Clinical information releases in progress
This page displays clinical information packages that are being prepared for release.
Proactive release refers to clinical information that Health Canada is processing for public release following its regulatory review of new products. On request releases refer to requests received on the clinical information portal.
Start date indicates when Health Canada initiated the process to prepare information for public release. Some on request releases may be listed as pending, for instance where a request requires clarification or where paper records need to be digitized.
Completed releases are available on Health Canada’s clinical information portal.
If you don’t see what you’re looking for, you can request clinical information for a drug or a medical device.
See Health Canada’s guidance document for more information.
View the lists of drugs and medical devices
Drugs
| Brand name | Manufacturer | Process | Status | Start Date |
|---|---|---|---|---|
| Tagrisso | AstraZeneca Canada Inc | On request | Pending | |
| Lynparza | AstraZeneca Canada Inc | On request | Pending | |
| Arimidex | AstraZeneca Canada Inc | On request | Pending | |
| Imjudo | AstraZeneca Canada Inc | Proactive | Active | 2023-08-31 |
| Epkinly | AbbVie Corporation | Proactive | Active | 2023-10-13 |
| Sibboran | Trimedic Therapeutics Inc. | Proactive | Active | 2023-11-20 |
| Jorveza | Avir Pharma Inc. | Proactive | Active | 2024-08-21 |
| Miebo | Bausch & Lomb Inc | Proactive | Active | 2024-09-04 |
| Mezavant | Takeda Canada Inc | On request | Pending | |
| Truvada | Gilead Sciences Canada Inc | On request | Pending | |
| Imdelltra | Amgen Canada Inc | Proactive | Active | 2024-09-11 |
| Ayvakyt | Blueprint Medicine Corporation | Proactive | Active | 2024-09-18 |
| Mezavant | Takeda Canada Inc | On request | Active | 2024-09-23 |
| Ojjaara | GlaxoSmithKline Inc | Proactive | Active | 2024-11-08 |
| Jornay PM | Ironshore Pharmaceuticals & Development, Inc. | Proactive | Active | 2024-11-13 |
| Cresemba | Avir Pharma Inc. | Proactive | Active | 2024-11-15 |
| Suboxone | Indivior UK Limited | On request | Active | 2024-12-05 |
| Welireg | Merck Canada Inc | Proactive | Active | 2024-12-17 |
| Ringza | Duchesnay Inc | Proactive | Active | 2024-12-18 |
| Vabomere | Xediton Pharmaceuticals Inc | Proactive | Active | 2024-12-20 |
| Trulance | Bausch Health, Canada Inc. | Proactive | Active | 2024-12-24 |
| Blincyto | Amgen Canada Inc | Proactive | Active | 2024-12-27 |
| Rybrevant | Janssen Inc | Proactive | Active | 2025-01-13 |
| Aripiprazole Oral Solution | Orimed Pharma Inc | Proactive | Active | 2025-01-15 |
| Baxdela | Xediton Pharmaceuticals Inc | Proactive | Active | 2025-01-17 |
| Imfinzi | AstraZeneca Canada Inc | Proactive | Active | 2025-01-17 |
| Enhertu | AstraZeneca Canada Inc | Proactive | Active | 2025-01-17 |
| Penthrox | Endo Operations Inc. | Proactive | Active | 2025-01-31 |
| Movapo | Paladin Pharma Inc. | On request | Active | 2025-02-05 |
| Wakix | Endo Ventures Ltd | Proactive | Active | 2025-02-14 |
| Eylea HD | Bayer Inc | Proactive | Active | 2025-03-03 |
| Botox Cosmetic | AbbVie Corporation | Proactive | Active | 2025-03-04 |
| Rebyota | Ferring Inc | Proactive | Active | 2025-03-05 |
| Zoryve | Arcutis Canada, Inc. | Proactive | Active | 2025-03-13 |
| Hyqvia | Takeda Canada Inc | Proactive | Active | 2025-03-13 |
| Skyclarys | Biogen Canada Inc | Proactive | Active | 2025-03-13 |
| Suboxone | Indivior UK Limited | On request | Pending | |
| Rybelsus | Novo Nordisk Canada Inc | On request | Pending | |
| Cardene | Hoffmann-La Roche Limited | On request | Pending | |
| Xfusor | Formative Pharma Inc. | Proactive | Active | 2025-03-20 |
| Wegovy | Novo Nordisk Canada Inc | Proactive | Active | 2025-03-24 |
| Altuviiio | Sanofi-Aventis Canada Inc | Proactive | Active | 2025-03-26 |
| Rystiggo | UCB Canada Inc | Proactive | Active | 2025-03-28 |
| Nduvra | Dermavant Sciences GMBH | Proactive | Active | 2025-04-04 |
| Imfinzi | AstraZeneca Canada Inc | Proactive | Active | 2025-04-08 |
| Elyxyb | Scilex Pharmaceuticals Inc. | Proactive | Active | 2025-04-09 |
| Opfolda | Amicus Therapeutics Canada Inc. | Proactive | Active | 2025-04-10 |
| Admelog | Sanofi-Aventis Canada Inc | On request | Active | 2025-04-15 |
| Pombiliti | Amicus Therapeutics Canada Inc. | Proactive | Active | 2025-04-15 |
| Jemperli | GlaxoSmithKline Inc | Proactive | Active | 2025-04-16 |
| Sarclisa | Sanofi-Aventis Canada Inc | Proactive | Active | 2025-04-17 |
| Tagrisso | AstraZeneca Canada Inc | Proactive | Active | 2025-04-23 |
| Zavesca | Janssen Inc | On request | Active | 2025-04-28 |
| Lynparza | AstraZeneca Canada Inc | Proactive | Active | 2025-04-29 |
| Rinvoq | AbbVie Corporation | Proactive | Active | 2025-04-30 |
| Opdivo SC | Bristol-Myers Squibb Canada | Proactive | Active | 2025-05-01 |
| Eylea | Bayer Inc | Proactive | Active | 2025-05-02 |
| Tzield | Sanofi-Aventis Canada Inc | Proactive | Active | 2025-05-05 |
| Orladeyo | Biocryst Pharmaceuticals Inc | Proactive | Active | 2025-05-07 |
| Augtyro | Bristol-Myers Squibb Canada | Proactive | Active | 2025-05-07 |
| Kevzara | Sanofi-Aventis Canada Inc | Proactive | Active | 2025-05-09 |
| Zepbound Kwikpen | Eli Lilly Canada Inc | Proactive | Active | 2025-05-13 |
| Fraxiparine | Aspen Pharmacare Canada Inc. | On request | Active | 2025-05-15 |
| Trimbow | Chiesi Farmaceutici S.P.A. | Proactive | Active | 2025-05-15 |
| Piasky | Hoffmann-La Roche Limited | Proactive | Active | 2025-06-04 |
| Apretude | ViiV HealthCare ULC | Proactive | Active | 2025-06-05 |
| Vanflyta | Daiichi Sankyo Pharma Canada Limited | Proactive | Active | 2025-06-09 |
| Firdapse | Kye Pharmaceuticals Inc | Proactive | Active | 2025-06-10 |
| Biktarvy | Gilead Sciences Canada Inc | Proactive | Active | 2025-06-10 |
| Kisqali | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2025-06-12 |
| Uplizna | Amgen Canada Inc | Proactive | Active | 2025-06-13 |
| Trajenta | Boehringer Ingelheim (Canada) Ltd Ltee | On request | Active | 2025-06-18 |
| Longavo | Teva Canada Limited | Proactive | Active | 2025-06-18 |
| Camzyos | Bristol-Myers Squibb Canada | Proactive | Active | 2025-06-19 |
| Calquence | AstraZeneca Canada Inc | Proactive | Active | 2025-06-24 |
| Aflivu | Apotex Inc | Proactive | Active | 2025-06-26 |
| Yesafili | Biosimilar Collaborations Irelands Limited | Proactive | Active | 2025-06-26 |
| Ilumya | Sun Pharmaceutical Industries Inc | Proactive | Active | 2025-06-27 |
| Cabenuva | ViiV HealthCare ULC | Proactive | Active | 2025-06-30 |
| Corzyna | Kye Pharmaceuticals Inc | Proactive | Active | 2025-06-30 |
| Isturisa | Recordati Rare Diseases Canada Inc | Proactive | Active | 2025-07-03 |
| Enhertu | AstraZeneca Canada Inc | Proactive | Active | 2025-07-03 |
| Amivas-Artesunate | Amivas Ireland Ltd. | Proactive | Active | 2025-07-04 |
| Omvoh | Eli Lilly Canada Inc | Proactive | Active | 2025-07-08 |
| Pavblu | Amgen Canada Inc | Proactive | Active | 2025-07-08 |
| Vyvanse | Takeda Canada Inc | On request | Pending | |
| Xipere | Bausch & Lamb Inc | Proactive | Active | 2025-07-14 |
| Opdivo | Bristol-Myers Squibb Canada | Proactive | Active | 2025-07-16 |
| Depo-Provera | Pfizer Canada ULC | On request | Active | 2025-07-16 |
| Depo-Provera | Pfizer Canada ULC | On request | Active | 2025-07-16 |
| Imfinzi | AstraZeneca Canada Inc | Proactive | Active | 2025-07-17 |
| Zoloft | BGP Pharma ULC | On request | Active | 2025-07-17 |
| Blenrep | GlaxoSmithKline Inc | Proactive | Active | 2025-07-18 |
| Fasenra | AstraZeneca Canada Inc | Proactive | Active | 2025-07-18 |
| Blenrep | GlaxoSmithKline Inc | Proactive | Active | 2025-07-21 |
| Alyftrek | Vertex Pharmaceuticals (Canada) Inc | Proactive | Active | 2025-07-21 |
| Buccolam | Neuraxpharm Pharmaceuticals, S.L. | Proactive | Active | 2025-07-22 |
| Retevmo | Loxo Oncology Inc | Proactive | Active | 2025-07-22 |
| Lynkuet | Bayer Inc | Proactive | Active | 2025-07-23 |
| Braftovi | Pfizer Canada ULC | Proactive | Active | 2025-07-25 |
| Scemblix | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2025-07-25 |
| Depo-Provera | Pfizer Canada ULC | On request | Pending | |
| Praluent | Sanofi-Aventis Canada Inc | On request | Pending | |
| Vabysmo | Hoffmann-La Roche Limited | Proactive | Active | 2025-07-25 |
| Dynavel XR Chewable tablets | Kye Pharmaceuticals Inc | Proactive | Active | 2025-07-28 |
| Truvada | Gilead Sciences Canada Inc | Proactive | Active | 2025-07-29 |
| Bridion | Merck Canada Inc | Proactive | Active | 2025-07-31 |
| Venclexta | AbbVie Corporation | Proactive | Active | 2025-07-31 |
| Phesgo | Hoffmann-La Roche Limited | Proactive | Active | 2025-08-01 |
| Bavencio | EMD Serono A Division of EMD Inc Canada | Proactive | Active | 2025-08-05 |
| Cyclophosphamide For Injection | Dr Reddys Laboratories LTD | Proactive | Active | 2025-08-05 |
| Veklury | Gilead Sciences Canada Inc | Proactive | Active | 2025-08-06 |
| Andembry | CSLBehring Canada Inc | Proactive | Active | 2025-08-06 |
| Soliris | Alexion Pharma GMBH | Proactive | Active | 2025-08-07 |
| Tremfya | Janssen Inc | Proactive | Active | 2025-08-07 |
| Hepcludex | Gilead Sciences Canada Inc | Proactive | Active | 2025-08-08 |
| Columvi | Hoffmann-La Roche Limited | Proactive | Active | 2025-08-13 |
| Ozempic | Novo Nordisk Canada Inc | Proactive | Active | 2025-08-13 |
| Amtagvi | Iovance Biotherapeutics, Inc | Proactive | Active | 2025-08-15 |
| Dupixent | Sanofi-Aventis Canada Inc | Proactive | Active | 2025-08-15 |
| Nubeqa | Bayer Inc | Proactive | Active | 2025-08-18 |
| Brineura | Biomarin International Limited | Proactive | Active | 2025-08-18 |
| Odan-Pregabalin | Odan Laboratories Ltd | Proactive | Active | 2025-08-19 |
| Rinvoq | AbbVie Corporation | Proactive | Active | 2025-08-21 |
| Anzupgo | Leo Pharma Inc | Proactive | Active | 2025-08-25 |
| Ubrelvy | AbbVie Corporation | Proactive | Active | 2025-08-26 |
| Epsolay | Searchlight Pharma Inc | Proactive | Active | 2025-08-27 |
| Evrysdi | Hoffmann-La Roche Limited | Proactive | Active | 2025-08-28 |
| Elahere | AbbVie Corporation | Proactive | Active | 2025-08-29 |
| Tremfya | Janssen Inc | Proactive | Active | 2025-09-03 |
| Slenyto | Neurim Pharmaceuticals Ltd. | Proactive | Active | 2025-09-08 |
| Cuvitru | Takeda Canada Inc | Proactive | Active | 2025-09-10 |
| Calquence | AstraZeneca Canada Inc | Proactive | Active | 2025-09-11 |
| Opsumit | Janssen Inc | Proactive | Active | 2025-09-12 |
| Oritiniv | Xediton Pharmaceuticals Inc | Proactive | Active | 2025-09-12 |
| Columvi | Hoffmann-La Roche Limited | Proactive | Active | 2025-09-16 |
| Osenvelt | Celltrion Inc | Proactive | Active | 2025-09-17 |
| Stoboclo | Celltrion Inc | Proactive | Active | 2025-09-17 |
| Tyruko | Polpharma Biologics S.A. | Proactive | Active | 2025-09-24 |
| Femara | Novartis Pharmaceuticals Canada Inc | On request | Active | 2025-09-24 |
| Spinraza | Biogen Canada Inc | Proactive | Active | 2025-09-26 |
| Agamree | Kye Pharmaceuticals Inc | Proactive | Active | 2025-09-29 |
| Mnexspike | Moderna Biopharma Canada Corporation | Proactive | Active | 2025-09-29 |
| Scemblix | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2025-10-01 |
| Blexten | Aralez Pharmaceuticals Canada Inc | Proactive | Active | 2025-10-01 |
| Elrexfio | Pfizer Canada ULC | Proactive | Active | 2025-10-03 |
| Sephience | PTC Therapeutics International Limited | Proactive | Active | 2025-10-07 |
| Spevigo | Boehringer Ingelheim (Canada) Ltd Ltee | Proactive | Active | 2025-10-07 |
| Opzelura | Incyte Corporation | Proactive | Active | 2025-10-09 |
| Keytruda | Merck Canada Inc | Proactive | Active | 2025-10-09 |
| Opuviz | Samsung Bioepis Co., Ltd | Proactive | Active | 2025-10-09 |
| Capvaxive | Merck Canada Inc | Proactive | Active | 2025-10-14 |
| Lyvdelzi | Gilead Sciences Canada Inc | Proactive | Active | 2025-10-16 |
| Avtozma | Celltrion Inc | Proactive | Active | 2025-10-16 |
| Jaypirca | Eli Lilly Canada Inc | Proactive | Active | 2025-10-17 |
| Rybelsus | Novo Nordisk Canada Inc | On request | Active | 2025-10-17 |
| Abrysvo | Pfizer Canada ULC | Proactive | Active | 2025-10-17 |
| Loqtorzi | Apotex Inc | Proactive | Active | 2025-10-17 |
| Jivi | Bayer Inc | Proactive | Active | 2025-10-20 |
| Dupixent | Sanofi-Aventis Canada Inc | Proactive | Active | 2025-10-21 |
| Voydeya | Alexion Pharma GMBH | Proactive | Active | 2025-10-23 |
| Piqray | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2025-10-24 |
| Leqembi | Eisai Limited | Proactive | Active | 2025-10-24 |
| Enhertu | AstraZeneca Canada Inc | Proactive | Active | 2025-10-27 |
| Dupixent | Sanofi-Aventis Canada Inc | Proactive | Active | 2025-10-27 |
| Doxycycline for Injection USP | Sterimax Inc | Proactive | Active | 2025-10-28 |
| Enzeevu | Sandoz Canada Incorporated | Proactive | Active | 2025-10-30 |
| Vyvgart SC | Argenx BV | Proactive | Active | 2025-11-03 |
| Kyzatrex | Marius Pharmaceuticals LLS | Proactive | Active | 2025-11-10 |
| Zoryve | Arcutis Canada, Inc. | Proactive | Active | 2025-11-12 |
| Tnkase | Hoffmann-La Roche Limited | Proactive | Active | 2025-11-13 |
| Lupron Depot | AbbVie Corporation | Poactive | Active | 2025-11-13 |
| Nilemdo | Esperion Therapeutics, Inc | Proactive | Active | 2025-11-14 |
| Tremfya | Janssen Inc | Proactive | Active | 2025-11-17 |
| Darzalex SC | Janssen Inc | Proactive | Active | 2025-11-18 |
| Ahzantive | Valorum Biologics LLC | Proactive | Active | 2025-11-19 |
| Wynzora | Knight Therapeutics Inc. | Proactive | Active | 2025-11-21 |
| Menveo | GlaxoSmithKline Inc | Proactive | Active | 2025-11-21 |
| Eydenzelt | Celltrion Inc | Proactive | Active | 2025-11-24 |
| Rinvoq | AbbVie Corporation | On request | Active | 2025-11-27 |
| Tagrisso | AstraZeneca Canada Inc | On request | Active | 2025-12-02 |
| Lataneo PF | Orimed Pharma Inc | Proactive | Active | 2025-12-02 |
| Sublocade | Indivior UK Limited | Proactive | Active | 2025-12-02 |
| Winrevair | Merck Canada Inc | Proactive | Active | 2025-12-03 |
| Ultomiris | Alexion Pharma Gmbh | Proactive | Active | 2025-12-03 |
| Twyneo | Searchlight Pharma Inc | Proactive | Active | 2025-12-04 |
| Zurzuvae | Biogen Canada Inc | Proactive | Active | 2025-12-05 |
| Imaavy | Janssen Inc | Proactive | Active | 2025-12-05 |
| Zykadia | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2025-12-10 |
| Jatenzo (Testosterone Undecanoate) | Tolmar International Ltd. | Proactive | Active | 2025-12-12 |
| Amvuttra | Alnylam Netherlands B.V. | Proactive | Active | 2025-12-12 |
| Bimzelx | Ucb Canada Inc | Proactive | Active | 2025-12-12 |
| Tryngolza | Theratechnologies Inc | Proactive | Active | 2025-12-16 |
| Maviret | AbbVie Corporation | Proactive | Active | 2025-12-16 |
| Tevimbra | Beigene Switzerland Gmbh | Proactive | Active | 2025-12-18 |
| Nemluvio | Galderma Canada Inc | Proactive | Active | 2025-12-18 |
| Balversa | Janssen Inc | Proactive | Active | 2025-12-18 |
| Blincyto | Amgen Canada Inc | On request | Active | 2025-12-19 |
Medical devices
| Device name | Manufacturer | Process | Status | Start Date |
|---|---|---|---|---|
| Lutonix 018 Drug Coated Balloon PTA Catheter | Lutonix, Inc | Proactive | Active | 2022-10-13 |
| Natrelle 410 Truform Microcell Silicone-filled Breast Implants | Allergan | On request | Active | 2023-05-10 |
| Erbecryo 2 Cryosurgical System | Erbe Elektromedizin GMGH | On request | Active | 2024-10-01 |
| CoolSculpting Elite System | Zeltiq Aesthetics, Inc. | Proactive | Active | 2024-10-21 |
| Sentio System | Oticon Medical AB | Proactive | Active | 2025-01-23 |
| Edwards Pascal Precision Transcatheter Valve Repair System | Edwards Lifesciences LLC | Proactive | Active | 2025-02-06 |
| Striate+ And Perform | Orthocell Ltd | Proactive | Active | 2025-02-25 |
| Folix | Lumenis BE Ltd. | Proactive | Active | 2025-03-12 |
| Amicus System | Fresenius Kabi AG | Proactive | Active | 2025-04-08 |
| Edwards Sapien 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent | Edwards Lifesciences LLC | Proactive | Active | 2025-04-24 |
| Cobas Babesia | Roche Molecular Systems, Inc | Proactive | Active | 2025-06-17 |
| Dexcom G7 Continuous Glucose Monitoring System | Dexcom, Inc. | On request | Active | 2025-07-10 |
| Edwards Evoque Tricuspid Valve Replacement System | Edwards LIfesciences LLC | Proactive | Active | 2025-07-14 |
| Passeo-18 Lux Paclitaxel-Releasing Percutaneous Transluminal Angioplasty Balloon Catheter | Biotronik AG | Proactive | Active | 2025-09-15 |
| Aptima SARS-COV-2 Assay | Hologic, Inc. | Proactive | Active | 2025-11-05 |
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