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 |
|---|---|---|---|---|
| Paxil | GlaxoSmithKline Inc. | On request | Active | 2022-02-28 |
| Celexa | Lundbeck Canada Inc | On request | Pending | |
| Cipralex | Lundbeck Canada Inc | On request | Active | 2022-05-06 |
| Zoloft | Upjohn Canada ULC | On request | Pending |
|
| Crestor | Astrazeneca Canada Inc. | On request | Pending | |
| Luvox | BGP Pharma ULC | On request | Active | 2022-06-06 |
| Elmiron | Janssen Inc. | On request | Active | 2022-05-30 |
| Enhertu | AstraZeneca Canada Inc. | Proactive | Active | 2021-04-19 |
| Lipitor | Upjohn Canada ULC | On request | Active | 2022-06-07 |
| Suboxone | Indivior UK Limited | On request | Active | 2022-04-11 |
| Breztri Aerosphere | AstraZeneca Canada Inc. | Proactive | Active | 2021-07-15 |
| Lyumjev | Eli Lilly Canada Inc. | Proactive | Active | 2021-09-14 |
| Rukobia | ViiV Healthcare ULC | Proactive | Active | 2021-10-01 |
| Vaxzevria previously AstraZeneca COVID-19 Vaccine | AstraZeneca Canada Inc. | Proactive | Active | 2021-11-19 |
| Slynd | Duchesnay Inc. | Proactive | Active | 2021-11-30 |
| Saphnelo | AstraZeneca Canada Inc. | Proactive | Active | 2021-12-01 |
| Crestor | AstraZeneca Canada Inc. | On request | Active | 2022-01-05 |
| Hyqvia | Amgen Canada Inc. | Proactive | Active | 2022-01-14 |
| Sohonos | Ipsen Biopharmaceuticals Canada Inc. | Proactive | Active | 2022-01-21 |
| Imfinzi | AstraZeneca Canada Inc. | Proactive | Active | 2022-02-08 |
| Zynrelef | Heron Therapeutics, Inc. | Proactive | Active | 2022-03-16 |
| Palynziq | Biomarin International Limited | Proactive | Active | 2022-03-30 |
| Dupixent | Sanofi-Aventis Canada Inc. | Proactive | Active | 2022-03-25 |
| Zeposia | Celgene Inc. | Proactive | Active | 2022-04-08 |
| Keytruda | Merck Canada Inc. | Proactive | Active | 2022-04-07 |
| Jardiance | Boehringer Ingelheim (Canada) Ltd Ltee | Proactive | Active | 2022-04-06 |
| Evusheld | AstraZenaca Canada Inc. | Proactive | Active | 2022-04-14 |
| Keytruda | Merck Canada Inc. | Proactive | Active | 2022-04-12 |
| Tavneos | VIFOR Fresenius Medical Care Renal Pharma Ltd. | Proactive | Active | 2022-04-14 |
| Vraylar | Allergan Inc. | Proactive | Active | 2022-04-22 |
| Trikafta | Vertex Pharmaceuticals (Canada) Incorporation | Proactive | Active | 2022-04-20 |
| Breyanzi | Celgene Inc. | Proactive | Active | 2022-05-06 |
| Keytruda | Merck Canada Inc. | Proactive | Active | 2022-05-04 |
| Qinlock | Deciphera Pharmaceuticals LLC | Proactive | Active | 2022-05-10 |
| Prevnar | Pfizer Canada ULD | Proactive | Active | 2022-05-09 |
| Lumify | Bausch Health, Canada Inc. | Proactive | Active | 2022-05-19 |
| Octagam | Octapharma Phramazeutika Produktionges MBH | Proactive | Active | 2022-05-19 |
| Prohance | Bracco Imaging Canada | Proactive | Active | 2022-05-25 |
| Tabrecta | Novartis Pharmaceuticals Canada Inc. | Proactive | Active | 2022-05-26 |
| Xpovio | Forus Therapeutics Inc. | Proactive | Active | 2022-05-31 |
| Orladeyo | Biocryst Pharmaceuticals Inc. | Proactive | Active | 2022-06-02 |
| Poteligeo | Kyowa Kirin Inc. | Proactive | Active | 2022-06-02 |
| Opdivo | Bristol-Myers-Squibb Canada | Proactive | Active | 2022-06-02 |
| Kimmtrak | Immunocore Ireland Limited | Proactive | Active | 2022-06-02 |
| Entyvio | Takeda Canada Inc. | Proactive | Active | 2022-06-08 |
| Cutaquig | Octapharma Pharmazeutika Produktionsges MBH | Proactive | Active | 2022-06-09 |
| Albrioza | Amylyx Pharmaceuticals Inc. | Proactive | Active | 2022-06-10 |
| Letybo | Croma Aesthetics Canada, Ltd | Proactive | Active | 2022-06-14 |
| Enhertu | AstraZeneca Canada Inc. | Proactive | Active | 2022-06-15 |
| Cabenuva, Vocabria | VIIV Healthcare ULC | Proactive | Active | 2022-06-15 |
| Propecia | Organon Canada Inc. | On request | Active | 2022-06-16 |
| Scemblix | Novartis Pharmaceuticals Canada Inc. | Proactive | Active | 2022-06-23 |
| Opdivo | Bristol-Myers Squibb Canada | Proactive | Active | 2022-06-27 |
| Spravato | Janssen Inc. | Proactive | Active | 2022-06-28 |
| Cibinqo | Pfizer Canada ULC | Proactive | Active | 2022-06-28 |
| Rydapt | Novartis Pharmaceuticals Canada Inc. | Proactive | Active | 2022-06-29 |
| Piqray | Novartis Pharmaceuticals Canada Inc. | Proactive | Active | 2022-06-30 |
| Octaplasma | Octapharma Pharmazeutika Produktionsges M B H | Proactive | Active | 2022-06-30 |
| Keytruda | Merck Canada Inc. | Proactive | Active | 2022-07-05 |
| Sublocade | Indivior UK Limited | Proactive | Active | 2022-07-05 |
| Entyvio | Takeda Canada Inc. | Proactive | Active | 2022-07-06 |
| Opdivo | Bristol-Myers Squibb Canada | Proactive | Active | 2022-07-07 |
| Vaxneuvance | Merck Canada Inc. | Proactive | Active | 2022-07-08 |
| Welireg | Merck Canada Inc. | Proactive | Active | 2022-07-11 |
| Rinvoq | Abbvie Corporation | Proactive | Active | 2022-07-13 |
| Cymbalta | Eli LIlly Canada Inc. | On request | Active | 2022-07-11 |
| Keytruda | Merck Canada | Proactive | Active | 2022-07-20 |
| Alunbrig | Takeda Canada | Proactive | Active | 2022-07-20 |
| Orencia | Bristol-Myers Squibb Canada | Proactive | Active | 2022-07-21 |
| Opdivo | Bristol-Myers Squibb Canada | Proactive | Active | 2022-07-25 |
| Gazyva | Hoffman-La Roche Limited | Proactive | Active | 2022-07-25 |
| Constella | Allergan Inc. | Proactive | Active | 2022-07-26 |
| Tafinlar | Novartis Pharmaceutical Canada Inc. | Proactive | Active | 2022-07-26 |
| Mekinist | Novartis Pharmaceutical Canada Inc. | Proactive | Active | 2022-07-26 |
| Lynparza | AstraZeneca Canada Inc. | Proactive | Active | 2022-07-27 |
| Rozlytrek | Hoffman-La Roche Limited | Proactive | Active | 2022-07-28 |
| Tezspire | AstraZeneca | Proactive | Active | 2022-07-28 |
| Simponi I.V | Jannsen Inc. | Proactive | Active | 2022-07-29 |
| Myxredlin | Baxter Corporation | Proactive | Active | 2022-08-03 |
| Octasa | Tillotts Pharma AG | Proactive | Active | 2022-08-08 |
| Cosentyx | Novartis Pharmaceutical Canada Inc. | Proactive | Active |
2022-08-10 |
| Ocaliva | Intercept Pharmaceuticals Inc. | Proactive | Active | 2022-08-11 |
| Epclusa | Gilead Sciences Canada Inc. | Proactive | Active | 2022-08-11 |
| Korsuva | Vifor Fresenius Medical Care Renal Pharma Ltd | Proactive | Active | 2022-08-16 |
| Bavencio | EMD Serono A Division of EMD Inc Canada | Proactive | Active | 2022-08-15 |
| Vyndamax | Pfizer Canada ULC | Proactive | Active | 2022-08-17 |
| Prezista | Janssen Inc | Proactive | Active | 2022-08-17 |
| Symtuza | Janssen Inc | Proactive | Active | 2022-08-17 |
| Prezcobix | Janssen Inc | Proactive | Active | 2022-08-17 |
| Keytruda | Merck Canada Inc | Proactive | Active | 2022-08-18 |
| Opdivo | Bristol-Myers Squibb Canada | Proactive | Active | 2022-08-18 |
| Zejula | GlaxoSmithKline Inc | Proactive | Active | 2022-08-24 |
| Pluvicto | Advanced Accelerator Applications USA, Inc. | Proactive | Active | 2022-08-25 |
| Trulicity | Eli Lilly Canada Inc | Proactive | Active | 2022-08-26 |
| Piqray | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2022-08-26 |
| Eyezirgan | Laboratoires Thea | Proactive | Active | 2022-09-08 |
| Spikevax Bivalent | Modernatx, Inc. | Proactive | Active | 2022-09-01 |
| Rymti | Lupin Pharma Canada Limited | Proactive | Active | 2022-08-31 |
| Koselugo | AstraZeneca Canada Inc | Proactive | Active | 2022-08-31 |
| Rylaze | Jazz Pharmaceuticals Ireland Limited | Proactive | Active | 2022-09-02 |
| Lutathera | Advanced Accelerator Applications USA, Inc. | Proactive | Active | 2022-09-09 |
| Comirnaty | BioNTech Manufacturing GMBH | Proactive | Active | 2022-09-09 |
| Sholyne | Kye Pharmaceuticals Inc | Proactive | Active | 2022-09-12 |
| Darzalex SC, Darzalex | Janssen Inc | Proactive | Active | 2022-09-13 |
| Susvimo | Hoffman-La Roche Limited | Proactive | Active | 2022-09-14 |
| Tamiflu | Hoffmann-La Roche Limited | Proactive | Active | 2022-09-14 |
| Imfinzi | AstraZeneca Canada Inc | Proactive | Active | 2022-09-15 |
| Livtencity | Takeda Canada Inc | Proactive | Active | 2022-09-15 |
| Ocaliva | Intercept Pharmaceuticals Inc | Proactive | Active | 2022-09-16 |
| Cosentyx | Novartis Pharmaceuticals Canada Inc. | Proactive | Active | 2022-09-20 |
| Ryaltris | Glenmark Specialty SA | Proactive | Active | 2022-09-21 |
| Taltz | Eli Lilly Canada Inc | Proactive | Active | 2022-09-21 |
| Xeomin | Merz Pharmaceuticals GMBH | Proactive | Active | 2022-09-22 |
| Pediacel |
Sanofi Pasteur Limited |
On request | Active | 2022-09-23 |
| Lariam | Hoffmann-La Roche Limited | On request | Active | 2022-09-27 |
| Sprycel | Bristol-Myers Squibb Canada | On request | Active | 2022-09-27 |
| Imfinzi | AstraZeneca Canada Inc | Proactive | Active | 2022-09-28 |
| Foquest | Elvium Life Sciences | Proactive | Active | 2022-09-28 |
| Yescarta | Gilead Sciences Canada Inc | Proactive | Active | 2022-09-29 |
| Iclusig | Takeda Pharmaceuticals U.S.A., Inc. | Proactive | Active | 2022-10-03 |
| Comirnaty Original and Omicron BA.4/BA.5 | BioNTech Manufacturing GMBH | Proactive | Active | 2022-10-07 |
| Auro-Levocarb | Auro Pharma Inc | Proactive | Active | 2022-10-11 |
| Trumenba | Pfizer Canada ULC | Proactive | Active | 2022-10-11 |
| Rebinyn | Novo Nordisk Canada Inc | Proactive | Active | 2022-10-12 |
| Actemra | Hoffmann-La Roche Limited | Proactive | Active | 2022-10-13 |
| Illuccix | Telix Pharmaceuticals (US) Inc | Proactive | Active | 2022-10-13 |
| Ninlaro | Takeda Canada Inc | Proactive | Active | 2022-10-14 |
| Vyndaqel | Pfizer Canada ULC | Proactive | Active | 2022-10-14 |
| Kerendia | Bayer Inc | Proactive | Active | 2022-10-14 |
| Evusheld | AstraZeneca | Proactive | Active | 2022-10-18 |
| Gleevec | Novartis Pharmaceuticals Canada Inc | On request | Active | 2022-10-19 |
| Comirnaty Original/ Omicron BA.1 | BioNTech Manufacturing GMBH | Proactive | Active | 2022-10-21 |
| Ibrance | Pfizer Canada ULC | On request | Active | 2022-10-24 |
| Effexor XR | UpJohn Canada ULC | On request | Pending | |
| Keytruda | Merck Canada Inc | On request | Active | 2022-10-25 |
Medical devices
| Device name | Manufacturer | Process | Status | Start Date |
|---|---|---|---|---|
| Micra Transcatheter Pacing System | Medtronic Inc. | Proactive | Active |
2021-02-12 |
| Savvywire | Opsens, Inc. | Proactive | Active | 2022-04-19 |
| Manta Vascular Closure Device | Essential Medical, Inc. | Proactive | Active | 2022-05-03 |
| Neo Iris | Immucor Inc. | Proactive | Active | 2022-05-10 |
| The Zenith Dissection Endovascular System | William Cook Europe APS | Proactive | Active | 2022-05-18 |
| Penumbra System | Penumbra Inc. | Proactive | Active | 2022-05-26 |
| Ossmem Hard/Ossmem Soft | Osstem Implant Co. Ltd. | Proactive | Active | 2022-06-15 |
| Physio Flex Annuloplasty Ring | Edwards Lifesciences LLC | Proactive | Active | 2022-06-15 |
| Multi-Spine High-Density Mapping Catheter | Biosense Webster, Inc. | Proactive | Active | 2022-06-16 |
| Mecta Sigma | Mecta Corporation | On request | Active | 2022-07-12 |
| Architet "I" System | Abbott GMBH & CO K.G | Proactive | Active | 2022-07-08 |
| Alinity I Syphilis TP Assay (Donor Screening and Cadaveric Testing) | Abbott GMBH & CO K.G | Proactive | Active | 2022-07-08 |
| Alinity I Chagas Assay (Donor Screening/Cadaveric) | Abbott GMBH & CO K.G | Proactive | Active | 2022-07-08 |
| Alinity I RHTLV-I/II | Abbott GMBH & CO K.G | Proactive | Active | 2022-07-08 |
| Alinity I Anti-HBC II Assay | Abbott GMBH & CO K.G | Proactive | Active | 2022-07-08 |
| Alinity I HIV AG/AB Combo Assay (Donor Screening and Cadaveric Testing) | Abbott GMBH & CO K.G | Proactive | Active | 2022-07-08 |
| Neo Iris | Immucor Inc. | Proactive | Active | 2022-07-18 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System | BioTronik AG | Proactive | Active | 2022-07-28 |
| Zeus Infinity Empowered (Anesthesia workstation) | Draegerwerk AG & CO. KGAA | Proactive | Active | 2022-07-29 |
| Accurate Neo2 Aortic Valve | Boston Scientific Corporation | Proactive | Active | 2022-07-29 |
| Sprint Quattro Secure S Lead | Medtronic Inc. | Proactive | Active | 2022-08-02 |
| Sprint Quattro Secure Lead | Medtronic Inc. | Proactive | Active | 2022-08-02 |
| Sprint Quattro Secure 6947 Ventricular Lead with Defibrilation Coil Electrodes | Medtronic Inc. | Proactive | Active | 2022-08-02 |
| Silk'N Tightra | Home Skinovations Corp. | On request | Active | 2022-08-16 |
| Venus Fiore | Venus Concept Ltd | On request | Active | 2022-08-16 |
| Shockwave Coronary (IVL) System | Shockwave Medical, Inc. | Proactive | Active | 2022-09-16 |
| Diamondtemp Ablation System | Medtronic Inc. | Proactive | Active | 2022-10-06 |
| Lutonix 018 Drug Coated Balloon PTA Catheter | Lutonix, Inc | Proactive | Active | 2022-10-13 |
| Sal6830 SARS-CoV-2 Saliva Test | Microgem U.S., Inc. | On request | Active | 2022-10-14 |
- Date modified: