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 |
|---|---|---|---|---|
| Zoloft | Upjohn Canada ULC | On request | Pending |
|
| Crestor | Astrazeneca Canada Inc | On request | Pending | |
| Enhertu | AstraZeneca Canada Inc | Proactive | Active | 2021-04-19 |
| Breztri Aerosphere | AstraZeneca Canada Inc | Proactive | Active | 2021-07-15 |
| Lyumjev | Eli Lilly Canada Inc | Proactive | Active | 2021-09-14 |
| Saphnelo | AstraZeneca Canada Inc | Proactive | Active | 2021-12-01 |
| Crestor | AstraZeneca Canada Inc | On request | Active | 2022-01-05 |
| Imfinzi | AstraZeneca Canada Inc | Proactive | Active | 2022-02-08 |
| Palynziq | Biomarin International Limited | Proactive | Active | 2022-03-30 |
| Breyanzi | Celgene Inc | Proactive | Active | 2022-05-06 |
| Letybo | Croma Aesthetics Canada, Ltd | Proactive | Active | 2022-06-14 |
| Enhertu | AstraZeneca Canada Inc | Proactive | Active | 2022-06-15 |
| Rinvoq | Abbvie Corporation | Proactive | Active | 2022-07-13 |
| Lynparza | AstraZeneca Canada Inc | Proactive | Active | 2022-07-27 |
| Tezspire | AstraZeneca Canada Inc | Proactive | Active | 2022-07-28 |
| Myxredlin | Baxter Corporation | Proactive | Active | 2022-08-03 |
| Opdivo | Bristol-Myers Squibb Canada | Proactive | Active | 2022-08-18 |
| Koselugo | AstraZeneca Canada Inc | Proactive | Active | 2022-08-31 |
| Imfinzi | AstraZeneca Canada Inc | Proactive | Active | 2022-09-15 |
| Imfinzi | AstraZeneca Canada Inc | Proactive | Active | 2022-09-28 |
| Nubeqa | Bayer Inc | Proactive | Active | 2022-09-29 |
| Auro-Levocarb | Auro Pharma Inc | Proactive | Active | 2022-10-11 |
| Kerendia | Bayer Inc | Proactive | Active | 2022-10-14 |
| Ibrance | Pfizer Canada ULC | On request | Active | 2022-10-24 |
| Effexor XR | Upjohn Canada ULC | On request | Pending | |
| Sunlenca | Gilead Sciences Canada Inc | Proactive | Active | 2022-11-02 |
| Ervebo | Merck Canada Inc | Proactive | Active | 2022-11-09 |
| Camzyos | Bristol-Myers Squibb Canada | Proactive | Active | 2022-11-08 |
| Keytruda | Merck Canada Inc | Proactive | Active | 2022-11-09 |
| Dovato | ViiV Healthcare ULC | Proactive | Active | 2022-11-15 |
| Ubrelvy | Abbvie Corporation | Proactive | Active | 2022-11-10 |
| Ferriprox | Chiesi Canada Corp. | Proactive | Active | 2022-12-06 |
| Evrysdi | Hoffmann-La Roche Limited | Proactive | Active | 2022-12-07 |
| Empaveli | Swedish Orphan Biovitrum AB (publ) | Proactive | Active | 2022-12-08 |
| Qulipta | Abbvie Corporation | Proactive | Active | 2022-12-22 |
| Imbruvica | Janssen Inc | On request | Pending | |
| Enhertu | AstraZeneca Canada Inc | Proactive | Active | 2023-01-06 |
| Effexor | Upjohn Canada ULC | On request | Active | 2023-01-10 |
| PRZ-Metformin | Pharmaris Canada Inc | Proactive | Active | 2023-01-24 |
| Carvykti | Janssen Inc | Proactive | Active | 2023-02-09 |
| Praluent | Sanofi-Aventis Canada Inc | Proactive | Active | 2023-02-17 |
| Tagrisso | AstraZeneca Canada Inc | On request | Pending | |
| Lynparza | AstraZeneca Canada Inc | On request | Pending | |
| Arimidex | AstraZeneca Canada Inc | On request | Pending | |
| Tasigna | Novartis Pharmaceuticals Canada Inc | On request | Active | 2023-08-22 |
| Femara | Novartis Pharmaceuticals Canada Inc | On request | Pending | |
| Xalkori | Pfizer Canada ULC | On request | Pending | |
| Calquence | AstraZeneca Canada Inc | Proactive | Active | 2023-02-27 |
| Rexulti | Otsuka Pharmaceutical Co LTD | On request | Active | 2023-03-01 |
| Rexulti | Otsuka Pharmaceutical Co LTD | On request | Active | 2023-03-21 |
| Tagrisso | AstraZeneca Canada Inc | Proactive | Active | 2023-03-09 |
| Botox | Abbvie Corporation | On request | Active | 2023-03-31 |
| Xtandi | Astellas Pharma Canada Inc | Proactive | Active | 2023-03-14 |
| Spevigo | Boehringer Ingelheim (Canada) Ltd Ltee | Proactive | Active | 2023-03-22 |
| Tecartus | Gilead Sciences Canada Inc | Proactive | Active | 2023-03-24 |
| Ferriprox | Chiesi Canada Corp. | Proactive | Active | 2023-03-30 |
| Fraxiparine | Aspen Pharmacare Canada Inc. | On request | Active | 2023-03-31 |
| Locametz | Advanced Accelerator Applications USA, Inc. | Proactive | Active | 2023-04-05 |
| Celexa | Lundbeck Canada Inc | On request | Active | 2023-04-06 |
| Orkambi | Vertex Pharmaceuticals (Canada) Incorporated | Proactive | Active | 2023-04-06 |
| Biktarvy | Gilead Sciences Canada Inc | Proactive | Active | 2023-04-14 |
| Dupixent | Sanofi-Aventis Canada Inc | Proactive | Active | 2023-04-14 |
| Immune VH | Takeda Canada Inc | Proactive | Active | 2023-04-18 |
| Beyfortus | AstraZeneca Canada Inc | Proactive | Active | 2023-04-19 |
| Keytruda | Merck Canada Inc | On request | Active |
2023-04-24 |
| Lumigan | AbbVie Corporation | On request | Pending | |
| Libtayo | Sanofi-Aventis Canada Inc | Proactive | Active | 2023-04-27 |
| Verquvo | Bayer Inc | Proactive | Active | 2023-04-28 |
| Zoryve | Arcutis Biotherapeutics, Inc | Proactive | Active | 2023-04-28 |
| Quviviq | Idorsia Pharmaceuticals Ltd | Proactive | Active | 2023-04-28 |
| Dupixent | Sanofi-Aventis Canada Inc | Proactive | Active | 2023-05-01 |
| Rinvoq | AbbVie Corporation | Proactive | Active | 2023-05-02 |
| Vyalev | AbbVie Corporation | Proactive | Active | 2023-05-04 |
| Imcivree | Rhythm Pharmaceuticals, Inc | Proactive | Active | 2023-05-05 |
| Eraxis | Pfizer Canada ULC | Proactive | Active | 2023-05-08 |
| Darzalex SC | Janssen Inc | On request | Active | 2023-05-08 |
| Xeljanz | Pfizer Canada ULC | Proactive | Active | 2023-05-12 |
| Onakta | Avir Pharma Inc | Proactive | Active | 2023-05-12 |
| Oxlumo | Alnylam Netherlands B.V. | Proactive | Active | 2023-05-12 |
| Skyrizi | AbbVie Corporation | Proactive | Active | 2023-05-15 |
| Vaxchora | Emergent Travel Heatlh Inc. | Proactive | Active | 2023-05-18 |
| Tecfidera | Biogen Canada Inc | Proactive | Active | 2023-05-18 |
| Spikevax Bivalent Original / Omicron BA.4/5 | Modernatx, Inc. | Proactive | Active | 2023-05-18 |
| Brukinsa | Beigene Swizerland GMBH | Proactive | Active | 2023-05-25 |
| Perseris | HLS Therapeutics Inc | Proactive | Active | 2023-05-25 |
| Xywav | Jazz Pharmaceuticals Ireland Limited | Proactive | Active | 2023-05-25 |
| Darzalex SC, Darzalex | Janssen Inc | Proactive | Active | 2023-05-29 |
| Jardinace | Boehringer Ingelheim (Canada) Ltd Ltee | Proactive | Active | 2023-05-29 |
| Pifeltro | Merck Canada Inc | Proactive | Active | 2023-05-30 |
| PMS-Iron Sucrose | Pharmascience Inc | On request | Active | 2023-05-31 |
| Silenor | Paladin Labs Inc. | On request | Active | 2023-06-02 |
| Idhifa | Celgene Inc | Proactive | Active | 2023-06-09 |
| Akeega | Janssen Inc | Proactive | Active | 2023-06-12 |
| Xcopri | Endo Ventures Ltd | Proactive | Active | 2023-06-12 |
| Olumiant | Eli Lilly Canada Inc | Proactive | Active | 2023-06-12 |
| Onpattro | Alnylam Netherlands B.V. | Proactive | Active | 2023-06-13 |
| Winlevi | Sun Pharmaceutical Industries Limited | Proactive | Active | 2023-06-15 |
| Ondexxya | AstraZeneca Canada Inc | Proactive | Active | 2023-06-16 |
| Dayvigo | Eisai Limited | Proactive | Active | 2023-06-22 |
| Absorica LD | Sun Pharmaceutical Industries Limited | Proactive | Active | 2023-06-22 |
| Alfuria Tetra | Seqirus PTY | Proactive | Active | 2023-06-26 |
| Tabrecta | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2023-06-28 |
| Wegovy | Novo Nordisk Canada Inc | Proactive | Active | 2023-06-29 |
| Eylea | Bayer Inc | Proactive | Active | 2023-06-29 |
| Delstrigo | Merck Canada Inc | Proactive | Active | 2023-07-06 |
| Crinone | EMD Serono, A Division of EMD Inc., Canada | Proactive | Active | 2023-07-05 |
| Vaxneuvance | Merck Canada Inc | Proactive | Active | 2023-07-07 |
| Welireg | Merck Canada Inc | Proactive | Active | 2023-07-11 |
| Rybrevant | Janssen Inc | Proactive | Active | 2023-07-11 |
| Lynparza | AstraZeneca Canada Inc | Proactive | Active | 2023-07-11 |
| Dupixent | Sanofi-Aventis Canada Inc | Proactive | Active | 2023-07-12 |
| Fabrazyme | Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc | On request | Pending | |
| Fraxiparine | Aspen Pharmacare Canada Inc. | On request | Pending | |
| Trodelvy | Gilead Sciences Canada Inc | Proactive | Active | 2023-07-19 |
| Scemblix | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2023-07-19 |
| Keytruda | Merck Canada Inc | Proactive | Active | 2023-07-20 |
| Omvoh | Eli Lilly Canada Inc | Proactive | Active | 2023-07-20 |
| Livmarli | Mirum Pharmaceuticals, Inc. | Proactive | Active | 2023-07-21 |
| Lenvima | Eisai Limited | Proactive | Active | 2023-07-21 |
| Prevnar 20 | Pfizer Canada ULC | Proactive | Active | 2023-07-21 |
| Rinvoq | Abbvie Corporation | Proactive | Active | 2023-07-21 |
| Mekinist | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2023-07-24 |
| Sogroya | Novo Nordisk Canada Inc | Proacive | Active | 2023-07-26 |
| Alhemo | Novo Nordisk Canada Inc | Proactive | Active | 2023-07-26 |
| Tafinlar | Novartis Pharmaceuticals Canada Inc | Proactive | Active | 2023-07-26 |
| Tecvayli | Janssen Inc | Proactive | Active | 2023-07-26 |
| Axberi | Baxter Corporation | Proactive | Active | 2023-07-27 |
| Erleada | Janssen Inc | Proactive | Active | 2023-08-02 |
| Jivi | Bayer Inc | Proactive | Active | 2023-08-03 |
| Imbruvica | Janssen Inc | Proactive | Active | 2023-08-04 |
| Arexvy | GlaxoSmithKline Inc | Proactive | Active | 2023-08-04 |
| Adtralza | Leo Pharma Inc | Proactive | Active | 2023-08-04 |
| Libtayo | Sanofi-Aventis Canada Inc | Proactive | Active | 2023-08-15 |
| Tasigna | Novartis Pharmaceuticals Canada Inc | On request | Pending | |
| Zejula | GlaxoSmithKline Inc | Proactive | Active | 2023-08-17 |
| Narcan Nasal Spray | Emergent Operations Ireland Limited | On request | Active | 2023-08-22 |
| Tepmetko | EMD Serono, A Division of EMD Inc., Canada | Proactive | Active | 2023-08-25 |
| Blincyto | Amgen Canada Inc | Proactive | Active | 2023-08-29 |
| Eucrisa | Pfizer Canada ULC | Proactive | Active | 2023-08-29 |
| Paxlovid | Pfizer Canada ULC | Proactive | Active | 2023-08-30 |
| Imjudo | AstraZeneca Canada Inc | Proactive | Active | 2023-08-31 |
| Comirnaty Original & Omicron BA.4/BA.5 | BioNTech Manufacturing GMBH | Proactive | Active | 2023-08-31 |
| Esperoct | Novo Nordisk Canada Inc | Proactive | Active | 2023-09-11 |
| Spikevax XBB.1.5 | Moderna Biopharma Canada Corporation | Proactive | Active | 2023-09-12 |
| Vabysmo | Hoffman-La Roche Limited | Proactive | Active | 2023-09-13 |
| Opdualag | Bristol-Myers Squibb Canada | Proactive | Active | 2023-09-13 |
| Vyepti | Lundbeck Canada Inc | Proactive | Active | 2023-09-19 |
| Vyvgart | Argenx BV | Proactive | Active | 2023-09-19 |
| Quillivant ER Chewable Tablets/Quillivant ER Oral Suspension | Kye Pharmaceuticals Inc | Proactive | Active | 2023-09-21 |
| Eligard | Tolmar International Ltd. | Proactive | Active | 2023-09-21 |
| Prevymis | Merck Canada Inc | Proactive | Active | 2023-09-21 |
Medical devices
| Device name | Manufacturer | Process | Status | Start Date |
|---|---|---|---|---|
| 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 |
| Shockwave Coronary (IVL) System | Shockwave Medical, Inc. | Proactive | Active | 2022-09-16 |
| Lutonix 018 Drug Coated Balloon PTA Catheter | Lutonix, Inc | Proactive | Active | 2022-10-13 |
| Preset Thrombectomy Device | Phenox LTD | Proactive | Active | 2022-11-18 |
| Minimed 780G System | Medtronic Minimed | Proactive | Active | 2022-10-27 |
| Stimulan | Biocomposites Ltd. | On request | Active | 2022-12-02 |
| Natrelle 410 Truform Microcell Silicone-filled Breast Implants | Allergan | On request | Active | 2023-05-10 |
| NxTag Respiratory Pathogen Panel v2 | Luminex Molecular Diagnostics, Inc. | Proactive | Active | 2023-08-24 |
| Dermatological Treatment Systems | Sharplight Technologies Ltd | On request | Active | 2023-09-12 |
| Heliostar Balloon Ablation Catheter | Biosense Webster, Inc. | Proactive | Active | 2023-09-13 |
| Lassostar Nav Catheter | Biosense Webster, Inc. | Proactive | Active | 2023-09-21 |
| Soprano Ice | Alma Lasers Ltd. | On request | Active | 2023-09-22 |
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