
Not applicable |
2019-11-15 |
Issued Notice of Compliance |
2020-08-20 |
195617 |
Canakinumab |
Immunosuppressants |
Not applicable |
2016-07-12 |
2017-01-06 |
|
237113 |
Canakinumab |
Immunosuppressants |
Not applicable |
2020-04-29 |
2021-02-22 |
|
225949 |
Carbetocin |
Pituitary and hypothalamic hormones and analogues |
Not applicable |
2019-05-02 |
Issued Notice of Compliance |
2020-02-24 |
237196 |
Carfilzomib |
Antineoplastic agents |
Not applicable |
2020-04-08 |
Issued Notice of Compliance |
2021-01-29 |
267413 |
Carfilzomib |
Antineoplastic agents |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2022-10-07 |
2023-07-26 |
|
227936 |
Carglumic acid |
Other alimentary tract and metabolism products |
Being reviewed under the Priority Review Policy |
2019-06-18 |
2020-11-06 |
|
224729 |
Ceftolozane, tazobactam sodium |
Antibacterials for systemic use |
Being reviewed under the Priority Review Policy |
2019-03-07 |
2019-08-30 |
|
246918 |
Cemiplimab |
Antineoplastic agents |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2020-12-31 |
2021-10-26 |
|
256178 |
Cemiplimab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2021-09-29 |
2022-03-23 |
|
263700 |
Cemiplimab |
Antineoplastic agents |
Not applicable |
2022-05-20 |
2023-04-27 |
|
209082 |
Certolizumab pegol |
Immunosuppressants |
Not applicable |
2017-10-23 |
2018-08-16 |
|
222049 |
Certolizumab pegol |
Immunosuppressants |
Not applicable |
2019-01-17 |
2019-11-13 |
|
259446 |
ChAdOx1-S (recombinant) *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2021-12-10 |
2022-03-31 |
|
290364 |
Chikungunya virus live-attenuated |
Vaccines |
Not applicable |
2024-10-18 |
2025-08-14 |
|
265382 |
Cilgavimab, tixagevimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins |
Part of an 'aligned review' with a health technology assessment organization For use in relation to COVID-19 |
2022-06-22 |
2022-10-18 |
|
277017 |
Ciltacabtagene autoleucel |
Antineoplastic agents |
Not applicable |
2023-08-23 |
2024-07-19 |
|
258126 |
Coagulation factor IX (recombinant), pegylated |
Antihemorrhagics |
Not applicable |
2021-12-16 |
2022-10-12 |
|
274244 |
Coagulation factor VIII (human), human plasma proteins, Von Willebrand factor (human) |
Antihemorrhagics |
Not applicable |
2023-05-03 |
Issued Notice of Compliance |
2024-02-27 |
195789 |
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
Not applicable |
2016-07-28 |
Issued Notice of Compliance |
2017-05-25 |
207251 |
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
Not applicable |
2017-08-23 |
2018-06-19 |
|
219784 |
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
Not applicable |
2018-10-04 |
2019-07-19 |
|
202488 |
Collagenase clostridium histolyticum |
Other drugs for disorders of the musculo-skeletal system |
Not applicable |
2017-03-08 |
2018-01-02 |
|
285411 |
Concizumab |
Antihemorrhagics |
Not applicable |
2024-05-03 |
2024-06-07 |
|
216208 |
Corynebacterium diphtheriae CRM-197 protein, pneumococcal conjugate serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F |
Vaccines |
Not applicable |
2018-06-19 |
2019-04-15 |
|
270922 |
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 |
Being reviewed under the Priority Review Policy |
2023-01-23 |
2023-07-21 |
|
259725 |
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 |
Being reviewed under the Priority Review Policy |
2022-01-14 |
2022-07-08 |
|
291819 |
Corynebacterium diphtheriae CRM-197 protein, pneumococcal polysaccharide serotypes 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, 35B, deOAc15B |
Vaccines |
Not applicable |
2024-11-22 |
Issued Notice of Compliance |
2025-10-14 |
240171 |
Crisaborole |
Other dermatological preparations |
Not applicable |
2020-07-17 |
2021-05-18 |
|
198322 |
Crizotinib |
Antineoplastic agents |
Not applicable |
2016-11-01 |
2017-08-28 |
|
199381 |
Dabrafenib |
Antineoplastic agents |
Not applicable |
2016-11-10 |
2017-05-16 |
|
210753 |
Dabrafenib |
Antineoplastic agents |
Not applicable |
2017-11-22 |
2018-05-18 |
|
213581 |
Dabrafenib |
Antineoplastic agents |
Not applicable |
2018-03-18 |
2018-09-21 |
|
270381 |
Dabrafenib mesylate |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-01-30 |
2023-07-26 |
|
278103 |
Dalbavancin |
Antibacterials for systemic use |
Not applicable |
2023-09-28 |
2024-07-24 |
|
227213 |
Dapagliflozin propanediol |
Drugs used in diabetes |
Not applicable |
2019-06-10 |
Issued Notice of Compliance |
2020-04-02 |
234304 |
Dapagliflozin propanediol |
Drugs used in diabetes |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2020-01-02 |
2020-06-30 |
|
248367 |
Dapagliflozin propanediol |
Drugs used in diabetes |
Being reviewed under the Priority Review Policy |
2021-02-11 |
2021-08-10 |
|
268982 |
Dapagliflozin propanediol monohydrate |
Drugs used in diabetes |
Not applicable |
2022-12-16 |
2023-10-11 |
|
228055 |
Dapagliflozin, metformin hydrochloride |
Drugs used in diabetes |
Not applicable |
2019-07-08 |
Issued Notice of Compliance |
2020-04-23 |
214792 |
Daptomycin |
Antibacterials for systemic use |
Not applicable |
2018-05-11 |
2019-02-21 |
|
198647 |
Daratumumab |
Antineoplastic agents |
Not applicable |
2016-10-17 |
2017-04-13 |
|
212559 |
Daratumumab |
Antineoplastic agents |
Not applicable |
2018-01-31 |
2018-11-27 |
|
226512 |
Daratumumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2019-05-03 |
2019-10-25 |
|
234407 |
Daratumumab |
Antineoplastic agents |
Not applicable |
2020-01-27 |
2020-11-17 |
|
244119 |
Daratumumab |
Antineoplastic agents |
Reviewed under Project Orbis Type B |
2020-11-02 |
2021-04-12 |
|
249815 |
Daratumumab |
Antineoplastic agents |
Not applicable |
2021-03-29 |
2022-01-21 |
|
259880 |
Daratumumab |
Antineoplastic agents |
Not applicable |
2022-02-14 |
2022-12-08 |
|
286426 |
Daratumumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy |
2024-05-31 |
2024-11-27 |
|
293030 |
Daratumumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2025-01-23 |
2025-11-18 |
|
262749 |
Darolutamide |
Endocrine therapy |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2022-04-20 |
2022-09-29 |
|
291388 |
Darolutamide |
Endocrine therapy |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2024-11-13 |
Issued Notice of Compliance |
2025-08-18 |
273747 |
Davesomeran, elasomeran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2023-03-31 |
2023-05-18 |
|
274717 |
Davesomeran, elasomeran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2023-05-03 |
2023-10-26 |
|
244597 |
Deferiprone |
All other therapeutic products |
Not applicable |
2020-12-18 |
Issued Notice of Compliance |
2021-10-13 |
261912 |
Deferiprone |
All other therapeutic products |
Not applicable |
2022-06-03 |
2023-03-30 |
|
203717 |
Denosumab |
Drugs for treatment of bone diseases |
Not applicable |
2017-04-19 |
2018-02-13 |
|
205235 |
Denosumab |
Drugs for treatment of bone diseases |
Not applicable |
2017-06-08 |
2018-04-04 |
|
241617 |
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract |
Allergens |
Not applicable |
2020-09-10 |
2022-12-29 |
|
285056 |
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract |
Allergens |
Not applicable |
2024-05-09 |
2025-03-05 |
|
215955 |
Dexlansoprazole |
Drugs for acid related disorders |
Not applicable |
2018-06-14 |
Issued Notice of Compliance |
2019-04-02 |
259869 |
Dimethyl fumarate |
Immunosuppressants |
Not applicable |
2022-04-14 |
2023-05-18 |
|
243463 |
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 |
Not applicable |
2020-10-02 |
2021-08-05 |
|
243456 |
Diphtheria toxoid adsorbed, filamentous haemagglutinin adsorbed, pertussis toxoid adsorbed, tetanus toxoid adsorbed |
Vaccines |
Not applicable |
2020-10-02 |
2021-08-05 |
|
220233 |
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 |
Not applicable |
2018-11-02 |
2020-09-28 |
|
220103 |
Diphtheria toxoid, filamentous haemagglutinin, fimbriae types 2 and 3 (FIM), pertactin, pertussis toxoid, tetanus toxoid |
Vaccines |
Not applicable |
2018-11-02 |
2020-09-28 |
|
207076 |
Dolutegravir |
Antivirals for systemic use |
Not applicable |
2017-08-09 |
2018-05-22 |
|
235583 |
Dolutegravir |
Antivirals for systemic use |
Not applicable |
2020-04-02 |
2021-01-27 |
|
264733 |
Doravirine |
Antivirals for systemic use |
Not applicable |
2022-07-22 |
2023-05-30 |
|
266249 |
Doravirine, lamivudine, tenofovir disoproxil fumarate |
Antivirals for systemic use |
Not applicable |
2022-09-12 |
2023-07-06 |
|
274515 |
Dostarlimab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2023-05-19 |
2023-11-15 |
|
286361 |
Dostarlimab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-06-20 |
2025-04-16 |
|
201964 |
Dulaglutide |
Drugs used in diabetes |
Not applicable |
2017-03-03 |
2017-12-22 |
|
232128 |
Dulaglutide |
Drugs used in diabetes |
Not applicable |
2019-11-18 |
2020-09-11 |
|
221043 |
Dupilumab |
Other dermatological preparations |
Not applicable |
2018-11-30 |
2019-09-25 |
|
231268 |
Dupilumab |
Other dermatological preparations |
Not applicable |
2019-10-18 |
2020-08-12 |
|
234105 |
Dupilumab |
Other dermatological preparations |
Not applicable |
2020-01-17 |
2020-11-12 |
|
237081 |
Dupilumab |
Other dermatological preparations |
Biosimilar |
2020-03-17 |
2021-02-22 |
|
252306 |
Dupilumab |
Other dermatological preparations |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2021-05-31 |
2022-03-25 |
|
264439 |
Dupilumab |
Other dermatological preparations |
Not applicable |
2022-06-20 |
2023-04-14 |
|
268311 |
Dupilumab |
Other dermatological preparations |
Being reviewed under the Priority Review Policy |
2022-11-02 |
2023-05-01 |
|
266537 |
Dupilumab |
Other dermatological preparations |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2022-09-16 |
2023-07-12 |
|
283782 |
Dupilumab |
Other dermatological preparations |
Being reviewed under the Priority Review Policy |
2024-03-11 |
2024-09-06 |
|
286477 |
Dupilumab |
Other dermatological preparations |
Not applicable |
2024-06-06 |
2025-10-21 |
|
292407 |
Dupilumab |
Other dermatological preparations |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2025-01-03 |
Issued Notice of Compliance |
2025-10-27 |
233107 |
Durvalumab |
Antineoplastic agents |
Not applicable |
2019-11-27 |
2020-09-21 |
|
262782 |
Durvalumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2022-04-21 |
2022-09-28 |
|
281318 |
Durvalumab |
Endocrine therapy |
Not applicable |
2024-01-12 |
2024-10-08 |
|
282097 |
Durvalumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-01-30 |
2025-01-17 |
|
290251 |
Durvalumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-10-10 |
2025-04-08 |
|
285745 |
Durvalumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-05-30 |
2025-04-10 |
|
292883 |
Durvalumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2025-01-03 |
2025-07-17 |
|
299521 |
Durvalumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2025-07-30 |
2026-01-22 |
|
281503 |
Durvalumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-01-16 |
Issued Notice of Compliance |
2026-02-20 |
212987 |
Eculizumab |
Immunosuppressants |
Not applicable |
2018-02-21 |
2018-08-20 |
|
225847 |
Eculizumab |
Immunosuppressants |
Being reviewed under the Priority Review Policy |
2019-04-01 |
2019-09-24 |
|
288497 |
Eculizumab |
Immunosuppressants |
Not applicable |
2024-08-29 |
2025-08-07 |
|
292379 |
Efgartigimod alfa |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization |
2025-01-08 |
2025-11-03 |
|
253430 |
Elasomeran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2021-06-04 |
2021-08-27 |
|
257293 |
Elasomeran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2021-10-06 |
2021-11-12 |
|
258658 |
Elasomeran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2021-11-16 |
2022-03-17 |
|
263775 |
Elasomeran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2022-04-29 |
2022-07-14 |
|
262952 |
Elasomeran *For use in relation to COVID-19 |
Vaccines |
Being reviewed under the Submissions Relying on Third-Party Data Guidance For use in relation to COVID-19 |
2022-04-21 |
2022-09-16 |
|
262408 |
Elasomeran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2022-03-16 |
2023-01-12 |
|
269428 |
Elasomeran, imelasomeran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2022-11-24 |
2023-02-17 |
|
255136 |
Elexacaftor, ivacaftor, tezacaftor |
Other respiratory system products |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2021-10-22 |
2022-04-20 |
|
271750 |
Elexacaftor, ivacaftor, tezacaftor |
Other respiratory system products |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-04-14 |
2023-10-16 |
|
282009 |
Elexacaftor, ivacaftor, tezacaftor |
Other respiratory system products |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2024-01-16 |
2024-07-12 |
|
195798 |
Eltrombopag olamine |
Antihemorrhagics |
Not applicable |
2016-07-05 |
2017-05-01 |
|
217802 |
Eltrombopag olamine |
Antihemorrhagics |
Not applicable |
2018-07-31 |
2019-05-15 |
|
216004 |
Eltrombopag olamine |
Antihemorrhagics |
Not applicable |
2018-06-19 |
Cancelled by sponsor |
2019-06-27 |
222209 |
Emicizumab |
Antihemorrhagics |
Being reviewed under the Priority Review Policy |
2018-12-18 |
2019-06-14 |
|
193840 |
Empagliflozin |
Drugs used in diabetes |
Not applicable |
2016-05-20 |
Issued Notice of Compliance |
2018-04-16 |
221628 |
Empagliflozin |
Drugs used in diabetes |
Not applicable |
2019-01-15 |
2019-04-18 |
|
246457 |
Empagliflozin |
Drugs used in diabetes |
Not applicable |
2021-01-04 |
2021-10-29 |
|
256491 |
Empagliflozin |
Drugs used in diabetes |
Being reviewed under the Priority Review Policy |
2021-10-08 |
2022-04-06 |
|
270652 |
Empagliflozin |
Drugs used in diabetes |
Not applicable |
2023-03-24 |
2024-01-18 |
|
204589 |
Empagliflozin, linagliptin |
Drugs used in diabetes |
Not applicable |
2017-06-09 |
2018-04-20 |
|
234525 |
Emtricitabine, tenofovir alafenamide |
Antivirals for systemic use |
Not applicable |
2020-02-03 |
2020-11-27 |
|
292474 |
Encorafenib |
Antineoplastic agents |
Being reviewed under the Notice of Compliance with Conditions Guidance Reviewed under Project Orbis Type B |
2024-12-17 |
Issued Notice of Compliance under the NOC/c Guidance |
2025-07-25 |
283003 |
Enfortumab vedotin |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2024-02-22 |
2024-08-20 |
|
209807 |
Enoxaparin sodium |
Antithrombotic agents |
Not applicable |
2017-11-15 |
2018-09-11 |
|
292028 |
Enoxaparin sodium |
Antithrombotic agents |
Not applicable |
2024-12-27 |
Cancelled by sponsor |
2025-08-22 |
216719 |
Enzalutamide |
Endocrine therapy |
Not applicable |
2018-06-25 |
Issued Notice of Compliance |
2018-12-20 |
233563 |
Enzalutamide |
Endocrine therapy |
Being reviewed under the Priority Review Policy |
2019-12-10 |
Issued Notice of Compliance |
2020-06-02 |
277282 |
Enzalutamide |
Endocrine therapy |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2023-08-17 |
2024-01-05 |
|
200866 |
Eptacog alfa |
Antihemorrhagics |
Not applicable |
2017-01-17 |
2017-11-10 |
|
267878 |
Eptacog alfa |
Antihemorrhagics |
Not applicable |
2022-11-07 |
2023-03-15 |
|
197739 |
Eribulin mesylate |
Antineoplastic agents |
Not applicable |
2016-10-14 |
2017-08-04 |
|
194018 |
Erlotinib hydrochloride |
Antineoplastic agents |
Not applicable |
2016-06-02 |
2017-03-29 |
|
244338 |
Esketamine hydrochloride |
Psychoanaleptics |
Not applicable |
2020-11-12 |
2021-09-02 |
|
208086 |
Eslicarbazepine acetate |
Antiepileptics |
Not applicable |
2017-09-18 |
2018-06-25 |
|
209753 |
Eslicarbazepine acetate |
Antiepileptics |
Not applicable |
2017-11-16 |
2018-09-12 |
|
193787 |
Etanercept |
Immunosuppressants |
Not applicable |
2016-05-18 |
2017-03-14 |
|
213347 |
Etanercept |
Immunosuppressants |
Not applicable |
2018-03-23 |
2019-01-17 |
|
226145 |
Etanercept |
Immunosuppressants |
Biosimilar |
2019-05-13 |
Issued Notice of Compliance |
2020-06-09 |
231313 |
Etanercept |
Immunosuppressants |
Biosimilar |
2019-10-25 |
2020-08-19 |
|
200814 |
Everolimus |
Antineoplastic agents |
Not applicable |
2017-01-23 |
2017-11-17 |
|
291743 |
Evinacumab |
Lipid modifying agents |
Being reviewed under the Priority Review Policy |
2024-11-20 |
2025-07-04 |
|
207038 |
Evolocumab |
Lipid modifying agents |
Not applicable |
2017-08-10 |
2018-06-05 |
|
208904 |
Evolocumab |
Lipid modifying agents |
Not applicable |
2017-10-16 |
2018-08-10 |
|
247936 |
Evolocumab |
Lipid modifying agents |
Not applicable |
2021-02-12 |
Issued Notice of Compliance |
2021-12-09 |
208034 |
Exenatide |
Drugs used in diabetes |
Not applicable |
2017-09-19 |
2018-07-04 |
|
268826 |
Famtozinameran, tozinameran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2022-10-27 |
2022-12-09 |
|
274152 |
Famtozinameran, tozinameran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2023-03-31 |
2023-07-06 |
|
275559 |
Famtozinameran, tozinameran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2023-06-09 |
2023-08-31 |
|
278042 |
Faricimab |
Ophthalmologicals |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2023-09-29 |
2024-07-24 |
|
230407 |
Fibrinogen (human) |
Antihemorrhagics |
Not applicable |
2019-09-20 |
2020-07-16 |
|
227551 |
Fibrinogen (human) |
Antihemorrhagics |
Not applicable |
2019-06-26 |
2020-11-30 |
|
281380 |
Fibrinogen (human), thrombin (human) |
Antihemorrhagics |
Not applicable |
2024-01-15 |
2024-11-18 |
|
295025 |
Finerenone |
Diuretics |
Part of an 'aligned review' with a health technology assessment organization Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2025-03-26 |
Issued Notice of Compliance |
2026-01-19 |
215423 |
Fingolimod hydrochloride |
Immunosuppressants |
Not applicable |
2018-05-11 |
2018-11-07 |
|
229727 |
Flibanserin |
Other gynecologicals |
Not applicable |
2019-07-26 |
Issued Notice of Compliance |
2021-01-27 |
208727 |
Fluticasone furoate |
Drugs for obstructive airway diseases |
Not applicable |
2017-10-20 |
2018-10-24 |
|
215148 |
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate |
Drugs for obstructive airway diseases |
Not applicable |
2018-05-24 |
2019-03-20 |
|
240101 |
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate |
Drugs for obstructive airway diseases |
Not applicable |
2020-07-15 |
2021-05-11 |
|
291390 |
Follitropin alfa, lutropin alfa |
Sex hormones and modulators of the genital system |
Not applicable |
2024-11-25 |
2025-08-11 |
|
239493 |
Formoterol fumarate dihydrate, mometasone furoate |
Drugs for obstructive airway diseases |
Not applicable |
2020-06-29 |
2021-04-23 |
|
256308 |
Fosfomycin sodium |
Antibacterials for systemic use |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-12-07 |
2022-10-18 |
|
295245 |
Fremanezumab |
Analgesics |
Not applicable |
2025-04-07 |
2026-01-30 |
|
201150 |
Fulvestrant |
Endocrine therapy |
Not applicable |
2017-01-17 |
2017-11-08 |
|
205610 |
Gadoterate meglumine |
Contrast media |
Not applicable |
2017-06-28 |
2018-04-24 |
|
252254 |
Gadoteridol |
Contrast media |
Not applicable |
2021-07-28 |
2022-05-24 |
|
232324 |
Galcanezumab |
Analgesics |
Not applicable |
2019-11-22 |
2020-09-17 |
|
279567 |
Gallium (68Ga) gozetotide |
Diagnostic radiopharmaceuticals |
Not applicable |
2023-11-24 |
2024-09-20 |
|
222816 |
Glecaprevir, pibrentasvir |
Antivirals for systemic use |
Being reviewed under the Priority Review Policy |
2018-12-31 |
2019-06-25 |
|
247707 |
Glecaprevir, pibrentasvir |
Antivirals for systemic use |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2021-02-02 |
2021-11-29 |
|
298254 |
Glecaprevir, pibrentasvir |
Antivirals for systemic use |
Being reviewed under the Priority Review Policy |
2025-06-23 |
Issued Notice of Compliance |
2025-12-18 |
289989 |
Glofitamab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-10-21 |
2025-08-13 |
|
259175 |
Glycerol phenylbutyrate |
Other alimentary tract and metabolism products |
Not applicable |
2022-02-07 |
2022-11-24 |
|
198552 |
Glycopyrronium bromide, indacaterol maleate |
Drugs for obstructive airway diseases |
Not applicable |
2016-11-07 |
2017-08-31 |
|
197362 |
Golimumab |
Immunosuppressants |
Not applicable |
2016-09-23 |
Issued Notice of Compliance |
2017-06-28 |
205724 |
Golimumab |
Immunosuppressants |
Not applicable |
2017-06-09 |
2018-04-05 |
|
255908 |
Golimumab |
Immunosuppressants |
Not applicable |
2021-10-07 |
2022-07-29 |
|
275599 |
Goserelin acetate |
Endocrine therapy |
Not applicable |
2023-07-11 |
2024-05-06 |
|
232124 |
Guselkumab |
Immunosuppressants |
Not applicable |
2019-11-15 |
2020-09-04 |
|
288802 |
Guselkumab |
Immunosuppressants |
Not applicable |
2024-09-13 |
2025-07-07 |
|
285952 |
Guselkumab |
Immunosuppressants |
Not applicable |
2024-06-06 |
2025-09-03 |
|
293414 |
Guselkumab |
Immunosuppressants |
Not applicable |
2025-01-21 |
Issued Notice of Compliance |
2025-11-17 |
199807 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B |
Vaccines |
Not applicable |
2016-11-21 |
Issued Notice of Compliance |
2017-05-30 |
295102 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B |
Vaccines |
Not applicable |
2025-04-03 |
Issued Notice of Compliance |
2026-01-27 |
225528 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
Not applicable |
2019-04-26 |
2020-02-20 |
|
229325 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
Not applicable |
2019-08-21 |
Issued Notice of Compliance |
2020-06-16 |
238479 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
Not applicable |
2020-05-12 |
Issued Notice of Compliance |
2021-03-08 |
246936 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
Not applicable |
2021-01-14 |
2021-11-30 |
|
251147 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
Not applicable |
2021-05-19 |
2022-03-08 |
|
218188 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Yamagata) |
Vaccines |
Not applicable |
2018-08-23 |
2019-06-19 |
|
273436 |
Hexaminolevulinate hydrochloride |
Diagnostic agents |
Not applicable |
2023-05-12 |
2024-03-21 |
|
208033 |
Human immunoglobulin |
Immune sera and immunoglobulins |
Not applicable |
2017-09-15 |
2018-07-12 |
|
276884 |
Hyaluronidase (human recombinant), immunoglobulin (human) |
Immune sera and immunoglobulins |
Not applicable |
2023-08-17 |
2024-06-11 |
|
276541 |
Hyaluronidase (human recombinant), immunoglobulin (human) |
Immune sera and immunoglobulins |
Not applicable |
2023-08-01 |
2025-03-13 |
|
223245 |
Hydromorphone hydrochloride |
Analgesics |
Being reviewed under the Priority Review Policy Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2019-01-22 |
2019-05-01 |
|
223031 |
Hydroxyethyl starch |
Blood substitutes and perfusion solutions |
Not applicable |
2019-04-24 |
Issued Notice of Compliance |
2020-02-18 |
222938 |
Hydroxyethyl starch |
Blood substitutes and perfusion solutions |
Not applicable |
2019-04-24 |
Issued Notice of Compliance |
2020-02-18 |
226144 |
Hydroxyurea |
Antineoplastic agents |
Not applicable |
2019-04-17 |
Issued Notice of Compliance |
2020-02-10 |
204436 |
Ibrutinib |
Immunosuppressants |
Not applicable |
2017-05-01 |
2017-10-25 |
|
212632 |
Ibrutinib |
Antineoplastic agents |
Not applicable |
2018-02-01 |
2018-07-24 |
|
218457 |
Ibrutinib |
Antineoplastic agents |
Not applicable |
2018-08-16 |
Issued Notice of Compliance |
2019-02-11 |
222804 |
Ibrutinib |
Antineoplastic agents |
Not applicable |
2019-01-11 |
Issued Notice of Compliance |
2019-11-06 |
235706 |
Ibrutinib |
Antineoplastic agents |
Reviewed under Project Orbis Type B |
2020-02-20 |
Issued Notice of Compliance |
2020-12-15 |
263702 |
Ibrutinib |
Antineoplastic agents |
Not applicable |
2022-05-30 |
2023-03-20 |
|
266710 |
Ibrutinib |
Antineoplastic agents |
Not applicable |
2022-10-13 |
2023-08-04 |
|
217805 |
Icatibant acetate |
Other hematological agents |
Not applicable |
2018-09-12 |
2019-06-28 |
|
203513 |
Idelalisib |
Antineoplastic agents |
Not applicable |
2017-04-26 |
Cancelled by sponsor |
2017-12-07 |
201326 |
Immunoglobulin (human) |
Immune sera and immunoglobulins |
Not applicable |
2017-01-23 |
2017-10-04 |
|
223557 |
Immunoglobulin (human) |
Immune sera and immunoglobulins |
Not applicable |
2019-02-27 |
2019-11-27 |
|
240691 |
Immunoglobulin (human) |
Immune sera and immunoglobulins |
Not applicable |
2020-07-24 |
2021-05-19 |
|
253256 |
Immunoglobulin (human) |
Immune sera and immunoglobulins |
Not applicable |
2021-07-23 |
2022-05-19 |
|
208713 |
Incobotulinumtoxina |
Muscle relaxants |
Not applicable |
2017-10-02 |
2019-06-18 |
|
234438 |
Incobotulinumtoxina |
Muscle relaxants |
Not applicable |
2020-01-22 |
2020-11-17 |
|
251521 |
Incobotulinumtoxina |
Muscle relaxants |
Not applicable |
2021-05-13 |
2022-03-15 |
|
257192 |
Incobotulinumtoxina |
Muscle relaxants |
Not applicable |
2021-11-19 |
2022-09-22 |
|
268590 |
Incobotulinumtoxina |
Muscle relaxants |
Not applicable |
2022-11-04 |
2023-10-06 |
|
278522 |
Incobotulinumtoxina |
Muscle relaxants |
Not applicable |
2023-10-12 |
2024-12-11 |
|
292615 |
Inebilizumab |
Immunosuppressants |
Being reviewed under the Priority Review Policy |
2024-12-16 |
Issued Notice of Compliance |
2025-06-13 |
220321 |
Infliximab |
Immunosuppressants |
Biosimilar |
2018-11-02 |
2019-08-28 |
|
236086 |
Infliximab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2020-04-03 |
2021-01-28 |
|
262141 |
Infliximab |
Immunosuppressants |
Biosimilar |
2022-04-29 |
2023-03-07 |
|
272981 |
Infliximab |
Immunosuppressants |
Biosimilar |
2023-04-21 |
2024-02-15 |
|
226586 |
Insulin aspart |
Drugs used in diabetes |
Not applicable |
2019-05-03 |
2020-02-26 |
|
254352 |
Insulin aspart |
Drugs used in diabetes |
Biosimilar |
2021-10-01 |
2022-07-20 |
|
208917 |
Insulin degludec |
Drugs used in diabetes |
Not applicable |
2017-10-27 |
2018-07-17 |
|
234406 |
Insulin degludec, liraglutide |
Drugs used in diabetes |
Not applicable |
2020-01-21 |
2020-11-13 |
|
228382 |
Insulin glargine |
Drugs used in diabetes |
Not applicable |
2019-07-17 |
Issued Notice of Compliance |
2020-05-12 |
232504 |
Insulin glargine, lixisenatide |
Drugs used in diabetes |
Not applicable |
2019-11-29 |
Issued Notice of Compliance |
2020-09-17 |
268527 |
Iohexol |
Contrast media |
Not applicable |
2023-03-06 |
2023-12-29 |
|
202533 |
Ipilimumab |
Antineoplastic agents |
Not applicable |
2017-02-13 |
2017-04-13 |
|
255450 |
Ipilimumab |
Antineoplastic agents |
Not applicable |
2021-09-23 |
2022-03-03 |
|
270801 |
Ipilimumab |
Antineoplastic agents |
Not applicable |
2023-02-09 |
2023-12-07 |
|
244601 |
Isatuximab |
Antineoplastic agents |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2020-10-30 |
2021-09-13 |
|
286449 |
Isatuximab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-06-21 |
2025-04-17 |
|
280928 |
Isavuconazonium sulfate |
Antimycotics for systemic use |
Not applicable |
2023-12-28 |
2024-11-15 |
|
218044 |
Ivacaftor |
Other respiratory system products |
Not applicable |
2018-08-03 |
2019-01-25 |
|
247481 |
Ivacaftor |
Other respiratory system products |
Being reviewed under the Priority Review Policy |
2021-02-26 |
2021-08-25 |
|
255781 |
Ivacaftor |
Other respiratory system products |
Being reviewed under the Priority Review Policy |
2021-09-14 |
2022-03-23 |
|
273575 |
Ivacaftor |
Other respiratory system products |
Being reviewed under the Priority Review Policy |
2023-06-01 |
2023-11-28 |
|
198036 |
Ivacaftor, lumacaftor |
Other respiratory system products |
Not applicable |
2016-10-20 |
2017-04-18 |
|
215032 |
Ivacaftor, lumacaftor |
Other respiratory system products |
Not applicable |
2018-06-15 |
2018-12-11 |
|
264825 |
Ivacaftor, lumacaftor |
Other respiratory system products |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2022-07-08 |
2023-04-06 |
|
204690 |
Ixekizumab |
Immunosuppressants |
Not applicable |
2017-06-05 |
2018-03-29 |
|
225178 |
Ixekizumab |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization |
2019-04-17 |
2020-02-04 |
|
233071 |
Ixekizumab |
Immunosuppressants |
Not applicable |
2019-12-20 |
2020-10-14 |
|
238580 |
Ixekizumab |
Immunosuppressants |
Not applicable |
2020-06-02 |
2021-03-29 |
|
203520 |
Japanese encephalitis virus vaccine inactivated |
Vaccines |
Not applicable |
2017-05-08 |
2018-03-02 |
|
193732 |
Lacosamide |
Antiepileptics |
Not applicable |
2016-05-04 |
2017-02-28 |
|
203094 |
Lanreotide acetate |
Pituitary and hypothalamic hormones and analogues |
Not applicable |
2017-04-10 |
2018-02-02 |
|
199607 |
Ledipasvir, sofosbuvir |
Antivirals for systemic use |
Not applicable |
2016-11-24 |
2017-05-24 |
|
197794 |
Lenvatinib mesylate |
Antineoplastic agents |
Not applicable |
2016-11-17 |
2017-09-13 |
|
212989 |
Lenvatinib mesylate |
Antineoplastic agents |
Not applicable |
2018-02-27 |
Issued Notice of Compliance |
2018-12-19 |
228723 |
Lenvatinib mesylate |
Antineoplastic agents |
Reviewed under Project Orbis Type A |
2019-07-09 |
2019-09-20 |
|
252195 |
Lenvatinib mesylate |
Antineoplastic agents |
Not applicable |
2021-06-07 |
2022-02-24 |
|
253057 |
Lenvatinib mesylate |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2021-07-12 |
2022-05-05 |
|
272553 |
Letermovir |
Antivirals for systemic use |
Being reviewed under the Priority Review Policy |
2023-03-28 |
2023-09-21 |
|
193372 |
Leuprolide acetate |
Endocrine therapy |
Not applicable |
2016-05-05 |
2017-02-10 |
|
269016 |
Leuprolide acetate |
Endocrine therapy |
Not applicable |
2022-12-02 |
2023-09-21 |
|
254192 |
Leuprolide acetate |
Endocrine therapy |
Not applicable |
2021-10-14 |
2024-01-12 |
|
290766 |
Leuprolide acetate |
Endocrine therapy |
Not applicable |
2025-01-21 |
Issued Notice of Compliance |
2025-11-13 |
222857 |
Levomilnacipran |
Psychoanaleptics |
Not applicable |
2019-01-22 |
Issued Notice of Compliance |
2019-11-15 |
204355 |
Levonorgestrel |
Sex hormones and modulators of the genital system |
Not applicable |
2017-05-19 |
2018-03-14 |
|
273103 |
Levonorgestrel |
Other gynecologicals |
Not applicable |
2023-04-28 |
2024-02-20 |
|
279169 |
Linaclotide |
Drugs for constipation |
Not applicable |
2023-11-10 |
2024-09-05 |
|
194075 |
Linagliptin |
Drugs used in diabetes |
Not applicable |
2016-06-03 |
2018-10-11 |
|
222572 |
Linagliptin |
Drugs used in diabetes |
Not applicable |
2019-01-16 |
Issued Notice of Compliance |
2019-11-08 |
194067 |
Linagliptin, metformin hydrochloride |
Drugs used in diabetes |
Not applicable |
2016-06-03 |
2017-05-02 |
|
229225 |
Linagliptin, metformin hydrochloride |
Drugs used in diabetes |
Not applicable |
2019-08-22 |
Issued Notice of Compliance |
2020-06-15 |
196457 |
Liraglutide |
Drugs used in diabetes |
Not applicable |
2016-08-19 |
2017-06-15 |
|
200821 |
Liraglutide |
Drugs used in diabetes |
Not applicable |
2017-01-23 |
2017-11-17 |
|
225809 |
Liraglutide |
Drugs used in diabetes |
Not applicable |
2019-05-03 |
Issued Notice of Compliance |
2020-02-26 |
237880 |
Liraglutide |
Drugs used in diabetes |
Not applicable |
2020-05-01 |
2021-02-25 |
|
279827 |
Lisocabtagene maraleucel |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2023-11-30 |
2024-09-25 |
|
247174 |
Lorlatinib |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2021-01-11 |
Issued Notice of Compliance |
2021-06-07 |
265088 |
Lumasiran sodium |
Other alimentary tract and metabolism products |
Not applicable |
2022-07-28 |
2023-05-12 |
|
197342 |
Lurasidone hydrochloride |
Psycholeptics |
Not applicable |
2016-09-23 |
2017-07-20 |
|
205325 |
Lurasidone hydrochloride |
Psycholeptics |
Not applicable |
2017-06-23 |
2018-04-19 |
|
279552 |
Luspatercept |
Antianemic preparations |
Not applicable |
2023-11-20 |
2024-09-13 |
|
282347 |
Lutetium (177Lu) oxodotreotide |
Therapeutic radiopharmaceuticals |
Not applicable |
2024-02-09 |
2024-12-13 |
|
219599 |
Macitentan |
Antihypertensives |
Not applicable |
2018-11-22 |
Cancelled by sponsor |
2019-11-08 |
221389 |
Macitentan |
Antihypertensives |
Not applicable |
2019-01-04 |
Issued Notice of Compliance |
2020-07-23 |
282456 |
Macitentan |
Antihypertensives |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2024-02-09 |
Issued Notice of Compliance |
2025-09-12 |
272517 |
Mavacamten |
Cardiac therapy |
Not applicable |
2023-04-06 |
2024-02-16 |
|
203844 |
Meningococcal polysaccharide antigen groups A, C, W-135, and Y, tetanus toxoid |
Vaccines |
Not applicable |
2017-04-25 |
2018-02-19 |
|
208467 |
Mepolizumab |
Drugs for obstructive airway diseases |
Not applicable |
2017-09-20 |
2018-07-17 |
|
212242 |
Mepolizumab |
Drugs for obstructive airway diseases |
Not applicable |
2018-02-02 |
2018-10-18 |
|
221528 |
Mepolizumab |
Drugs for obstructive airway diseases |
Not applicable |
2018-12-12 |
2019-10-08 |
|
226197 |
Mepolizumab |
Drugs for obstructive airway diseases |
Not applicable |
2019-05-17 |
2020-03-12 |
|
247542 |
Mepolizumab |
Drugs for obstructive airway diseases |
Not applicable |
2021-01-14 |
2021-11-05 |
|
255153 |
Mesalazine |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
Not applicable |
2021-09-17 |
2022-08-08 |
|
262828 |
Methyl aminolevulinate hydrochloride |
Antineoplastic agents |
Not applicable |
2022-04-29 |
2023-02-17 |
|
214860 |
Methylphenidate hydrochloride |
Psychoanaleptics |
Not applicable |
2018-05-11 |
Issued Notice of Compliance |
2019-03-05 |
224342 |
Methylphenidate hydrochloride |
Psychoanaleptics |
Not applicable |
2019-03-21 |
Issued Notice of Compliance |
2020-01-15 |
210496 |
Midostaurin |
Antineoplastic agents |
Not applicable |
2017-12-07 |
2018-10-03 |
|
200856 |
Mifepristone, misoprostol |
Sex hormones and modulators of the genital system |
Not applicable |
2017-01-11 |
2017-11-07 |
|
262810 |
Migalastat hydrochloride |
Other alimentary tract and metabolism products |
Not applicable |
2022-05-12 |
2023-03-23 |
|
288758 |
Mirikizumab |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization |
2024-09-11 |
Issued Notice of Compliance |
2025-07-08 |
195973 |
Nadroparin calcium |
Antithrombotic agents |
Not applicable |
2016-08-05 |
2017-07-19 |
|
221031 |
Naloxegol oxalate |
Drugs for constipation |
Not applicable |
2018-11-27 |
Cancelled by sponsor |
2019-09-27 |
242449 |
Neratinib maleate |
Antineoplastic agents |
Not applicable |
2020-09-03 |
Issued Notice of Compliance |
2021-06-23 |
211052 |
Nilotinib |
Antineoplastic agents |
Not applicable |
2017-12-21 |
Issued Notice of Compliance |
2018-10-16 |
227166 |
Nintedanib |
Antineoplastic agents |
Being reviewed under the Priority Review Policy |
2019-05-28 |
2019-11-22 |
|
232923 |
Nintedanib |
Antineoplastic agents |
Being reviewed under the Priority Review Policy |
2019-11-29 |
2020-05-20 |
|
241747 |
Nintedanib |
Antineoplastic agents |
Not applicable |
2020-08-31 |
2021-06-25 |
|
237670 |
Niraparib |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2020-04-08 |
Issued Notice of Compliance |
2020-10-02 |
199379 |
Nivolumab |
Antineoplastic agents |
Not applicable |
2016-11-15 |
2017-05-12 |
|
203286 |
Nivolumab |
Antineoplastic agents |
Not applicable |
2017-03-17 |
2017-11-10 |
|
203593 |
Nivolumab |
Antineoplastic agents |
Not applicable |
2017-04-20 |
2018-01-25 |
|
206974 |
Nivolumab |
Antineoplastic agents |
Not applicable |
2017-07-14 |
2018-03-23 |
|
212067 |
Nivolumab |
Antineoplastic agents |
Not applicable |
2018-01-08 |
2018-07-06 |
|
211838 |
Nivolumab |
Antineoplastic agents |
Not applicable |
2018-01-19 |
2018-11-15 |
|
215535 |
Nivolumab |
Antineoplastic agents |
Not applicable |
2018-06-04 |
2019-11-26 |
|
236255 |
Nivolumab |
Antineoplastic agents |
Reviewed under Project Orbis Type A |
2020-03-18 |
2020-08-06 |
|
234228 |
Nivolumab |
Antineoplastic agents |
Not applicable |
2020-01-24 |
2020-11-18 |
|
239474 |
Nivolumab |
Antineoplastic agents |
Being reviewed under the Notice of Compliance with Conditions Guidance |
2020-06-01 |
2021-02-11 |
|
243600 |
Nivolumab |
Antineoplastic agents |
Reviewed under Project Orbis Type B |
2020-09-30 |
2021-05-28 |
|
247045 |
Nivolumab |
Antineoplastic agents |
Reviewed under Project Orbis Type B |
2021-01-08 |
2021-07-02 |
|
245851 |
Nivolumab |
Antineoplastic agents |
Not applicable |
2020-12-18 |
2021-10-13 |
|
247339 |
Nivolumab |
Antineoplastic agents |
Reviewed under Project Orbis Type B |
2021-01-12 |
2021-10-28 |
|
253652 |
Nivolumab |
Antineoplastic agents |
Not applicable |
2021-07-29 |
2022-06-27 |
|
257103 |
Nivolumab |
Antineoplastic agents |
Reviewed under Project Orbis Type B |
2021-11-17 |
2022-07-25 |
|
261300 |
Nivolumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2022-03-10 |
2022-08-18 |
|
272504 |
Nivolumab |
Antineoplastic agents |
Reviewed under Project Orbis Type C |
2023-03-31 |
2023-12-29 |
|
282374 |
Nivolumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2024-01-03 |
2024-06-28 |
|
288843 |
Nivolumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-08-23 |
2025-06-19 |
|
289379 |
Nivolumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-09-19 |
2025-07-16 |
|
282961 |
Nivolumab |
Antineoplastic agents |
Reviewed under Project Orbis Type B |
2024-03-07 |
2026-02-09 |
|
208906 |
Norfloxacin |
Antibacterials for systemic use |
Not applicable |
2017-10-06 |
Issued Notice of Compliance |
2017-12-05 |
208089 |
Obinutuzumab |
Antineoplastic agents |
Not applicable |
2017-09-08 |
2018-07-05 |
|
295777 |
Obinutuzumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2025-03-28 |
2026-01-22 |
|
289602 |
Odevixibat |
Bile and liver therapy |
Not applicable |
2024-09-26 |
Issued Notice of Compliance |
2025-07-22 |
210204 |
Olaparib |
Antineoplastic agents |
Not applicable |
2017-11-09 |
2018-05-08 |
|
219799 |
Olaparib |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2018-11-19 |
Issued Notice of Compliance |
2019-05-06 |
230309 |
Olaparib |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2019-08-23 |
Issued Notice of Compliance |
2020-02-14 |
235698 |
Olaparib |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2020-02-27 |
Issued Notice of Compliance |
2020-08-21 |
259417 |
Olaparib |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2022-01-18 |
2022-07-27 |
|
265427 |
Olaparib |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2022-08-10 |
2023-07-11 |
|
286243 |
Olaparib |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-05-15 |
Issued Notice of Compliance |
2025-04-29 |
223910 |
Olodaterol hydrochloride, tiotropium bromide monohydrate |
Drugs for obstructive airway diseases |
Not applicable |
2019-03-11 |
Issued Notice of Compliance |
2019-12-06 |
194542 |
Omalizumab |
Drugs for obstructive airway diseases |
Not applicable |
2016-06-16 |
2017-04-12 |
|
241064 |
Omalizumab |
Drugs for obstructive airway diseases |
Not applicable |
2020-08-14 |
2021-07-19 |
|
195504 |
Ombitasvir, paritaprevir, ritonavir |
Antivirals for systemic use |
Not applicable |
2016-07-11 |
Issued Notice of Compliance |
2017-05-05 |
211053 |
OnabotulinumtoxinA |
Muscle relaxants |
Not applicable |
2017-12-20 |
Issued Notice of Compliance |
2018-10-16 |
237685 |
OnabotulinumtoxinA |
Muscle relaxants |
Not applicable |
2020-05-15 |
2021-03-11 |
|
273166 |
OnabotulinumtoxinA |
Muscle relaxants |
Not applicable |
2023-04-13 |
2024-02-07 |
|
275576 |
OnabotulinumtoxinA |
Muscle relaxants |
Not applicable |
2023-06-28 |
2024-04-23 |
|
285064 |
OnabotulinumtoxinA |
Muscle relaxants |
Not applicable |
2024-05-08 |
2025-03-04 |
|
211762 |
Osimertinib mesylate |
Antineoplastic agents |
Not applicable |
2018-01-12 |
2018-07-10 |
|
243288 |
Osimertinib mesylate |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2020-09-15 |
2021-01-18 |
|
279138 |
Osimertinib mesylate |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2023-10-17 |
2024-07-10 |
|
288417 |
Osimertinib mesylate |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2024-08-07 |
2025-04-23 |
|
209413 |
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 |
Not applicable |
2017-11-02 |
2018-08-14 |
|
248992 |
Ozanimod |
Immunosuppressants |
Not applicable |
2021-05-28 |
2022-04-08 |
|
195948 |
Palbociclib |
Antineoplastic agents |
Not applicable |
2016-07-26 |
2017-05-19 |
|
219500 |
Palbociclib |
Antineoplastic agents |
Not applicable |
2018-10-11 |
2019-08-06 |
|
273901 |
Palbociclib |
Antineoplastic agents |
Not applicable |
2023-05-17 |
2024-03-07 |
|
215829 |
Palonosetron hydrochloride |
Antiemetics and antinauseants |
Not applicable |
2018-06-14 |
2019-04-08 |
|
193962 |
Panitumumab |
Antineoplastic agents |
Not applicable |
2016-06-09 |
2017-04-05 |
|
209345 |
Pasireotide |
Pituitary and hypothalamic hormones and analogues |
Not applicable |
2017-11-02 |
2018-08-29 |
|
201200 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2017-01-13 |
2017-09-08 |
|
203157 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2017-03-24 |
2017-09-20 |
|
212388 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2018-01-26 |
2018-09-21 |
|
215699 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2018-05-18 |
2019-03-13 |
|
216451 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2018-06-06 |
2019-04-02 |
|
209011 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2017-09-25 |
2019-04-11 |
|
218779 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2018-08-22 |
2019-04-18 |
|
219700 |
Pembrolizumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2018-10-15 |
2019-07-04 |
|
228721 |
Pembrolizumab |
Antineoplastic agents |
Reviewed under Project Orbis Type A |
2019-07-09 |
2019-09-20 |
|
223819 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2019-02-18 |
2019-12-13 |
|
219213 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2018-09-27 |
2020-03-16 |
|
232775 |
Pembrolizumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2019-12-20 |
2020-10-09 |
|
236910 |
Pembrolizumab |
Antineoplastic agents |
Being reviewed under the Notice of Compliance with Conditions Guidance |
2020-04-03 |
2020-12-14 |
|
239505 |
Pembrolizumab |
Antineoplastic agents |
Reviewed under Project Orbis Type A |
2020-06-19 |
2021-02-05 |
|
240864 |
Pembrolizumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2020-07-29 |
2021-03-03 |
|
246922 |
Pembrolizumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2020-12-15 |
2021-06-04 |
|
246373 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2020-12-18 |
Issued Notice of Compliance under the NOC/c Guidance |
2021-11-19 |
252263 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2021-06-07 |
2022-02-24 |
|
257236 |
Pembrolizumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2021-11-05 |
2022-04-07 |
|
256659 |
Pembrolizumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2021-10-15 |
2022-04-12 |
|
253060 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2021-07-12 |
2022-05-04 |
|
259703 |
Pembrolizumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type C |
2022-01-05 |
2022-07-05 |
|
256537 |
Pembrolizumab |
Antineoplastic agents |
Reviewed under Project Orbis Type B |
2021-10-22 |
2022-08-18 |
|
264318 |
Pembrolizumab |
Antineoplastic agents |
Reviewed under Project Orbis Type C |
2022-06-24 |
2023-04-19 |
|
272409 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2023-03-30 |
2024-02-06 |
|
273487 |
Pembrolizumab |
Antineoplastic agents |
Reviewed under Project Orbis Type C |
2023-05-10 |
2024-03-21 |
|
275053 |
Pembrolizumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2023-06-13 |
2024-04-12 |
|
276501 |
Pembrolizumab |
Antineoplastic agents |
Not applicable |
2023-08-03 |
2024-05-29 |
|
282981 |
Pembrolizumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type C |
2024-02-22 |
2024-08-20 |
|
278399 |
Pembrolizumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2023-10-13 |
2024-08-29 |
|
274453 |
Pembrolizumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2023-06-06 |
2025-02-06 |
|
285469 |
Pembrolizumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-05-10 |
Issued Notice of Compliance |
2025-03-05 |
286343 |
Pembrolizumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-06-17 |
2025-04-11 |
|
284571 |
Pembrolizumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2024-04-17 |
2025-07-14 |
|
294481 |
Pembrolizumab |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2025-02-13 |
2025-08-11 |
|
204327 |
Perampanel |
Antiepileptics |
Not applicable |
2017-05-26 |
2018-03-21 |
|
225719 |
Perampanel |
Antiepileptics |
Not applicable |
2019-05-01 |
Issued Notice of Compliance |
2020-02-25 |
209467 |
Pertuzumab |
Antineoplastic agents |
Not applicable |
2017-11-03 |
2018-08-30 |
|
222022 |
Pertuzumab, trastuzumab |
Antineoplastic agents |
Not applicable |
2018-12-12 |
Issued Notice of Compliance |
2020-07-30 |
230602 |
Pertuzumab, trastuzumab |
Antineoplastic agents |
Not applicable |
2019-09-25 |
2021-02-25 |
|
254251 |
Pertuzumab, trastuzumab |
Antineoplastic agents |
Not applicable |
2021-07-28 |
2022-01-05 |
|
220947 |
Pimecrolimus |
Other dermatological preparations |
Not applicable |
2018-11-30 |
2019-09-26 |
|
247851 |
Pimecrolimus |
Other dermatological preparations |
Not applicable |
2021-01-05 |
2023-09-14 |
|
270856 |
Pitolisant hydrochloride |
Other nervous system drugs |
Not applicable |
2023-02-13 |
2024-01-25 |
|
284477 |
Pitolisant hydrochloride |
Other nervous system drugs |
Not applicable |
2024-04-22 |
2025-02-14 |
|
279583 |
Plecanatide |
Drugs for constipation |
Not applicable |
2024-01-18 |
2024-12-24 |
|
213345 |
Plerixafor |
Immunostimulants |
Not applicable |
2018-02-01 |
Issued Notice of Compliance |
2019-01-10 |
259726 |
Polatuzumab vedotin |
Antineoplastic agents |
Not applicable |
2022-01-21 |
2022-11-14 |
|
218459 |
Pomalidomide |
Immunosuppressants |
Not applicable |
2018-09-07 |
Issued Notice of Compliance |
2019-07-02 |
201272 |
Ranibizumab |
Ophthalmologicals |
Not applicable |
2017-01-09 |
2017-11-03 |
|
233361 |
Ranibizumab |
Ophthalmologicals |
Not applicable |
2019-11-29 |
Issued Notice of Compliance under the NOC/c Guidance |
2021-11-19 |
264421 |
Ranolazine |
Cardiac therapy |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2022-08-26 |
2025-06-30 |
|
259173 |
Ravulizumab |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization |
2022-01-05 |
Issued Notice of Compliance |
2022-11-01 |
261864 |
Ravulizumab |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization |
2022-03-16 |
2023-01-06 |
|
269852 |
Ravulizumab |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization |
2023-01-03 |
2023-10-30 |
|
223244 |
Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein |
Vaccines |
Not applicable |
2019-02-11 |
2020-08-20 |
|
251509 |
Recombinant human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, 58 L1 protein |
Vaccines |
Not applicable |
2021-05-28 |
2022-04-06 |
|
203322 |
Regorafenib |
Antineoplastic agents |
Not applicable |
2017-04-03 |
2017-09-18 |
|
250151 |
Remdesivir *For use in relation to COVID-19 |
Antivirals for systemic use |
For use in relation to COVID-19 |
2021-04-22 |
2022-04-22 |
|
266313 |
Remdesivir *For use in relation to COVID-19 |
Antivirals for systemic use |
For use in relation to COVID-19 |
2022-08-02 |
2023-06-16 |
|
282013 |
Respiratory syncytial virus prefusion F protein (RSVPreF3) |
Vaccines |
Not applicable |
2024-01-08 |
Issued Notice of Compliance |
2024-11-15 |
225074 |
Ribociclib succinate |
Antineoplastic agents |
Not applicable |
2019-04-16 |
Issued Notice of Compliance |
2020-02-07 |
233623 |
Ribociclib succinate |
Antineoplastic agents |
Not applicable |
2019-12-18 |
Issued Notice of Compliance |
2020-10-09 |
262779 |
Ribociclib succinate |
Antineoplastic agents |
Not applicable |
2022-04-21 |
2023-02-10 |
|
283993 |
Ribociclib succinate |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-08-20 |
Issued Notice of Compliance |
2025-06-12 |
209230 |
Rifaximin |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
Not applicable |
2018-02-07 |
Issued Notice of Compliance |
2018-12-03 |
251455 |
Risankizumab |
Immunosuppressants |
Not applicable |
2021-05-20 |
2022-03-16 |
|
258394 |
Risankizumab |
Immunosuppressants |
Not applicable |
2021-12-23 |
2022-10-19 |
|
280386 |
Risankizumab |
Immunosuppressants |
Not applicable |
2023-12-15 |
2024-10-10 |
|
284770 |
Risdiplam |
Other drugs for disorders of the musculo-skeletal system |
Being reviewed under the Priority Review Policy |
2024-04-09 |
2024-10-16 |
|
204718 |
Rituximab |
Antineoplastic agents |
Not applicable |
2017-05-25 |
2018-03-21 |
|
228130 |
Rituximab |
Antineoplastic agents |
Biosimilar |
2019-07-19 |
Issued Notice of Compliance |
2020-05-22 |
242572 |
Rituximab |
Antineoplastic agents |
Biosimilar |
2020-09-24 |
2021-06-30 |
|
211611 |
Rivaroxaban |
Antithrombotic agents |
Not applicable |
2018-01-12 |
2018-09-14 |
|
233166 |
Rivaroxaban |
Antithrombotic agents |
Not applicable |
2020-02-04 |
2020-11-27 |
|
234756 |
Rivaroxaban |
Antithrombotic agents |
Not applicable |
2020-03-19 |
2021-01-12 |
|
280534 |
Roflumilast |
Antipsoriatics |
Not applicable |
2023-12-22 |
2024-10-17 |
|
285437 |
Roflumilast |
Antipsoriatics |
Not applicable |
2024-05-17 |
2025-03-13 |
|
292646 |
Roflumilast |
Antipsoriatics |
Not applicable |
2025-01-16 |
Issued Notice of Compliance |
2025-11-12 |
243699 |
Romiplostim |
Antihemorrhagics |
Not applicable |
2020-10-09 |
2021-08-04 |
|
262756 |
Romosozumab |
Drugs for treatment of bone diseases |
Not applicable |
2022-05-09 |
2023-03-21 |
|
294768 |
RSV F-protein mRNA, 5'(m7G-5'-ppp-5'-Gm), 3' poly(A) |
Vaccines |
Not applicable |
2025-03-20 |
Issued Notice of Compliance |
2026-01-14 |
290813 |
RSV subgroups A, B stabilized prefusion F protein |
Vaccines |
Not applicable |
2024-12-13 |
2025-10-17 |
|
194343 |
Rufinamide |
Antiepileptics |
Not applicable |
2016-06-24 |
2017-04-20 |
|
250022 |
Ruxolitinib phosphate |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2021-03-24 |
2022-05-19 |
|
292164 |
Ruxolitinib phosphate |
Other dermatological preparations |
Not applicable |
2024-12-13 |
Issued Notice of Compliance |
2025-10-09 |
270849 |
Sacituzumab govitecan |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2023-01-20 |
2023-07-19 |
|
211993 |
Sarilumab |
Immunosuppressants |
Not applicable |
2018-01-26 |
2019-08-08 |
|
287263 |
Sarilumab |
Immunosuppressants |
Not applicable |
2024-07-16 |
2025-05-09 |
|
266285 |
SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2022-07-22 |
2022-11-17 |
|
265342 |
SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2022-06-21 |
2022-12-06 |
|
273313 |
SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2023-03-16 |
2023-11-09 |
|
219231 |
Secukinumab |
Immunosuppressants |
Not applicable |
2018-09-28 |
Issued Notice of Compliance |
2019-07-25 |
235994 |
Secukinumab |
Immunosuppressants |
Not applicable |
2020-03-26 |
2021-01-20 |
|
240496 |
Secukinumab |
Immunosuppressants |
Not applicable |
2020-07-30 |
2021-05-26 |
|
250272 |
Secukinumab |
Immunosuppressants |
Not applicable |
2021-05-06 |
2022-03-01 |
|
257230 |
Secukinumab |
Immunosuppressants |
Not applicable |
2021-11-24 |
2022-09-20 |
|
269287 |
Secukinumab |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization |
2022-12-23 |
2024-05-17 |
|
296426 |
Selumetinib sulfate |
Antineoplastic agents |
Not applicable |
2025-05-06 |
Issued Notice of Compliance |
2026-02-25 |
227387 |
Semaglutide |
Drugs used in diabetes |
Not applicable |
2019-06-20 |
2020-03-06 |
|
231580 |
Semaglutide |
Drugs used in diabetes |
Not applicable |
2019-10-11 |
2020-08-04 |
|
245932 |
Semaglutide |
Drugs used in diabetes |
Not applicable |
2020-12-17 |
Issued Notice of Compliance |
2021-10-13 |
266244 |
Semaglutide |
Drugs used in diabetes |
Not applicable |
2022-09-02 |
2023-06-29 |
|
279915 |
Semaglutide |
Drugs used in diabetes |
Not applicable |
2023-12-07 |
2024-11-25 |
|
284023 |
Semaglutide |
Drugs used in diabetes |
Not applicable |
2024-05-30 |
2025-04-08 |
|
287074 |
Semaglutide |
Drugs used in diabetes |
Not applicable |
2024-07-15 |
2025-08-13 |
|
296143 |
Semaglutide |
Drugs used in diabetes |
Being reviewed under the Priority Review Policy |
2025-04-08 |
2025-12-10 |
|
295001 |
Semaglutide |
Drugs used in diabetes |
Not applicable |
2025-03-07 |
Issued Notice of Compliance |
2025-12-31 |
282056 |
Semaglutide |
Drugs used in diabetes |
Not applicable |
2024-02-05 |
Issued Notice of Compliance |
2026-02-25 |
211598 |
Sevelamer carbonate |
All other therapeutic products |
Not applicable |
2018-04-13 |
2019-02-07 |
|
197253 |
Simeprevir |
Antivirals for systemic use |
Not applicable |
2016-09-23 |
2017-07-20 |
|
199753 |
Sofosbuvir, velpatasvir |
Antivirals for systemic use |
Not applicable |
2016-12-06 |
2017-09-14 |
|
233923 |
Sofosbuvir, velpatasvir |
Antivirals for systemic use |
Not applicable |
2020-01-16 |
2020-11-06 |
|
205985 |
Somatropin |
Pituitary and hypothalamic hormones and analogues |
Not applicable |
2017-06-29 |
2018-04-24 |
|
241147 |
Somatropin |
Pituitary and hypothalamic hormones and analogues |
Not applicable |
2020-08-14 |
2021-06-09 |
|
229726 |
Somatropin R-DNA origin |
Pituitary and hypothalamic hormones and analogues |
Not applicable |
2019-08-28 |
2020-06-22 |
|
298213 |
Sotatercept |
Antihypertensives |
Being reviewed under the Priority Review Policy |
2025-06-06 |
2025-12-03 |
|
278317 |
Spesolimab |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization |
2023-10-06 |
2024-07-31 |
|
287138 |
Standardized allergen extract, white birch (Betula verrucosa) |
Allergens |
Not applicable |
2024-07-08 |
2025-05-02 |
|
234565 |
Standardized short ragweed pollen allergenic extract |
Allergens |
Not applicable |
2020-02-24 |
Issued Notice of Compliance |
2020-12-18 |
234372 |
Sugammadex |
All other therapeutic products |
Not applicable |
2020-01-27 |
2021-10-19 |
|
289615 |
Sugammadex |
All other therapeutic products |
Not applicable |
2024-10-04 |
2025-07-31 |
|
231944 |
Sulfur hexafluoride |
Contrast media |
Not applicable |
2019-11-07 |
2020-08-20 |
|
208710 |
Sunitinib malate |
Antineoplastic agents |
Not applicable |
2017-10-05 |
2019-04-23 |
|
271537 |
Talazoparib |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2023-05-09 |
Issued Notice of Compliance |
2025-01-30 |
223862 |
Teduglutide |
Other alimentary tract and metabolism products |
Being reviewed under the Priority Review Policy |
2019-02-15 |
2019-08-13 |
|
288031 |
Tenecteplase |
Antithrombotic agents |
Not applicable |
2024-08-14 |
2025-11-13 |
|
231739 |
Teriflunomide |
Immunosuppressants |
Not applicable |
2019-11-07 |
Issued Notice of Compliance |
2020-09-02 |
295190 |
Tezepelumab |
Drugs for obstructive airway diseases |
Part of an 'aligned review' with a health technology assessment organization |
2025-04-03 |
2026-02-09 |
|
199259 |
Thioguanine |
Antineoplastic agents |
Not applicable |
2016-11-25 |
2017-09-21 |
|
231818 |
Ticagrelor |
Antithrombotic agents |
Not applicable |
2019-10-31 |
2020-08-26 |
|
199839 |
Tinzaparin sodium |
Antithrombotic agents |
Not applicable |
2016-12-19 |
2018-11-22 |
|
227070 |
Tipiracil hydrochloride, trifluridine |
Antineoplastic agents |
Being reviewed under the Priority Review Policy |
2019-05-24 |
2019-11-19 |
|
293412 |
Tirzepatide |
Drugs used in diabetes |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2025-02-06 |
2025-11-26 |
|
263500 |
Tisagenlecleucel |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2022-05-20 |
2022-12-19 |
|
204251 |
Tocilizumab |
Immunosuppressants |
Not applicable |
2017-05-01 |
2017-10-27 |
|
219690 |
Tocilizumab |
Immunosuppressants |
Not applicable |
2018-10-02 |
Issued Notice of Compliance |
2019-07-29 |
220039 |
Tocilizumab |
Immunosuppressants |
Not applicable |
2018-10-22 |
2019-08-16 |
|
261220 |
Tocilizumab *For use in relation to COVID-19 |
Immunosuppressants |
For use in relation to COVID-19 |
2022-02-04 |
2022-10-13 |
|
209522 |
Tofacitinib |
Immunosuppressants |
Not applicable |
2017-11-15 |
Issued Notice of Compliance |
2018-09-11 |
209643 |
Tofacitinib |
Immunosuppressants |
Not applicable |
2017-12-08 |
2018-10-04 |
|
213578 |
Tofacitinib |
Immunosuppressants |
Not applicable |
2018-04-07 |
Issued Notice of Compliance |
2019-01-30 |
264582 |
Tofacitinib citrate |
Immunosuppressants |
Not applicable |
2022-07-15 |
2023-05-12 |
|
271059 |
Tofacitinib citrate |
Immunosuppressants |
Not applicable |
2023-03-28 |
2024-04-12 |
|
213262 |
Tolvaptan |
Diuretics |
Not applicable |
2018-03-15 |
Issued Notice of Compliance |
2019-01-19 |
251730 |
Tozinameran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2021-04-16 |
2021-05-05 |
|
257162 |
Tozinameran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2021-10-01 |
2021-11-09 |
|
257698 |
Tozinameran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2021-10-18 |
2021-11-19 |
|
261729 |
Tozinameran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2022-02-23 |
2022-06-01 |
|
264621 |
Tozinameran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2022-05-27 |
2022-08-19 |
|
265483 |
Tozinameran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2022-06-23 |
2022-09-09 |
|
261661 |
Tralokinumab |
Other dermatological preparations |
Part of an 'aligned review' with a health technology assessment organization |
2022-04-13 |
2023-02-03 |
|
199382 |
Trametinib |
Antineoplastic agents |
Not applicable |
2016-11-17 |
2017-05-16 |
|
210760 |
Trametinib |
Antineoplastic agents |
Not applicable |
2017-11-22 |
2018-05-18 |
|
213580 |
Trametinib |
Antineoplastic agents |
Not applicable |
2018-03-08 |
2018-09-21 |
|
270386 |
Trametinib |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-01-27 |
2023-07-24 |
|
226272 |
Trastuzumab |
Antineoplastic agents |
Biosimilar |
2019-04-11 |
Issued Notice of Compliance |
2019-08-15 |
239083 |
Trastuzumab |
Antineoplastic agents |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2020-06-17 |
2021-04-14 |
|
242479 |
Trastuzumab |
Antineoplastic agents |
Biosimilar |
2020-09-24 |
Issued Notice of Compliance |
2021-04-14 |
237674 |
Trastuzumab |
Antineoplastic agents |
Biosimilar |
2020-05-29 |
2021-04-16 |
|
247842 |
Trastuzumab |
Antineoplastic agents |
Biosimilar |
2021-02-11 |
2021-12-06 |
|
259440 |
Trastuzumab deruxtecan |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2022-01-06 |
2022-06-15 |
|
265333 |
Trastuzumab deruxtecan |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2022-07-15 |
2023-01-06 |
|
285834 |
Trastuzumab deruxtecan |
Antineoplastic agents |
Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2024-05-14 |
2025-01-17 |
|
288114 |
Trastuzumab deruxtecan |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2024-08-07 |
2025-07-03 |
|
291846 |
Trastuzumab deruxtecan |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-12-19 |
Issued Notice of Compliance |
2025-10-27 |
227372 |
Trastuzumab emtansine |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2019-05-30 |
2019-11-25 |
|
282179 |
Treosulfan |
Antineoplastic agents |
Not applicable |
2024-03-14 |
Cancelled by sponsor |
2025-07-02 |
235656 |
Tretinoin |
Anti-acne preparations |
Not applicable |
2020-03-16 |
2021-01-08 |
|
222505 |
Umeclidinium bromide |
Drugs for obstructive airway diseases |
Not applicable |
2019-01-16 |
2020-09-23 |
|
241253 |
Upadacitinib |
Immunosuppressants |
Not applicable |
2020-08-10 |
Issued Notice of Compliance |
2021-06-03 |
245530 |
Upadacitinib |
Immunosuppressants |
Not applicable |
2020-12-10 |
2021-10-06 |
|
247702 |
Upadacitinib |
Immunosuppressants |
Not applicable |
2021-02-03 |
Issued Notice of Compliance |
2022-07-14 |
264612 |
Upadacitinib |
Immunosuppressants |
Not applicable |
2022-07-15 |
2023-05-02 |
|
257284 |
Upadacitinib |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization |
2021-12-17 |
2023-07-21 |
|
267554 |
Upadacitinib |
Immunosuppressants |
Not applicable |
2022-12-16 |
2023-10-12 |
|
290301 |
Upadacitinib |
Immunosuppressants |
Not applicable |
2024-10-30 |
Issued Notice of Compliance |
2025-08-21 |
224739 |
Ustekinumab |
Immunosuppressants |
Not applicable |
2019-03-29 |
2020-01-23 |
|
230279 |
Ustekinumab |
Immunosuppressants |
Not applicable |
2019-08-21 |
2020-06-16 |
|
285419 |
Ustekinumab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2024-05-17 |
2024-11-13 |
|
289290 |
Ustekinumab |
Immunosuppressants |
Biosimilar |
2024-09-25 |
2025-02-28 |
|
291252 |
Ustekinumab |
Immunosuppressants |
Biosimilar |
2024-12-06 |
Issued Notice of Compliance |
2025-06-04 |
296870 |
Ustekinumab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2025-07-15 |
2026-02-02 |
|
246933 |
Varicella-zoster virus glycoprotein E (GE) |
Vaccines |
Not applicable |
2021-01-14 |
2021-11-24 |
|
214078 |
Venetoclax |
Antineoplastic agents |
Not applicable |
2018-03-27 |
2018-09-21 |
|
228475 |
Venetoclax |
Antineoplastic agents |
Not applicable |
2019-07-04 |
Issued Notice of Compliance |
2020-04-28 |
240541 |
Venetoclax |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2020-06-17 |
Issued Notice of Compliance |
2020-12-04 |
289982 |
Venetoclax |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-10-08 |
Issued Notice of Compliance |
2025-07-31 |
210066 |
Vilazodone hydrochloride |
Psychoanaleptics |
Not applicable |
2017-11-27 |
2018-10-24 |
|
267448 |
Virus-like particles (VLP) of SARS-CoV-2 spike protein *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2022-08-30 |
2023-03-30 |
|
294120 |
Vutrisiran sodium |
Other nervous system drugs |
Part of an 'aligned review' with a health technology assessment organization |
2025-02-17 |
Issued Notice of Compliance |
2025-12-12 |
254556 |
Zanubrutinib |
Antineoplastic agents |
Being reviewed under the Priority Review Policy |
2021-09-01 |
2022-02-18 |
|
264963 |
Zanubrutinib |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2022-07-29 |
2023-05-24 |
|
273215 |
Zanubrutinib |
Antineoplastic agents |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2023-04-12 |
2024-02-02 |