Drug and Health Product Submissions Under Review (SUR): New drug 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 |
|---|---|---|---|---|---|---|
234673 |
5-aminolevulinic acid |
Antineoplastic agents |
Being reviewed under the Priority Review Policy |
2020-03-13 |
Issued Notice of Compliance |
2020-09-09 |
259301 |
Abaloparatide |
Calcium homeostasis |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2022-03-01 |
Cancelled by sponsor |
2023-01-11 |
215268 |
Abemaciclib |
Antineoplastic agents |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2018-06-12 |
2019-04-08 |
|
265223 |
Abiraterone acetate, niraparib |
Endocrine therapy |
Not applicable |
2022-08-05 |
2023-06-12 |
|
245854 |
Abrocitinib |
Other dermatological preparations |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2020-12-18 |
2022-06-29 |
|
214504 |
Acalabrutinib |
Antineoplastic agents |
New active substance |
2018-04-27 |
2019-08-23 |
|
259246 |
Acalabrutinib |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2022-05-04 |
2023-02-27 |
|
209478 |
Acetaminophen |
Analgesics |
Not applicable |
2018-02-02 |
2018-11-29 |
|
244695 |
Acetaminophen |
Analgesics |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-04-30 |
2023-02-24 |
|
260262 |
Acetaminophen, ibuprofen sodium dihydrate |
Analgesics |
Not applicable |
2022-06-03 |
2024-02-02 |
|
234460 |
Acetylsalicylic acid, atorvastatin calcium, ramipril |
Cardiac therapy |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2020-02-19 |
2021-03-08 |
|
253702 |
Ad26.COV2.s (recombinant) *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2021-07-26 |
2021-11-23 |
|
246758 |
Ad26.COV2.s (recombinant) *For use in relation to COVID-19 |
Vaccines |
Part of an 'aligned review' with a health technology assessment organization For use in relation to COVID-19 |
2020-11-30 |
2021-03-05 |
|
229124 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2019-09-26 |
2020-11-25 |
|
247265 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2021-03-04 |
2021-12-24 |
|
230637 |
Adalimumab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2019-10-04 |
2020-10-30 |
|
244990 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2021-02-26 |
2022-01-05 |
|
235685 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2020-03-20 |
2021-01-14 |
|
203250 |
Adalimumab |
Immunosuppressants |
Not applicable |
2017-04-24 |
2018-05-08 |
|
203292 |
Adalimumab |
Immunosuppressants |
Not applicable |
2017-04-24 |
2018-05-08 |
|
217314 |
Adalimumab |
Immunosuppressants |
Biosimilar |
2018-11-16 |
2020-11-04 |
|
271199 |
Adapalene, benzoyl peroxide, clindamycin phosphate |
Anti-acne preparations |
Part of an 'aligned review' with a health technology assessment organization |
2023-10-20 |
2024-08-14 |
|
251005 |
Aducanumab |
Other nervous system drugs |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2021-06-02 |
2022-05-27 |
|
276955 |
Aflibercept |
Ophthalmologicals |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2023-10-13 |
2025-07-08 |
|
282152 |
Aflibercept |
Ophthalmologicals |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2024-02-09 |
2025-06-26 |
|
259183 |
Aflibercept |
Ophthalmologicals |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2022-05-09 |
2025-06-26 |
|
274179 |
Aflibercept |
Ophthalmologicals |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2023-09-15 |
Issued Notice of Compliance |
2025-11-24 |
286134 |
Aflibercept |
Ophthalmologicals |
Biosimilar |
2024-07-17 |
2025-10-09 |
|
290401 |
Aflibercept |
Ophthalmologicals |
Biosimilar |
2025-01-02 |
2025-10-30 |
|
292152 |
Aflibercept |
Ophthalmologicals |
Biosimilar |
2025-01-23 |
2025-11-19 |
|
189442 |
Alectinib |
Antineoplastic agents |
Not applicable |
2016-02-11 |
2016-09-29 |
|
246730 |
Alfa 1-proteinase inhibitor (human) |
Antihemorrhagics |
Not applicable |
2021-01-11 |
2021-11-12 |
|
183116 |
Alirocumab |
Lipid modifying agents |
Not applicable |
2015-06-16 |
2016-04-11 |
|
226941 |
Alpelisib |
Antineoplastic agents |
New active substance |
2019-05-17 |
2020-03-11 |
|
273683 |
Alpha1-proteinase inhibitor (human) |
Antihemorrhagics |
Not applicable |
2023-05-15 |
2023-11-10 |
|
189825 |
Alvimopan |
Drugs for constipation |
Not applicable |
2016-03-16 |
2017-03-29 |
|
234655 |
Amifampridine |
Other nervous system drugs |
New active substance Being reviewed under the Priority Review Policy |
2020-02-21 |
2023-01-10 |
|
232685 |
Amifampridine phosphate |
Other nervous system drugs |
New active substance Being reviewed under the Priority Review Policy |
2020-02-07 |
2020-07-31 |
|
235705 |
Amisulpride |
Psycholeptics |
New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2020-03-20 |
2021-01-21 |
|
254440 |
Amivantamab |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Reviewed under Project Orbis Type C |
2021-07-30 |
2022-03-30 |
|
211854 |
Amlodipine besylate |
Calcium channel blockers |
Not applicable |
2018-07-17 |
2019-01-11 |
|
221964 |
Amoxicillin sodium, clavulanic acid |
Antibacterials for systemic use |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2019-04-04 |
2020-01-28 |
|
279991 |
Amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine sulfate, mixed salts amphetamine |
Psychoanaleptics |
Not applicable |
2024-04-05 |
2025-07-28 |
|
266464 |
Andexanet alfa |
All other therapeutic products |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2022-10-26 |
2023-06-16 |
|
275936 |
Andusomeran *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2023-06-30 |
2023-09-12 |
|
246187 |
Anifrolumab |
Immunosuppressants |
New active substance |
2020-12-23 |
2021-11-30 |
|
212387 |
Anthrax antigen filtrate |
Vaccines |
Not applicable |
2018-02-16 |
2018-12-13 |
|
200446 |
Anthrax immunoglobulin (human) |
Immune sera and immunoglobulins |
Not applicable |
2017-01-12 |
2017-11-06 |
|
194071 |
Antihemophilic factor (human), von Willebrand factor (human) |
Antihemorrhagics |
Not applicable |
2016-06-27 |
2018-05-11 |
|
189709 |
Antihemophilic factor (recombinant), pegylated |
Antihemorrhagics |
Not applicable |
2016-01-22 |
2016-11-17 |
|
210935 |
Antihemophilic factor (recombinant, B-domain deleted, pegylated) |
Antihemorrhagics |
Not applicable |
2017-12-22 |
2018-10-18 |
|
218531 |
Antihemophilic factor VIII (recombinant, B-domain truncated), pegylated |
Antihemorrhagics |
Not applicable |
2018-09-07 |
2019-07-04 |
|
211942 |
Apalutamide |
Endocrine therapy |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2018-01-05 |
2018-07-03 |
|
217320 |
Apomorphine hydrochloride |
Anti-parkinson drugs |
Not applicable |
2018-08-23 |
2020-06-12 |
|
290073 |
Aprocitentan |
Antihypertensives |
New active substance |
2025-01-28 |
Issued Notice of Compliance |
2025-12-23 |
247924 |
Aprotinin |
Antihemorrhagics |
Not applicable |
2021-02-19 |
2022-02-01 |
|
286599 |
Aripiprazole |
Psycholeptics |
Not applicable |
2024-07-25 |
2025-01-15 |
|
285622 |
Artesunate |
Antiprotozoals |
New active substance Being reviewed under the Priority Review Policy |
2024-09-06 |
2025-07-04 |
|
255700 |
Asciminib hydrochloride |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2021-08-27 |
2022-06-23 |
|
273065 |
Ascorbic acid, polyethylene glycol 3350, potassium chloride, sodium chloride, sodium sulfate |
Drugs for constipation |
Not applicable |
2023-07-24 |
2024-08-16 |
|
217349 |
Ataluren |
Other drugs for disorders of the musculo-skeletal system |
Not applicable |
2018-09-13 |
Cancelled by sponsor |
2019-10-08 |
186992 |
Ataluren |
All other therapeutic products |
Not applicable |
2015-09-15 |
2016-03-17 |
|
196843 |
Atezolizumab |
Antineoplastic agents |
Not applicable |
2016-08-19 |
2017-04-12 |
|
253186 |
Atogepant |
Analgesics |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2021-07-15 |
2022-12-22 |
|
262121 |
Atropine sulfate |
Ophthalmologicals |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2023-04-06 |
2024-07-15 |
|
248255 |
Avacopan |
Immunosuppressants |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2021-05-24 |
2022-04-14 |
|
245680 |
Avalglucosidase alfa |
Other alimentary tract and metabolism products |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2020-11-30 |
2021-11-12 |
|
220887 |
Avanafil |
Urologicals |
New active substance |
2019-06-25 |
2021-10-05 |
|
278913 |
Avapritinib |
Antineoplastic agents |
New active substance |
2023-11-23 |
2024-09-18 |
|
251688 |
Avatrombopag maleate |
Antihemorrhagics |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2021-06-11 |
2023-11-03 |
|
204052 |
Avelumab |
Antineoplastic agents |
Not applicable |
2017-04-21 |
2017-12-18 |
|
208742 |
Avelumab |
Antineoplastic agents |
Not applicable |
2017-09-19 |
2018-05-04 |
|
218389 |
Axicabtagene ciloleucel |
Antineoplastic agents |
Not applicable |
2018-08-17 |
2019-02-13 |
|
240668 |
Azacitidine |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type C |
2020-07-13 |
2021-01-05 |
|
221579 |
Bacillus Calmette-Guerin BCG - Strain Russian BCG-I |
Immunostimulants |
Not applicable |
2018-12-27 |
2020-12-24 |
|
227361 |
Baloxavir marboxil |
Antivirals for systemic use |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2019-05-31 |
2020-02-19 |
|
253646 |
Bamlanivimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins |
New active substance Part of an 'aligned review' with a health technology assessment organization For use in relation to COVID-19 |
2021-07-23 |
2023-02-20 |
|
244947 |
Bamlanivimab *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 |
2020-10-12 |
2020-11-20 |
|
193687 |
Bamlanivimab *For use in relation to COVID-19 |
Antiinflammatory and antirheumatic products |
Not applicable |
2016-05-17 |
2018-08-17 |
|
271063 |
Beclomethasone dipropionate, formoterol fumarate dihydrate, glycopyrronium bromide |
Drugs for obstructive airway diseases |
Part of an 'aligned review' with a health technology assessment organization |
2023-05-12 |
2025-05-16 |
|
288908 |
Belantamab mafodotin |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-09-24 |
2025-07-18 |
|
289008 |
Belantamab mafodotin |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2024-09-24 |
2025-07-21 |
|
208886 |
Belinostat |
Antineoplastic agents |
Not applicable |
2017-12-21 |
Cancelled by sponsor |
2019-11-18 |
245791 |
Belumosudil mesylate |
Immunosuppressants |
New active substance Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2021-01-05 |
2022-03-16 |
|
254495 |
Belzutifan |
Antineoplastic agents |
New active substance Reviewed under Project Orbis Type B |
2021-09-01 |
2022-07-11 |
|
291745 |
Bempedoic acid |
Lipid modifying agents |
New active substance |
2025-01-20 |
Issued Notice of Compliance |
2025-11-14 |
249957 |
Bendamustine hydrochloride |
Antineoplastic agents |
Not applicable |
2021-07-09 |
2022-05-04 |
|
248962 |
Bendamustine hydrochloride |
Antineoplastic agents |
Not applicable |
2021-03-26 |
2022-01-14 |
|
204008 |
Benralizumab |
Immunosuppressants |
Not applicable |
2017-04-28 |
2018-02-22 |
|
286948 |
Benzoyl peroxide |
Anti-acne preparations |
Not applicable |
2024-09-12 |
2025-08-27 |
|
293525 |
Benzoyl peroxide, tretinoin |
Anti-acne preparations |
Not applicable |
2025-02-07 |
2025-12-04 |
|
179294 |
Bepotastine besilate |
Ophthalmologicals |
Not applicable |
2015-10-07 |
2016-07-27 |
|
252301 |
Berotralstat hydrochloride |
Other hematological agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2021-08-09 |
2022-06-02 |
|
292802 |
Betamethasone dipropionate, calcipotriol |
Antipsoriatics |
Not applicable |
2025-01-20 |
Issued Notice of Compliance |
2025-11-21 |
203765 |
Betamethasone valerate, fusidic acid |
Corticosteroids, dermatological preparations |
Not applicable |
2017-06-16 |
2018-04-12 |
|
227270 |
Betula verrucosa extract |
Nasal preparations |
Not applicable |
2019-06-20 |
2020-04-15 |
|
201427 |
Bevacizumab |
Antineoplastic agents |
Not applicable |
2017-02-17 |
2018-04-30 |
|
244450 |
Bevacizumab |
Antineoplastic agents |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2020-11-19 |
2021-09-23 |
|
237499 |
Bevacizumab |
Antineoplastic agents |
Biosimilar |
2020-07-23 |
2021-11-05 |
|
258973 |
Bevacizumab |
Antineoplastic agents |
Biosimilar |
2022-03-09 |
2023-01-03 |
|
242395 |
Bevacizumab |
Antineoplastic agents |
Biosimilar |
2020-10-02 |
2021-09-23 |
|
218183 |
Bevacizumab |
Antineoplastic agents |
Not applicable |
2018-08-17 |
2019-06-14 |
|
217524 |
Bevacizumab |
Antineoplastic agents |
Not applicable |
2018-08-17 |
Issued Notice of Compliance |
2021-01-05 |
247724 |
Bevacizumab |
Antineoplastic agents |
Biosimilar |
2021-02-03 |
Issued Notice of Compliance |
2021-11-30 |
247369 |
Bevacizumab |
Antineoplastic agents |
Biosimilar |
2021-02-03 |
2021-11-30 |
|
203718 |
Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
Not applicable |
2017-09-14 |
2018-07-10 |
|
184231 |
Bilastine |
Antihistamines for systemic use |
Not applicable |
2015-06-26 |
2016-04-21 |
|
259843 |
Bimatoprost |
Ophthalmologicals |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2022-02-11 |
2022-12-14 |
|
238499 |
Bimekizumab |
Immunosuppressants |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2021-04-13 |
2022-02-14 |
|
237410 |
Binimetinib |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2020-05-07 |
Issued Notice of Compliance |
2021-03-02 |
231842 |
Bisoprolol fumarate |
Beta blocking agents |
Not applicable |
2020-05-19 |
2020-09-16 |
|
203050 |
Bisoprolol fumarate |
Beta blocking agents |
Not applicable |
2017-07-07 |
2019-11-18 |
|
232423 |
Bivalirudin |
Antithrombotic agents |
Not applicable |
2019-11-29 |
2020-09-24 |
|
181723 |
Blinatumomab |
Antineoplastic agents |
Not applicable |
2015-04-15 |
2015-12-22 |
|
273611 |
Bortezomib |
Antineoplastic agents |
Not applicable |
2023-07-26 |
2024-07-19 |
|
190645 |
Botulinum antitoxin, serotypes A, B, C, D, E, F, G |
Immune sera and immunoglobulins |
Not applicable |
2016-02-12 |
2016-12-08 |
|
192684 |
Brexpiprazole |
Psycholeptics |
Not applicable |
2016-04-22 |
2017-02-16 |
|
246355 |
Brexucabtagene autoleucel |
Antineoplastic agents |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2020-12-10 |
2021-06-08 |
|
210369 |
Brigatinib |
Antineoplastic agents |
Not applicable |
2017-11-17 |
2018-07-26 |
|
232449 |
Brilliant blue G |
Ophthalmologicals |
New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2020-03-23 |
Issued Notice of Compliance |
2021-01-15 |
262030 |
Brincidofovir |
Antivirals for systemic use |
Extraordinary use submission |
2022-05-26 |
2023-12-11 |
|
183355 |
Brivaracetam |
Antiepileptics |
Not applicable |
2015-05-14 |
2016-03-09 |
|
195317 |
Brodalumab |
Immunosuppressants |
Not applicable |
2016-07-15 |
2018-03-06 |
|
226224 |
Brolucizumab |
Ophthalmologicals |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2019-05-17 |
2020-03-12 |
|
227232 |
Budesonide |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
Being reviewed under the Priority Review Policy |
2019-05-27 |
2019-11-06 |
|
220876 |
Budesonide |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
Not applicable |
2019-06-21 |
2020-04-15 |
|
242357 |
Budesonide, formoterol fumarate dihydrate, glycopyrronium bromide |
Drugs for obstructive airway diseases |
Part of an 'aligned review' with a health technology assessment organization |
2020-09-18 |
2021-07-15 |
|
293441 |
Bulevirtide acetate |
Antivirals for systemic use |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2025-02-11 |
2025-08-08 |
|
231224 |
Bupivacaine |
Anesthetics |
Not applicable |
2019-12-18 |
2021-08-05 |
|
233561 |
Bupivacaine, meloxicam |
Antiinflammatory and antirheumatic products |
Not applicable |
2020-01-10 |
2022-03-16 |
|
215660 |
Buprenorphine |
Other nervous system drugs |
Not applicable |
2018-05-25 |
2018-11-21 |
|
204746 |
Buprenorphine hydrochloride |
Other nervous system drugs |
Not applicable |
2017-06-08 |
2018-04-18 |
|
196428 |
Buprenorphine hydrochloride |
Other nervous system drugs |
Not applicable |
2016-08-25 |
2017-06-21 |
|
202774 |
Bupropion hydrochloride, naltrexone hydrochloride |
Antiobesity preparations, excluding diet products |
Not applicable |
2017-04-19 |
2018-02-13 |
|
216239 |
Burosumab |
Drugs for treatment of bone diseases |
Not applicable |
2018-06-08 |
2018-12-05 |
|
198308 |
C1 esterase inhibitor (human) |
Other hematological agents |
Not applicable |
2016-11-09 |
2017-09-01 |
|
280033 |
Cabotegravir, cabotegravir sodium |
Antivirals for systemic use |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-11-14 |
2024-05-10 |
|
227315 |
Cabotegravir, rilpivirine |
Antivirals for systemic use |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2019-05-24 |
2020-03-18 |
|
206230 |
Cabozantinib |
Antineoplastic agents |
Not applicable |
2017-07-26 |
2018-09-14 |
|
225810 |
Caffeine citrate |
Psychoanaleptics |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2019-05-09 |
2020-03-04 |
|
268282 |
Calaspargase pegol |
Antineoplastic agents |
New active substance |
2022-11-17 |
2023-11-08 |
|
205392 |
Calcifediol |
Vitamins |
Not applicable |
2017-09-14 |
2018-07-10 |
|
262870 |
Calcium oxybate, magnesium oxybate, potassium oxybate, sodium oxybate |
Other nervous system drugs |
Not applicable |
2022-07-29 |
2023-05-25 |
|
213303 |
Canakinumab |
Immunosuppressants |
Not applicable |
2018-06-14 |
2018-12-11 |
|
255032 |
Cangrelor tetrasodium |
Antithrombotic agents |
New active substance |
2021-11-18 |
2023-01-20 |
|
268559 |
Cannabidiol |
Antiepileptics |
Not applicable |
2023-01-20 |
2023-11-15 |
|
274859 |
Capivasertib |
Antineoplastic agents |
New active substance Reviewed under Project Orbis Type A |
2023-06-05 |
2024-01-26 |
|
230001 |
Caplacizumab |
Antithrombotic agents |
New active substance Being reviewed under the Priority Review Policy |
2019-08-16 |
2020-02-28 |
|
255972 |
Capmatinib dihydrochloride |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2021-09-16 |
2022-05-26 |
|
248574 |
Captopril |
Agents acting on the renin-angiotensin system |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-04-19 |
2023-12-18 |
|
257242 |
Carbidopa, levodopa |
Anti-parkinson drugs |
Not applicable |
2022-04-14 |
2022-10-11 |
|
184479 |
Carfilzomib |
Antineoplastic agents |
Not applicable |
2015-07-20 |
2016-01-15 |
|
249774 |
Cariprazine hydrochloride |
Psycholeptics |
New active substance |
2021-06-28 |
2022-04-22 |
|
256264 |
Casirivimab, imdevimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins |
New active substance Part of an 'aligned review' with a health technology assessment organization For use in relation to COVID-19 |
2021-09-02 |
2024-06-21 |
|
249830 |
Casirivimab, imdevimab *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 |
2021-02-24 |
2021-06-09 |
|
234610 |
Cedazuridine, decitabine |
Antineoplastic agents |
New active substance Reviewed under Project Orbis Type A |
2020-01-27 |
Issued Notice of Compliance |
2020-07-07 |
261973 |
Cefditoren pivoxil |
Antibacterials for systemic use |
New active substance |
2022-07-28 |
2024-03-11 |
|
189720 |
Cefixime |
Antibacterials for systemic use |
Not applicable |
2016-05-13 |
2017-10-11 |
|
280702 |
Celecoxib |
Antiinflammatory and antirheumatic products |
Part of an 'aligned review' with a health technology assessment organization |
2024-02-12 |
2025-04-09 |
|
218718 |
Cemiplimab |
Antineoplastic agents |
Not applicable |
2018-08-24 |
2019-04-10 |
|
218145 |
Cenegermin |
Ophthalmologicals |
Not applicable |
2018-08-14 |
2019-02-08 |
|
261689 |
Cenobamate |
Antiepileptics |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2022-07-29 |
2023-06-12 |
|
216539 |
Cerliponase alfa |
Other alimentary tract and metabolism products |
Not applicable |
2018-06-22 |
2018-12-19 |
|
240337 |
Cevimeline hydrochloride |
Other nervous system drugs |
New active substance |
2020-09-25 |
2022-04-06 |
|
244627 |
ChAdOx1-S (recombinant) *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2020-10-01 |
2021-02-26 |
|
253700 |
ChAdOx1-S (recombinant) *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2021-06-14 |
2021-11-19 |
|
248651 |
ChAdOx1-S (recombinant) *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2021-01-23 |
2021-02-26 |
|
275762 |
Chikungunya virus live-attenuated |
Vaccines |
New active substance |
2023-08-25 |
2024-06-20 |
|
238994 |
Chlormethine |
Antineoplastic agents |
Not applicable |
2020-08-13 |
2021-06-08 |
|
270862 |
Chloroprocaine hydrochloride |
Anesthetics |
Not applicable |
2023-05-05 |
2024-08-22 |
|
223801 |
Chromic chloride, cupric chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate, sodium selenite, zinc chloride |
Blood substitutes and perfusion solutions |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2019-06-07 |
2020-04-01 |
|
200865 |
Cidofovir |
Antivirals for systemic use |
Not applicable |
2017-04-24 |
2018-03-14 |
|
296713 |
Cilastatin sodium, imipenem, relebactam |
Antibacterials for systemic use |
New active substance Being reviewed under the Priority Review Policy |
2025-05-06 |
Issued Notice of Compliance |
2026-01-30 |
258295 |
Cilgavimab, tixagevimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins |
New active substance Part of an 'aligned review' with a health technology assessment organization For use in relation to COVID-19 |
2021-11-12 |
2022-04-14 |
|
240368 |
Cilostazol |
Antithrombotic agents |
New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-02-18 |
2022-07-14 |
|
262122 |
Ciltacabtagene autoleucel |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
2022-04-01 |
2023-02-09 |
|
195151 |
Cinnarizine, dimenhydrinate |
Other nervous system drugs |
Not applicable |
2016-09-16 |
2018-11-20 |
|
284815 |
Cipaglucosidase alfa |
Other alimentary tract and metabolism products |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-06-19 |
2025-04-14 |
|
298071 |
Citalopram hydrobromide |
Psychoanaleptics |
Not applicable |
2025-08-29 |
Issued Notice of Compliance |
2026-02-25 |
200943 |
Cladribine |
Immunosuppressants |
Not applicable |
2017-02-03 |
2017-11-30 |
|
265619 |
Clascoterone |
Anti-acne preparations |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2022-08-22 |
2023-06-15 |
|
295182 |
Clesrovimab |
Immune sera and immunoglobulins |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2025-04-07 |
Issued Notice of Compliance |
2026-01-30 |
193638 |
Clozapine |
Psycholeptics |
Not applicable |
2016-05-13 |
2016-11-08 |
|
201114 |
Coagulation factor IX (recombinant), pegylated |
Antihemorrhagics |
Not applicable |
2017-02-02 |
2017-11-29 |
|
199705 |
Cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
Not applicable |
2017-05-12 |
2018-03-08 |
|
182788 |
Cobimetinib fumarate |
Antineoplastic agents |
Not applicable |
2015-04-29 |
2016-02-22 |
|
248423 |
Colchicine |
Antigout preparations |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2021-02-26 |
2021-08-23 |
|
248711 |
Colchicine *For use in relation to COVID-19 |
Antigout preparations |
Part of an 'aligned review' with a health technology assessment organization For use in relation to COVID-19 |
2021-01-25 |
2021-06-07 |
|
267120 |
Concizumab |
Antihemorrhagics |
New active substance Being reviewed under the Priority Review Policy Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2022-09-13 |
2023-03-10 |
|
267314 |
Concizumab |
Antihemorrhagics |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2022-09-29 |
2023-07-26 |
|
255077 |
Copanlisib dihydrochloride |
Antineoplastic agents |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2021-08-25 |
2021-12-21 |
|
246125 |
Copper, manganese sulfate, selenious acid, sodium iodide, zinc sulfate |
Blood substitutes and perfusion solutions |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-03-05 |
2023-03-15 |
|
253111 |
Corynebacterium diphtheria CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F |
Vaccines |
New active substance |
2021-07-13 |
2022-05-09 |
|
247042 |
Corynebacterium diphtheria CRM-197 protein, pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F |
Vaccines |
New active substance |
2021-01-22 |
2021-11-16 |
|
281914 |
Corynebacterium diphtheriae CRM-197 protein, pneumococcal conjugate serotype 33F, pneumococcal polysaccharide serotypes 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, deOAc15B, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 35B |
Vaccines |
New active substance Being reviewed under the Priority Review Policy |
2024-01-04 |
2024-07-15 |
|
206906 |
Crisaborole |
Other dermatological preparations |
Not applicable |
2017-08-11 |
2018-06-07 |
|
257092 |
Crisantaspase, recombinant |
Antineoplastic agents |
Reviewed under Project Orbis Type C |
2021-11-10 |
2022-09-02 |
|
285444 |
Crovalimab |
Immunosuppressants |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-05-17 |
2025-06-04 |
|
276960 |
Cyclophosphamide, cyclophosphamide monohydrate |
Antineoplastic agents |
Not applicable |
2023-08-24 |
Issued Notice of Compliance |
2025-08-05 |
194580 |
Cyclosporine |
Ophthalmologicals |
Not applicable |
2016-08-31 |
2018-04-13 |
|
215813 |
Cyclosporine |
Ophthalmologicals |
Not applicable |
2018-07-05 |
2018-12-24 |
|
234677 |
Cyclosporine |
Ophthalmologicals |
Not applicable |
2020-04-22 |
2021-02-16 |
|
211635 |
Cysteamine hydrochloride |
Ophthalmologicals |
Not applicable |
2018-02-06 |
Issued Notice of Compliance |
2019-02-11 |
242743 |
Cytarabine, daunorubicin |
Antineoplastic agents |
Being reviewed under the Priority Review Policy |
2020-11-02 |
2021-04-29 |
|
190458 |
Daclizumab |
Immunosuppressants |
Not applicable |
2016-02-12 |
2016-12-08 |
|
214572 |
Dacomitinib |
Antineoplastic agents |
Not applicable |
2018-05-03 |
2019-02-26 |
|
212390 |
Dalbavancin |
Antibacterials for systemic use |
Not applicable |
2018-03-08 |
2018-09-04 |
|
274338 |
Danicopan |
Other hematological agents |
New active substance |
2023-09-06 |
2024-07-19 |
|
263001 |
Daprodustat |
Antianemic preparations |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2022-05-27 |
Cancelled by sponsor |
2023-07-10 |
187648 |
Daratumumab |
Antineoplastic agents |
Not applicable |
2015-11-10 |
2016-06-29 |
|
255507 |
Daridorexant hydrochloride |
Other nervous system drugs |
New active substance |
2021-10-15 |
2023-04-28 |
|
226146 |
Darolutamide |
Endocrine therapy |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2019-04-26 |
2020-02-20 |
|
217347 |
Darvadstrocel |
Unassigned |
Not applicable |
2018-08-09 |
2019-06-05 |
|
284807 |
Datopotamab deruxtecan |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-07-02 |
Cancelled by sponsor |
2025-03-21 |
267589 |
Davesomeran, elasomeran *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2022-09-12 |
2022-11-03 |
|
217663 |
Decitabine |
Antineoplastic agents |
Not applicable |
2018-09-17 |
2019-07-11 |
|
207372 |
Decitabine |
Antineoplastic agents |
Not applicable |
2018-03-27 |
Issued Notice of Compliance |
2019-01-21 |
200808 |
Defibrotide |
Antithrombotic agents |
Not applicable |
2017-01-11 |
2017-07-10 |
|
284667 |
Delafloxacin meglumine |
Antibacterials for systemic use |
New active substance Being reviewed under the Priority Review Policy |
2024-06-07 |
Issued Notice of Compliance |
2025-01-17 |
282015 |
Delgocitinib |
Other dermatological preparations |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-02-13 |
2025-08-25 |
|
278930 |
Denosumab |
Drugs for treatment of bone diseases |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2024-05-16 |
2025-09-17 |
|
282455 |
Denosumab |
Drugs for treatment of bone diseases |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2024-05-16 |
2025-09-17 |
|
271806 |
Denosumab |
Drugs for treatment of bone diseases |
Biosimilar |
2023-03-20 |
2024-02-16 |
|
267788 |
Denosumab |
Drugs for treatment of bone diseases |
Biosimilar |
2023-03-20 |
2024-03-01 |
|
227886 |
Dequalinium chloride |
Gynecological antiinfectives and antiseptics |
Not applicable |
2019-07-05 |
2021-07-28 |
|
195186 |
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract |
Allergens |
Not applicable |
2016-07-08 |
2017-05-04 |
|
208152 |
Dermatophagoides farinae, dermatophagoides pteronyssinus |
Allergens |
Not applicable |
2017-09-22 |
Cancelled by sponsor |
2020-07-22 |
199626 |
Desvenlafaxine |
Psychoanaleptics |
Not applicable |
2017-02-03 |
2017-08-08 |
|
259397 |
Deucravacitinib |
Immunosuppressants |
New active substance |
2022-01-28 |
2022-11-24 |
|
281029 |
Deutivacaftor, tezacaftor, vanzacaftor calcium |
Other respiratory system products |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-09-24 |
2025-07-21 |
|
212391 |
Dexamethasone sodium phosphate, netilmicin sulfate |
Ophthalmologicals |
Not applicable |
2018-02-09 |
2019-10-18 |
|
258157 |
Dexamethasone, levofloxacin |
Ophthalmologicals |
Not applicable |
2021-12-20 |
2023-12-12 |
|
254850 |
Diamorphine hydrochloride |
Other nervous system drugs |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-08-13 |
2022-02-16 |
|
254548 |
Difelikefalin |
All other therapeutic products |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2021-10-21 |
2022-08-16 |
|
212066 |
Dinutuximab |
Antineoplastic agents |
Not applicable |
2018-02-01 |
2018-11-28 |
|
240071 |
Diroximel fumarate |
Immunosuppressants |
New active substance |
2020-07-17 |
2023-02-28 |
|
220402 |
Disodium phosphate, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate, sodium phosphate monobasic |
All other non-therapeutic products |
Not applicable |
2018-11-23 |
2019-09-19 |
|
206402 |
Dolutegravir sodium, rilpivirine hydrochloride |
Antivirals for systemic use |
Not applicable |
2017-07-26 |
2018-05-18 |
|
220275 |
Dolutegravir, lamivudine |
Antivirals for systemic use |
Part of an 'aligned review' with a health technology assessment organization |
2018-10-31 |
2019-08-22 |
|
211293 |
Doravirine |
Antivirals for systemic use |
Not applicable |
2017-12-15 |
Issued Notice of Compliance |
2018-10-12 |
211708 |
Doravirine, lamivudine, tenofovir disoproxil fumarate |
Antivirals for systemic use |
Not applicable |
2018-01-17 |
2018-11-09 |
|
251105 |
Dostarlimab |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2021-04-23 |
Issued Notice of Compliance under the NOC/c Guidance |
2021-12-23 |
218346 |
Dotatate |
Diagnostic radiopharmaceuticals |
Not applicable |
2018-09-06 |
2019-07-03 |
|
290784 |
Doxycycline hyclate |
Antibacterials for systemic use |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2025-01-03 |
2025-10-28 |
|
240372 |
Dronabinol |
Antiemetics and antinauseants |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-05-28 |
2023-05-02 |
|
242176 |
Drospirenone |
Sex hormones and modulators of the genital system |
Not applicable |
2021-02-05 |
2021-11-30 |
|
236197 |
Drospirenone, estetrol monohydrate |
Sex hormones and modulators of the genital system |
New active substance |
2020-05-12 |
Issued Notice of Compliance |
2021-03-05 |
201285 |
Dupilumab |
Immunosuppressants |
Not applicable |
2017-02-03 |
2017-11-30 |
|
202953 |
Durvalumab |
Antineoplastic agents |
Not applicable |
2017-03-17 |
2017-11-03 |
|
208834 |
Durvalumab |
Antineoplastic agents |
Not applicable |
2017-09-22 |
2018-05-04 |
|
256568 |
Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live, attenuated) |
Vaccines |
New active substance |
2021-10-29 |
2022-11-09 |
|
214391 |
Edaravone |
Other nervous system drugs |
Not applicable |
2018-04-06 |
2018-10-03 |
|
187363 |
Edoxaban |
Antithrombotic agents |
Not applicable |
2015-12-10 |
2016-11-04 |
|
283753 |
Efanesoctocog alfa |
Antihemorrhagics |
New active substance |
2024-05-17 |
2025-03-26 |
|
267438 |
Efgartigimod alfa |
Immunosuppressants |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2022-11-23 |
2023-09-19 |
|
287772 |
Elafibranor |
Bile and liver therapy |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2024-09-03 |
2025-04-25 |
|
209513 |
Elagolix |
Sex hormones and modulators of the genital system |
Not applicable |
2017-12-12 |
2018-10-05 |
|
244946 |
Elasomeran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2020-10-12 |
2020-12-23 |
|
252733 |
Elasomeran *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2021-05-15 |
2021-09-16 |
|
265656 |
Elasomeran, imelasomeran *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2022-06-30 |
2022-09-01 |
|
185866 |
Elbasvir, grazoprevir |
Antivirals for systemic use |
Not applicable |
2015-07-23 |
2016-01-19 |
|
246955 |
Elexacaftor, ivacaftor, tezacaftor |
Other respiratory system products |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2020-12-23 |
2021-06-18 |
|
183050 |
Eliglustat tartrate |
Other alimentary tract and metabolism products |
Not applicable |
2015-05-04 |
2017-04-21 |
|
289506 |
Elinzanetant |
Other gynecologicals |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2024-09-27 |
Issued Notice of Compliance |
2025-07-23 |
188144 |
Elotuzumab |
Antineoplastic agents |
Not applicable |
2015-12-24 |
2016-06-21 |
|
273519 |
Elranatamab |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2023-04-14 |
2023-12-06 |
|
190162 |
Eluxadoline |
Drugs for functional gastrointestinal disorders |
Not applicable |
2016-04-01 |
2017-01-26 |
|
237121 |
Emapalumab |
Immunosuppressants |
New active substance |
2020-05-06 |
2021-01-29 |
|
212635 |
Emicizumab |
Antihemorrhagics |
Not applicable |
2018-02-05 |
2018-08-02 |
|
217033 |
Enasidenib mesylate |
Antineoplastic agents |
Not applicable |
2018-07-13 |
2019-02-06 |
|
237413 |
Encorafenib |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2020-05-07 |
Issued Notice of Compliance |
2021-03-02 |
238571 |
Encorafenib |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization |
2020-06-04 |
2021-03-31 |
|
251438 |
Enfortumab vedotin |
Antineoplastic agents |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2021-05-06 |
2021-10-29 |
|
266545 |
Enoxaparin sodium |
Antithrombotic agents |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2022-09-16 |
2023-07-27 |
|
243026 |
Enoxaparin sodium |
Antithrombotic agents |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2021-12-09 |
2022-10-26 |
|
233058 |
Enoxaparin sodium |
Antithrombotic agents |
Biosimilar |
2019-12-19 |
2020-10-14 |
|
233987 |
Enoxaparin sodium |
Antithrombotic agents |
Biosimilar |
2020-01-10 |
2020-11-05 |
|
231767 |
Enoxaparin sodium |
Antithrombotic agents |
Biosimilar |
2019-11-07 |
2020-12-07 |
|
262815 |
Enterococcus faecalis inactivated, Escherichia coli inactivated, Klebsiella pneumoniae inactivated, Proteus vulgaris inactivated |
Vaccines |
New active substance |
2022-05-19 |
2023-05-26 |
|
227517 |
Entrectinib |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
2019-06-03 |
2020-02-10 |
|
228159 |
Entrectinib |
Antineoplastic agents |
Not applicable |
2019-07-17 |
2020-05-05 |
|
271331 |
Epcoritamab |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
2023-02-10 |
2023-10-13 |
|
274598 |
Eplontersen |
Other nervous system drugs |
New active substance |
2023-08-24 |
2024-06-19 |
|
233288 |
Eptinezumab |
Analgesics |
New active substance |
2020-03-18 |
2021-01-11 |
|
224529 |
Erdafitinib |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2019-03-08 |
2019-10-25 |
|
208607 |
Erenumab |
Analgesics |
Not applicable |
2017-10-06 |
2018-08-01 |
|
204724 |
Ertugliflozin pidolate |
Drugs used in diabetes |
Not applicable |
2017-07-14 |
2018-05-09 |
|
201005 |
Ertugliflozin pidolate, metformin hydrochloride |
Drugs used in diabetes |
Not applicable |
2017-08-03 |
2018-05-30 |
|
201006 |
Ertugliflozin pidolate, sitagliptin phosphate monohydrate |
Drugs used in diabetes |
Not applicable |
2017-07-27 |
2018-05-22 |
|
255132 |
Erwinia L-asparaginase |
Antineoplastic agents |
Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2021-09-28 |
2023-07-19 |
|
222855 |
Esketamine hydrochloride |
Psychoanaleptics |
Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2019-01-04 |
2020-05-20 |
|
223938 |
Estradiol hemihydrate |
Sex hormones and modulators of the genital system |
Not applicable |
2019-10-24 |
Issued Notice of Compliance |
2020-08-17 |
224010 |
Estradiol hemihydrate, progesterone |
Sex hormones and modulators of the genital system |
Not applicable |
2019-11-25 |
2020-09-17 |
|
267148 |
Estradiol, norethindrone acetate, relugolix |
Pituitary and hypothalamic hormones and analogues |
New active substance |
2022-11-29 |
2023-09-22 |
|
268111 |
Estradiol, norethindrone acetate, relugolix |
Pituitary and hypothalamic hormones and analogues |
Not applicable |
2022-12-21 |
2023-10-17 |
|
203472 |
Estriol, lactobacillus acidophilus |
Sex hormones and modulators of the genital system |
Not applicable |
2017-06-16 |
Issued Notice of Deficiency - Withdrawal |
2019-01-24 |
234562 |
Etanercept |
Immunosuppressants |
Biosimilar |
2020-02-10 |
2022-08-31 |
|
193864 |
Etanercept |
Immunosuppressants |
Not applicable |
2016-06-10 |
2017-04-06 |
|
256653 |
Etesevimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins |
New active substance Part of an 'aligned review' with a health technology assessment organization For use in relation to COVID-19 |
2021-09-20 |
2023-02-20 |
|
279315 |
Ethinyl estradiol, segesterone acetate |
Sex hormones and modulators of the genital system |
New active substance |
2023-11-10 |
2024-12-18 |
|
231245 |
Etomidate |
Anesthetics |
New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2019-12-24 |
2020-07-15 |
|
226314 |
Etonogestrel |
Sex hormones and modulators of the genital system |
Not applicable |
2019-05-16 |
2020-05-25 |
|
273721 |
Etranacogene dezaparvovec |
Other hematological agents |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-04-26 |
2023-10-23 |
|
271038 |
Etrasimod L-arginine |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
New active substance |
2023-03-10 |
2024-01-31 |
|
272688 |
Evinacumab |
Lipid modifying agents |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-03-27 |
2023-09-22 |
|
284351 |
Exagamglogene autotemcel |
Other hematological agents |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2024-03-27 |
2024-09-23 |
|
267502 |
Famtozinameran, tozinameran *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2022-09-02 |
2022-10-07 |
|
253904 |
Faricimab |
Ophthalmologicals |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2021-08-03 |
2022-05-27 |
|
256417 |
Favipiravir *For use in relation to COVID-19 |
Antivirals for systemic use |
New active substance For use in relation to COVID-19 |
2021-09-13 |
2022-02-24 |
|
285129 |
Fecal microbiota |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-05-09 |
2025-03-05 |
|
229866 |
Fedratinib dihydrochloride monohydrate |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2019-10-25 |
Issued Notice of Compliance |
2020-07-27 |
272960 |
Ferric carboxymaltose |
Antianemic preparations |
New active substance |
2023-04-24 |
2024-03-11 |
|
260666 |
Ferric maltol |
Antianemic preparations |
New active substance |
2022-06-30 |
2024-08-21 |
|
239850 |
Ferric pyrophosphate citrate |
Antianemic preparations |
New active substance |
2020-06-19 |
Issued Notice of Compliance |
2021-04-22 |
258248 |
Ferumoxytol |
Antianemic preparations |
Part of an 'aligned review' with a health technology assessment organization |
2022-03-01 |
Cancelled by sponsor |
2023-02-23 |
280470 |
Fezolinetant |
Other gynecologicals |
New active substance |
2024-01-04 |
2024-12-02 |
|
195870 |
Fibrinogen (human) |
Antihemorrhagics |
Not applicable |
2016-08-11 |
2017-06-07 |
|
239016 |
Fibrinogen (human), thrombin (human) |
Antihemorrhagics |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2020-05-29 |
2021-03-25 |
|
275853 |
Fidanacogene elaparvovec |
Antihemorrhagics |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-06-30 |
2023-12-27 |
|
235219 |
Filgotinib |
Immunosuppressants |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2020-04-06 |
2021-01-06 |
|
267597 |
Filgrastim (r-metHuG-CSF) |
Immunostimulants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2023-01-06 |
2024-07-22 |
|
273870 |
Filgrastim (r-metHuG-CSF) |
Immunostimulants |
Biosimilar |
2024-05-10 |
2025-03-24 |
|
214080 |
Filgrastim (r-metHuG-CSF) |
Immunostimulants |
Not applicable |
2018-04-16 |
2020-04-16 |
|
212016 |
Filgrastim (r-metHuG-CSF) |
Immunostimulants |
Not applicable |
2018-02-02 |
2019-08-06 |
|
220512 |
Filgrastim (r-metHuG-CSF) |
Immunostimulants |
Biosimilar |
2019-03-08 |
2021-10-08 |
|
249486 |
Finerenone |
Diuretics |
New active substance |
2021-04-01 |
2021-10-05 |
|
258231 |
Finerenone |
Diuretics |
New active substance |
2021-12-22 |
2022-10-14 |
|
189352 |
Flibanserin |
Other gynecologicals |
Not applicable |
2016-04-01 |
2018-02-27 |
|
193105 |
Florbetaben (18F) |
Diagnostic radiopharmaceuticals |
Not applicable |
2016-04-09 |
Issued Notice of Compliance |
2017-02-22 |
201510 |
Fluocinolone acetonide |
Ophthalmologicals |
Not applicable |
2017-02-17 |
2018-11-23 |
|
211768 |
Fluorouracil |
Antineoplastic agents |
Not applicable |
2018-04-09 |
Issued Notice of Compliance |
2019-02-01 |
198520 |
Fluoxetine hydrochloride |
Psychoanaleptics |
Not applicable |
2016-12-15 |
2017-06-13 |
|
204880 |
Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate |
Drugs for obstructive airway diseases |
Not applicable |
2017-06-08 |
2018-04-04 |
|
197873 |
Fluticasone propionate |
Drugs for obstructive airway diseases |
Not applicable |
2016-10-27 |
2017-08-22 |
|
197974 |
Fluticasone propionate, salmeterol xinafoate |
Drugs for obstructive airway diseases |
Not applicable |
2016-11-29 |
2018-04-06 |
|
188743 |
Follitropin delta |
Sex hormones and modulators of the genital system |
Not applicable |
2016-01-29 |
2018-03-22 |
|
201306 |
Formoterol fumarate dihydrate, glycopyrronium bromide |
Drugs for obstructive airway diseases |
Not applicable |
2017-02-24 |
2018-03-05 |
|
263826 |
Foscarbidopa, foslevodopa |
Anti-parkinson drugs |
Not applicable |
2022-07-08 |
2023-05-03 |
|
233046 |
Foscarnet sodium |
Antivirals for systemic use |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2019-12-12 |
2020-10-05 |
|
219662 |
Fosfomycin sodium |
Antibacterials for systemic use |
Being reviewed under the Priority Review Policy |
2018-11-02 |
2019-05-01 |
|
232078 |
Fostamatinib disodium |
Antihemorrhagics |
New active substance |
2020-01-24 |
2020-11-19 |
|
250213 |
Fostemsavir tromethamine |
Antivirals for systemic use |
New active substance Being reviewed under the Priority Review Policy |
2021-04-06 |
2021-10-01 |
|
226828 |
Fremanezumab |
Analgesics |
New active substance |
2019-06-17 |
2020-04-09 |
|
275803 |
Fruquintinib |
Antineoplastic agents |
New active substance Reviewed under Project Orbis Type C Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2023-11-21 |
2024-09-10 |
|
186333 |
Gadoteric acid |
Contrast media |
Not applicable |
2015-12-17 |
2016-11-25 |
|
219521 |
Galcanezumab |
Analgesics |
New active substance |
2018-10-05 |
2019-07-30 |
|
221824 |
Gallium (68Ga) chloride |
Diagnostic radiopharmaceuticals |
New active substance |
2019-04-15 |
2019-11-13 |
|
227804 |
Gallium (68Ga) chloride, germanium (68Ge) chloride |
Diagnostic radiopharmaceuticals |
New active substance |
2019-10-25 |
2020-08-20 |
|
263638 |
Gallium (68Ga) gozetotide |
Diagnostic radiopharmaceuticals |
New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2022-06-10 |
2023-04-05 |
|
242332 |
Gallium (68Ga) gozetotide |
Diagnostic radiopharmaceuticals |
New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-02-05 |
2022-10-13 |
|
248874 |
Gallium oxodotreotide |
Diagnostic radiopharmaceuticals |
New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-05-03 |
2022-02-24 |
|
221456 |
Ganciclovir |
Ophthalmologicals |
Not applicable |
2019-02-12 |
2022-09-08 |
|
280174 |
Garadacimab |
Antithrombotic agents |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2023-12-29 |
2025-08-06 |
|
255697 |
Gefapixant |
Cough and cold preparations |
New active substance |
2021-12-16 |
2024-06-12 |
|
223091 |
Gemtuzumab ozogamicin |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2019-02-01 |
2019-11-28 |
|
227918 |
Gilteritinib fumarate |
Antineoplastic agents |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2019-06-27 |
2019-12-23 |
|
237194 |
Givosiran |
Bile and liver therapy |
New active substance Being reviewed under the Priority Review Policy |
2020-04-15 |
2020-10-09 |
|
225793 |
Glasdegib |
Antineoplastic agents |
New active substance |
2019-07-05 |
2020-04-28 |
|
202233 |
Glecaprevir, pibrentasvir |
Antivirals for systemic use |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2017-02-10 |
2017-08-16 |
|
265517 |
Glofitamab |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
2022-07-25 |
2023-03-24 |
|
220839 |
Glucagon |
Pancreatic hormones |
Part of an 'aligned review' with a health technology assessment organization |
2018-11-30 |
2019-09-25 |
|
231585 |
Glycine, histidine, L-alanine, L-arginine, L-isoleucine, L-leucine, L-lysine acetate, L-methionine, L-phenylalanine, L-proline, L-threonine, L-tryptophan, L-tyrosine, L-valine, serine, taurine |
Blood substitutes and perfusion solutions |
Not applicable |
2020-03-05 |
2020-12-30 |
|
197038 |
Glycopyrrolate |
Drugs for functional gastrointestinal disorders |
Not applicable |
2017-01-03 |
2017-10-30 |
|
228353 |
Glycopyrronium bromide, indacaterol acetate, mometasone furoate |
Drugs for obstructive airway diseases |
Not applicable |
2019-09-06 |
2020-07-02 |
|
232286 |
Goserelin acetate |
Endocrine therapy |
Not applicable |
2020-07-28 |
2021-10-20 |
|
200590 |
Guselkumab |
Immunosuppressants |
Not applicable |
2017-01-16 |
2017-11-10 |
|
235556 |
Haemagglutinin, neuraminidase antigen |
Vaccines |
Not applicable |
2020-03-13 |
2021-01-07 |
|
289304 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain A(Yam) |
Vaccines |
Not applicable |
2024-09-25 |
2024-12-03 |
|
200726 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B |
Vaccines |
Not applicable |
2017-05-26 |
2019-03-01 |
|
203436 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
Not applicable |
2017-04-28 |
2018-02-22 |
|
234113 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
Not applicable |
2020-01-30 |
2020-11-17 |
|
222669 |
Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) |
Vaccines |
Not applicable |
2019-01-28 |
2019-11-22 |
|
212718 |
Halobetasol propionate, tazarotene |
Corticosteroids, dermatological preparations |
Not applicable |
2018-05-25 |
Issued Notice of Compliance |
2020-06-09 |
212276 |
Hemin |
Other alimentary tract and metabolism products |
Not applicable |
2018-01-16 |
2018-07-13 |
|
259302 |
Hepatitis B surface antigen (recombinant) |
Vaccines |
New active substance |
2022-02-09 |
2022-12-06 |
|
205160 |
Human heterologous liver cells |
Other alimentary tract and metabolism products |
Not applicable |
2017-06-16 |
2018-07-10 |
|
251360 |
Human insulin (recombinant) |
Drugs used in diabetes |
Biosimilar |
2021-05-28 |
2022-08-03 |
|
247727 |
Hyaluronidase (human recombinant), immunoglobulin (human) |
Immune sera and immunoglobulins |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2021-02-05 |
2022-01-14 |
|
212396 |
Hydrochlorothiazide, zofenopril calcium |
Agents acting on the renin-angiotensin system |
Not applicable |
2018-06-08 |
Cancelled by sponsor |
2019-06-26 |
216854 |
Hydrogen peroxide |
Other dermatological preparations |
Not applicable |
2018-12-14 |
Cancelled by sponsor |
2019-08-26 |
227235 |
Icosapent ethyl |
Lipid modifying agents |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2019-07-05 |
2019-12-30 |
|
182503 |
Idarucizumab |
All other therapeutic products |
Not applicable |
2015-05-19 |
2016-04-29 |
|
244266 |
Idecabtagene vicleucel |
Antineoplastic agents |
New active substance Being reviewed under the Priority Review Policy |
2020-10-19 |
2021-05-26 |
|
194291 |
Immunoglobulin (human) |
Immune sera and immunoglobulins |
Not applicable |
2016-10-21 |
2017-08-17 |
|
226576 |
Immunoglobulin (human) |
Immune sera and immunoglobulins |
Not applicable |
2019-06-14 |
2019-12-10 |
|
202924 |
Immunoglobulin g (human) |
Immune sera and immunoglobulins |
Not applicable |
2017-04-21 |
2018-02-15 |
|
288071 |
Inavolisib |
Antineoplastic agents |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-08-22 |
2025-02-14 |
|
243470 |
Inclisiran sodium |
Lipid modifying agents |
New active substance Part of an 'aligned review' with a health technology assessment organization Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2020-09-30 |
2021-07-26 |
|
227987 |
Indacaterol acetate, mometasone furoate |
Drugs for obstructive airway diseases |
Not applicable |
2019-07-11 |
2020-05-06 |
|
271065 |
Inebilizumab |
Immunosuppressants |
New active substance |
2023-02-17 |
2023-12-15 |
|
246904 |
Infigratinib phosphate |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Reviewed under Project Orbis Type A |
2021-01-15 |
Issued Notice of Compliance under the NOC/c Guidance |
2021-09-27 |
226189 |
Infliximab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2019-05-17 |
2020-03-12 |
|
248134 |
Infliximab |
Immunosuppressants |
Biosimilar |
2021-02-25 |
2021-12-21 |
|
267444 |
Influenza virus type A (H1N1) |
Vaccines |
Not applicable |
2022-10-21 |
2023-10-27 |
|
214274 |
Inotersen sodium |
Other nervous system drugs |
Not applicable |
2018-04-06 |
2018-10-03 |
|
204077 |
Inotuzumab ozogamicin |
Antineoplastic agents |
Not applicable |
2017-05-19 |
2018-03-15 |
|
243229 |
Insulin aspart |
Drugs used in diabetes |
Biosimilar |
2020-12-17 |
2021-10-12 |
|
226573 |
Insulin aspart |
Drugs used in diabetes |
Biosimilar |
2019-12-20 |
2020-10-15 |
|
198124 |
Insulin degludec |
Drugs used in diabetes |
Not applicable |
2016-10-31 |
2017-08-25 |
|
194513 |
Insulin degludec, liraglutide |
Drugs used in diabetes |
Not applicable |
2017-06-15 |
2018-04-11 |
|
202772 |
Insulin glargine |
Drugs used in diabetes |
Not applicable |
2017-04-20 |
2019-02-15 |
|
252068 |
Insulin glargine |
Drugs used in diabetes |
Biosimilar |
2021-06-14 |
2022-04-08 |
|
207006 |
Insulin glargine, lixisenatide |
Drugs used in diabetes |
Not applicable |
2017-09-13 |
2018-07-06 |
|
273850 |
Insulin icodec |
Drugs used in diabetes |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2023-05-17 |
2024-03-12 |
|
189076 |
Insulin injection human biosynthetic |
Drugs used in diabetes |
Not applicable |
2016-09-30 |
2017-07-27 |
|
244611 |
Insulin lispro |
Drugs used in diabetes |
Not applicable |
2020-11-18 |
2021-09-14 |
|
200792 |
Insulin lispro |
Drugs used in diabetes |
Not applicable |
2017-01-20 |
2017-11-16 |
|
196107 |
Iodine |
Contrast media |
Not applicable |
2016-09-19 |
2017-07-13 |
|
201481 |
Ioflupane (123I) |
Diagnostic radiopharmaceuticals |
Not applicable |
2017-02-10 |
2017-12-07 |
|
283206 |
Iptacopan hydrochloride |
Immunosuppressants |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-03-14 |
Issued Notice of Compliance |
2025-01-06 |
189897 |
Iron dextran |
Antianemic preparations |
Not applicable |
2016-05-09 |
2017-06-08 |
|
193890 |
Iron isomaltoside 1000 |
Antianemic preparations |
Not applicable |
2016-07-13 |
2018-06-22 |
|
229245 |
Isatuximab |
Antineoplastic agents |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2019-07-29 |
2020-04-29 |
|
208919 |
Isavuconazonium sulfate |
Antimycotics for systemic use |
Not applicable |
2018-02-27 |
2018-12-19 |
|
263460 |
Isotretinoin |
Anti-acne preparations |
Part of an 'aligned review' with a health technology assessment organization |
2022-08-26 |
2023-06-22 |
|
211292 |
Ivacaftor, tezacaftor |
Other respiratory system products |
Not applicable |
2017-12-29 |
2018-06-27 |
|
211000 |
Ivermectin |
Anthelmintics |
Not applicable |
2017-12-19 |
2018-09-05 |
|
277139 |
Ivosidenib |
Antineoplastic agents |
New active substance |
2023-09-26 |
Issued Notice of Compliance |
2024-07-19 |
190498 |
Ixazomib citrate |
Antineoplastic agents |
Not applicable |
2016-02-09 |
2016-08-04 |
|
184993 |
Ixekizumab |
Immunosuppressants |
Not applicable |
2015-07-30 |
2016-05-25 |
|
276831 |
Labetalol hydrochloride |
Beta blocking agents |
Not applicable |
2023-11-23 |
2025-04-24 |
|
213920 |
Lanadelumab |
Other hematological agents |
Not applicable |
2018-03-23 |
2018-09-19 |
|
259953 |
Landiolol hydrochloride |
Beta blocking agents |
New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2022-02-21 |
2023-11-20 |
|
219998 |
Larotrectinib |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2018-11-05 |
2019-07-10 |
|
236369 |
Lasmiditan |
Analgesics |
New active substance |
2020-04-09 |
2021-01-26 |
|
289987 |
Latanoprost |
Ophthalmologicals |
Not applicable |
2025-01-03 |
Issued Notice of Compliance |
2025-12-02 |
211732 |
Latanoprostene bunod |
Ophthalmologicals |
Not applicable |
2018-03-08 |
2018-12-27 |
|
285014 |
Lazertinib mesylate monohydrate |
Antineoplastic agents |
New active substance Reviewed under Project Orbis Type B |
2024-04-23 |
Issued Notice of Compliance |
2025-03-06 |
272660 |
Lebrikizumab |
Other dermatological preparations |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2023-05-23 |
2024-06-24 |
|
273840 |
Lecanemab |
Psychoanaleptics |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2023-05-15 |
2025-10-24 |
|
233292 |
Lefamulin acetate |
Antibacterials for systemic use |
New active substance Being reviewed under the Priority Review Policy |
2020-01-13 |
2020-07-10 |
|
231286 |
Lemborexant |
Psycholeptics |
New active substance |
2020-01-10 |
2020-11-04 |
|
262999 |
Lenacapavir sodium |
Antivirals for systemic use |
New active substance Being reviewed under the Priority Review Policy |
2022-05-06 |
2022-11-02 |
|
250805 |
Leronlimab *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 |
2021-03-22 |
2021-09-16 |
|
204165 |
Letermovir |
Antivirals for systemic use |
Not applicable |
2017-05-05 |
2017-11-01 |
|
251157 |
LetibotulinumtoxinA |
Muscle relaxants |
Not applicable |
2021-08-18 |
2022-06-14 |
|
246800 |
Leuprolide mesylate |
Endocrine therapy |
Not applicable |
2021-01-20 |
2021-11-16 |
|
213656 |
Levetiracetam |
Antiepileptics |
Not applicable |
2018-09-14 |
2019-07-11 |
|
232047 |
Levothyroxine sodium |
Thyroid therapy |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2020-01-31 |
2020-11-25 |
|
265823 |
Lidocaine hydrochloride, nifedipine |
Vasoprotectives |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2022-11-17 |
2024-05-30 |
|
293019 |
Lifileucel |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
2025-01-07 |
2025-08-15 |
|
199810 |
Lifitegrast |
Ophthalmologicals |
Not applicable |
2016-12-19 |
2017-12-22 |
|
247562 |
Lisocabtagene maraleucel |
Antineoplastic agents |
New active substance |
2021-02-05 |
2022-05-06 |
|
193862 |
Lixisenatide |
Drugs used in diabetes |
Not applicable |
2016-06-17 |
2017-05-25 |
|
284436 |
Loncastuximab tesirine |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2024-06-07 |
2025-03-07 |
|
190891 |
Lonoctocog alfa |
Antihemorrhagics |
Not applicable |
2016-02-17 |
2016-12-12 |
|
198689 |
Lorcaserin hydrochloride |
Antiobesity preparations, excluding diet products |
Not applicable |
2016-11-25 |
2018-02-02 |
|
215733 |
Lorlatinib |
Antineoplastic agents |
Not applicable |
2018-06-18 |
2019-02-22 |
|
254883 |
Lumasiran |
Other alimentary tract and metabolism products |
New active substance Being reviewed under the Priority Review Policy |
2021-08-25 |
Issued Notice of Compliance |
2022-03-07 |
247485 |
Lurbinectedin |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Reviewed under Project Orbis Type C |
2021-01-21 |
Issued Notice of Compliance under the NOC/c Guidance |
2021-09-29 |
236441 |
Luspatercept |
Antianemic preparations |
New active substance Being reviewed under the Priority Review Policy |
2020-03-30 |
2020-09-25 |
|
236625 |
Luspatercept |
Antianemic preparations |
Not applicable |
2020-04-17 |
2021-02-11 |
|
217184 |
Lutetium (177Lu) oxodotretotide |
Therapeutic radiopharmaceuticals |
Not applicable |
2018-07-13 |
2019-01-09 |
|
260951 |
Lutetium (177Lu) vipivotide tetraxetan |
Therapeutic radiopharmaceuticals |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2022-02-28 |
2022-08-25 |
|
245848 |
Macitentan, tadalafil |
Antihypertensives |
Not applicable |
2020-12-18 |
2021-10-14 |
|
217446 |
Mannitol |
Diagnostic agents |
Not applicable |
2018-08-17 |
2019-06-13 |
|
271030 |
Maralixibat chloride |
Bile and liver therapy |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-01-26 |
2023-07-21 |
|
259676 |
Maribavir |
Antivirals for systemic use |
New active substance Being reviewed under the Priority Review Policy |
2022-03-22 |
2022-09-15 |
|
280462 |
Marstacimab |
Antihemorrhagics |
New active substance |
2023-12-15 |
Cancelled by sponsor |
2024-10-10 |
263505 |
Masitinib mesylate |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2022-05-24 |
2024-02-19 |
|
258772 |
Mavacamten |
Cardiac therapy |
New active substance |
2022-01-12 |
2022-11-08 |
|
235023 |
Mecasermin |
Pituitary and hypothalamic hormones and analogues |
New active substance |
2020-02-24 |
2020-12-17 |
|
287534 |
Melatonin |
Psycholeptics |
Not applicable |
2024-08-01 |
2025-09-08 |
|
233632 |
Meningococcal group A polysaccharide-tetanus toxoid conjugate, meningococcal group C polysaccharide-tetanus toxoid conjugate, meningococcal group W polysaccharide-tetanus toxoid conjugate, meningococcal group Y polysaccharide-tetanus toxoid conjugate |
Vaccines |
Not applicable |
2020-01-03 |
2020-10-29 |
|
191347 |
Mercaptamine bitartrate |
Other alimentary tract and metabolism products |
Not applicable |
2016-03-16 |
2017-06-13 |
|
266553 |
Meropenem trihydrate |
Antibacterials for systemic use |
Not applicable |
2023-03-10 |
2024-01-04 |
|
280730 |
Meropenem trihydrate, vaborbactam |
Antibacterials for systemic use |
New active substance Being reviewed under the Priority Review Policy |
2024-01-29 |
2024-12-20 |
|
204605 |
Mesalazine |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
Not applicable |
2017-05-25 |
2018-03-20 |
|
198475 |
Mesalazine |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
Not applicable |
2017-02-02 |
Cancelled by sponsor |
2020-08-04 |
247241 |
Mesalazine |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
Not applicable |
2021-03-25 |
2022-01-18 |
|
194646 |
Mesalazine |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
Not applicable |
2016-09-06 |
2021-05-18 |
|
263913 |
Metformin hydrochloride |
Drugs used in diabetes |
Not applicable |
2022-07-20 |
2023-01-24 |
|
262108 |
Methotrexate |
Immunosuppressants |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2022-05-24 |
2024-03-26 |
|
254599 |
Methotrexate sodium |
Immunosuppressants |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2021-11-23 |
2022-09-15 |
|
204879 |
Methoxyflurane |
Analgesics |
Not applicable |
2017-06-12 |
2018-04-07 |
|
219788 |
Methylene blue |
Diagnostic agents |
Not applicable |
2018-10-26 |
2021-05-21 |
|
281510 |
Methylphenidate hydrochloride |
Psychoanaleptics |
Not applicable |
2024-01-18 |
2024-11-13 |
|
243224 |
Methylphenidate hydrochloride |
Psychoanaleptics |
Not applicable |
2021-01-08 |
2023-09-21 |
|
273908 |
Metreleptin |
Other alimentary tract and metabolism products |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-04-28 |
2024-01-17 |
|
283160 |
Midazolam hydrochloride |
Psycholeptics |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2024-06-14 |
2025-07-22 |
|
201101 |
Midostaurin |
Antineoplastic agents |
Not applicable |
2017-01-06 |
2017-07-21 |
|
196956 |
Migalastat hydrochloride |
Other alimentary tract and metabolism products |
Not applicable |
2016-11-08 |
2017-09-05 |
|
276366 |
Miglustat |
Other alimentary tract and metabolism products |
Part of an 'aligned review' with a health technology assessment organization |
2024-06-17 |
2025-04-10 |
|
266471 |
Mirikizumab |
Immunosuppressants |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2022-09-15 |
2023-07-20 |
|
294637 |
Mirvetuximab soravtansine |
Antineoplastic agents |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2025-03-03 |
2025-08-29 |
|
251277 |
Mogamulizumab |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2021-05-17 |
2022-06-02 |
|
255584 |
Molnupiravir *For use in relation to COVID-19 |
Antivirals for systemic use |
New active substance For use in relation to COVID-19 Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2021-08-20 |
2023-04-26 |
|
281695 |
Momelotinib dihydrochloride monohydrate |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-01-17 |
2024-11-08 |
|
199704 |
Mometasone furoate |
Corticosteroids, dermatological preparations |
Not applicable |
2017-09-20 |
Cancelled by sponsor |
2019-10-21 |
238027 |
Mometasone furoate monohydrate, olopatadine hydrochloride |
Nasal preparations |
Not applicable |
2020-07-31 |
2022-09-21 |
|
298079 |
Mosunetuzumab |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2025-06-17 |
2026-02-06 |
|
293542 |
mRNA encoding haemagglutinin of B/Victoria lineage, haemagglutinin of influenza A/H1N1, haemagglutinin of influenza A/H3N2, SARS-CoV-2 spike protein NTD-RBD subdomains |
Vaccines |
New active substance For use in relation to COVID-19 |
2025-02-06 |
Cancelled by sponsor |
2025-06-30 |
291323 |
mRNA encoding SARS-CoV-2 spike protein NTD-RBD subdomains |
Vaccines |
New active substance For use in relation to COVID-19 |
2024-12-03 |
Issued Notice of Compliance |
2025-09-29 |
193199 |
Naloxone hydrochloride |
All other therapeutic products |
Not applicable |
2016-04-22 |
2016-10-03 |
|
281754 |
Naloxone hydrochloride dihydrate |
All other therapeutic products |
Not applicable |
2024-04-18 |
2025-02-12 |
|
211970 |
Naloxone hydrochloride dihydrate |
All other therapeutic products |
Not applicable |
2018-01-26 |
2019-06-17 |
|
225848 |
Naproxen sodium, sumatriptan succinate |
Analgesics |
Not applicable |
2019-05-03 |
2020-02-27 |
|
286523 |
Natalizumab |
Immunosuppressants |
Biosimilar |
2024-06-24 |
2025-09-24 |
|
193689 |
Necitumumab |
Antineoplastic agents |
Not applicable |
2016-05-20 |
2017-03-16 |
|
195550 |
Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B |
Vaccines |
Not applicable |
2016-07-22 |
2017-10-05 |
|
286429 |
Nemolizumab |
Other dermatological preparations |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-06-24 |
2025-12-18 |
|
218224 |
Neratinib maleate |
Antineoplastic agents |
New active substance |
2018-09-19 |
2019-07-16 |
|
196495 |
Netupitant, palonosetron hydrochloride |
Antiemetics and antinauseants |
Not applicable |
2016-12-02 |
2017-09-28 |
|
216257 |
Nicardipine hydrochloride |
Calcium channel blockers |
Not applicable |
2018-07-20 |
2020-04-02 |
|
293081 |
Nipocalimab |
Immunosuppressants |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2025-01-21 |
Issued Notice of Compliance |
2025-12-05 |
216792 |
Niraparib |
Antineoplastic agents |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2018-09-28 |
2019-06-27 |
|
259186 |
Nirmatrelvir, ritonavir *For use in relation to COVID-19 |
Antivirals for systemic use |
New active substance Part of an 'aligned review' with a health technology assessment organization For use in relation to COVID-19 |
2021-12-01 |
2022-01-17 |
|
269388 |
Nirsevimab |
Immune sera and immunoglobulins |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2022-12-13 |
2023-04-19 |
|
193770 |
Nitisinone |
Other alimentary tract and metabolism products |
Not applicable |
2016-05-09 |
2016-11-04 |
|
190564 |
Nitisinone |
Other alimentary tract and metabolism products |
Not applicable |
2016-03-24 |
2016-09-20 |
|
193226 |
Nitisinone |
Other alimentary tract and metabolism products |
Not applicable |
2016-07-08 |
2016-12-13 |
|
253630 |
Nitric oxide *For use in relation to COVID-19 |
Other nervous system drugs |
For use in relation to COVID-19 |
2021-06-15 |
2021-09-01 |
|
256629 |
Nivolumab, relatlimab |
Antineoplastic agents |
New active substance |
2022-09-13 |
2023-09-13 |
|
200070 |
Nusinersen |
Other drugs for disorders of the musculo-skeletal system |
Not applicable |
2016-12-12 |
2017-06-29 |
|
198418 |
Obeticholic acid |
Bile and liver therapy |
Not applicable |
2016-10-18 |
Issued Notice of Compliance under the NOC/c Guidance |
2017-05-24 |
230825 |
Obiltoxaximab |
Immune sera and immunoglobulins |
Extraordinary use submission New active substance |
2019-10-04 |
2020-07-30 |
|
197969 |
Ocrelizumab |
Immunosuppressants |
Not applicable |
2016-10-04 |
2018-02-14 |
|
198094 |
Ocrelizumab |
Immunosuppressants |
Not applicable |
2016-10-18 |
2017-08-14 |
|
273741 |
Odevixibat |
Bile and liver therapy |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2023-05-04 |
2023-10-30 |
|
237346 |
Ofatumumab |
Antineoplastic agents |
Part of an 'aligned review' with a health technology assessment organization Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2020-05-07 |
2021-01-22 |
|
182823 |
Olaparib |
Antineoplastic agents |
Not applicable |
2015-06-04 |
2016-04-29 |
|
203478 |
Olaratumab |
Antineoplastic agents |
Not applicable |
2017-04-06 |
2017-11-23 |
|
297894 |
Olezarsen sodium |
Lipid modifying agents |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2025-06-19 |
Issued Notice of Compliance |
2025-12-16 |
275236 |
Olipudase alfa |
Other alimentary tract and metabolism products |
New active substance Being reviewed under the Priority Review Policy |
2023-06-12 |
2024-02-28 |
|
279053 |
Omalizumab |
Drugs for obstructive airway diseases |
Biosimilar |
2024-02-12 |
2024-12-06 |
|
289541 |
Omaveloxolone |
Other nervous system drugs |
New active substance Being reviewed under the Priority Review Policy |
2024-09-16 |
2025-03-13 |
|
239719 |
Onasemnogene abeparvovec |
Other drugs for disorders of the musculo-skeletal system |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2020-06-18 |
2020-12-15 |
|
288760 |
Oritavancin diphosphate |
Antibacterials for systemic use |
New active substance Being reviewed under the Priority Review Policy |
2024-08-23 |
2025-09-12 |
|
269568 |
Osilodrostat phosphate |
Corticosteroids for systemic use |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2023-02-21 |
2025-07-03 |
|
188171 |
Osimertinib |
Antineoplastic agents |
Not applicable |
2015-11-13 |
2016-07-05 |
|
222001 |
Ospemifene |
Sex hormones and modulators of the genital system |
New active substance |
2019-03-08 |
Issued Notice of Compliance |
2021-07-16 |
198865 |
Oxycodone |
Analgesics |
Not applicable |
2016-11-18 |
2018-07-27 |
|
232761 |
Ozanimod hydrochloride |
Immunosuppressants |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2019-12-09 |
2020-10-02 |
|
192925 |
Ozenoxacin |
Antibiotics and chemotherapy for dermatological use |
Not applicable |
2016-07-05 |
Issued Notice of Compliance |
2017-05-01 |
294475 |
Palopegteriparatide |
Calcium homeostasis |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2025-03-28 |
Issued Notice of Compliance |
2026-01-28 |
252065 |
Palovarotene |
Other drugs for disorders of the musculo-skeletal system |
New active substance Being reviewed under the Priority Review Policy |
2021-07-26 |
Issued Notice of Compliance |
2022-01-21 |
187504 |
Panobinostat |
Antineoplastic agents |
Not applicable |
2015-11-02 |
2016-06-23 |
|
210368 |
Patiromer sorbitex calcium |
All other therapeutic products |
Not applicable |
2017-12-07 |
2018-10-03 |
|
221896 |
Patisiran |
Other nervous system drugs |
New active substance Being reviewed under the Priority Review Policy |
2018-12-11 |
2019-06-07 |
|
189795 |
Pegaspargase |
Antineoplastic agents |
Not applicable |
2016-05-02 |
2017-02-24 |
|
272381 |
Pegcetaclopan |
Immunosuppressants |
Part of an 'aligned review' with a health technology assessment organization Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2023-03-24 |
2025-01-24 |
|
263432 |
Pegcetaclopan |
Immunosuppressants |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2022-06-13 |
2022-12-08 |
|
204841 |
Pegfilgrastim |
Immunostimulants |
Not applicable |
2017-06-09 |
2018-04-05 |
|
200807 |
Pegfilgrastim |
Immunostimulants |
Not applicable |
2017-01-27 |
2018-12-24 |
|
271699 |
Pegfilgrastim |
Immunostimulants |
Biosimilar |
2023-06-08 |
Cancelled by sponsor |
2024-07-22 |
294441 |
Pegfilgrastim |
Immunostimulants |
Biosimilar |
2025-03-12 |
Issued Notice of Compliance |
2026-01-06 |
273871 |
Pegfilgrastim |
Immunostimulants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2023-12-04 |
2024-12-13 |
|
262990 |
Pegfilgrastim |
Immunostimulants |
Biosimilar |
2022-05-20 |
2024-08-16 |
|
262438 |
Pegfilgrastim |
Immunostimulants |
Biosimilar |
2022-05-16 |
2024-04-17 |
|
233373 |
Pegfilgrastim |
Immunostimulants |
Biosimilar |
2020-01-02 |
2020-10-28 |
|
232048 |
Pegfilgrastim |
Immunostimulants |
Biosimilar |
2019-11-15 |
2021-07-20 |
|
220445 |
Pegfilgrastim |
Immunostimulants |
Biosimilar |
2019-05-27 |
2020-04-21 |
|
287986 |
Pegunigalsidase alfa |
Other alimentary tract and metabolism products |
New active substance |
2024-11-08 |
2025-12-09 |
|
251687 |
Pegvaliase |
Other alimentary tract and metabolism products |
New active substance |
2021-06-04 |
2022-03-30 |
|
242569 |
Pemigatinib |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2020-10-15 |
2021-09-17 |
|
191280 |
Peramivir |
Antivirals for systemic use |
Not applicable |
2016-03-11 |
2017-01-05 |
|
272066 |
Perfluorohexyloctane |
Ophthalmologicals |
New active substance |
2023-08-11 |
2024-09-04 |
|
201189 |
Perindopril arginine |
Agents acting on the renin-angiotensin system |
Not applicable |
2017-08-25 |
2018-03-09 |
|
237402 |
Pertuzumab, trastuzumab |
Antineoplastic agents |
Not applicable |
2020-05-06 |
2021-03-01 |
|
293854 |
Pirtobrutinib |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2025-03-13 |
Issued Notice of Compliance under the NOC/c Guidance |
2025-10-17 |
238175 |
Pitolisant |
Other nervous system drugs |
New active substance |
2020-05-22 |
2021-05-25 |
|
215288 |
Plecanatide |
Drugs for constipation |
New active substance |
2018-12-14 |
2019-10-10 |
|
298667 |
Plozasiran |
Lipid modifying agents |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2025-07-08 |
Issued Notice of Compliance |
2026-01-02 |
232303 |
Polatuzumab vedotin |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
2019-11-08 |
2020-07-09 |
|
239537 |
Ponesimod |
Immunosuppressants |
New active substance |
2020-07-02 |
2021-04-28 |
|
208364 |
PrabotulinumtoxinA |
Muscle relaxants |
Not applicable |
2017-10-20 |
2018-08-16 |
|
207545 |
Pralatrexate |
Antineoplastic agents |
Not applicable |
2017-11-15 |
2018-10-26 |
|
243731 |
Pralsetinib |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Reviewed under Project Orbis Type C |
2020-11-03 |
Issued Notice of Compliance under the NOC/c Guidance |
2021-06-30 |
252270 |
Pralsetinib |
Antineoplastic agents |
Being reviewed under the Notice of Compliance with Conditions Guidance Reviewed under Project Orbis Type C |
2021-06-28 |
Cancelled by sponsor |
2022-04-05 |
198822 |
Prasterone |
Anabolic agents for systemic use |
Not applicable |
2016-12-05 |
2019-11-01 |
|
293526 |
Pregabalin |
Analgesics |
Not applicable |
2025-02-21 |
2025-08-19 |
|
239820 |
Progesterone |
Sex hormones and modulators of the genital system |
Not applicable |
2020-07-08 |
2021-04-30 |
|
211548 |
Progesterone |
Sex hormones and modulators of the genital system |
Not applicable |
2018-02-28 |
2018-08-22 |
|
188323 |
Propiverine hydrochloride |
Urologicals |
Not applicable |
2016-03-11 |
2017-01-05 |
|
288150 |
Quizartinib |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2024-08-13 |
Issued Notice of Compliance |
2025-06-09 |
211541 |
Rabies immune globulin human |
Immune sera and immunoglobulins |
Not applicable |
2018-01-11 |
2018-11-07 |
|
254848 |
Ranibizumab |
Ophthalmologicals |
Not applicable |
2021-09-03 |
2022-09-14 |
|
251162 |
Ranibizumab |
Ophthalmologicals |
Biosimilar |
2021-05-12 |
2022-03-08 |
|
268288 |
Ranibizumab |
Ophthalmologicals |
Biosimilar |
2022-12-09 |
2023-10-11 |
|
239943 |
Ranolazine |
Cardiac therapy |
New active substance Being reviewed under the Priority Review Policy Being reviewed under the Submissions Relying on Third-Party Data Guidance Part of an 'aligned review' with a health technology assessment organization |
2020-07-06 |
2020-12-31 |
|
217955 |
Ravulizumab |
Immunosuppressants |
New active substance |
2018-11-02 |
2019-08-28 |
|
276302 |
Raxtozinameran *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2023-06-30 |
2023-09-28 |
|
180793 |
Recombinant fusion protein linking factor IX with recombinant albumin (RIX-FP) |
Antihemorrhagics |
Not applicable |
2015-04-01 |
2016-01-26 |
|
230211 |
Recombinant haemagglutinin-strain A (H1N1) virus-like particles, Recombinant haemagglutinin-strain A (H3N2) virus-like particles, Recombinant haemagglutinin-strain B (Victoria lineage) virus-like particles, Recombinant haemagglutinin-strain B (Yamagata lineage) virus-like particles |
Vaccines |
New active substance |
2019-09-23 |
Cancelled by sponsor |
2021-09-03 |
235672 |
Recombinant influenza strain A H1N1 HA protein, recombinant influenza strain A H3N2 HA protein, recombinant influenza strain B (Victoria lineage) HA protein, recombinant influenza strain B (Yamagata lineage) HA protein |
Vaccines |
New active substance |
2020-03-20 |
2021-01-14 |
|
252929 |
Regdanvimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins |
New active substance Part of an 'aligned review' with a health technology assessment organization For use in relation to COVID-19 |
2021-05-28 |
2024-07-31 |
|
271756 |
RelabotulinumtoxinA |
Muscle relaxants |
Not applicable |
2023-03-29 |
2024-01-16 |
|
269372 |
Relugolix |
Endocrine therapy |
New active substance |
2022-12-15 |
2023-10-10 |
|
240551 |
Remdesivir |
Antivirals for systemic use |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
2020-06-19 |
2020-07-27 |
|
284373 |
Repotrectinib |
Antineoplastic agents |
New active substance Reviewed under Project Orbis Type C |
2024-05-28 |
2025-05-07 |
|
185873 |
Reslizumab |
Immunosuppressants |
Not applicable |
2015-09-25 |
2016-07-20 |
|
269021 |
Respiratory syncytial virus prefusion F protein (RSVPreF3) |
Vaccines |
New active substance |
2022-11-29 |
2023-08-04 |
|
284125 |
Retifanlimab |
Antineoplastic agents |
New active substance |
2024-04-12 |
2025-02-06 |
|
203884 |
Ribociclib |
Antineoplastic agents |
Not applicable |
2017-05-08 |
2018-03-02 |
|
293336 |
Rifapentine |
Antimycobacterials |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2025-03-28 |
Issued Notice of Compliance |
2026-02-12 |
266189 |
Riltozinameran, tozinameran *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2022-07-25 |
2022-10-21 |
|
268384 |
Rimegepant |
Analgesics |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2023-01-18 |
2023-12-01 |
|
234688 |
Ripretinib |
Antineoplastic agents |
New active substance Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2020-03-11 |
2020-06-19 |
|
215753 |
Risankizumab |
Immunosuppressants |
Not applicable |
2018-06-21 |
2019-04-17 |
|
242373 |
Risdiplam |
Other drugs for disorders of the musculo-skeletal system |
New active substance Being reviewed under the Priority Review Policy |
2020-10-16 |
Issued Notice of Compliance |
2021-04-14 |
233331 |
Risperidone |
Psycholeptics |
Not applicable |
2020-01-21 |
2020-11-19 |
|
264840 |
Risperidone |
Psycholeptics |
Not applicable |
2022-12-29 |
2024-03-21 |
|
259861 |
Risperidone |
Psycholeptics |
Part of an 'aligned review' with a health technology assessment organization |
2022-03-11 |
2025-06-18 |
|
268723 |
Ritlecitinib |
Immunosuppressants |
New active substance |
2023-02-02 |
2023-11-29 |
|
237814 |
Rituximab |
Antineoplastic agents |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2020-05-15 |
2021-03-11 |
|
207702 |
Rituximab |
Antineoplastic agents |
Not applicable |
2017-09-08 |
2019-03-14 |
|
208107 |
Rituximab |
Antineoplastic agents |
Not applicable |
2017-09-08 |
2019-03-14 |
|
208204 |
Rituximab |
Antineoplastic agents |
Not applicable |
2017-09-08 |
2019-04-04 |
|
280385 |
Rituximab |
Antineoplastic agents |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2024-02-15 |
2026-02-13 |
|
224164 |
Rituximab |
Antineoplastic agents |
Biosimilar |
2019-03-25 |
2020-05-04 |
|
224672 |
Rituximab |
Antineoplastic agents |
Biosimilar |
2019-03-25 |
2019-04-02 |
|
214058 |
Rituximab |
Antineoplastic agents |
Biosimilar |
2018-04-20 |
2020-04-28 |
|
264296 |
Roflumilast |
Other dermatological preparations |
Part of an 'aligned review' with a health technology assessment organization |
2022-07-04 |
2023-04-28 |
|
197713 |
Romosozumab |
Drugs for treatment of bone diseases |
Not applicable |
2016-10-07 |
2019-06-17 |
|
271972 |
Ropivacaine hydrochloride |
Anesthetics |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2023-05-05 |
2025-03-20 |
|
236566 |
Roxadustat |
Antianemic preparations |
New active substance Part of an 'aligned review' with a health technology assessment organization Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2020-03-31 |
2021-10-29 |
|
274979 |
Rozanolixizumab |
Other drugs for disorders of the musculo-skeletal system |
New active substance Part of an 'aligned review' with a health technology assessment organization Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2023-11-24 |
2025-03-28 |
|
279310 |
RSV F-protein mRNA, 5'(m7G-5'-ppp-5'-Gm), 3' poly(A) |
Vaccines |
New active substance |
2024-01-11 |
2024-11-06 |
|
272785 |
RSV subgroups A, B stabilized prefusion F protein |
Vaccines |
New active substance |
2023-03-24 |
2023-12-21 |
|
186488 |
Rupatadine fumarate |
Antihistamines for systemic use |
Not applicable |
2015-09-24 |
2016-07-20 |
|
269729 |
Ruxolitinib phosphate |
Other dermatological preparations |
Part of an 'aligned review' with a health technology assessment organization |
2023-03-17 |
2024-10-11 |
|
270055 |
Sabizabulin *For use in relation to COVID-19 |
Antivirals for systemic use |
New active substance Part of an 'aligned review' with a health technology assessment organization For use in relation to COVID-19 |
2022-11-24 |
2023-06-08 |
|
248753 |
Sacituzumab govitecan |
Antineoplastic agents |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2021-03-31 |
2021-09-24 |
|
207115 |
Safinamide |
Anti-parkinson drugs |
Not applicable |
2018-03-16 |
2019-01-10 |
|
189577 |
Salbutamol sulfate |
Drugs for obstructive airway diseases |
Not applicable |
2016-11-18 |
2017-11-01 |
|
191745 |
Sarilumab |
Immunosuppressants |
Not applicable |
2016-03-18 |
2017-01-12 |
|
254715 |
SARS-CoV-2 prefusion spike delta TM protein, recombinant *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2021-07-21 |
2023-02-27 |
|
269939 |
SARS-CoV-2 prefusion spike delta TM protein, recombinant *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2022-12-16 |
2023-02-27 |
|
278519 |
SARS-CoV-2 recombinant spike protein (Omicron XBB.1.5) *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2023-09-01 |
2023-12-05 |
|
255370 |
SARS-CoV-2 recombinant spike protein *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2021-08-30 |
2022-02-17 |
|
233642 |
Satralizumab |
Immunosuppressants |
New active substance Being reviewed under the Priority Review Policy |
2019-12-04 |
2020-06-01 |
|
204085 |
Sebelipase alfa |
Other alimentary tract and metabolism products |
Not applicable |
2017-04-21 |
2017-12-15 |
|
294551 |
Seladelpar lysine |
Bile and liver therapy |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization |
2025-02-28 |
2025-10-16 |
|
253182 |
Selinexor |
Antineoplastic agents |
New active substance |
2021-08-06 |
Issued Notice of Compliance |
2022-05-31 |
243748 |
Selpercatinib |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2020-10-19 |
Issued Notice of Compliance under the NOC/c Guidance |
2021-06-15 |
243733 |
Selumetinib |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2020-11-23 |
2022-08-31 |
|
202059 |
Semaglutide |
Drugs used in diabetes |
Not applicable |
2017-03-10 |
2018-01-04 |
|
226906 |
Semaglutide |
Drugs used in diabetes |
Not applicable |
2019-06-06 |
2020-03-31 |
|
247235 |
Semaglutide |
Drugs used in diabetes |
Not applicable |
2021-01-29 |
2021-11-23 |
|
287973 |
Sepiapterin |
Other alimentary tract and metabolism products |
New active substance Being reviewed under the Priority Review Policy |
2024-07-24 |
Issued Notice of Compliance |
2025-10-07 |
268412 |
Setmelanotide acetate |
Antiobesity preparations, excluding diet products |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2022-11-09 |
2023-05-05 |
|
297051 |
Sevabertinib |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type A |
2025-05-08 |
Issued Notice of Compliance under the NOC/c Guidance |
2026-01-29 |
283047 |
Sipavibart |
Immune sera and immunoglobulins |
New active substance For use in relation to COVID-19 |
2024-03-05 |
Issued Notice of Compliance |
2025-03-21 |
223225 |
Siponimod |
Immunosuppressants |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2019-02-07 |
2020-02-20 |
|
205568 |
Sirukumab |
Immunosuppressants |
Not applicable |
2017-06-30 |
2017-10-19 |
|
270800 |
Smallpox vaccine dried |
Vaccines |
Extraordinary use submission |
2023-02-08 |
2023-12-05 |
|
225953 |
Sodium chloride, sodium citrate |
Blood substitutes and perfusion solutions |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2019-05-08 |
2020-03-03 |
|
231915 |
Sodium pertechnetate Tc-99m |
Diagnostic radiopharmaceuticals |
Not applicable |
2020-01-31 |
2020-11-26 |
|
253502 |
Sodium phenylbutyrate, ursodoxicoltaurine |
Other nervous system drugs |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2021-08-23 |
2022-06-10 |
|
218799 |
Sodium zirconium cyclosilicate |
All other therapeutic products |
New active substance |
2018-09-28 |
2019-07-25 |
|
190521 |
Sofosbuvir, velpatasvir |
Antivirals for systemic use |
Not applicable |
2016-01-15 |
2016-07-11 |
|
202324 |
Sofosbuvir, velpatasvir, voxilaprevir |
Antivirals for systemic use |
Not applicable |
2017-02-17 |
2017-08-16 |
|
237511 |
Solriamfetol hydrochloride |
Psychoanaleptics |
New active substance |
2020-07-17 |
Issued Notice of Compliance |
2021-05-13 |
267443 |
Somapacitan |
Pituitary and hypothalamic hormones and analogues |
New active substance |
2022-09-29 |
2023-07-26 |
|
246729 |
Somatrogon |
Pituitary and hypothalamic hormones and analogues |
New active substance Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2020-12-31 |
2021-10-26 |
|
229407 |
Sonidegib |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2019-08-20 |
2020-06-12 |
|
217853 |
Sotagliflozin |
Drugs used in diabetes |
Not applicable |
2018-08-20 |
Cancelled by sponsor |
2019-06-06 |
283307 |
Sotatercept |
Antihypertensives |
New active substance Being reviewed under the Priority Review Policy Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2024-03-01 |
2024-08-28 |
|
248435 |
Sotorasib |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Reviewed under Project Orbis Type A |
2021-02-11 |
2021-09-10 |
|
251285 |
Sotrovimab *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 |
2021-04-01 |
2021-07-30 |
|
257895 |
Sotrovimab *For use in relation to COVID-19 |
Immune sera and immunoglobulins |
New active substance Part of an 'aligned review' with a health technology assessment organization For use in relation to COVID-19 |
2021-10-25 |
2024-04-29 |
|
267362 |
Spesolimab |
Immunosuppressants |
New active substance Being reviewed under the Priority Review Policy |
2022-09-23 |
2023-03-22 |
|
201492 |
Sucroferric oxyhydroxide |
All other therapeutic products |
Not applicable |
2017-02-16 |
2018-01-05 |
|
180385 |
Sugammadex |
All other therapeutic products |
Not applicable |
2015-04-13 |
2016-02-05 |
|
196367 |
Suvorexant |
Psycholeptics |
Not applicable |
2016-08-26 |
2018-11-29 |
|
209210 |
Tacrolimus |
Immunosuppressants |
Not applicable |
2018-04-23 |
2019-02-15 |
|
240239 |
Tafamidis |
Other nervous system drugs |
Not applicable |
2020-09-14 |
2021-07-09 |
|
228368 |
Tafamidis meglumine |
Other nervous system drugs |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2019-07-24 |
2020-01-20 |
|
247025 |
Tafasitamab |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Reviewed under Project Orbis Type C |
2020-12-24 |
2021-08-19 |
|
220584 |
Talazoparib |
Antineoplastic agents |
New active substance |
2018-11-15 |
2019-09-06 |
|
278277 |
Talquetamab |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Reviewed under Project Orbis Type C |
2023-09-13 |
2024-04-30 |
|
272063 |
Tapinarof |
Antipsoriatics |
New active substance |
2023-05-19 |
2025-04-04 |
|
281963 |
Tarlatamab |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type B |
2024-01-10 |
2024-09-11 |
|
236286 |
Tazarotene |
Antipsoriatics |
Not applicable |
2020-09-11 |
2021-07-08 |
|
258717 |
Tebentafusp |
Antineoplastic agents |
New active substance Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type B |
2021-12-13 |
2022-06-07 |
|
269369 |
Teclistamab |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Reviewed under Project Orbis Type C |
2022-12-01 |
2023-07-26 |
|
247561 |
Tecovirimat monohydrate |
Antivirals for systemic use |
Extraordinary use submission New active substance |
2021-02-02 |
2021-11-29 |
|
208730 |
Telotristat etiprate |
Antidiarrheals, intestinal anti-inflammatory/anti-infective agents |
Not applicable |
2017-12-15 |
2018-10-10 |
|
224850 |
Tenapanor |
Drugs for constipation |
New active substance |
2019-06-20 |
2020-04-15 |
|
193066 |
Tenofovir alafenamide hemifumarate |
Antivirals for systemic use |
Not applicable |
2016-07-21 |
Issued Notice of Compliance |
2017-05-17 |
289990 |
Teplizumab |
Drugs used in diabetes |
New active substance Being reviewed under the Priority Review Policy |
2024-10-02 |
2025-05-05 |
|
242300 |
Tepotinib |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Reviewed under Project Orbis Type A |
2020-10-05 |
Issued Notice of Compliance under the NOC/c Guidance |
2021-05-27 |
285296 |
Teprotumumab |
Immunosuppressants |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-05-17 |
2025-04-17 |
|
281005 |
Terbinafine hydrochloride |
Antifungals for dermatological use |
Part of an 'aligned review' with a health technology assessment organization |
2024-01-04 |
2025-04-01 |
|
215409 |
Teriparatide |
Calcium homeostasis |
Not applicable |
2018-06-01 |
2020-01-13 |
|
290038 |
Testosterone undecanoate |
Sex hormones and modulators of the genital system |
Not applicable |
2024-12-18 |
Issued Notice of Compliance |
2025-11-10 |
293552 |
Testosterone undecanoate |
Sex hormones and modulators of the genital system |
Not applicable |
2025-01-31 |
Issued Notice of Compliance |
2025-12-12 |
256188 |
Tezepelumab |
Drugs for obstructive airway diseases |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2021-10-04 |
2022-07-28 |
|
206099 |
Tibolone |
Sex hormones and modulators of the genital system |
Not applicable |
2017-10-02 |
2019-05-10 |
|
224036 |
Tildrakizumab |
Immunosuppressants |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2019-02-27 |
2021-05-19 |
|
205852 |
Tipiracil hydrochloride, trifluridine |
Antineoplastic agents |
Not applicable |
2017-07-31 |
2018-01-25 |
|
262080 |
Tirbanibulin |
Antibiotics and chemotherapy for dermatological use |
New active substance |
2022-07-27 |
2023-05-12 |
|
259103 |
Tirzepatide |
Drugs used in diabetes |
New active substance Part of an 'aligned review' with a health technology assessment organization Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2022-02-24 |
2022-11-24 |
|
275333 |
Tirzepatide |
Drugs used in diabetes |
Not applicable |
2024-07-18 |
Issued Notice of Compliance |
2025-05-13 |
213547 |
Tisagenlecleucel-T |
Antineoplastic agents |
Not applicable |
2018-03-09 |
2018-09-05 |
|
213698 |
Tisagenlecleucel-T |
Antineoplastic agents |
Not applicable |
2018-03-09 |
2018-09-05 |
|
293878 |
Tislelizumab |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2025-02-24 |
2025-12-18 |
|
286094 |
Tocilizumab |
Immunosuppressants |
Biosimilar |
2024-10-11 |
Cancelled by sponsor |
2025-10-17 |
283028 |
Tocilizumab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2024-07-08 |
2025-10-16 |
|
280011 |
Tocilizumab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2023-12-08 |
2024-10-11 |
|
283158 |
Tofersen |
Other nervous system drugs |
New active substance |
2024-03-18 |
Issued Notice of Compliance under the NOC/c Guidance |
2025-02-28 |
290985 |
Toripalimab |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-12-23 |
2025-10-17 |
|
244906 |
Tozinameran *For use in relation to COVID-19 |
Vaccines |
For use in relation to COVID-19 |
2020-10-09 |
2020-12-09 |
|
252736 |
Tozinameran *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2021-06-10 |
2021-09-16 |
|
245877 |
Tralokinumab |
Other dermatological preparations |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2020-12-18 |
2021-10-13 |
|
275910 |
Trastuzumab |
Antineoplastic agents |
Biosimilar |
2023-07-20 |
2024-08-20 |
|
208836 |
Trastuzumab |
Antineoplastic agents |
Biosimilar |
2017-10-13 |
2020-02-27 |
|
204579 |
Trastuzumab |
Antineoplastic agents |
Not applicable |
2017-06-02 |
2019-05-03 |
|
210238 |
Trastuzumab |
Antineoplastic agents |
Not applicable |
2017-11-17 |
2019-09-03 |
|
212140 |
Trastuzumab |
Antineoplastic agents |
Not applicable |
2018-02-01 |
2019-08-15 |
|
253850 |
Trastuzumab |
Antineoplastic agents |
Biosimilar |
2021-08-27 |
2023-06-30 |
|
235995 |
Trastuzumab |
Antineoplastic agents |
Biosimilar |
2020-04-17 |
2022-01-28 |
|
242104 |
Trastuzumab deruxtecan |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance Part of an 'aligned review' with a health technology assessment organization Reviewed under Project Orbis Type C |
2020-08-21 |
2021-04-15 |
|
262740 |
Tremelimumab |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2022-05-16 |
2023-08-31 |
|
231223 |
Treosulfan |
Antineoplastic agents |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2020-01-08 |
2021-06-29 |
|
244137 |
Treosulfan |
Antineoplastic agents |
Being reviewed under the Priority Review Policy |
2020-12-21 |
2021-06-25 |
|
280633 |
Triamcinolone acetonide |
Corticosteroids, dermatological preparations |
Not applicable |
2024-03-28 |
2025-07-14 |
|
201546 |
Triamcinolone hexacetonide |
Corticosteroids for systemic use |
Not applicable |
2017-02-15 |
2017-12-12 |
|
228708 |
Trientine hydrochloride |
Other alimentary tract and metabolism products |
New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2019-11-21 |
Issued Notice of Compliance |
2020-09-14 |
237287 |
Trientine hydrochloride |
All other therapeutic products |
New active substance Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2020-06-24 |
2021-04-20 |
|
221945 |
Trifarotene |
Anti-acne preparations |
New active substance |
2019-01-31 |
2019-11-25 |
|
242196 |
Triheptanoin |
Other alimentary tract and metabolism products |
New active substance Being reviewed under the Priority Review Policy |
2020-08-20 |
Issued Notice of Compliance |
2021-02-15 |
285051 |
Trofinetide |
Other nervous system drugs |
New active substance Being reviewed under the Priority Review Policy |
2024-04-18 |
2024-10-11 |
|
235295 |
Tucatinib |
Antineoplastic agents |
New active substance Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2020-02-07 |
2020-06-05 |
|
256191 |
Ubrogepant |
Analgesics |
New active substance |
2021-10-18 |
2022-11-10 |
|
223734 |
Upadacitinib |
Immunosuppressants |
New active substance |
2019-03-01 |
2019-12-23 |
|
281536 |
Ustekinumab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2024-05-14 |
Issued Notice of Compliance |
2026-01-21 |
269097 |
Ustekinumab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2023-03-03 |
2023-12-27 |
|
284892 |
Ustekinumab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2024-05-27 |
Issued Notice of Compliance |
2025-10-17 |
274939 |
Ustekinumab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2023-08-21 |
2024-07-30 |
|
279373 |
Ustekinumab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2024-03-05 |
2024-12-30 |
|
268742 |
Ustekinumab |
Immunosuppressants |
Biosimilar Part of an 'aligned review' with a health technology assessment organization |
2023-01-13 |
2023-11-09 |
|
277532 |
Ustekinumab |
Immunosuppressants |
Biosimilar |
2023-10-12 |
2024-08-07 |
|
278712 |
Ustekinumab |
Immunosuppressants |
Biosimilar |
2023-10-12 |
2024-08-07 |
|
295463 |
Vamorolone |
Corticosteroids for systemic use |
New active substance Being reviewed under the Priority Review Policy Part of an 'aligned review' with a health technology assessment organization |
2025-04-03 |
Issued Notice of Compliance |
2025-09-29 |
200244 |
Varicella-zoster virus glycoprotein E (GE) |
Vaccines |
Not applicable |
2016-12-22 |
2017-10-13 |
|
190761 |
Venetoclax |
Antineoplastic agents |
Not applicable |
2016-02-03 |
2016-09-30 |
|
240862 |
Vericiguat |
Cardiac therapy |
New active substance |
2021-01-27 |
2023-04-28 |
|
190817 |
Vernakalant hydrochloride |
Cardiac therapy |
Not applicable |
2016-05-17 |
2017-03-13 |
|
264995 |
Vibrio cholerae, strain CVD 103-HgR, live |
Vaccines |
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative |
2022-07-22 |
2023-05-18 |
|
254598 |
Virus-like particles (VLP) of SARS-CoV-2 spike protein *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2021-08-09 |
2022-02-24 |
|
219321 |
Vitamin D3 |
Vitamins |
Not applicable |
2019-01-04 |
2021-02-05 |
|
225983 |
Vitamin K1 |
Antihemorrhagics |
Being reviewed under the Submissions Relying on Third-Party Data Guidance |
2019-08-06 |
2021-06-17 |
|
209280 |
Volanesorsen |
Lipid modifying agents |
Not applicable |
2017-11-02 |
2018-11-15 |
|
213188 |
Vonicog alfa |
Antihemorrhagics |
Not applicable |
2018-03-16 |
2019-01-10 |
|
282910 |
Vorasidenib citrate |
Antineoplastic agents |
New active substance Being reviewed under the Priority Review Policy Reviewed under Project Orbis Type A |
2024-03-06 |
2024-08-27 |
|
233097 |
Voretigene neparvovec |
Ophthalmologicals |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2019-12-18 |
2020-10-13 |
|
290788 |
Vosoritide |
Drugs for treatment of bone diseases |
New active substance |
2025-02-05 |
2026-01-21 |
|
267923 |
Vutrisiran |
Other nervous system drugs |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2022-12-23 |
2023-10-18 |
|
254518 |
Whole virion inactivated coronavirus *For use in relation to COVID-19 |
Vaccines |
New active substance For use in relation to COVID-19 |
2021-07-13 |
2022-08-26 |
|
296499 |
Zanidatamab |
Antineoplastic agents |
New active substance Being reviewed under the Notice of Compliance with Conditions Guidance |
2025-04-29 |
2026-01-15 |
|
242748 |
Zanubrutinib |
Antineoplastic agents |
New active substance Being reviewed under the Priority Review Policy |
2020-09-03 |
Issued Notice of Compliance |
2021-03-01 |
242885 |
Zanubrutinib |
Antineoplastic agents |
Not applicable |
2020-09-29 |
2021-07-22 |
|
276757 |
Zilucoplan |
Immunosuppressants |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2023-08-21 |
2024-07-11 |
|
212392 |
Zofenopril calcium |
Agents acting on the renin-angiotensin system |
Not applicable |
2018-06-08 |
Cancelled by sponsor |
2019-06-26 |
282144 |
Zolbetuximab |
Antineoplastic agents |
New active substance Part of an 'aligned review' with a health technology assessment organization |
2024-02-05 |
2024-12-13 |
|
290103 |
Zuranolone |
Psychoanaleptics |
New active substance |
2024-12-13 |
2025-12-05 |